Hygienic Plant Manual
Hygienic Plant Manual
Hygienic Plant Manual
Edition 1999
Produced by:
SHE 6
September 1999
Hygienic Plant Manual
This Manual has been produced by the Safe Processing and Hygiene Group of Unilever Research
Vlaardingen.
Edited by:
Adress:
Table of Contents
1.1 Preface...................................................................................................................................1
1.1.1 Preface - General.............................................................................................................1
1.1.2 Changes since last version .................................................................................................2
2 Introduction....................................................................................................................................7
3 Materials .....................................................................................................................................16
4.5 Welding.................................................................................................................................43
4.5.1 Welding - General...........................................................................................................43
4.5.2 Pipe welding ...................................................................................................................45
4.5.3 Orbital Welds..................................................................................................................46
4.5.4 Specification of Pipe and Preparation for Orbital Welding ..................................................47
5. 2 Deaerators ...........................................................................................................................54
5.2.1 Deaerators - General.......................................................................................................54
5. 5 Pipe Work............................................................................................................................64
5.5.1 Pipe Work - General.......................................................................................................64
5.5.1.1 Pipe Work - General.................................................................................................64
5.5.1.2 Dimensions of Stainless Steel Tube ............................................................................65
5.5.1.3 Stainless Steel Pipe ...................................................................................................66
5.5.2 Pipe Couplings ................................................................................................................67
5.5.2.1 Pipe Couplings - General...........................................................................................67
5.5.2.2 DIN 11864...............................................................................................................69
5.5.2.3 ISO 2853 Screwed Coupling......................................................................................70
5.5.2.4 'I' Line Coupling .......................................................................................................72
5.5.2.5 Clamp Type Coupling (ISO 2852) ..............................................................................73
5.5.2.6 O-Ring Couplings .....................................................................................................74
5.5.2.7 SKS Insert for DIN 11851 ........................................................................................75
5.5.3 Flexible Tubing................................................................................................................76
5.5.3.1 Flexible Tubing - General..........................................................................................76
5.5.3.2 Flexible Tubing - Manufacturers ................................................................................77
5.5.4 Tee Pieces .....................................................................................................................78
5.5.4.1 Tee Pieces - General................................................................................................78
5.5.4.2 Tee Piece with Blank Branch and Swept Tees ...........................................................79
5. 7 Pumps..................................................................................................................................84
5.7.1 Pumps - General.............................................................................................................84
5.7.2 Centrifugal Pumps...........................................................................................................87
5.7.3 Positive displacement pumps .........................................................................................88
5.7.3.1 Diaphragm Pumps ....................................................................................................88
5.7.3.2 Hose Pumps............................................................................................................89
5.7.3.3 Piston Pumps ...........................................................................................................90
5.7.3.4 Rotary Gear and Lobe Pumps ...................................................................................91
5.7.3.5 Screw Pumps, Mono-type .........................................................................................92
5.7.3.6 Other pumps ............................................................................................................93
5. 8 Sensors ................................................................................................................................94
5.8.1 Detectors-FlowSensors ...................................................................................................94
5.8.1.1 Flow Switch.............................................................................................................94
5.8.2 Flowmeters.....................................................................................................................95
5.8.2.1 Flowmeters - General...............................................................................................95
5.8.2.2 Mass Flowmeter.......................................................................................................96
5.8.2.3 Magnetic/inductive flowmeter....................................................................................97
10 Index....................................................................................................................................... 189
Sub-Paragraph
The Hygienic Plant Manual (HPM) provides information about materials of construction, fabrication,
process line components and subassemblies and is intended to assist process engineers to design and
install safe processes for foods and HPC products. Information in the HPM will also form the basis for
category based process manuals and process recommendations.
The HPM also describes the selection criteria for equipment and the reason behind the hygienic design
and implications for microbiological safety and hygiene. All recommendations in the HPM are based on
design evaluation or hygienically tested equipment and in some cases on factory-proven applications
Specialist advice on hygienic design of processes can be obtained from the Safe Processing and Hygiene
Group (SPH) at URV. General information can be found in category specific Best Practice Documents and
internal and external publications (e.g. EHEDG documents).
This manual has been prepared on behalf of SHEACO by the Safe Processing and Hygiene group at
Unilever Research Vlaardingen with input from Foods, HPC and CMast. The Hygienic Plant Manual will be
of greatest relevance to:
• Project engineers
• Production managers
• Development managers
• QA managers
• Microbiologists
The HPM, SHE 6 document, will be distributed as a hard copy and as an electronic database via Lotus
Notes. Quick and brief information about recommended equipment can be found in the Hygienic Plant
Reference Manual (HPRM), SHE 7 document, which will be distributed as a hard and electronic copy.
Information about the Manufacturing Hygiene programme and the Safe Processing and Hygiene Group can
be found on our intranet page “http://vlisis.vl.u2488.unilever.com:8100/micropres/man_hyg/”
Sub-Paragraph
The newly restructured 1999 Hygienic Plant Manual (HPM) will be available as a hard copy and as an
electronic version on Lotus Notes. The HPM consists of ten sections, each section is devided into
chapters and subparagraphs.
Compared to the previous issue, the layout is more logically structured, starting with the Preface and
Introduction sections followed by the sections corresponding to relevant areas of hygienic equipment and
plant design, i.e. Materials, Fabrication, Process Line Components, Sub Assemblies, Building &
Production area and ending with the sections Cleaning, References and Contacts and Index.
The summary information about process line components is presented in a table as shown below. This
table shows the name of the manufacturer and type of equipment that has been evaluated, the
recommendation, which hygiene tests have been done and if there is any experience with such equipment
within Unilever.
Another improvement is the higher quality color drawings that are included on the relevant pages. In the
Lotus Notes version, drawings are attached to as Portable Document Format (PDF) files, which can be
viewed with the Adobe Acrobat viewer supplied with the database (see 1.2.2).
see EHEDG definitions, Tested according to the HYPDAT (data base, see 1.2.3)
chapter 2.1 (pages 10-11) EHEDG procedures by third contains in most cases more
parties (EHEDG) or Unilever information about the relevant
(URV) subject, and the number must be
quoted in case of correspondence
Sub-Paragraph
The HPM lists equipment which have been evaluated by design study and or tested according to the
EHEDG procedure (see 9.1.2) with respect to ease of cleaning. Equipment intended for aseptic processing
have additionally been tested on sterilizability (see 9.1.2) and microbial impermeability (see 9.1.2 ).
The cleanability test is a basic screening test for hygienic equipment design and is based on comparing
the cleanability of a test item with that of a straight piece of pipe, and is not indicative of performance in
industrials cleaning situations. CLEANING PROCEDURES are not discussed.
The manual does not only discuss equipment, but also covers sub assemblies, materials of construction,
piping and equipment fabrication (welding, soldering and pipe bending), and corrosion risk of stainless
steel.
It is possible that some items mentioned in the manual cannot be purchased everywhere. We hope that, in
such cases, the relevant pages and the design principles given in the introductory chapter will provide
sufficient information for making the best selection from the available alternatives. The Safe Processing and
Hygiene (SPH) Group, Unilever Research Vlaardingen The Netherlands, can always be contacted for
support on details of individual equipment design as well as complete layouts for new processing lines.
Although the design of equipment may be correct in every detail, close inspection on delivery may reveal
that the specifications set have not been met. Also equipment may differ, depending on the country of
production, even when sold under similar names and type numbers. In such cases, it would be greatly
appreciated if the SPH group would be informed immediately.
The designs given in this manual are TYPICAL EXAMPLES. Other tested, evaluated and/or approved
makes may also be suitable. In case of doubt, please contact the SPH group.
A process line (or sections of it) may incorporate equipment or components which do not fully conform to
the guidelines set out in this manual. In such cases, the effect of such parts on the performance of the line
should be investigated and if necessary discussed with the SPH group. Where necessary, suppliers can
be asked to make specific modifications.
Although in several instances equipment conform 3-A STANDARDS is indeed of hygienic design, the
Hygienic Processing Team have concluded that sometimes it is not of acceptable Unilever Hygienic
design.
If additional information is required on process equipment listed in the manual, please consult the SPH
group and quote the relevant HYPDAT number. This number refers to the database where information on all
evaluated process equipment is kept (see 1.2.3).
Sub-Paragraph
The electronic version of the HPM is based on the hard copy. The Hygienic Plant Database uses the
normal operations of Lotus Notes and Windows. The manual is devided into ten sections and each section
is sub-devided into chapters, sub-paragraphs and titles. Some manual pages may have a drawing of the
piece of equipment dealt with. Under "picture" an icon with the Portable Document Format (PDF) extension
can then be seen. This PDF file can be viewed with the Adobe Acrobat viewer. This shareware is supplied
with the database and can be installed from the Main Menu by clicking on the "View Install Utilities"
button. An advantage over the hard copy is that updating can be done continuously. Another advantage is
the higher quality of drawings that can be attached to and viewed in this database. Further it is possible to
respond on the content.
The reader is kindly asked to respond to the database or to send comments and queries to the SPH
group, Unilever Research Vlaardingen, The Netherlands, either by post, E-mail or by Internet e-mail
(Manufac-Hygiene.URV@unilever.com).
Sub-Paragraph
HYPDAT is the Hygienic Processing Database on Lotus Notes which is used to manage data for the
Hygienic Plant Manual. The information in HYPDAT is much more detailed and covers more subjects than
the HPM. The database serves as a basis for this manual. If an item cannot be found in this manual it may
be that this information is available in HYPDAT and can be provided upon request.
The reader is also requested to submit information and experience (good or bad) about equipment, whether
or not mentioned in this manual.
N.B. HYPDAT is only replicated to some servers within Unilever Research and is accessible to a limited
group of users.
Sub-Paragraph
The European Commission (EC) of the European Union (EU) has provided the
required legislation on food safety, in the form of two directives. The first one
is directive 89/392/EEC and covers the safety and hygiene of machinery,
including machinery for the food industry. The second one, directive
94/43/EEC, covers the hygiene of foodstuffs in general. Both directives
require that food is produced in a hygienic way and that food processing
machinery is of hygienic design.
How does the EHEDG interact with legislation on hygienic processing issues
It is left to the industry, however, how to comply with the requirements. To assist in the design of safe and
hygienic machinery, the EC has mandated the European federation of standardization institutes, the CEN,
to produce standards. The EHEDG is well represented in the responsible technical committee of the CEN
(TC 153) and its working groups. To assist in the development of the standards, the EHEDG has set up a
number of committees to produce guidelines on a range of subjects, from hygienic design criteria, via
design of components of process lines and methods to verify compliance, to application in process and
packaging lines.
The production of standards is a time-consuming process and sofar no standards have been published yet.
The EHEDG guidelines have been published and are available from the EHEDG secretariat, C&CFRA (in
English) and from ASEPT (in French).
Meanwhile, the EHEDG guidelines are widely used and equipment manufacturers mention in their
publications compliance with the EHEDG design criteria. There are currently ten institutes in Europe where
the EHEDG methods are used commercially to test the cleanability and other hygienic characteristics of
for food processing equipment.
The EHEDG actively promotes harmonization of hygienic design requirements and therefore cooperates
with many other organizations with an interest in the subject, European or Global. Of particular interest is
the cooperation with the American 3-A organization, which has been producing standards on hygiene in
the USA for a very long time (and in close cooperation with the US authorities, viz. the FDA and the USDA)
and with organizations such as the International Standardization Organization (ISO), International Dairy
Federation (IDF), National Sanitation Foundation (NSF International), the European Federation of Food
Science and Technology (EFFoST) and others.
Sub-Paragraph
Manufacturing Processes in Unilever Foods and HPC factories must be designed, constructed and
operated such that microbiological Safety and Quality criteria can be met on a routine basis. This applies
to consumer products for current as well as future markets. Trends in markets show a clear need and a
move towards bacteriologically more vulnerable products and there is a notable decrease in acceptance of
chemical preservation systems by consumer organisations and individual consumers.
Major safety incidents, i.e. where the health of consumers is jeopardized, have rarely occurred within
Unilever, but when they did, they had a dramatic effect for the company involved and Unilever as a whole.
Spoilage incidents or products being produced outside standards occur more frequently and, in case of a
public recall, have damaged the corporate image of Unilever as a reliable manufacture of consumer
products.
Microbiological safety assurance of processes must include all elements of the manufacturing chain from
raw materials intake to storage, distribution of finished products, consumer instructions and should also
include secondary processes and utilities (e.g. water and air).
The microbiological requirement for equipment and plant lay-out must always be established in relation to
the product to be processed, because safety hazards can only be avoided when the process is safe by
design. All requirements for the process must therefore be derived from a conceptual HACCP study.
Due to poor hygienic design equipment may be difficult or even impossible to clean so that destruction of
micro-organisms may be ineffective. Surviving micro-organisms present in product residues in crevices and
other so-called 'dead areas' may multiply and contaminate successive production
Ingress: Micro-organisms are able to migrate from the non product side to product side
Residence time: Micro-organisms are able to multiply due to presence of stagnant areas present in a
process line or process line components
Knowledge of the number and type of micro-organisms (bacteria, moulds and yeasts) is of paramount
importance because they have an adverse effect on the product quality. In addition, some micro-organisms
may cause diseases or produce toxins. Micro-organisms can de killed by heat, however, toxins are not
always destroyed by the pasteurization and sterilization conditions applied.
A concentration of ten million - but often also fewer - bacteria per gram final product generally means that
the product is spoiled. For yeasts and moulds, the concentrations required to cause spoilage are much
lower. Depending on the type of infection, even a single cell may ultimately spoil a product unit during its
normal shelf-life. The generation times in Table 2.1.2 are only valid at optimal growth conditions;
fortunately, such conditions do not always occur. If processing is carried out at temperatures not optimal
for microbial growth, the rate of deterioration will be lower.
Pseudomonas 5 7h
Aerobacter aerogenes 30 1h
Oidium lactis 5h
Fig. 2.1.1 gives an impression of the influence of temperature on the generation time.
Generation
time (min)
160
120
80
40
0
10 20 30 40 50
Temperature (°C)
To attain a certain microbial stability, there are methods that kill micro-organisms or control their numbers.
Frequently, only the relevant micro-organisms are killed while the rate of multiplication of any survivors is
prevented.
Section 2 Introduction
Sub-Paragraph
The following pages give the definitions used by the European Hygienic Equipment Design Group
(EHEDG). )
1. General
RELEVANT MICRO-ORGANISMS1
Micro-organisms able to contaminate, multiply or survive in the product and harmful to the consumer or
product quality.
SOIL
Any undesired matter including product residues whether containing micro-organisms or not.
CLEANING
The removal of soil.
DESTRUCTION OF MICRO-ORGANISMS
Irreversible physical or chemical damage to micro-organisms to prevent them from surviving and
multiplying.
THERMAL DESTRUCTION
Destruction of micro-organisms using heat which may or may not be in combination with water or steam.
CHEMICAL DESTRUCTION
Destruction of micro-organisms using biocidal chemical(s).
STERILIZATION
The removal or destruction of micro-organisms, including all relevant bacterial spores.
PASTEURIZATION2
Thermal destruction of vegetative micro-organisms i.e. excluding thermoresistant bacterial spores.
CLEANABILITY
The suitability to be freed from soil.
COMPARATIVE CLEANABILITY
The cleanability of equipment relative to a reference.
IN-PLACE CLEANABILITY
The suitability to be cleaned without dismantling.
STEAM STERILISABILITY3
The suitability of clean equipment to be freed from viable micro-organisms including relevant bacterial
spores (i.e. sterilized) by a treatment with saturated steam at 120°C for 30 minutes.
PASTEURISABILITY3
The suitability of clean equipment to be freed from viable micro-organisms with the exception of
thermoresistant bacterial spores by a treatment with hot potable water of up to 95°C for 20 minutes (i.e.
pasteurized).
MICROBIAL IMPERMEABILITY
The ability of equipment to prevent the ingress of bacteria, yeasts and moulds from the outside
(environment) to the inside (the product area).
ASEPTIC EQUIPMENT
Hygienic equipment that in addition is impermeable to micro-organisms.
1 Throughout this document the term micro-organisms includes bacteria, yeasts and moulds.
2 In the dairy industry pasteurization usually means the destruction of pathogenic and some spoilage
micro-organisms.
4 If equipment does not comply with the definitions, this will be due to sharp corners, narrow orifices,
crevices, hollow bodies, dead legs, etc. Such equipment can still be used to produce microbiologically
safe products, provided that the dismantling and after-cleaning inspection is totally carried out before
each production period and the equipment is not soiled again during re-assembly. Furthermore, it may be
necessary to use more-aggressive decontamination methods and to increase the frequency of cleaning.
The disadvantages is that less productive and, therefore, more costly procedures are required. Future aim
should be to redesign such equipment.
5 By e.g. steam or hot water sterilization, or pasteurization, in accordance with the definitions for
sterilisability and pasteurisability.
As this manual frequently refers to hygienic and aseptic processing lines, below a further explanation of
these expressions is given.
A HYGIENIC PROCESSING LINE can receive a range of ingredients and will only cause an acceptably low
increase of micro-organisms during processing.
The equipment of such a line will not necessarily prevent the ingress of micro-organisms from the
environment to the product, although it should limit the extent of such contamination. Because the
ingredients in hygienic lines often contain micro-organisms or micro-organisms may enter from the outside,
the possibility for such micro-organisms to increase their numbers should be controlled. Therefore it is
important that the number and total volume of areas which will retain product for much longer than the
average processing time (dead or stagnant areas such as in T-pieces) is kept to a minimum.
An ASEPTIC PROCESSING LINE is one which is capable of receiving sterile ingredients and maintain this
sterility throughout the whole process..
For unpreserved, neutral-pH products the equipment should be sterilized (by either chemical or physical
means), but for many preserved or low pH products it may be sufficient to decontaminate the line using
milder treatments.
Aseptic lines may be used for several purposes, for example the manufacture of long-life products for
aseptic packaging or they may be used to increase the running time of a process before cleaning and
decontamination is necessary (thus increasing production efficiency and saving energy, labour and
materials).
Section 2 Introduction
Sub-Paragraph
Usually hygienic equipment costs are similar to standard food processing equipment. The costs may,
however, also be lower because hygienic designs may be simpler and easier to construct.
Aseptic equipment, however, is usually more expensive and may cost an extra 5-15 % over the equivalent
hygienic equipment. The extra costs may be justified by reduction in operation costs, because aseptic
equipment is bacteria-tight and can be disinfected completely, resulting in increased production runs
(increasing the production capacity of the process line).
Section 2 Introduction
Sub-Paragraph
1. All product contact surfaces must be resistant to the product, and to all cleaning and antimicrobial
agents under the specified conditions of use.
3. Food contact surfaces should have a surface finish of 0.8 µm Ra (see 4.4.3 Surface Finish).
Equipment with food contact surfaces rougher than 1,0 µm Ra should not be accepted.
4. All surfaces in contact with product must be either easily accessible for visual inspection and
manual cleaning or it must be demonstrated that routine cleaning procedures eliminate the
possibility of contamination. If cleaning in-place (CIP) techniques are used, it must be demonstrated
that the results achieved without dismantling, are satisfactory.
5. Avoid, whenever possible, risk of condensation on equipment and pipework and civil constructions. If
unavoidable, design methods to collect condensate preventing contact with product.
6. The exterior and interior of all equipment should be self-draining and easily cleanable.
7. Equipment and support structures shall be sealed to the building (floor, walls, columns,
ceiling) in such a way that no pockets or gaps exist. Any clearance between equipment and
civil construction shall be adequate for cleaning and inspection.
8. Reworking or recycling of product must be kept to a minimum and whenever done, or where
applicable, the storage condition and times must be strictly controlled, because it increases
the risk of microbial growth.
More information can be found in the booklet Hygienic Plant Engineering Requirements, SHE 8,
which has been produced for the use of equipment manufacturers, suppliers and contractors working in
Unilever plants. It discusses the minimum requirements for hygienically acceptable process plant (see
9.1 References). This booklet is also available in the German, Portuguese and Spanish
language.
In the United States, the 3-A Sanitary Standards and Accepted Practices represent criteria for cleanability
of dairy and food processing equipment. These standards and practices are formulated by the cooperative
effort of industry and regulatory groups as represented by the Dairy Industry Committee (DIC), International
Association of Milk, Food and Environmental Sanitarians (IAMFES), U.S. Public Health Service (USPHS)
U.S. Department of Agriculture (USDA), Dairy and Food Industries Supply Association (DFISA) and United
Egg Association (UEA). The standards and practices are published in Dairy and Food and Environmental
Sanitation, the primary publication of IAMFES, 6200 Aurora Ave., Suite 200W, Des Moines, Iowa, USA.
The European Hygienic Equipment Design Group (EHEDG) is also publishing minimum requirements for
food processing equipment. Obtaining copies of their publications is strongly recommended (see 9.1
References for more details)
The EEC Council Directive of 14 June 1989, 89/392/EEC (machinery Directive) is primarily aimed at the
safety of machinery at large. There are, however, additional requirements for machinery used in food
processing. A number of hygienic requirements, copied from the Official Journal of the European
Communities, is given below.
Agro-foodstuffs machinery
In addition to the essential health and safety requirements set out in section 1, where machinery is
intended to prepare and process foodstuffs (e.g. cooking, refrigeration, thawing, washing, handling,
packaging, storage, transport or distribution), it must be so designed and constructed as to avoid any
risk of infection, sickness or contagion and the following hygiene rules must be observed:
(a) materials in contact, or intended to come into contact, with the foodstuffs must satisfy the
conditions set down in the relevant Directives. The machinery must be so designed and
constructed that these materials can be clean before each use;
(b) all surfaces including their connections must be smooth, and must have neither ridges nor
crevices which could harbour organic materials;
(c) assemblies must be designed in such a way as to reduce projections, edges and recesses to a
minimum. They should preferably be made by welding or continuous bonding. Screws,
screwheads and rivets may not be used except where technically unavoidable;
(d) all surfaces in contact with the foodstuffs must be easily cleaned and disinfected, where possible
after removing easily dismantled parts. The inside surfaces must have curves of a radius sufficient
to allow thorough cleaning;
(e) liquid deriving from foodstuffs as well as cleaning, disinfecting and rinsing fluids should be able to
be discharged from the machine without impediment (possibly in a 'clean' position);
(f) machinery must be so designed and constructed as to prevent any liquids or living creatures, in
particular insects, from entering or any organic matter accumulating in areas that cannot be
cleaned
(e.g. for machinery not mounted on feet or casters, by placing a seal between the machinery and
its base, by the use of sealed units, etc.);
(g) machinery must be so designed and constructed that no ancillary substances (e.g. lubricants,
etc.) can come into contact with foodstuffs. Where necessary, machinery must be designed and
constructed so that continuing compliance with this requirement can be checked.
Instructions
In addition to the information required in section 1, the instructions must indicate recommended products
and methods for cleaning, disinfecting and rinsing (not only for easily accessible areas but also where areas
to which access is impossible or inadvisable, such as piping, have to be cleaned in situ).
Note: Further reference on Hygienic Design can be found in section 9.1 References.
Section 3 Materials
Sub-Paragraph
Materials used for the construction of food plant must fulfil certain specific requirements. Product contact
materials must be inert to the product under operating conditions, as well as to the detergents and the
antimicrobial chemicals (disinfectants or sanitizers) under conditions of use. They must be corrosion
resistant, nontoxic, mechanically stable, and have a surface finish that is not adversely affected under
conditions of use.
As the presence of toxins in food is unacceptable, the use of nontoxic materials in direct contact with
products is a must. It is imperative to check legislative aspects. This is particularly important where
materials other than stainless steel (plastics, elastomers, adhesives etc.) are used.
Materials not in contact with product should be mechanically stable, smoothly finished and easily
cleanable.
In general, stainless steel types AISI-304, AISI-316 or AISI-316L offer sufficient corrosion protection, and
they are therefore widely used. Depending on the application, some plastics may have advantages over
stainless steel, such as lower cost and weight as well as better chemical resistance.
Other materials such as aluminum and coated steel are also used. Some materials, however, must be
avoided; these include zinc, lead, cadmium, antimony, plastic materials containing free phenol,
formaldehyde or plasticisers and wood. Except in brewing, distilling and the manufacture of sugar
confectionery, copper is generally unsatisfactory and contact must be avoided with meat, fats, fruit and
vegetables, especially if brine is present.
Many countries have codes of practice and directives covering the composition of materials in contact
with food and it should be ensured that the use of a specific material is permitted under existing or
pending legislation.
The Council of the European Communities has adopted the Directive 89/109/EEC of 21 December 1988
relating to materials and articles intended to come into contact with foodstuffs.
Materials and articles must be manufactured in compliance with good manufacturing practice so that,
under their normal or foreseeable conditions of use, they do not transfer their constituents to foodstuffs
in quantities which could:
- bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the
organoleptic characteristics thereof.
Materials and articles, such as plastics (including varnish and coatings), elastomers and rubber, ceramics,
glass and metals and alloys and, where appropriate, shall be covered by specific directives.
Section 3 Materials
Composition
Stainless steels are best described in terms of composition, using the widely-accepted AISI classification.
This defines the '300' and '400' series, depending upon the Cr and Ni contents. For true stainless
properties, the level of chromium should not be below about 10-12%; where nickel is used, this should be
>8%. There exists the low-chromium (4-6%) '500' series, with better oxidation resistance at high
temperatures.
The '300' series, or 'austenitic' steels contain chromium and nickel, commonly at about 18%Cr and 8% Ni,
giving the well-known '18-8 steels'. These are non-magnetic and may not be hardened by heat treatment.
The '400' steels, in general, contain little nickel and comprise the magnetic 'ferritic' (non-hardenable) and
'martensitic' (hardenable) steels. The materials most commonly used for our purposes are ferric and
austenitic, with the latter predominating owing to a generally higher corrosion resistance.
Uses
The austenitic stainless steels are frequently the logical choice for materials of construction and find wide
application in the field of food processing equipment and machinery. They are used for the storage and
transport of foods, in the equipment used for processing and in the pipework and valves associated with
this. Operations such as ice-cream, sauce and fat spreads processing, and the dairy industry are
examples where stainless steels are widely used. Storage vessels, mixing tanks, evaporators and
concentrators, heaters and coolers, pasteurizers, sterilizers and heat exchangers have all been
constructed using stainless steel.
The two most commonly used grades are the AISI 304 (18Cr, 10Ni) and the 316 (18Cr, 10Ni, 2.5Mo)
types. They are sometimes employed in their low carbon grades, 304L and 316L. In the majority of
corrosive environments, the molybdenum-containing steel (316) is more corrosion-resistant than the non-
molybdenum-containing grade (304). Therefore, grades 316/316L are normally specified for equipment on
more arduous duties where service conditions introduce a corrosion risk. Since localized corrosion of
stainless steel is nearly always associated with the chloride ion, the 316 and 316L grades are required in
chloride-containing and high acid products especially when the products are hot. Previous experience of
plant and equipment is a good indication of the grade of stainless steel that is required.
Section 3 Materials
Controlling factors
The resistance of stainless steels depends upon their oxide film and the film stability will be highest in the
neutral or mildly alkaline regions. At too low a pH, the material may depassivate, leading to attack. Higher pH
values are safer, but in very alkaline media, stainless steels are not resistant. A pH of 9 or thereabouts is
reasonable. The safe range may be modified by the presence of other chemical species. Though a pH within
the safe range may be intended, deviations may occur by accident. Thus, carry over of concentrated CIP
solution may raise the pH; while residues of acidic cleaning agents may lower it. Localized concentration by
heating or evaporation may change the local H+ or OH- concentrations and with them the pH. Such
concentrations may arise with other materials such as chloride. This ion is, perhaps, the single worst cause
of attack on stainless steels (and many other materials). Its capacity, by specific adsorption, to disrupt
protective films makes it very dangerous. So the use of hydrochloric acid to remove scale should be avoided.
As some water-treatment systems are regenerated by the use of NaCl solution, any breakthrough from the
system may give problems. In some systems calcium or other brines are used as coolants; they provide a
potential hazard. Again, while some foods are quite harmless, others contain much chloride, or may introduce
chloride ion or other aggressive materials.
Increased temperature will tend to accelerate attack. Corrosion at heat-transfer surfaces can be serious.
Given the relatively low thermal conductivity of austenitic steels, a large thermal gradient may occur. This
can cause differential expansion with cracking of the oxide and consequent attack.
The stability of the oxide film may be enhanced by oxidation. The use of nitric acid for removal of, for
example, beerstone or scale is to be preferred to using sulphuric or hydrochloric acid. Treatment with
strong nitric acid may reinforce the passivation film; 35% acid is used in this way for stainless tanks.
As localized attack such as pitting is, to some extent, a stochastic phenomenon, reducing the time of
exposure will reduce the probability of trouble. For a sterilization process, the required temperature-time cycle
is obligatory; so that scope for change may be limited. However, the factor should be kept in mind.
Information on passivation can be found in the EHEDG puplication 'Passivation of stainless steel' (see 9.1.2).
Section 3 Materials
Plastics can fulfil different functions necessary for processing and protection of food products. It is most
important before using a plastic that it is approved for food contact applications, and it is checked for its
compatibility not only with the product but also for chemicals used for cleaning and decontamination.
Polypropylene, for example, is used for vessels and chutes; it has excellent resistance to attack from
most organic and inorganic chemicals but certain oxidizing agents such as hypochlorites (sodium
hypochlorite is often used to destruct micro-organisms) have been observed to attack polypropylene at
quite low concentrations. Glass reinforced plastic (GRP) vessels are being used increasingly for storage
vessels. It is known that certain wetting agents in detergents can react with the components of GRP
making it turn black and causing off-flavours. Externally a GRP vessel may not show signs of impact
damage but internally pieces of the material may have become detached causing foreign body
contamination of the product.
According to the relevant committee for Standards in the German Institute for Standardization (DIN),
plastics are materials, the fundamental components of which consist of those macro molecular organic
compounds which are produced synthetically or by modification of naturally occurring products. They are
as a rule fusible and malleable under certain conditions (heat and pressure). Plastics contains in addition
to the basic polymers listed in Figures 3.2.1 and 3.2.2, further chemical components which consist of the
so-called additives. These are added in small amounts to alter the properties of the polymers in the desired
way and/or simplify their processing. Only fillers or softeners (plasticisers) are used at high concentrations
to increase volume and/or weight or improve softness, flexibility, elasticity (malleability) and processibility.
Other additives are stabilizers (including antioxidants) which are of very different structures and whose
function is to reduce or prevent undesirable changes caused by light or oxidative processes. Antistats
(antistatic agents) are added to reduce the build-up of electrostatic charges, which can lead to a tendency
for polymers to attract and hold dust and dirt particles including microorganisms. The addition of light
stabilizers (UV absorbers) will improve the light resistance of polymers and will also protect the processed
food from UV radiation.
Further groups of low molecular weight substances which may be added to polymers or may initially be
present in these: fillers (extenders); microbiocides; foaming agents (propellants); production aids such as
polymerization auxiliaries like initiators, regulators, emulsifiers, protective colloids, defoamers etc.
These additives are added to polymers at levels below 2% w/w, but can possess high mobility and hence,
also a tendency to migrate into the processed food. Care should be taken that all components including
the additives meet the regulations for contact with food products.
Thermosets Thermoplastics
Synthetic polymers
Phenolic resins Polyarnides (PA) Polyethylene (PE) Epoxy resins Linear polyurethanes
Urea resins Polycarbonates (PC) Polypropylene (PP) Cross-linked Chlorinated polyethers
Thiourea resins Polyesters, e.g. Poly(vinyl chloride) (PVC) polyurethanes
Melamine resins -Poly(ethyleneterephtha- Polyvinylidene chloride (PVDC)
Alkyd resins lates) (PET) Polyacrylonitrile (PAN)
Allyl resins Poly(phenylene oxides) Polystyrene (PS)
Silicone resins (PPO) Polyacetals (POM)
Polyimides Poly(vinyl acetals), e.g. Poly(vinyl alcohol) (PVAL)
-poly(vinylformal) (PVFM) Poly(vinyl acetate) (PVAC)
Copolymers of
- ethylene and vinyl acetate (EVA)
- ethylene and vinyl alcohol (EVAL)
- acrylonitrile, butadiene and styrene (ABS)
- acrylonitrile and styrene (SAN)
Cleanability:
The results of tests on the relative cleanability of a selection of plastic materials and plastic coatings,
using a spray jet, are given in 3.2.2.3 (Cleanability groups) and are placed in 3 groups. Plastic materials
are more easily abraded than metals and it has been shown that a roughened plastic surface may take up
to four times longer to clean than the original surface.
Section 3 Materials
Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into
contact with foodstuffs. A positive list, which is still subject to amendment, of monomers and substances is
given in this regulation.
Special requirements deal with frequently used pigments and colouring in plastic materials, and content of
heavy metals is particularly checked.
The USA Code of Federal Regulations of the FDA (CFR 21, parts 170 to 199) (latest edition).
If any component is not covered in the above regulations, SEAC TOXICOLOGY must be consulted
(assuming the component cannot be replaced by BgVV or FDA accepted components). If the manufacturer
of the plastic is not prepared to disclose information on suspect materials, they may contact SEAC
TOXICOLOGY directly. Address:
Unilever Research
SEAC TOXICOLOGY
Colworth House,
Sharnbrook
Bedford MK44 lLQ
United Kingdom
Tel.: + 31 10 2174395
Fax: + 31 10 2174149
Section 3 Materials
Group 1
Group 1 consists of the most easily to clean plastics. The results of tests (1) suggest that these
materials, when undamaged, have superior cleanability to stainless steel having similar surface
roughness values. Polytetrafluoroethylene (PTFE) has been excluded from Group 1, because practical
experience has shown that PTFE is very difficult to clean.
polypropylene (PP)
polyvinyl chloride unplasticised (PVC)
acetal copolymer
polycarbonate (PC)
polyethylene (PE) (high density)
Halar (ECTFE) (coating)
TFM(modified PTFE)
PFA
Group 2
Group 3
Group 3 consists of the most difficult to clean plastics taking about four times as long as those in
Group 1.
REFERENCE
1. P CW 81 1298
Section 3 Materials
The use of elastomers is generally limited to specialized applications where the flexibility, resilience and
compression set are of particular importance. Some of the main applications for food contact elastomers
include;
• Seals and gaskets. These would mainly be associated with process equipment including heat-
exchanger gaskets and items such as manhole cover and pipe-coupling seals.
• Valve diaphragms and pump impellers used in pumping liquid foods.
• Conveyor belting for transport of solid foods.
• Hosing and tubing for liquid foods, particularly in milk processing and as components of milking
equipment.
• Sweet moulds (silicones).
• Gloves for food preparation, including handling poultry and fish.
In the absence of specific guidelines on permissible components of food contact rubber formulations,
compounders normally rely on formulating materials to either the American FDA or the German BgVV
regulations. These are two schemes which list permitted ingredients and migration control limits, and will
be covered briefly in 3.2.3.2, "Regulation for elastomers".
An elastomer can be defined as a material which at room temperature can be stretched repeatedly to at
least twice its original length and, on release of the stress, rapidly returns to its approximate original
length. The elastomeric properties are brought about by chemical vulcanization and formation of a cross-
linked elastic structure. Thermoplastic elastomers are a group of polymers that are similar to elastomers in
resilience and rapid recovery. However, they can be repeatedly softened by heating, regaining their
elastomeric properties on cooling to room temperature. They do not need curing or vulcanization.
Section 3 Materials
Food approved elastomers are normally compounded to meet the requirements of either the US FDA
regulations or the German BgVV requirements.
The FDA scheme is the more straightforward. The compound is considered suitable for food contact
providing that the ingredients are listed as approved, and that the water or hexane solubles under reflux
extraction conditions are within the prescribed limits.
Sections of the FDA regulations (CFR 21, parts 170-199) which apply to elastomeric materials are:
177.2600 Rubber articles intended for repeat use; 177.1210 Closures with sealing gaskets for food
containers.
The German BgVV regulations Elastomers are more complex. Four (4) use categories are defined and
also a special category.
Category I relates to materials which contact food for more than one day to several months, e.g. storage
containers, container coatings, large surface seals and seals for cans, glass vessels, bottles etc.
Category 2 covers commodity materials which are not intended to contact food for more than 24 hours,
e.g. tubes for food transport, bottle stoppers and bottle caps, sealing rings for steam cooking pots, tubes
for coffee makers, lock seals etc.
Category 3 covers materials, which are in contact with food for not more than 10 minutes (short-term
contact). Listed examples are milking liners, milking machine tubes, seals for milk processing machines,
diaphragms, pistons, fittings and similar parts, pump stators, roll coatings and conveyor belts (fatty food
contact only), gloves and aprons intended to be worn during food handling.
Category 4 relates to materials, which are used in conditions where no migration is expected. This
applies particularly if the material contacts food only for a very short duration, or over a very small area, and
if it is not covered by categories 1-3. Examples are conveyor belts and roll coatings, suction and pressure
conduits (e.g. for loading and unloading tanks on vessels, railway carriages and similar applications), seals
for pipelines, pumps, cocks, bevel seat valves and similar applications for the supply of drinking water.
Special category covers oral contact, e.g. toys, balloons, baby teats and teat dummies, breast caps,
teething rings and gum shields.
Regulatory requirements for potable water are usually separate and different from those for food contact
materials. In the United Kingdom the requirements are covered by law and test methods are given in
British Standard BS 6920, sections 2.2-2.6 (1988).
If any component is not covered in the above regulations, SEAC TOXICOLOGY must be consulted :
Unilever Research
SEAC TOXICOLOGY
Colworth House,
Sharnbrook
Bedford MK44 lLQ
United Kingdom
Tel.: + 31 10 2174395
Fax: + 31 10 2174149
Section 3 Materials
Various types of rubbers are widely used in the food industry for seals, gaskets and joint rings.
Although natural rubber is used for some of these components, the major proportion are made from one
of the wide range of synthetic polymers which are now available. The most important types of
elastomers used in contact with food are listed in the table below:
1. Corrosion of metal (usually stainless steel) caused by contact with rubbers, often occurring under
seals or gaskets. The ingress of liquids containing chlorides under gaskets and seals can lead to
chloride concentration and severe corrosion problems.
2. Corrosion of metal (usually stainless steel) due to degradation of adhesive used to locate gaskets. To
avoid this type of problem (which is also due to chlorides released during the degradation of the
adhesive) only adhesives recommended by the equipment suppliers should be used.
3. Corrosion (or degradation) of rubber by products or cleaning agents. When a rubber is exposed to an
environment, it may adsorb some of the constituents and undergo general chemical breakdown. The
magnitude of the absorption and/or chemical attack, determines whether a rubber can be classified as
resistant or non-resistant.
ASSESSMENT OF COMPATIBILITY
The suitability of a rubber to a particular environment can be assessed by an immersion test, details of
which are given in standards e.g. ISO 1817 International Standardization Organisation, DIN 53521,
ASTM D471, BS 903 part A 16.
Although differing slightly in experimental detail, all the above standards have the similar objective of
assessing the rubber's resistance to a particular environment and so predicting the probable service
performance.
The assessment is based on changes in the mechanical properties of the rubbers and also upon the general
appearance of the rubber after immersion. It is generally accepted that a weight or volume change of 10%,
and hardness change greater than 10 IRHD (International Rubber Hardness Degrees) is indicative of the
unsuitability of a rubber for a particular environment.
It is strongly recommended to use either nitrile or silicone rubber when resistance to edible oils and fats is
needed.
The life and service performance of any rubber component is usually related to its previous history. This can
be strongly influenced by the conditions of storage of the rubber components. It therefore follows that
adequate precautions should be adopted to ensure correct storage conditions. The correct storage
conditions are:
5. Store well away from ozone generating equipment (switchgear, arc welding bays)
Section 3 Materials
Sub-Paragraph
Recommendation:
The PermaBond single-part epoxies (ESP) and anaerobic adhesives (A) can be used in food processing
lines.
Description:
PermaBond ESP and A are very good adhesives suitable for many surfaces. The already-mixed components
require heating to cure and should therefore be stored in a refrigerator. The joints can withstand
temperatures up to 200°C. However, it is recommended to do practical testing.
The single-part bond is suitable for equipment for handling foods and beverages. It is approved by the
UK Water Authorities for contact with drinkingwater.
Remarks:
ESP 108, ESP 110 and A 131 are used by URL Vlaardingen and by some Unilever factories for several
years, in equipment that is steam-sterilized.
REFERENCES
Section 3 Materials
Sub-Paragraph
Lubricants used in food production areas, which can or may come into contact with the product must
have safety clearance.
These lubricants must have a manufacturers declaration that they are suitable for use for
indirect/accidental food contact and the components should comply with the FDA rules which are
registrated in the code of federal regulations 21 CFR 178.3570 (Lubricants for occasionally contact with
food) and must have a USDA - H1 status.
In addition to the primary requirements for lubricants, food grade lubricants must be free of mineral oil and
should be resistant to the food products and show neutral behaviour towards the materials of construction.
Where several types of lubricants are used in food production areas there should also procedures to
ensure that the wrong grades are not used where indirect/accidental contact is possible.
There are a number of such lubricants which have safety clearance, and these are listed on the Lotus
Notes ESL Foods Clearance Database positive list.
A few Manufacturers of food grade lubricants are listed, however, for more information SEAC Toxicology at
Colworth House should be contacted.
Sub-Paragraph
PIPE BENDING is a sophisticated technical operation. Many engineering companies have pipe-bending
machines at their disposal for this purpose. An evaluation of the effects of bending on material properties is
integral to the use of such products in piping systems. Therefore the following statement should be
considered: Pipe may be bent by any method which is suitable for the material, product flow and the
severity of the bending process such that the material properties will remain satisfactory for the intended
use.
As part of an engineering evaluation, the bending company should check the following effects of bending
on material properties:
- Bending parameters on strength, ductility, hardness and notch toughness.
- The resulting microstructure on the general corrosion, localized corrosion, stress corrosion
cracking, surface roughness, or long term mechanical properties.
- The risks relative to formation of hard spots, undesirable fouling effects, fatigue resistance, and
creep resistance.
The above checks should be done by the engineering companies with the help of metallurgical and/or
corrosion specialists, in combination with suitable testing when appropriate.
The need for changes to the direction of flow in piping systems has traditionally been accommodated
through the use of manufactured fittings such as elbows and tees. However, changes to direction of flow
may also be made through the use of pipe bends. Pipe bends may be used to limit the number of pipe-
connections to a minimum and is highly preferable over the use of welded elbows with couplings (see
figures 4.1.1 and 4.1.2). In particular where insufficient accessibility may make proper welding impossible,
the preparation of pre-fabricated pipe-sections is highly recommendable. With modern bending equipment,
substantial economic benefits can be derived by virtue of reduced fittings, welding, and non-destructive
examination costs.
Bending reference:
The Pipe Fabrication Institute (PFI) Standard ES-24, Pipe Bending Methods, Tolerances, Process &
Material Requirements (R95), is a good reference for pipe bends and includes information on terminology,
bending methods, tolerances and metallurgical precautions.
Sub-Paragraph
Description:
When skillfully manufactured, pre-fabricated bent pipe sections may be the ideal solution to interconnect
individual pieces of equipment in food processing lines. Often 5 to 10 pipe connections (welds, elbows or
couplings) may be replaced by a single pre-bent pipe section ( see figures 4.1.1 and 4.1.2.).
Pipe bending machines are able to bend stainless steel pipes in the dimensions used in the food industry
and require considerable capital investment.
It is recommended to use the service of specialized engineering companies that have suitable machines at
their disposal.
If not skillfully done, bending pipes may result in a rough inner surface in particular due to scratches.
Also, "waves" may occur in the pipe wall at the inside of the bends. It is recommended to specify the
quality required and to ask for samples prepared from sections of pipe that meet the specification of
hygienic design.
The companies mentioned above will be able to send lists of companies near the location of the factory
that own suitable machines.
Sub-Paragraph
Pipework must be installed so that they are self-draining. Pipework should be adequately supported to
prevent undue strain on the joint and subsequent leakage.
Under no circumstances should personnel lean on pipework or use this for support (see picture below).
WRONG
Sub-Paragraph
Insulation
Thermal insulation of pipes and fittings is required in processes where cooling and heating is used. The
use of only bare pipes will result in energy loss or heat gain for hot or cold pipes. From a safety point of
view, hot pipes can result in potential burn hazard. From a hygiene point of view, cold pipes causing
condensation which can drip onto product, equipment etc. can result in product safety hazard.
Although insulation material - being present at the non-product side of equipment - does not have a direct
influence on hygienic design, attention must be paid to the fact that insulation materials may be corrosive.
As a result, stainless steel equipment may corrode and develop pinholes, so that microorganisms may get
past. For pipelines, a jacketed pipe with vacuum may be the most hygienic, cost-effective and
maintenance-free method.
However, when choosing thermal insulation for food processing pipework, apart from the insulative values,
also the hygienic aspects must be considered. Insulation materials should meet USDA guidelines and
must be non-absorbent e.g. closed cell structured materials. The material should be resistant to water
(water absorption according to DIN 53 428 and 53 495) and water vapour (diffusion resistance according to
DIN 52 615).
The insulation material should be covered by protective jacketing or cladding materials such as flat
stainless steel sheet, stainless steel or synthetic pipe or jacket. The jacketing or cladding should be
properly sealed or welded to prevent the ingress of water, product etc.
To detect leakage due to weld failures it is advisable to install a leak warning system.
The Nondestructive Testing Information Analysis Center (NTIAC), operated by the Texas Research Institute
Austin Inc., has completed a report on Nondestructive Evaluation used for detecting component damage
through thermal insulation. This report was funded by the Materials Technology Institute (MTI) of the
Chemical Process Industries and should be available through MTI. Several ultrasonic, acoustic,
radiographic and electromagnetic tools were found to be promising.
Sub-Paragraph
Soft-soldering of stainless steels is usually carried out using low-melting point (usually less than 300°C)
silver-tin alloys. Soft-soldering is seldom applied for piping for food processing as these joints are not
resistant to corrosion and because they should not be exposed to temperatures over 100°C.
Low-temperature brazing of stainless steel gives higher strength bonds (that can withstand sterilization
temperatures of 120°C) than soft- soldering and uses filler metals based on silver-copper-zinc alloys, with
melting points in the range 600-850°C. Hard-soldering and silver- soldering are other terms used to describe
low-temperature brazing. A convenient, low-melting (620°C) silver solder is no. B AG-7 (AWS/ASTM
standard) which contains Ag/Cu/Zn/Sn: 56/22/17/5. This alloy should not contain cadmium.
Brazing alloys
A particular form of corrosion, known as interfacial corrosion, can arise with soldered and brazed joints in
stainless steel. Special care must be taken in the selection of alloys for soldering and brazing when the
resultant joint is exposed to water or even humid environments. In these circumstances, failure of the joint
can result from corrosion at the alloy/stainless steel interface. Brazing alloys which are resistant to this form
of corrosion contain nickel and manganese; example: L-Ag49 according to German DIN 8513 (B-AG 22
according to AWS and AG18 according to BS). It is important that alloys are chosen which are cadmium-
free for food handling equipment. Special alloys, resistant to interfacial corrosion, are also available if
protective atmosphere brazing techniques are used.
The Industrial Silver Division of Engelhard-Clal, Paris, France, can supply different brazing alloys in different
alloy designations, such as those specified by the French Association for Stadardisation (L'Association
Francaise de Normalisation, AFNOR), the American Welding Society (AWS), the British Standards (BS)
and the German Institute for Standardization (Deutsches Institut für Normung, DIN).
Engelhard-Clal and Vitta Corporation can deliver cadmium-free and special brazing alloys according to the
above mentioned standards for the fabrication and repair of food processing apparatus and equipment. These
companies can study and develop specific alloys to solve brazing problems with special materials.
Brazing fluxes
The brazing operation of stainless steels always require the use of a brazing alloy in conjunction with a
suitable flux. The purpose of the flux is to attack the surface of metals to be joined, reduce any oxides on
the surface and unable brazing alloys to wet the surfaces. The flux also protect both the brazing alloy and
the surfaces of the metals to be joined from oxidation during the brazing process. The active temperature
range of the flux must extend over the melting temperature of the brazing alloy used. Fluxes are corrosive
and many contain fluorides and there have been reports of residual flux causing pitting problems with
stainless steels. It is therefore recommended that soldered or brazed joints be thoroughly washed,
preferably with hot water, to remove any residual flux. Strict attention must be paid to safety, health and
environment requirements.
Sub-Paragraph
As a specification for the surface roughness (1) is included in the ISO Recommendation (2) for stainless
steel tubes for the food industry, a short explanation of the assessment of surface roughness is given.
All manufactured surfaces depart, to some extent, from absolute perfection and in order to specify surface
requirements, instruments have been developed to measure surface texture on a numerical basis. The main
measuring parameter, which is recognized internationally, has the designation Ra and is identical to that
previously known as CLA (centre-line-average).
The imperfections of any surface take the form of a series of peaks and valleys varying both in height and
spacing and result in a texture often characteristic of the production process. Grinding or mechanical
polishing produce a surface having closely spaced, sharp peaks and valleys whereas electropolishing
results in a surface having widely spaced, rounded peaks and valleys.
The centre line is a line representing the form of the geometrical profile and parallel to the general direction
of the profile throughout the sampling length, such that the sums of the areas contained between it and
those parts of the profile which lie on each side of it are equal.
a1
a3 a5 a7
a2 a4 a6 a8
Centre line
The Ra value, given in micrometres, is obtained by adding the areas above and below the centre line
and dividing by the sampling length.
Ra
Ra
Examples of Ra
The Ra value is a quantifying concept and bears no physical resemblance to the profile. It can give an
indication of the amplitude of surface irregularities but it takes no account of their spacing. It has,
however, been shown to give a good correlation with the bacteriological assessment of the cleanability
of internal surfaces of pipes.
When surfaces are mechanically polished, abrasives of particular grain sizes, indicated by grit numbers, are
used to obtain the required finish by using finer grit for each subsequent operation. The initial condition of the
surface will determine the number of operations and the grades of grit required. Whilst these and other
factors affect the final finish, there is an approximate relationship between the abrasive grit number and the
surface roughness, which is given in the following table.
Note. The grain size specifications apply to aluminum oxide and silicon carbide abrasives only. These
abrasives are used mainly for polishing stainless steels.
The specified surface finish should be related to one of the following classification bands set out in ISO 4287
International Standardization Organisation-1 and ISO 4287-2 and to the method by which it is obtained (e.g.
electropolishing, mechanical polishing etc.).
Roughness Classification
Roughness values in micro-inches are 40 times the values in micrometers.
Roughness Ra Ra
Grade Micrometer Micro-inch
Numbers µm µ in
(Classes)
N3 0.1 4
N4 0.2 8
N5 0.4 16
N6 0.8 32
N7 1.6 63
N8 3.2 125
N9 6.3 250
REFERENCES
Sub-Paragraph
Roughness is only one characteristic of the texture of a surface but the centre-line-average (CLA) height
method of assessment denoted by the symbol Ra (roughness average) has been adopted internationally (1)
and is quoted as the main parameter to specify surface finish. Many different types of instruments are
available for measuring surface texture. Three methods are described; the stylus instrument which is
accurate but expensive, surface finish specimens for tactile and visual comparison, which are inexpensive
with reasonable accuracy, and the friction instrument, also inexpensive, but giving reasonable accuracy in a
more objective and analogous manner than tactile comparison.
Stylus
The stylus instrument for the measurement of surface finish is that which is recognized internationally (2). A
stylus having a radiused tip is traversed across the surface and its vertical movements are converted, by a
pick-up to which it is attached, into proportionate variations of an electrical signal. This signal is amplified
and used to operate a recorder to produce a surface profile graph and/or filtered to give a direct reading of
the Ra value on a digital or analogue meter. This type of instrument is available in many forms as a bench-
mounted unit for the measurement of straight and curved surfaces. If components are too large to be taken
to a surface measuring instrument, then there are small portable stylus instruments, such as the Rank
Taylor Hobson Surtronic 10, which may be hand-held against the surface to be measured. The component
may still be on the machine and may be in any attitude. Should the surface be inaccessible to the
measuring pick-up or it is possible only to traverse the stylus along the lay instead of across it, then a
replica of the surface can be made using a synthetic resin. Setting takes about 15 minutes, after which the
replica is removed and measurements made on it. The use of a release agent facilitates removal of the
replica from a surface. Although the profile of the replica is inverted the Ra value is the same.
Comparison
Stylus instruments are fairly expensive and it is unlikely that one will be found even in a medium-sized
engineering company. However, the smallest of companies usually possesses a set of comparison
specimens. These comprise sets of small stainless steel blocks which are electroformed eplicas of
standard surfaces and are available for almost all known machining and other methods such as grinding,
milling, turning, planing, lapping, honing, hand grinding, hand filing, shot blasting and spark erosion. There is
an ISO (3) for comparison specimens. The blocks are used for visual and tactile comparison. An operator
with little experience, can easily and fairly accurately assess which grade of finish resembles that of the
component by running his nail across the specimen and then across the surface being checked; he is also
aided by visual comparison.
Friction
The measurement of friction provides an indirect way of assessing the surface because the frictional
characteristics of surfaces on which the irregularities are random, such as in grinding, can be correlated
with roughness. The Rubert & Co Mecrin 3, a small pocket-sized and fairly inexpensive instrument,
evaluates the frictional quality and average slope of the irregularities similar to the tactile comparison of
surface roughness, but in an objective and analogous manner. When a thin metallic blade is pushed
Unilever 1999 38 Not to be copied for third parties
Hygienic Plant Manual
against a surface at a certain angle it will either slide or buckle depending upon the surface roughness and
the angle of attack. The Mecrin utilises this buckling phenomenon.
It consists of a body on which a blade with a tungsten carbide tip slides and can be pushed against the
test surface by a trigger. The angle of attack is measured with a gravity dial indicator, calibrated in µm Ra,
incorporated in the body.
The instrument can be used to measure surfaces at any inclination by placing the calibration standard
(supplied) on the surface and rotating the dial indicator to obtain the reading of the standard. On removal of
the calibration standard, the unknown surface at that inclination may be measured. Whilst this method can
assess a surface with an accuracy of only ± 20% of the actual Ra max value, it is a simple and inexpensive
means of assessing surface roughness with an acceptable degree of accuracy. For this reason, however,
readings obtained by this method should not be used for discussions with equipment manufacturers.
REFERENCES
1. ISO 468 (1982)
2. ISO 1880 (1974)
3. ISO 2632 Parts 1 (1975) and 2 (1977)
Sub-Paragraph
The internal surfaces of equipment should have a surface texture of 0,8 µm Ra or less for maximum
cleanability. Whilst rougher surfaces may be cleaned, tests have shown that the cleaning time increases
directly with the Ra value to achieve the same standard of cleaning. As an example, the effect of surface
finish of piping on the residual count of micro-organisms after cleaning and on cleaning time (1) is given on
next pages.
The ISO Recommendation (2) for pipes and fittings for the food industry states that the internal surfaces of
pipes shall have a finish less than 1 µm Ra. The ISO also lists the dimensions of piping. The main
measuring parameter of surface texture, designated Ra, is internationally recognized in an ISO-standard
(3).
It should be realized that a shiny surface is not necessarily smooth. It should also be noted that cold rolled
steel has a roughness of approximately 0.3 µm Ra (type 2B surface finish (4) or ISO N4 Class (5)) and need
not to be extra polished.
It is recommended to add the following sentence to order specifications for food equipment:
For large surface areas food contact surfaces should have a surface finish of 0.8 µm Ra or better.
Under special circumstances roughnesses between 0.8 and 1.0 µm may be acceptable ( for definition of Ra
- value, see ISO 468, 1982).
A roughness over 1,0 µm might be acceptable for small areas (e.g. inaccessible welds) if agreed in
advance.
If no roughness testing instrument is available the research laboratories in Vlaardingen, Colworth and Port
Sunlight can assist and advise. Usually metal testing laboratories of universities or of large machine
manufacturers will also accept external orders for surface testing.
REFERENCE(S)
1. PCW 73 1412
2. ISO/R 2037 (1972)
3. ISO 468 (1982)
4. BS 1449:Part 2 1983 (1983)
5. ISO 4287-1 and ISO 4287-2
Sub-Paragraph
Effect of surface finish on residual count of organisms after cleaning test pieces of stainless steel pipe for
10 minutes.
0.30
0.25
0.20
0.15
0.10
0.05
Reference:
PCW 73 1412
Sub-Paragraph
Effect of surface finish on cleaning time for test pieces of stainless steel pipe to obtain 99.99% soil removal.
25
20
15
10
Reference:
PCW 73 1412
Sub-Paragraph
The major advantages of automation are that once the parameters have been established for the geometry
and thickness of the joint, high-quality reproducible welds are formed, and to some extent the operation
demands a lower level of skill than for hand welding. It is preferable to use the automatic process wherever
possible.
A surface roughness of (Ra) 3-4 µm can be achieved on high-quality TIG welds, though Ra values of 7-8 µm
are more likely on 'industry standard' welds. This is a little higher than ideal, but is acceptable as the weld
area is relatively small overall; however, allowance may be necessary for additional cleaning times
required.
The main drawback with TIG welding is the low speed at which the weld runs are accomplished,
particularly for thicker-walled vessels. A technique with a faster deposition rate, such as MIG or MMA
(manual metal arc) can be used, on top of a TIG root run adjacent to the product.
Sub-Paragraph
In permanent installations, pipe couplings can be a costly method of joining sections of pipe and may
result in a hygiene risk if they are not properly attached; also, they will not be bacteria-tight if they are not
tightened correctly (see 5.5.2, Pipe Couplings). In principle, welding is to be preferred over the use of
couplings. Proper welding requires considerable skill and may be needed at places that can be accessed
with great difficulty only. Hence, welding too should not be done unnecessarily. Pipe weldings should be
done by selected manual welders of proven competence (coded for pressure vessel work, BS 5500, ASME
VII, or to appropriate National Pipework Standards) or preferably by orbital welding.
Pipe systems to be welded should be designed such that butt welds are the only construction requiring
welding. Pre-assembly of sections in controlled conditions prior to final installation is recommended.
The welds must exactly fill the gap between pipe ends/fittings and there should be no underpenetration or
excessive overpenetration, and no surface weld defects (e.g. inclusions, porosity, lack of fusion, cracking
etc.).
During welding the internal surface must be gas shielded, ideally with argon purge gas, although nitrogen is
acceptable.
Welds may be removed from the installation for inspection if so agreed in advance.
Further requirements for hygienic welds in stainless steel pipework are given in 4.5.4., "Specification of
pipe and preparation for orbital welding".
Sub-Paragraph
Description:
All machines for orbital welding are basically the same, consisting of a welding head which is rotated at
constant speed around the pipe. The head, which is small enough to be used in situ, contains a tungsten
electrode and the arc is shielded by an inert gas to prevent oxidation. The process is often referred to as
TIG (Tungsten Inert Gas). It is also necessary to purge the inside of the pipe with an inert gas during the
process. Although orbital welding is an automatic process, the correct parameters have to be determined
and certain conditions satisfied. If carried out properly, no post-weld treatment, such as grinding or
polishing, is necessary. The welding equipment is expensive and for small installations the capital cost
would be difficult to justify. Specialist contractors, however, also carry out orbital welding.
Samples of orbitally welded connections, which had been made using different machines, have been tested
for cleanability and compared with the best pipe coupling, the welded IDF (ISO type, see 5.5.2 - Pipe
Couplings). All connections examined would be suitable for clean-in-place systems and applications where
bacteria tightness is of prime importance.
Remarks:
ORBITAL WELDING of pipework has been used for several years in the dairy and brewing industries to join
sections of pipe as an alternative method to couplings. It is particularly suitable for large installations where
there are long runs of piping which do not require re-arranging for long periods. There are such applications
in the food industry.
Sub-Paragraph
If properly programmed, an orbital welding machine is consistently capable of producing high-quality welds.
However, it is necessary to note that because orbital welding is an automatic process, the equipment
cannot compensate for wide variations in the pre-set parameters. Orbital welding requires a high
standard of accuracy in the configuration to be welded if good quality welds are to be produced.
a) Pipework, which is to be orbitally welded, must be clean especially near the fusion area. Grease
and dirt must be removed prior to welding. The pipe ends must be cleaned prior to welding,
preferably with a wire brush followed by a solvent. When welding stainless steel, a stainless steel
wire brush should be used.
b) When no weld preparation is necessary, the pipe ends must be at right angles to the longitudinal
axis of the pipe. This means that a mechanical method of cutting the pipes must be used. It is not
possible to achieve the required accuracy by hand. The cut ends must be burr-free and not
distorted. When weld preparations are required, they must not be done by hand.
c) The diameters of the two pipes to be joined must be the same. It is, of course, possible to get size
variations in outer diameter and also wall thickness for any nominal tube size of a given outer
diameter and wall thickness.
If the diameters of the pipe or tube are not the same, it is necessary to expand the smaller size up
to the larger. Specialized expanding tools are available for this purpose. They are normally hydraulic
in operation and can also be used to ensure that the tubes are round. Such tools are frequently only
available for tube sizes over 50 mm (2 inches). A typical tool would be capable of increasing the
diameter by 0,38 mm (0,015 inches) to 0,76 mm (0,030 inches). Different tools are needed for
different diameters although one tool can cover a range of sizes e.g. 50 mm to 75 mm (2 inches to 3
inches). Standard tools will normally expand wall thickness up to about 2,0 mm (0,080 inches).
It is also important to note that not only outer diameters can vary within a general classification by ±
10% (depending upon type of tube and standard), but that tube manufacturers may produce a wide
range of standard sizes which can be quite similar. The most obvious difference is Metric and
Imperial sizes. Some manufacturers only supply metric-sized tube and convert the sizes into
imperial units.
However, other suppliers actually supply slightly different sizes for their metric and imperial tubes. A
further complication is that there are other standards and sizes to which tubing may be supplied
e.g. ISO and ANSI.
The practical implications of the variation in standard sizes is that it is quite easy to be supplied
with a mixture of tubes. The tube sizes may be similar but the differences in outer diameter may be
sufficient to cause problems after orbital welding.
d) The misalignment of the tubes which are to be orbitally welded should be less than 20% of the wall
thickness. Normally, if the sizes are correct the clamping arrangement of the orbital welder will keep
this accuracy.
However, if wear takes place, the necessary accuracy may be lost and this could lead to excessive
misalignment.
e) The gap between the two ends to be welded should be less that 0,25 mm (0,010 inches). As above,
this is normally realized with new equipment but if the machine is not properly maintained, loss of
accuracy can result.
f) It is necessary to establish the correct welding conditions with respect to the type of material to be
welded, outer diameter, and wall thickness.
This has to be done by trials. Once the correct conditions have been established, they should be
repeated for every similar configuration.
Sub-Paragraph
Introduction
Inspection, Examination & Testing are activities carried out to ensure that process line components, piping
systems or the whole plant meet the minimum requirements for safe and hygienic design.
Clauses covering these activities are found mainly in:
Ø USA; - 3-A standards
Ø EC; - The Machinery Directive (98/37/EC) EN 1672-1, Food Processing Machinery
Basic concepts - Part 1: Safety Requirements; EN 1672-2, Food Processing Machinery
Basic concepts - Part 2: Hygiene Requirements
The CEN/TC 153 Food Processing Machinery Standards for specific pieces of equipment
Ø International; The International Standardization Organization ISO 14159; Safety of Machinery –
Hygienic Requirements for the Design of Machinery
Ø Unilever; - SHEACO guidelines
Ø Others; - EHEDG guidelines and other codes of engineering design.
Inspection and examination do not mean the same thing. Table 4.6.1 compares certain defining
characteristics for each activity.
Inspection Examination
Corporate Owner Manufacturer, Fabricator, or
Responsibility: Installer (contractor)
Individual Responsibility: Owner's inspector or delegates of the Examination (QC) personnel
owner's inspector
Work Description: Verify that all required examinations and Perform examinations required
tests have been completed. Inspect by specifications (Note that most
piping to the extent necessary to be QC manuals have sections
satisfied that it conforms to all devoted specifically to
applicable examination requirements of completion of examinations,
the Code and the engineers design such as material control, welding
control, NDE control, pressure
testing, and record keeping)
Primary Quality Quality assurance, including quality Quality control
Management Function: audit
Examination
When assessing examination requirements for a project (i.e., the above requirements), the usual starting
point is a review of the hygiene and safety requirements and contract clauses, followed by a listing of
examination requirements, and then by developing tables, if appropriate. Table 4.6.3 has been included to
illustrate visual examination requirements.
Items to be examined
Most examination requirements are applicable to welds, but examinations may also be necessary for other
items including surface roughness, castings, seals and bends. Items requiring examination depend upon
the process and product. The left column of Table 4.6.3 lists several items which may require examination.
The first five types of examination are also referred to as methods of examination, which can be confirmed
by referring to the official methods. Progressive examination is included as a type of examination, even
though it is only used when defects are revealed by spot or random examination. The examinations can be
followed by testing the hygienic characteristics with one or more EHEDG test protocols (see 9.1.2 EHEDG
Guidelines).
Nondestructive examination (NDE) methods are generally described in terms of the probing medium used
to detect surface and internal discontinuities in materials, welds, and fabricated parts and components.
Examples include the radiographic method, which uses electromagnetic radiation as a probing medium,
and the ultrasonic method, which uses high frequency sound waves (ultrasound) as a probing medium (see
Table 4.6.2).
An NDE technique is a specific way of using a particular NDE method. For example, a weld could be
examined by the ultrasonic method using a shear wave technique, where the sound beam propagates in a
shear wave mode.
An NDE procedure is an orderly sequence of actions describing how a specific technique shall be applied.
a) How many items must be examined by the method (e.g., lot extent)?
b) How much of each item must be examined by the method (e.g., item extent)?
For most process lines and plants, requirements distinguish between "Visual Examinations" and "Other
Examinations" which are more sophisticated forms of nondestructive examination. Tables 4.6.3 provide an
overview of the extent of "visual examination" required for various types processes and kinds of items to be
examined.
Please note that this table expresses the author's interpretation of the hygiene requirements. The
requirements should be carefully reviewed and supplemented where necessary prior to project use.
Further to the above, the following questions regarding examination requirements should be answered:
Sub-Paragraph
Plant intended for food contact applications must be fabricated to a high standard such that potentially
harmful crevices, which could allow the build-up of bacterial contamination, are not present.
In the case of components fabricated by welding, the areas most likely to contain unwanted defects are the
welds and the immediately surrounding areas. For this reason, it is necessary to carry out some form of
non-destructive inspection of the welded areas to ensure that cracks, crack-like defects, and porosity are
absent. The fact that austenitic stainless steels are virtually non-magnetic, precludes the use of magnetic
particle inspection techniques. Therefore, the most useful technique for detecting surface-breaking defects is
dye penetrant testing. It is, of course, possible that some fabricators use radiography to check weld quality
and ensure freedom from internal defects. However, in many instances, food processing vessels are no
pressure vessels and therefore need not be non-destructively inspected by manufacturers.
Dye penetrant testing is a relatively simple inspection method. Before starting, the surface to be inspected
should be properly degreased. Then the surface is sprayed with the dye, which is drawn into the flaw by
capillary action. The dye is usually red. The time the dye must be left on the surface depends upon the
characteristics of the penetrant and the size of the flaw. Usually, the dye must remain on the surface for at
least 20 min. The penetrant is then removed, using a cloth or absorbent paper. The dye in the defect is not
removed. A developer is sprayed onto the surface, which then becomes white. If there is a flaw, the dye is
drawn out, causing a clear red colouration on the white background.
Sub-Paragraph
bursting disk
gasket
o
5
Description:
The Graphilor disks, made from impregnated graphite, are available in active diameters of
12,7-600 mm, for pressures from 0,07-100 bar. The maximum temperature of use is 350°C.
Also available are non- impregnated disks, coated with a fluorinated polymer, which can be used up to
200°C (2). The disk should preferably be mounted in a horizontal position above the liquid level.
The BS&B SAF-T-GRAF disks are made from impregnated graphite and are available in the following
sizes with the related minimum and maximum burst pressures (barg):
25 mm (2.76 - 13.79), 40 mm (0.93 - 10.34), 50 mm (0.79 - 4.83) and 80 mm (0.79 - 2.76). Other burst
pressures may be available, consult BS&B.
The GFR bursting disks are made from stainless steel 316 or 316L in the sizes 1, 2 and 3 inch. The
pressure rating are from 0.79 till 13.79 bar.
They are mounted in a special holder with Tri-clamp, and available as tankwall or pipeline model.
The Rembe bursting disks are made of stainless steel . The design is similar to the GFR disks of
BS&B.
Remarks:
The bursting disks mounted as shown in the pictures above have no crevices or recesses; it is therefore
expected to be easily cleanable and has been proven to prevent penetration of micro-organisms .
Chapter 5. 2 Deaerators
Sub-Paragraph
In the food industry it is of increasing interest that liquids and gasses (mixed or dissolved in liquid) are
separated efficiently. Gas bubbles have e.g. a dramatic influence on the fouling of heat-exchangers.
Gasses can be separated by heating, lowering the pressure above the liquid, or by mechanical methods.
Several deaerators have been evaluated and regrettably the designs does not meet the basic hygienic
design principles.
If deaerators have to be used, special care must be given to the avoidance of microbiological problems.
This is likely to require dismantling for manual cleaning and a severe treatment after reassembly to destroy
micro-organisms.
Air can be contaminated with micro-organisms and may contain up to 10 000 colony forming units per
cubic metre. Without a proper treatment, the air may contaminate food products. Air that is intended to
come in contact with sterile product or used to maintain a positive pressure in aseptic tanks and
equipment must be sterile. The air to be treated must itself be of good quality; thus, removal of moisture,
oil and particles is essential.
The quality of air is laid down by the maximum level of contamination permitted. According to the US-
Federal Standard 209b, there are four classes recognised, viz. Class 100, Class 1000, Class 10000 and
Class 100000. The maximum numbers of particles 0.5 µm or larger per cubic foot (litre) are, respectively,
100 (3.5), 1000 (35), 10000 (350) and 100000 (3500). The figure below shows the class limits in particles
per cubic foot of equal size to or greater than particle size shown. The Class 10 and 1 shown are under
discussion and not yet widely applied. Class 100 is the most commonly used for aseptic applications,
hence in sterile areas.
10000
100000
1000
CL
AS
S1
00
10000
,00
0
CL
AS
S1
100
0,0
00
CL
AS
1000
S1
Particles per cubic foot
00
10
CL
AS
S1
00
100
CL
0
AS
S1
0
1
CL
10
AS
S1
0.1
0.01
0.1
The fibrous sheet filters have a low resistance to air flow and a large surface area. Such a filter is required
to provide air with an extremely low microbiological load to aseptic areas. High efficiency particulate air
(HEPA) filters meet those requirements and are able to remove particles of 0.3 µm or larger and may
remove even particles much smaller than this. They have efficiencies of 99.97-99.997% retention for
particles of 0.3 µm or larger. This type of filter is mostly used in laminar airflow (LAF) systems, such as
LAF rooms and cabinets.
Once the air is clean or sterile, recontamination should be prevented. First the air distribution system (air
lines and equipment) should be hygienically designed to prevent any recontamination of the air and growth
of micro-organisms in the system. Other areas such as sterile tunnels, tanks and cabinets should be kept
under super-atmospheric pressure to prevent recontamination.
Sterile locks and air filtration units can be used for microbial free environments. Ultra clean rooms should
also be kept under a super-atmospheric pressure of sterile LAF. Aseptic packing/processing require the
use of sterile air and LAF cabinets, rooms, tunnels etc. Building, Rooms, Cabinets, Tanks and Container
(packaging) must then be kept under super-atmospheric pressure.
Two types of filters are available: membrane filters and HEPA depth filters. In case of membrane filters the
particles are retained by sieving, for depth filters they are retained by adsorption and interception. Sieve
filters are so-called membrane or absolute filters, adsorption filters are depth filters and have no defined
pore size.
The efficiency of HEPA filters is commonly specified according to the dioctyl phthalate (DOP) test
By this test particles with an average diameter of 0.3µm are sucked through the filter layer and the
efficiency is expressed as an percentage of particles retained. Due to mechanical shocks or vibrations
depth filters can release particles.
Sterilizing grades of membrane filters have pores ranging from 0.1 to 0.8 µm.
A too high pressure drop across a filter element is normally a criterion for replacement. Pinholes and other
small defects, however, cannot be detected in this way. To check whether the filter still is within the
manufacturers specifications, special laser counters (91069) can be used. These are capable to detect
particles of 0.3 µm and above. Membrane filters, which are often used to supply sterile air to fermentation
processes, can be checked by the water intrusion test. For this test the filter is completely wetted and a
fixed pressure is applied which allows air to diffuse through the liquid, which can be quantified with a flow
metre. This value is a measure for the effective pore size.
For the quality of a filter one should rely on the manufacturer that his quality control system ensures a
product that meets the requirements specified. Particles normally remain or stay attached to the filter. This
is not necessarily so with micro-organisms. Moist air allows bacteria to grow on the filter surface and often
through the filter. To check whether membrane filters are able to retain micro-organisms, challenge tests
have been developed by which the filter is exposed to large amounts of Brevundimonas diminuta, which is
a very small and motile bacterium. It has been proven that this bacterium can grow through filters with
pores of 0.3 µm within 24 hours. This means that there should be no water in the pores and for this reason
air filters should be hydrophobic.
That a filter can effectively retain micro-organisms does not automatically imply that it is also sterilizable.
Sterilizability depends on the materials used for the filter, the housing and its construction.
This section discusses the properties of various filter materials and housings.
Description:
The filters are suitable for in situ steam sterilization. Housings
and other metal parts are made from stainless steel AISI 316.
According to manufacturers, the membrane filter elements can
withstand steam sterilization’s up to140°C. The cartridges are
available in length between 65 and 1000 mm with filter areas
between 0.1 and 2.8 m2 .
Houses with up to 12 cartridges can be supplied.
sterile or
clean side
Remarks:
For sterile filtration membrane filters with pore sizes between 0.2 and 0.45 µm can be used.
The filters and seals are bacteria-tight and repeated steam sterilization is possible.
Condensation of water vapour in the filter element must be avoided otherwise the filters will be blocked.
Housings should be ordered with recommended pipe couplings (see 5.5.2).
Description:
The efficiency of filters is classified according to the EN 779 standard and the EN 1822 draft standard as
shown below:
G2 70 10 0 0 0 10 80 H11 > 98
HEPA3
G3 85 25 0 0 0 20 90 H12 > 99.99
Bacteria filters
G4 90 35 0 5 10 35 95 H13 > 99.997
F5 97 50 10 20 35 65 98 H14 > 99.999
F6 98 70 15 30 50 80 99
F7 98 85 25 50 70 90 100 ULPA4 U15 > 99.9995
fine
Description:
Dependent on the application the strainer is available with pores between 0.5 and 1.0
mm diameter or slits of 1 x 10 mm. The free passage is determined by the pore size
and varies from 10 till 40 % .
The filters are available with pipe connections of 1, 1.5 and 2 inch (drawings 3225 R3,
3226 R3 and 3227 R3) and are made of stainless steel AISI 316.
Remarks:
The strainer is bacteria tight and sterilizable. Dependent on the application it has to be
dismantled periodically for manual cleaning and inspection.
The strainer should be ordered with recommended pipe connections.
The recommended strainer should be ordered from APV The Netherlands. If the
above mentioned drawing numbers are used, APV will recognize that the Unilever
execution is required.
Chapter 5. 4 Homogenizers
Sub-Paragraph
Homogenizers for hygienic and, in particular, aseptic processing of food products should meet rigid
hygiene requirements.
Piston type
The homogenizers principal components are a high-pressure pump (usually a three-cylinder piston pump
with non-return valves) and a back pressure device, the homogenizer head. The pump is driven by a
powerful electric motor through a crankshaft and connecting rod transmission which converts the rotary
motion of the motor into the reciprocating motion of the pump pistons.
The pistons run in cylinders bored in a high-pressure block and are sealed by rings to prevent leakage of
the product and a flushed double seal (see 6.1.2 ABS) is used for lubrication and to prevent reinfection in
aseptic processing, i.e. when the homogenizer is treating sterile products.
The reciprocating pistons and seals are difficult to clean and disinfect. The non-return valves can also be
very difficult to clean-in-place (see 5.14.2 for non-return valves). Due to the non-return valves, draining of the
homogenizer is impossible. Special measures should be taken such as preservation of the homogenizer or
the whole line.
Dampening devices:
In the operation of a homogeniser two distinctly different pressure fluctuations are created:
1. Low frequency fluctuations due to the pulsating flow generated by the reciprocating plungers
(plunger peaks).
2. High frequency noise resulting from the action of the discharge valves producing a ringing effect
(water hammer pulsation).
The low frequency fluctuations can cause potentially destructive vibrations in pipelines and large
equipment. The high frequency noise has relatively little energy but can damage small items like gauges
and instrumentation.
Pressure fluctuations can effectively be dampened by pulsation dampeners (see 5.6).
By-pass
Sometimes a by-pass is required because of capacity problems and to obtain the cleaning velocity for the
line downstream from the homogeniser. In such a case, care should be taken to prevent dead ends and
stagnant product lines (see 5.7.1 pumps general for a recommended by-pass).
Rotary type
The rotary type homogenizer is a high shear in-line mixer and the principle resembles the centrifugal pump
with an additional homogenizing effect. The homogenizers principal components are a bladed or multi-
toothed rotor which is mounted on the extended sealed shaft of an electric motor and a stator in the front of
the housing.
The stator can consist of a screen provided with round holes, square holes, slots etc. or a multi-toothed
plate. The product is fed in the mixer through a central inlet in the front of the housing.
The rotor is driven by an electric motor and due to this rotating action the product is forced through the
holes, slots or small gaps. The high degree of dispersion and formation of small particles is caused by the
forced-feed passage through the small rotor-stator gaps.
Hygiene problems with this type of homogeniser are mainly associated with cleaning in-place. Some
design details which can decrease cleanability are seals, gaskets, geometry and couplings.
Similar to the centrifugal pump, the inlet is in the center of the housing and the outlet at the top such that
after draining a considerable amount of liquid remains in the housing. To ensure drainability the outlet
must be situated at the bottom.
The other design details should be such, e.g. hygienic seals (see 5.9) and gaskets, tangential outlet etc.,
that cleanability is easy. Also the recommended couplings as discussed in 5.5.2 should be used.
Chapter 5. 4 Homogenizers
Sub-Paragraph
Description:
APV Gaulin/Rannie
Improvement of two homogenizers in cooperation with APV Gaulin and APV Rannie resulted in two
designs which probably comply with the hygiene requirements. The product side of both designs has
been discussed in detail and APV has revised the designs based on Unilever recommendations. The
machines have been tested at Unilever Research laboratorium Vlaardingen using the EHEDG method:
"A method for the assessment of in-place cleanability of moderately-sized food processing equipment".
The test results show that both homogenisers were slightly more difficult to clean compared to a
straight piece of pipe (reference pipe).The test results were used to modify and build two final
prototypes.
Bran + Luebbe
From a hygienic point of view this homogeniser was the best one available in 1988. Minor further
hygienic improvements have been agreed and implemented on the existing pilot plant homogeniser in
1992. However, in-place cleanabilty was not as expected and the homogeniser had to be dismantled for
manual cleaning after each use.
Remarks:
The final design of the APV homogenizers still has to be tested for cleanability and practical
performance. For aseptic process lines, also the sterilizability and bacteria tightness should be tested.
Chapter 5. 4 Homogenizers
Sub-Paragraph
Fryma MZ
Description:
In the manufacture of liquid products and creams the in-line mixer homogenizer is an effective tool.
Fryma:
The gap between rotor and stator of Fryma colloid mill can be varied as shown in the picture above. The
space behind the hygienic Shamban Variseal as well as inner space of the mechanical shaft seal can
be flushed to improve hygiene. Two types are available with capacities between 1500 and 16000
kg/hour.
Silverson:
The original non-hygienic design of the Silverson mixer has been improved in cooperation with AMTG
Vlaardingen and Personal and Home Care at Port Sunlight. The mixer's main elements are a four
bladed rotor mounted on an electric motor shaft and a stator screen equipped with small holes vacuum
brazed to the front cover. The mixer has been tested according to the EHEDG method for cleaning in-
place with good results. Improvement of the hygiene and reliability aspects can be found in report VD
96 0103 .
Stainless steel tube for use in the food industry is available in either seamless or welded form. The
longitudinally welded tube is widely used as it is suitable for most applications and is cheaper than
seamless, but care should be taken in selecting welded tube to ensure that full weld penetration has
been achieved and that the internal weld bead is smooth (see 4.4 - Surface Finish and 5.5.1.3 - Pipe
Finishes).
AISI-316 (DIN Werkstoff No. 1.4401) and AISI-316L (DIN Werkstoff No. 1.4404) are mostly recommended
for pipework where chlorides are present and operating temperatures are moderate (<60°C). Stress
corrosion cracking of AISI 316 types steel due to chloride attack does not occur at temperatures below
60°C, but will occur in the temperature range of 60-150°C. For further information see 3.2.1 (Materials
Selection & Avoidance of Corrosion; Stainless Steel).
After fabrication, the tubes should be sealed with PVC or other plastic caps and packaged in suitable
protective materials, e.g. wooden crates, for transport. The end caps should be kept in place until the
tubes are actually ready to be used or installed.
Every tube should be supplied with an identification number. The tubes should be marked to show steel
grade, heat and lot number, dimension and manufacturer.
Standards for Stainless Steel Tubes for the Food Industry are the International Organization for
Standardization ISO 2037 International Standardization Organization (1980) and the British Standard BS
4825 Part 1: 1972 which is in technical agreement with the ISO.
Tube size is specified by the outside diameter and the wall thickness. Metric/ISO dimensions are in
accordance with DIN 17457, DIN 17458 and DIN 11850. Diameter and wall thickness tolerances for
Metric/ISO dimensions are in accordance with ISO 1127 International Standardization Organization and DIN
2462. Imperial dimensions, including tolerances, are according to ASTM A269 and ASTM A270.
The surface roughness should be < 0.8 µm Ra value (< 1.6 µm Ra for the weld) according to ISO 462
International Standardization Organization and ISO 4288. The specified surface properties should be
obtained after production of the tubes without any further grinding or polishing treatment. Experiences
and tests have shown that grinded, mechanically polished and pickled/passivated tubes do not meet
the hygiene requirements for the food industry. Tubes with a high surface roughness which are
mechanically polished to meet the specifications should not be accepted.
Tubes manufactured from cold rolled stainless steel according to AISI 316L (DIN Werkstoff no. 1.4435),
longitudinally welded with the TIG method will meet the surface roughness specifications without further
mechanical treatment.
Finishes will vary according to supplier but typical examples are given below (reference no. 92072).
The above manufacturers/suppliers are represented world-wide by subsidiary companies or agents (see 9.2
Suppliers and Manufacturers). The name of the subsidiary company may not necessarily be the same as
that of the parent company.
1. Couplings designed by Tuchenhagen (O-ring) and APV Rosista (profiled gasket), in co-
operation with the EHEDG Subgroup pipe couplings, for in-place cleaning and aseptic
processing: DIN 11864-1/2 screw/clamp type/flange type (model a=O-ring and model
b=profiled gasket (diamond shape))
2. Couplings designed for in-place cleaning and considered to be acceptable for most clean in-
place systems:
ISO 2853 welded
'I' Line welded
Clamp ISO 2852 welded
3. Of the couplings evaluated, the following are NOT RECOMMENDED for hygienic or aseptic
processing:
SMS(91131)
CB/TS (91126)
ILC
DS (91128)
DIN 11851(91127) *
RJT(91129)
3A Cone(91130)
ACME(8764)
4. All expanded type couplings are NOT RECOMMENDED in the food processing.
* To upgrade plants with DIN 11851 couplings, special inserts from SKS are available (see 5.5.2.7).
The couplings are usually available in two grades of stainless steel, AISI 304 and 316. For welding it is
most important that the same grade of material is used for both the pipe and those parts of the coupling
welded to it to avoid galvanic corrosion.
In the majority of corrosive environments, the AISI 3I6 grade is more corrosion resistant than the AISI 304,
therefore, the 316 grade is normally specified for equipment on more arduous duties.
The 316/316L grades are required with chloride and/or high acid containing products especially when they
are hot. Corrosion under seals due to crevice attack can arise if the couplings are not tightened sufficiently
or if the seal material degrades during service. To avoid the latter, the manufacturer's recommendations
concerning maximum temperature of operation and replacement intervals should be followed.
Note:
When purchasing welded couplings ensure that the inside diameter of the coupling is the same as that of
the pipe to give a smooth, continuous bore and to avoid excessive grinding and polishing. It is important to
check that the inside diameters of the weld parts, the gasket and the tube all match to give, on assembly,
a smooth, continuous bore.
flange type, with O-ring seal, screwed type, with diamond shaped seal ring,
(Tuchenhagen design model a) (APV design model b)
Description:
The APV coupling has a special diamond shaped sealing with a minimal contact surface at the product
side. Because of the expansion chamber at the non product side of the seal, the sealing material will
not protude into the pipe line during temperature changes. The coupling can be supplied as screwed
type (DIN 11864-1) flange type (DIN 11864-2) and clamp type, in pipe diameters from 10 till 100 mm
and pressures up to 40 bar.
The Tuchenhagen coupling has an O-ring which is deformed in such a way that the contact surface at the
product side is minimal. The coupling can be supplied as screwed type (DIN 11864-1 in the sizes 10 to
100 mm and 1 to 4 inches) and flange type (DIN 11864-2 in the sizes 10 to 162 mm and 1 to 4 inches).
Remarks:
Both designs can be supplied by any other manufacturer as soon as the official DIN 11864 standard
has been published.
. metal metal
elastomer elastomer
.
special T-gasket gasket with support ring
Description:
This coupling is designed for cleaning in-place and is covered by an ISO Standard (1). The British
Standard (2) is in technical agreement with the ISO.
The coupling comprises a male part and liner which are drawn together by a nut on to a gasket. There
are several types of gaskets available for the ISO couplings; the gaskets without support ring are
very sensitive to unacceptable deformation and should NOT be used. The coupling is made for welding
to pipes of 25.0 mm to 101.6 mm outside diameter.
Pressure rating:
size (mm) 25 38 51 63.5 76.1 101.6
pressure without support
ring (bar) 20.7 20.7 17.2 13.8 13.8 13.8
pressure with support ring (bar) 48.2 48.2 34.4 20.7 20.7 20.7
Remarks:
The coupling is the most easily cleanable in-place of a large number of types tested. There also exist
an expanded version, although that version is only slightly less easily cleaned in-place, it is not
recommended because factory experience has shown that it is relatively easy to trap product, water
and soil between coupling and pipewall. Also, in practice, the quality of expansion joints look very
different from model joints. Gaskets without support ring should not be used as it may easily be
displaced during assembling.
The special metal-T gaskets are to be preferred as they do not only provide a relatively smooth inner
surface at the seal, but also protects the rubber against excessive compression. Moreover, they cannot be
misaligned.
Safety note:
These couplings should not be used for applications requiring frequent dismantling because the
trapezoidal screw threads are sensitive to mechanical damage.
REFERENCES:
Description:
This coupling is designed specifically for cleaning in-place. It meets the US 3A Standard and has been
approved by the International Association of Milk Sanitarians, USPHS and the Dairy Industry
Committee. It is available for both welding or expanding to pipes of 25.4 mm (1.0 inch) to 101.6 mm (4.0
inch) outside diameter. The male and female ferrules, available for welding and expanding, are drawn
together by a hinged clamp on to a gasket which may be of silicone, PTFE or Viton.
Pressure rating:
size (mm) 38.1 50.8 63.5 76.2 101.6
pressure (bar) 22.4 22.4 20.7 13.8 13.8
Remarks:
The expanded version is not recommended because factory experience has shown that it is easy to
trap product, water and soil between coupling and pipewall.
The coupling with a PTFE gasket is not recommended because it may not remain crevice-free and
bacteria tight due to cold flow problems with PTFE.
SAFETY NOTE
The hinged clamp may be secured by a nut and bolt or toggle for quick opening and closing. The
toggleclamp is not recommended because it can accidentally or inadvertently be released resulting in
the discharge of the contents of the pipeline which may cause serious injury.
metal stop
Description:
Couplings to this design for both
cleaning in-place or regular dismantling
have been made in the US for many
years and comply with U.S. Public
Health Service (USPHS) requirements.
The two identical taper-flanged ferrules
are drawn together by a hinged clamp
on to a gasket available in various
materials, depending upon process
temperatures.
small diameter coupling
(4-15 mm)
The couplings are available for both metric and imperial pipe sizes ranging from 4 mm to 150 mm (1/4 inch
to 6 inch).
Pressure / temperature ratings with Buna N gasket and nut tightened to a torque of 2.8 Nm:
Remarks:
The welded version of the coupling was found from tests to be as cleanable as the ISO 2853 type
screwed coupling and is therefore suitable for clean in-place. The coupling is steam sterilizable and
bacteria tight if assembled properly.
Hygienic Note:
From a hygienic design point of view, the design is not optimal. The alignment is obtained by the
elastomer ring and for the larger diameters (from 15 mm) there is no metal to metal stop.
Safety Note:
The hinged clamp may be secured by a nut and bolt or toggle for quick opening and closing. The
toggle clamp is not recommended because it can easily or accidentally/inadvertently be released,
resulting in the discharge of the contents of the pipeline which may cause serious injury.
Naue coupling
Description:
The coupling is made according to the ISO standard and is suitable for process pipes starting with a
diameter of 4 mm. The coupling halves are sealed by an O-ring in such a way that no crevices are
created. The coupling has as standard an EPDM O-ring, but any other material can be delivered upon
request.
Remarks:
The couplings are cleanable in-place.
In addition, the Naue coupling is sterilisable and bacteria-tight and can withstand high pressures (up to
100 bar).
O-ring couplings are preferably used for small diameter pipes, and for pipe couplings which are not
frequently dismantled. For the usual pipe sizes the other recommended couplings are to be preferred.
Note:
As the dimensions of the ring are very important it is recommended to use only the original O-rings as
specified by the suppliers.
elastomer ring
Description:
This insert can be used to replace the standard DIN 11851 gasket and is designed for cleaning in-place.
The insert consists of two separate parts, a stainless steel ring and an elastomer ring. The stainless
steel ring allows for location and hence, correct alignment of the two coupling halves and controlled
compression of the gasket.
The SKS insert can be supplied in the ranges: NW-sizes, NW 10 - 100 and inch-sizes 1 - 4.
There are two different stainless steel rings with a difference in height for the sizes NW 10, 15,
20, 50 and 100 and inch sizes 2 and 4. This is because of changes in some dimensions in the DIN
standard in 1976 and 1985. Specific changes are the outside diameter of the liner and a deeper groove
in the male part which can be measured easily. Please contact the supplier in case of doubts.
Remarks:
Note: The SKS insert is only recommended to replace the standard O-ring where DIN 11851 couplings
are already in use. The DIN 11851 coupling is not recommended for new plants.
Flexible tubing is frequently used to connect vessels, etc. Clamping of the pipe coupling must be in
such a way that no product can be trapped between the hose and the pipe tail piece (see below).
wrong correct
product residue
Clamps connecting flexible and rigid materials must be as close as possible to the product side, otherwise
product will become trapped between the flexible and rigid surfaces.
Hose liner
Description:
The outside of the flexible tubing is of Neoprene, the inside of Nitrile rubber which is smooth, non porous
and resistant to oil, fats and detergents. The hoses can resist 100°C permanently and can be
disinfected with steam up to 130°C for a short period. A reinforced type is also available to be used as
suction and pressure hose.
The working pressure of the non-reinforced execution is 7 bar overpressure and 0.3 bar vacuum. The
metal-reinforced version too can be used up to 7 bar but can withstand a vacuum of 0.9 bar. The
flexibles can be supplied in lengths up to 40 m, with diameters between 25 and 100 mm. The pipe
couplings are available in stainless steel 304 or 316L .
Remarks:
A hose with 50 mm ISO couplings appeared to be well cleanable in-place. Avoid contact of an open end
with the floor to reduce the risk of contamination and damaging of the coupling halves. The supplier
provides special rubber protection rings to reduce the risk of damaging the couplings.
Hoses should only be ordered with recommended pipe couplings.
The use of Tee pieces and swept Tees with one branch blanked off should be avoided but they often have
to be installed in pipelines for the mounting of instruments, as sampling points or by-passes. These
applications result in a 'dead leg', allowing product to accumulate, and may create a microbial hazard
during production or present difficulties, particularly during cleaning in-place.
A 'dead leg' of a Tee piece can be cleaned in-place more effectively if it faces the direction of flow of the
cleaning fluid and its depth is kept to a minimum (see figure 5.5.4.1below).
Wrong Correct
Figure 5.5.4.1 It is much easier to clean the dead legs on the right than those on the left
Under these conditions, ‘the dead end’ can be cleaned with a mainstream velocity of 1.5 m/s. If product
becomes tightly packed in the 'dead leg', higher flow rates and cleaning times may be necessary.
For insertion of probes, the ‘dead end’ of the Tee-piece or swept Tee must have a maximum
length of 28 mm. This is the minimum length that can be obtained, so that a coupling, male part
can be included and attached by orbital welding.
Swept Tees are easier to clean in-place than the usual Tee pieces. The use of swept Tees therefore is to
be preferred. So far, there seems to be a limited number of manufacturers of swept Tees.
Title 5.5.4.2 Tee Piece with Blank Branch and Swept Tees
‘stagnant product’
28 mm
28 mm
Description:
A standard Tee piece or swept Tee, in the size range 25.4 mm (1.0 inch) to 76.2 mm (3.0 inch) outside
diameter tube, can be modified to give a 'dead leg' depth of 28 mm. This is the minimum length that can
be obtained, so that an ISO 2853 coupling, male part can be included and attached by orbital
welding.
Remarks:
The 'dead leg' of a Tee piece can only be cleaned in-place properly if it faces the direction of flow of the
cleaning fluid and its depth is kept to a minimum. Under these conditions, it can be cleaned with a
mainstream velocity of 1.5 m/s even though the fluid velocities in the 'dead leg' are substantially lower. If
product becomes tightly packed in the 'dead leg', higher flow rates may be necessary but if the
standard depth of a Tee piece forms the 'dead leg', it may be necessary to double the mainstream fluid
velocity and the circulation time to clean it.
Sub-Paragraph
Homogenisers, piston pumps, and sometimes other equipment, may cause pulsations in process
lines, detrimental to components like measuring devices plate heat exchangers, etc. Damping of the
pulsations may be needed to avoid damage.
The usual pulse-damping devices (Fig.below) contain large areas where product may remain stagnant for a
very long time, thus creating a source of microbiological problems (1, 2) .
Damping devices should be so designed that they do not cause microbiological hazards.
Sub-Paragraph
air connection
Bredel
Description:
The Bredel model PD dampener consists of a reinforced tube of natural (NR) or Perbunan (NBR) rubber
and has an air chamber of which the pressure is adjusted to 95 % of the minimum working pressure of
the pump. They can be delivered for pipe sizes of 40, 65 and 100 mm.
The DMT (Burdosa) pulsation dampener consists of a flexible tube (FPM elastomer), a hydraulic
chamber filled with glycerin and an air chamber. Both chambers are separated by a flat membrane. It
can be sterilized at temperatures up to 140°C.
Dampeners can be supplied for pipe sizes of 32-100 mm diameter.
To improve the cleanability of the connections between the flexible tubing and couplings, a modification
has been made. The manufacturer has adopted the modification for devices to be delivered to Unilever
Companies. The apparatus is available for maximum pressures of 10, 25 and 40 bar.
Remarks:
Important: when ordering the DMT dampener, please state 'according to Unilever modification'.
The Bredel pulsation dampener is recommended with a NBR hose and can be used in combination with
the recommended Bredel hose pump (see 5.7 Pumps). It is, however, not entirely smooth at the
product side and must be inspected regularly.
The dampeners have to be ordered with the recommended pipe couplings (see 5.5.2).
Sub-Paragraph
air cylinder
membrane
Description:
The working principle is a rubber diaphragm with a balanced load of compressed air on one side and the
product on the other side. The flat circular diaphragm is mounted between two stainless steel flanges in
a stainless steel housing. The only moving part is the rubber diaphragm which, in the center, is
attached to a guiding shaft and conical valve seat (see picture) . The product inlet is tangential to
improve cleanability and the outlet is positioned in the center and can be closed by the conical valve
seat.
The ratio of product volume to air is 1:10. The varying product pressure moves the diaphragm which
moves the attached guiding shaft to create an electronic signal for controlling the feedpump, return flow
or the filling machine. The pneumatic pressure is set equal to the product pressure upstream from the
compensator. An interrupted flow downstream from the compensator will create an overpressure and the
diaphragm will move and offer accumulation space. When overpressure decreases the air-pressure will
move the diaphragm back and discharge the accumulated product. A constant system pressure and
flow is maintained.
The product contact surfaces of the housing are of stainless steel AISI 316L and the diaphragm is made
of black foodgrade NBR, complying FDA regulations and 3-A standards.
Remarks:
Maximum operating limits:
The compensator is hygienic and cleanable in-place and in addition also impermeable to
microorganisms and therefore also suitable for aseptic applications.
Chapter 5. 7 Pumps
Sub-Paragraph
Pumps for the food industry should meet rigid hygiene requirements.
Pumps with moving-shaft passages generally allow micro-organisms to enter the product. In case of a
rotating shaft, double shaft seals may prevent this. Reciprocating shafts are extremely difficult to clean and
sanitize. Diaphragm, peristaltic pumps and magnetically driven pumps have no shaft seals and thus can be
expected to prevent penetration of micro-organisms completely. The cleanability of peristaltic pumps may
diminish with time due to ageing or erosion of the flexible hose. Moreover - if improperly designed - the joint
between the hose and the steel connection may cause microbiological problems.
Diaphragm pumps usually incorporate a sharp crevice where the diaphragm is clamped in the housing. In
magnetically driven pumps the distance between inner and outer magnet must be very small and therefore
such pumps always have a narrow space left between the housing and the (inner) magnet. Unless special
precautions have been incorporated, this creates stagnancy and makes cleaning in-place difficult if not
impossible. Wrongly designed diaphragm pumps and magnetically driven pumps may thus also be difficult
to clean and hence to decontaminate.
Some pumps are not suitable for the flowrate required for cleaning of the process line, which usually is
several times higher than the production flowrate. In such cases the use of a by-pass is required. To
ensure that the by-pass does not present a microbiological risk during production, it must be free from
dead spaces. This valve can also be used as safety valve for positive pressure pumps.
Fig. 5.7.1 shows the wrong way of bypassing; Fig. 5.7.2 the correct way. The valve shown in Fig. 5.7.2 is
a dead space-free valve. For aseptic lines a diaphragm valve would be adequate; for non-aseptic (but
nevertheless hygienic) lines, lipseal valves may be used.
Fig. 5.7.1. Wrong way of by-passing a positive pump, Fig. 5.7.2. Dead-space free bypass of a positive which,
moreover is not drainable pump which is drainable.
If the requirements of a process are such that a non-recommendable pump cannot be avoided, special
measures must be taken (such as dismantling for manual cleaning) to ensure proper cleaning. Regular
inspection of the effectiveness of the measures taken is essential.
Centrifugal pumps
Most centrifugal pumps have a shaft passage. This results in a risk of penetration of microbes from the
outside to the product side. Also, such pumps will cause leakage of product and microbes growing in such
product may subsequently re-infect the product in the pump. The design of shaft seals often is such that it
incorporates crevices which make such pumps difficult to clean and moreover cause stagnancy of product
even during pumping. Some manufacturers have improved designs by e.g. double mechanical seals. If the
space between the seals is properly flushed e.g. with sterile condensate, steam or another antimicrobial
fluid, this may prevent the accumulation of product between the seals and thus eliminate the penetration of
microbes to the product in the pump.
If required, centrifugal pumps should be mounted in such away that they can be drained (see drawing
below).
Piston pumps
Piston pumps have the major disadvantage that the product-contacting piston is moving in and out of the
product area. In this way it transports product to the non-product side where it may accumulate and enable
micro-organisms to multiply. Subsequently the piston may convey the micro-organisms to the product
side.
Piston pumps usually need valves (incorporating springs) which often badly affect cleanability. Also a part
of the walls of piston and cylinder is usually permanently in contact and thereby difficult to clean.
- limit the possibilities for growth, e.g. by application of a double shaft seal with a bacteristatic or
bactericidal liquid in between. In addition, the stroke of the piston must be shorter than the distance
between both seals
- avoid valves, e.g. by using a reciprocating/turning piston ;
- improve cleanability, e.g. by improved valves and seals, avoiding permanent piston/cylinder
contact (free position of piston during cleaning)
Chapter 5. 7 Pumps
Sub-Paragraph
Description:
The pumps mentioned have mechanical seals but can also be obtained with special double seals for
aseptic applications.
Remarks:
To make sure that no liquid remains in the pumphousing, the pump outlet must be at the lowest point of
the pump housing.
Chapter 5. 7 Pumps
Description:
The Burdosa tubular pump basically consists of a flexible
hose (diaphragm) in a sealed chamber, the space between
them filled with the pressure transducing liquid, that is
connected to a normal piston pump. Inlet and outlet are
provided with recommended non-return valves.
Remarks:
The Burdosa pump is bacteria-tight. The in-place cleaning is
difficult due to restricted cleaning velocity. So cleaning
requires a long time or need to be done by hand. After
cleaning and re-assembling the pump can be pasteurized
membrane easily.
non return
valve
Chapter 5. 7 Pumps
Description:
The hose pump of Bredel type SPU (improved model) consists of a reinforced tube which is alternatingly
closed by two sliding shoes.
To reduce friction of the sliding shoes the rotor is running in a glycerin bath. The hose is made of
Perbunan (nitrile rubber, NBR) or natural rubber (NR). NBR is resistant to oil and is fully complying with
both the German Health Regulation (22nd year, par. 21, category 3) and the American Food & Drug
Administration (FDA)(category 3).
Under mechanical pressure, temperatures up to 80°C are allowed. The maximum pressure is 15 bar.
However, means have been provided to relief the pressure from the hose by turning the sliding shoes in
such a position that they are free from the hose. In this way the hose can easily be flushed with hot
water, steam or cleaning agent.
The peristaltic pump is available for capacities of 65-60000 l/h depending on counter pressure and
temperature. The life time of the hose varies from 1000-8000 h depending on the conditions of use.
Remarks:
The pump type SPU with the NBR hose, supplied with the recommended couplings is cleanable in-
place and bacteria-tight. As lubricant 95% of pure glycerin (Unichema; Pricerine) supplemented with 5%
glycol- 400 is recommended.
The pump with the retractable shoe can be steam sterilized in-line.
The retractable shoe is not standard and should be specified when ordering.
The pump can be used in combination with the Bredel in-line pulsation dampeners (see 5.6).
Chapter 5. 7 Pumps
Description:
The Bran & Lübbe is a low pressure piston pump. The original design has a piston sealed by a
compressed chevron packing situated in such a way that soil accumulates between packing, piston
and pump housing. Moreover, the valves were not in-place cleanable. A ‘new design’ has Garlock seals
and improved valves.
The high pressure Euwe pump (drawing 62 07 17 A) is provided with Bran & Lübbe non return valves.
Remarks:
The ‘new design’ Bran + Luebbe pump showed in practice accumulation of soil in the barrier space.
The improved Euwe pump is cleanable in-place. The space behind the pistons can be flushed with an
antimicobial fluid (see 6.1.2 ABS).
Chapter 5. 7 Pumps
Description:
The APV DW pump replaces the Microbeclean and Cleanline pumps. All shaft seals are identical and
access to the shaftseals is achieved by removing the front cover and the rotors. Two different rotor
designs are available: bi-lobe or rotary pistons with two wings. The pump can be provided with a single
or double mechanical seal.
The lobe rotors of the Johnson SQ pump are retained from outside the pump housing to improve
cleanability. The seal of the front cover is crevice free mounted and its compression is controlled.
Double and single mechanical seals are available of which the latter can be flushed for aseptic
applications.
The rotors of the Waukesha pump are arc shaped. The pump can have ‘twin wing’ rotors and ‘single
wing’ rotors which are used for fluids with discrete particles. Single and double mechanical seals are
available in carbon, ceramic, or silicon carbide.
Remarks:
The APV DW, Johnson SQ, Waukesha and ITT Jabsco have been successfully tested for in-place
cleanability according to the EHEDG method. These pumps are therefore recommended for hygienic
process lines.
Chapter 5. 7 Pumps
Description:
The Dresser mono pump has been designed in cooperation with Unilever. A prototype has been built
and tested for practical performance with positive results.
The flexishaft ,which is made of stainless steel 431, has a food approved HALAR coating. Stators are
available in natural rubber, Nitrile and high Nitrile rubber. The pump is suitable for temperatures up to
110 °C and can be provided with a single or double mechanical seal of Huhnseal.
Remarks:
To improve drainage of the pump the inlet and outlet must be placed excentric.
Chapter 5. 7 Pumps
Description:
The Maso Sine pump has a sinusoidal rotor in which two sine curves create four separate pumping
compartments. A sliding scraper gate prevents product to return back to the suction side of the pump.
As the volume of the compartments never change in size, compression of product is eliminated
resulting in less shear to the product to be pumped. The pump can be equipped with various types of
mechanical seals
The Mouvex pump type S has a hermetically closed elastomer sleeve as shaft seal. The shaft of the
drive pump does not rotate but makes a planetary movement with a radius of 10 mm.
Remarks:
The manufacturer of the Maso pump claims that it is cleanable in-place, however, if the results are not
satisfactory, the pump has to be cleaned manually.
The Mouvex is self priming and suitable as metering pump. It can easily be opened for manual cleaning
or inspection.
Chapter 5. 8 Sensors
Description:
Remarks:
Visual evaluation of the Varivent switch justifies recommendation for use in aseptic and hygienic
process lines as the design is entirely based on design principles of other Tuchenhagen Varivent
equipment, tested with good results.
When ordering Tuchenhagen equipment the ordering number must begin with U 1, followed by the
typical equipment number.
Chapter 5. 8 Sensors
The flow measuring devices most frequently used by the food industry are listed in order of
decreasing cleanability:
- Ultrasonic (external)
- mass flowmeter;
- electromagnetic flow meter;
- tapered metering tube;
- positive displacement meter;
- turbine flowmeter;
- measuring flange with bypass meter.
Turbine flowmeters, positive displacement meters and measuring flanges with bypass meter are not
recommended for food process lines because they are very difficult to clean and sterilize.
Chapter 5. 8 Sensors
Micro Motion
E&H Promass I
Description:
The coriolis mass flowmeter measures flow rate directly in terms of mass with indication in pounds,
kilograms or tonnes. The meter includes a balanced oscillating system consisting of a metering tube or
two tubes which are oscillating at their natural frequency. One sensor is mounted at the inlet side of the
sensor and one at the outlet. The straight tube design is preferred over the two tube one. Various
designs of the straight tube are available, e.g. U-shaped, S-shaped and even B-shaped, but the
measuring technique employed remains the same. The straight tube design is compact, drainable and
easily cleaned. The Danfoss MASS 1100 is a 2-pipe system while the 2100 series is a 1-pipe system
which is self-draining and easily cleanable in-place.
Remarks:
The mass flowmeters are cleanable in-place and can be steam sterilized. The flowmeter should be
ordered with the recommended pipe couplings (see 5.5.2).
Chapter 5. 8 Sensors
The Krohne IFS 6000 meter has an FDA approved PFA liner and Hastelloy C4 electrodes. The
electrodes are mounted spring loaded to provide a leakage free seal. Other electrode materials are
delivered on request. The meter is resistant to vacuum and temperatures up to 140°C. The meter can be
supplied in sizes from DN 2.5 to DN 80.
The Endress & Hauser, Promag H has a PFA liner in which two electrodes are mounted. These
electrodes are spring loaded to provide a leakage free seal. The meter can withstand temperatures up to
150°C. The meter is available in pipe sizes between 25 and 100 mm.
The Danfoss MAG 1100 FOOD flowmeter is equipped with aluminum oxide (Al2O3, ceramic) liner. Two
platinum electrodes are mounted brazed to the liner by gold/titanium brazing alloy. The standard meter
can withstand temperatures up to 150°C . The meter can be supplied in sizes from DN 15 to DN 100.
All meters can be supplied with various types of hygienic couplings (see 5.5.2).
Note: Magnetic induction flowmeters with a PTFE liner are NOT RECOMMENDED.
Chapter 5. 8 Sensors
- load cell;
- microwave;
- ultrasonic detector (external);
- photoelectric cell;
- pressure transmitter;
- ultrasonic detector (internal);
- capacitance level detector;
- conductance level detector;
- gauge glass.
The load cell is the best system because it does not affect the product side. A few manufacturers of load
cells are listed below:
The next best measuring technique is microwave. Microwave or radar level measurement is a non-contact,
reflection based technique using electromagnetic energy to detect the level. The sensor can be mounted
non-invasive and non intrusive by means of measuring through a low dielectric constant window or plastic
material on top of a tank.
Gauge glasses are not recommended for the food industry because they create stagnant areas where
bacteria may grow and are very difficult to clean.
Chapter 5. 8 Sensors
Description:
The Endress + Hauser electrode (1) is meant for level control of
vessels. The metal PTFE-insulated electrode forms, when
introduced into a metallic vessel, a capacitor between the probe
and the vessel wall. The dielectric constant of the air or gas in
an empty vessel is approximately 1. When the vessel is filled,
the air or gas is displaced by the product with a higher dielectric
constant value. The capacity between the wall and probe will
therefore increase and this change in capacity is used for level
measurements or switch point.
The variation in capacity can be measured with the E&H
Multicap DC 11 (1). Only the DN50/PN40 flange mounted type
should then be used.The rigid electrodes can be supplied in
lengths from 1000 mm to up to 4000 mm.
Remarks:
Some liquids and foam may adhere to the PTFE insulation causing further product build-up and thus
affect the hygiene, cleanability and the accuracy of the measurement (2). The same holds for the
occurrence of condensate on the electrode. This should be borne in mind when selecting a level
electrode.
For these reasons it is strongly recommended to use load cells instead (see also the general page
5.8.3.1 of this chapter).
REFERENCES
1. Manufacturers' catalogue 1999.
2. Manufacturers' publication: Food & Beverages, Measurement and Automation, ISBN 3-9520220-2-0
Chapter 5. 8 Sensors
X 2:1 Description:
The level limit switch is intended for direct use in storage
tanks and mixing vessels containing liquids.
The sensor takes the form of a tuning fork which vibrates
at its natural resonant frequency in air. When the tines
X
O - ring come into contact with the product, this will result in
frequency change. This change is detected by an
electronic module and used for switch-point. The level
switch requires no maintenance since it has no moving
parts.
The density of the products must be greater than 0.5
g/cm3. It operates reliably up to a viscosity of 10000
mm2/s and even with high deposit formation. The
temperature range is from -40 till 150°C and pressures up
to 40 bar. The length of the fork is 100 mm.
Remarks:
The Liquiphant should be mounted in the special hygienic welding socket of Endress + Hauser or
mounted in a Tuchenhagen Varivent flange.
The Klay and Vega switches should only be used with the Tuchenhagen Varivent or APV Delta flanges
or mounted on a T-piece with recommended pipe coupling (see 5.5.2).The level switches are cleanable
in-place and can be steam sterilized.
Chapter 5. 8 Sensors
KDG
membrane
Description:
The hydrostatic level transmitters measure pressure differences by means of a metal diaphragm welded
to the body. A sensor converts the pressure into an electric signal which is then used as a direct
indication of level.
Remarks:
The KDG and Holledge level transmitters are bacteria-tight, cleanable in-place and sterilisable.
The KDG transmitter is damaged if subjected to vacuum.
The pipeline application of the transmitters has not been evaluated but is expected to be problematic
as the mounting on a T-piece would create annular crevices which are difficult to clean.
Chapter 5. 8 Sensors
Description:
Ultrasonic level measurement is a non-contact technique; the only possible product contact part is the
sensor emitting membrane. The sensor is mounted on top of a tank with the membrane at the product
side. The sensor emits an ultrasonic pulse downwards and receives an echo from the surface of the
product. The time between emitting and receiving the pulse is directly proportional to the distance
between the sensor and the product surface (level).
Remarks:
When using ultrasound for level measurement, the following points should be considered:
- Ultrasound requires air or gas for transmission and therefore this technique is not suitable for vacuum
applications.
- Pressures above 3 bar can restrict the mechanical movements of the sensor membrane.
- High temperatures limit the use of ultrasound; therefore temperature change compensation should be
used.
- Care should be taken in processes with CO2; this gas is a very poor transmitter of ultrasonic energy.
- The presence of foam on the surface will result in reduction of the reflected energy and accuracy.
- There is a so-called blocking distance in front of the sensor in which no measurement can be done.
- The system may not be suitable for small tanks (up to 10 m3) due to the bounce back effect;
recommended for >500 m3 tanks.
Chapter 5. 8 Sensors
Many processes require frequent pH-measurement so that a continuous measuring system is preferable
over frequent sampling. Most commercial pH-probes constructed for mounting in the walls of vessels and
pipelines cannot be recommended because their dead spaces create stagnant areas and hamper
cleaning. Examples are shown below.
Chapter 5. 8 Sensors
30 mm
Description:
In the aseptic housing of Mettler Toledo, the pH electrode is sealed by an 0-ring which is deformed by
tightening of a nut to get a seal as close as possible to the product side. The housing is suitable for
(gel) filled pH electrodes with an insertion length of 120 mm (head with PG 13.5 screw thread) and
diameter of 12 mm. The assembly can be welded directly onto a tank or be welded onto a flange (e.g.
Tuchenhagen Varivent flange).
Remarks:
The Mettler Toledo type Infit 761-19BT/90 electrode assembly is in-line sterilizable, bacteria-tight, and
can easily be cleaned in-place.
The housing is also suitable for p O2 probes of Mettler Toledo.
The Mettler types CIP/70 and CIP/TC incorporate large dead areas, which in practice will be less
cleanable.
* The Endress & Hauser retractable electrode assembly is not suitable for products with particles.
Unilever 1999 104 Not to be copied for third parties
Hygienic Plant Manual
Chapter 5. 8 Sensors
Durafet pH electrode
Description:
The Metller type Inpro 3000 glass gell filled electrode is sterilizable and can withstand pressures up to
4 bar. The electrode should be used in combination with the Elscolab housing (see 5.8.4.2).
The Honeywell Durafet electrode has an ISFET sensor and is in principle unbreakable. The electrode
has a reference electrode and a temperature sensor build in. It can withstand 130 °C for a short period.
the body is made of polysulfone (in compliance with FDA ).The sensor is available for 1.5, 2, and 3 inch
tri-clamp couplings.
Remarks:
pH electrodes must be calibrated at regular time intervals. It is therefore recommended to remove the
electrode from the housing directly after production and to calibrate and insert it after the CIP cleaning
just before production.
Chapter 5. 8 Sensors
Most of the pressure gauges were originally designed for general industrial use rather than for the food
industry. Bourdon gauges and membrane types with membrane chamber are considered unsuitable for
the food industry because they cannot be cleaned internally.
Membrane-type gauges without a chamber are more suitable for food processes. The membranes in these
gauges are corrugated or tubular. The tubular types can only be mounted in pipelines causing hardly any
dead spaces. The more frequently applied corrugated membranes always require a T-piece, which may
cause a dead space (see 5.5.4 Tee pieces).
Membranes are made from stainless steel, rubber or PTFE. In most cases, they are clamped between
flanges. Stainless steel membranes are sometimes welded to the meter body, so that no flanges need to
be used and a crevice-free device is obtained.
Chapter 5. 8 Sensors
4 6
Description:
2 8 The housings are made of stainless steel. The product side of the gauge
corresponds to the male part of a coupling, closed with a welded stainless
steel diaphragm.
0 10 The standard size is 38 mm (1.5 inch). Special sizes, couplings or gauges
for high pressures can be supplied on request.
The flange type gauges have stainless steel AISI 316 membrane welded to
the flange and a elastomer gasket to clamp the gauge to the flange of a
vessel or an in-line housing (e.g. Tuchenhagen Varivent).
Remarks:
The gauges are bacteria-tight and sterilizable. When correctly mounted in a process line, they are also
cleanable in-place (see 5.5.4 TEE pieces), provided the flow of cleaning liquid is directed at the
membrane.
The gauge has to be ordered with a recommended pipe coupling (see 5.5.2 Pipe Couplings).
Chapter 5. 8 Sensors
Description:
The pressure gauges are designed to perform pressure measurements without contact between
process liquid and gauging mechanism and without causing obstructions in the process line.
The Labom and Armaturenbau gauges have stainless steel tubular diaphragms which are welded to the
outer pipe on inlet side and outlet side.
The instruments can be fitted with a direct-reading gauge or with different types of pressure transducers
or switches.
Remarks:
The Armaturenbau and Labom gauges are bacteria-tight, sterilizable and cleanable in-place. They are
recommended particularly when highly viscous products or solids-containing products must be
processed.
The Labom gauge can be delivered with an overpressure protection.
Chapter 5. 8 Sensors
Sight glasses are used where visual check points are needed to monitor e.g. the turbidity, colour or flow in
a process line, or the product level, foam, etc., in a vessel. Because of the risk of breakage the use of
glass has to be reduced to a minimum e.g. plain sightglasses may not be reinstalled after replacement of
gaskets as the glass may break due to internal stresses. However, in those cases where visual monitoring
is still required plastic sight windows or metal fused windows can be applied.
Metal fused sight glasses are better pressure and impact resistant than plain sight glasses and can be re-
used after replacement of gaskets. In addition, metal fused sight glasses can be provided with a metal stop
to prevent over compression of the elastomer.
Sight windows must be crevice free and mounted in such a way, that cleaning in-place is possible.
On the next pages suitable commercially available sightglasses are discussed.
Chapter 5. 8 Sensors
space washer
Description:
The Tuchenhagen Varivent housing (type TXI) with polysulfone windows can withstand temperatures up
to 90 °C (see remarks), at a maximum working pressure of 10 bar.
Herbert Industrieglass and Canty can supply metal fused sight windows for all current applications.
Most commercially available flat sight glasses will be suitable for hygienic and aseptic process lines if
they are mounted as detailed in the Papenmeier picture. The standard Papenmeier "Lumiglass" light
sightglass Unit series SL consists of stainless steel flanges, gaskets, hexagonal setscrews and a
halogen light unit.
The Tuchenhagen cylindrical sight glass consists of heat and shock resistant glass, clamped between
two coupling halves. The sealing is performed by pressing rubber ring between two coupling halves and
glass in such a way that crevices are prevented. The sight glass is available in pipe sizes up to 150 mm
diameter, the maximum working pressure is 6 bar (for 150 mm sight glasses).
Remarks:
Tests have shown that polysulfone windows, as clamped in the Tuchenhagen Varivent housing, are not
suitable for aseptic processing as the edges swell and become untransparent. The standard glass
windows of Tuchenhagen must not be used as they can easily crack.
It is advisable to replace standard sightglasses which are in direct contact with consumer product with
metal fused sight windows (see also 5.8.6.4) or with polysulfone sight windows. They can be used as
replacement windows to fulfil the present Unilever policy to avoid contact of plain glass windows with
consumer products.
Metal fused sight glasses are much stronger (even bullet proof) than plain glasses and may be removed
for inspection and replacement of gaskets. Ordinary glasses have to be replaced after any
disassembly as they might break due to stresses incurred during bolting up.
The sight glass assembly is impervious to micro-organisms, sterilizable and cleanable in-place.
The Tuchenhagen cylindrical sight glass assembly is impervious to micro-organisms, sterilizable and
cleanable in-place. To prevent breakage of the glass, the clamps must be evenly tightened. The sight
glass should only be ordered with the recommended pipe couplings (see 5.5.2).
Chapter 5. 8 Sensors
The temperature in pipelines, tanks and food processing equipment is generally measured by a
temperature probe (thermocouple, bimetal, gas- or liquid-filled systems or resistance thermometer) placed
in a thermometer pocket. Sometimes probes are an integral part of the pocket.
The way in which pockets are mounted to process lines affects the hygiene of the line. The pockets should
therefore be designed very accurately. If the measurements required need not be very accurate, pockets
may be replaced by surface probes.
10
screw-
thread
dead end
Screw-type pockets mostly cause dead spaces, which are very difficult to clean, so that micro-organisms
may multiply.
If screwthread is at the product side, cleaning is almost impossible and sterilization will be extremely
difficult.
Chapter 5. 8 Sensors
Pt 100 connection
tube
O-ring
Mounting suggestion for a Pt 100 swept Tee with adapter piece for a temperature probe
probe
Description:
Pockets for temperature measurements in vessels or pipe lines can be soldered or welded. To prevent
corrosion, the pocket should be made from the same material as the equipment.
Brazing can be done with a silver alloy (approved for food contact application, see 4.3.1), but when there
is a possibility of corrosion, welded pockets are to be preferred. Seams have then to be smooth and
without pits.
The factory workshops probe for mounting on swept Tees (see 5.5.4, Tee Pieces) has been designed
and developed specifically for hygienic and aseptic applications to provide a robust, cleanable in-place,
temperature sensor.
The probes in the Labom tubular meter are mounted on the non-product side of the pipe wall. The
sensor is thermally insulated such that the ambient temperature has very little or no effect on the
temperature measurements.
From a hygienic point of view, the system is ideal for it does not affect the product side of the line. A
drawback is that, depending on the degree of turbulence, the temperature of the product contacting the
wall may be different from that of the product elsewhere in the line (1). This difference is greatly
influenced by flow-rate and product viscosity. The measuring system comprises a Pt-100 ohm
temperature resistance and an electronic measuring display unit. Pipes with diameters between 25 and
51 mm can be supplied.
Remarks:
If response time and accuracy are important, it is recommended to consult URL Vlaardingen for advice
on type of probe and direction of mounting of the probe in the equipment. The pockets should be filled
with a food grade glycerin or oil for better accuracy and faster response.
Cleanability of the Labom type E1232 surface probe is very easy because the inside is the same as that
of a straight pipe line. The unit is bacteria-tight, provided the recommended couplings are used.
Sub-Paragraph
In process lines, shaft passages of stirrers, valves, etc. must be sealed to prevent leakage. However, the
shaft seal does not prevent the ingress of bacteria able to spoil the product inside the line. Axially moving
seals constitute a higher risk of infection than rotary types. To reduce the infection risk, double seals may
be used. The space between both seals can be sterilized and flushed with a sterile agent or antimicrobial
fluid during processing (see 6.1.2 Antimicrobial Barrier Systems). If well-constructed, such a double seal is
indeed bacteria-tight.
Rotating shaft seals are mounted in pumps, stirrers, butterfly valves, etc. and axially moving seals in valves
with O-ring seals, lip seal valves, piston pumps etc.
For stirrers, an open construction (as shown on the left below) is often used. Compressed sterile air flowing
from the inside to the outside should prevent the ingress of bacteria. A disadvantage of such a system is
that any build-up of dirt, which may infect the product, can be removed only with great difficulty or not at
all.
A better alternative for hygienic vented tanks is the shaft passage/venthole shown on the right. In this
construction a perforated sheet is used to prevent the entrance of insects and there is a CIP connection to
clean the passage and shaft.
motor support
perforated CIP
sheet connection
vessel
Sub-Paragraph
wear resistant
barrier coating
space
lipseals
Description:
The seal consists of one or two stationary sealing rings, elastically pressed against the shaft. The
sealing ring is as close as possible to the product side to reduce the difficult to clean dead space below
this ring to a minimum. With a double seal, cleaning of the shaft is improved by flushing a cleaning
liquid between both rings. At a sufficiently high pressure the lower ring is opened while the upper ring is
pressed against the shaft.
Remarks:
To improve the live time of the seals, the chamber can be flushed with sterile water, glycerol or a non-
toxic antimicrobial liquid (see 6.1.2) which makes the seal also suitable for use in aseptic processes.
Besides, the shaft has to be provided with a wear-resistant coating, and be free from vibration, otherwise
the seals will be damaged.
Without special requirements, e.g. bearings at the lower end of the shaft, the seals can be used for
shafts up to 1.5 m in length and speeds up to 700 rev/min.
Sub-Paragraph
Description:
The HCU seal is used for light applications and consists of
one stationary ring, and a rotary sealring of carbon, silicon
carbide or tungsten carbide. The sealring is pressed against
the stationary ring by means of a spring, fully protected by a
rubber bellows. This bellows has a very smooth surface for
cleaning.
The BFU seal is used for light to heavy applications.
The BAU seal is a double mechanical seal of which the barrier
space can be flushed with an antimicrobial liquid (see 6.1.2)
Remarks:
The HCU seal should be ordered with a stationary seat type L
and a bellows type HC (see manufacturers prospect). Tungsten
carbide as rotary sealing is not recommended.
The nonproduct side of the HCU and BFU seal can be filled
with a food grade grease which has to be renewed at regular
time intervals
Sub-Paragraph
Spray devices are used to clean industrial tanks and are available as stationary and rotary types. The latter
are driven by the cleaning liquid itself. The spray devices must be mounted in such a way, that all parts of
the tank surface are reached and cleaned.
Most spray devices are able to clean tanks effectively but are not recommended because they are not
selfcleaning.
Sub-Paragraph
Description:
The Sani Midget rotating spray device is made of stainless 316 L, and
has a diameter of 45 mm . The construction is very simple, with only
one weld in the neck of the device. The spray device is delivered
without couplings, but with a pipe of 1 m length with a diameter of 25
mm (ISO 2037).
The impact cleaning radius is 1.4 m.
Alternatively the Toftejorg Sani Magnum device ( 65 mm) may be
used, which is of similar design but has a cleaning radius of 2 m.
For large diameter tanks more spray devices are needed.
The TJ 20G tank cleaner is used for vessel between 15 and 150 m3.
The flow of the cleaning liquid makes the nozzles perform a rotation
around the vertical and horizontal axis.
Remarks:
The cleaning efficiency is good, no dirt is accumulated on the device itself. A slope of 5º in the conical
part of the tube is essential for a proper rotation. Various spray patterns are available, but the 360 º
pattern is to be preferred. A mounting suggestion is shown in the figure.
The threaded and clip on versions are not recommended.
Though the TJ 20G is self cleaning and sterilizable, it is not advi sable to leave the device in the tank as
during processing, foam or product might block the gear wheels.
Sub-Paragraph
In-line (static) mixing is realized by stationary elements successively dividing and recombining portions
of a fluid stream.
Because there are many manufacturers of static mixers there seems little benefit in evaluating them all.
Therefore minimum hygienic requirements have been specified:
The clearance between the inner pipewall and elements must be about 1% of the inner pipe diameter. The
connections between elements should be welded without crevices. Pipewall sides of elements should be
rounded off. Surface roughness should be 0.8 µm Ra, elements should therefore preferable be electro
polished.
Well-designed static mixers require little maintenance and can be dismantled easily for inspection or
replacement of parts. For this reason, the mixers can be very hygienic and can be used for aseptic
processing.
Sub-Paragraph
Description:
The elements of the mixer divide the fluid stream into portions. At each set of
elements, these portions are recombined and divided again.
The mixers are made from stainless steel (AISI 304 or 316) in many sizes.
Remarks:
The mixers are steam-sterilizable and bacteria-tight .
Cleaning in-place is possible but it is more difficult than for a section of pipework
without elements, having a surface finish of Ra = 0.8 µm.
The soil between the wall and the outer rim of the elements is most persistent.
Therefore, regular inspection is recommended.
The mixers must be ordered with recommended pipe couplings (see 5.5.2)
Example of a hygienic
static mixer
Sub-Paragraph
Many commercially available stirrers for hygienic and/or aseptic processing do not fulfil hygiene
requirements. Usually they incorporate crevices or other dead spaces in which product rests may
accumulate (see picture below).
sealring
To avoid that bolted stirrer blades accumulate product rests they should be sealed with a food grade
sealant ( see 3.3.1.1)
Sub-Paragraph
Description:
Magnetically-coupled mixers are bottom mounted and have an inner and an outer rotor of magnets. The
magnets of the rotor inside the vessel are fully enclosed in a stainless steel housing to which the stirrer
blades are welded. Bearings are made of titanium or tungsten carbide, which are lubricated by the
product in the vessel. Cleaning in-place is possible because due to the open structure of the mixing
head.
They are available in different models for volumes between 10 and 30.000 litres.
Sub-Paragraph
Description:
The all-stainless steel stirrers are constructed in such a way that crevices are absent. The shaft
passage can be fitted with various types of mechanical seals (see 5.9.2) for hygienic sealing.
Remarks:
The stirrers can be fitted with a lipseal (Garlock) or mechanical seal (Huhnseal) for hygienic or aseptic
processing. The Garlock seal can be delivered with a spare-seals cassette to keep maintenance costs
to a minimum. The old seal rings can be cut away and new seal inserted without dismantling of the
stirrer assembly.
Sub-Paragraph
Sampling devices are used to remove material from closed systems. As during these handlings both the
process line and sample might get infected, precautions have to be taken to avoid this. These precautions
depend on the status of the line: e.g. for a hygienic line less stringent requirements apply as for an aseptic
line.
In case of a non hygienic sample tap, (see figs. 1 and 2) the apparatus is flushed with product before the
actual sample is taken, but for perishable products such devices are not suitable as the stagnant product
that is present in the open outlet of the valve will be infected by micro-organisms.
Stagnant product stagnant product
sample
container
product
tundish
To take samples from vessels via the manway, pre-disinfected/sterilized spoons or containers connected
to a chain are used. Such methods are in general not recommended as there is an increased risk of
contaminating the product.
A hygienic sampling device will not fully prevent the ingress of micro-organisms from the environment to the
product during sampling, but following the right procedure, the ingress of micro-organisms into the process
line will be limited to an acceptable level.
For hygienic sampling, a sampling device with a membrane, through which a needle is pierced, can be
used. The risk of infection with such a system is normally acceptable as the needle is exposed to the
environment for only a very short time. However, this method is less suitable for viscous products or
products with particles and the amount of sample is limited by the size of syringes available.
For that reason special hygienic or aseptic sampling valves have been developed which can be mounted in-
line. Those sampling valves do not have stagnant areas and have the possibility for cleaning and
disinfection to avoid that product rests from a previously taken sample have an influence on the sample or
process.
Aseptic sampling implies that during all modes of operations the process line and/or sample is protected
against recontamination from the environment.
For aseptic lines, the device should be easily cleanable, sterilizable and bacteria-tight.
More information about sampling can be found in the booklet ‘Sampling for Hygienic and Aseptic
Applications’ (SHE 45).
Sub-Paragraph
sample
needle
cap
elastomer
membrane
cotton
plug
product
Description:
The sampling devices are made from stainless steel and if properly mounted, they do not create
stagnant areas in which bacteria may grow. The Janz in-line and tank wall model has to be welded as
shown.
Remarks:
The product-side is in-line cleanable, sterilizable and bacteria-tight. The rubber membrane must be
disinfected, e.g. with an 70% ethanol-saturated cotton wad (for at least 10 min.), before piercing it with
a sterile needle for sampling. If one hole is used more than once, there is a risk of infection of the line or
tank. Leakages may also occur.
Sub-Paragraph
rinse connection
lipseal
actuator for hand and
remote control
sample outlet
Tuchenhagen hygienic sample valve TIU Tuchenhagen aseptic sample valve TIU
mounted on a tank wall
Description:
The Het Stempel sampling devices can be used for vessels and pipe lines. The valves are available in
non-insulated (type 55) and insulated executions (type 56). The dead volume at the product side is in
this design reduced to a minimum. The housing is of stainless steel. In case of the insulated version
(type 56) the housing is separated from the pipeline or vessel by means of a 2 mm thick sheet of
rubber. The only metal-to-metal contact is by two securing bolts and two small protuberances
preventing overtightening. In both executions there are two other valves permanently connected to the
housing to enable decontamination of the valve chamber, and the tube to the sampling vial prior to
sampling.
The Tuchenhagen Varivent sampling devices can be mounted on in-line housings or on vessels and
have no stagnant area at the product side. The valves are available as a flow-through type enabling
cleaning and disinfection.
Remarks:
Due to the thermal insulation, the Het Stempel type 56 taps can be steam-sterilized without difficulty,
even when cold product is flowing through the pipeline. Because of the insulation, a small dead space is
created, which might affect cleanability.
The Tuchenhagen sampling valve can be opened manually or by remote control. This makes it possible to
clean and sterilize the seat of the valve during an automated CIP and sterilization of the plant.
There is such great variability in the design of valves for controlling the flow of fluids and air, that it is
unrealistic to examine them all. However, they can be divided into two groups according to design
principles.
1. Valves without a shaft passage, e.g. membrane (or diaphragm) and pinch valves which can be
expected to prevent penetration of micro-organisms.
2. Valves with a shaft passage through the valve body which cannot be made bacteria-tight easily.
In addition, there are valves e.g. plug and ball valves which also retain an amount of product in the
hole of the plug or ball when closed. If the valve remains closed for some time, micro-organisms may
considerably multiply in that dead space.
If cleaning is to be carried out simultaneously with production, it is of utmost importance to ensure that
the cleaning agents do not contaminate the product. Therefore, more than one valve must be used
between the flow streams (block and bleed system). As normal valves tend to introduce relatively large
dead areas, mixproof or double-seat valves are recommended.
There is great variability in the design of valves but also in valve configurations, e.g. number of ports and port
connections etc. For this reason, a list of valve symbols is included to make this clear and also the specific
symbols will be used in the discussion of the individual valve types (see also 5.14.1.3 for examples).
Valve (general)
Membrane valve
Ball valve
Needle valve
Butterfly valve
Valve body
Valve
elastomer
membrane
Description:
The valve seat consists of a rubber ring, clamped between two flanges and has on both sides of the
shaft bushes of plastic or other materials to improve rotation. It is suitable for pressures up to 10 bar
and can withstand temperatures up to 135°C. The valve is controlled manually or by a pneumatic
actuator and can be supplied for pipe sizes of 25-100 mm diameter.
The APV butterfly valves have intermediate flanges which make removal possible without displacing of
the pipework.
Amri delivers multi-port butterfly valves in pipe sizes of 50 to 100 mm diameter. They are made of a light
alloy, epoxy coated with an inner lining of nitrile-K rubber and can withstand temperatures up to 110°C.
Special flanges are required to connect the valves to the pipe system. Drawings are available from URL
Vlaardingen.
Remarks:
Although the valve has a shaft seal, it does not allow penetration of micro-organisms as easily as valves
with an axially moving shaft, provided the rubber ring is undamaged and the recommended food-grade
grease is used.
For the same reason, the valve is not sterilizable although it can withstand sterilization temperatures.
Cleaning in-place efficiency is moderate.
Description:
The aseptic APV valve is very similar to the APV Rosista valve discussed in 5.13.1.4. The control part
is a cone exactly fitting the ground seat of the valve. The pneumatically activated valve can be adapted
to various capacities.
The hygienic Tuchenhagen valve is available in a wide range of flow capacities in pipe sizes up to 125
mm. The seals are made of FKM-Viton, HNBR or EPDM rubber.
Remarks:
When ordering APV Rosista valves the ordering number must begin with 009, followed by the typical
valve number.
When ordering Tuchenhagen equipment the ordering number must begin with U1, followed by the
typical equipment number
Description:
The APV Rosista Delta M4 valve has an elastomer diaphragm with at
the product side a layer made from TFM. Other seals are made from
HNBR or EPDM. Leakage can be detected easily as a drain is
connected to the non product side of the membrane. A large number
of types is available in pipe diameters up to 100mm. The maximum
pressure is 5 bar but valves with a higher pressure are available on
request.
Remarks:
The APV M4 valve replaces the types M3 and MF3 diaphragm valves.
When ordering APV Rosista valves the ordering number must begin with 009, followed by the typical
valve number. This ensures individual quality control and correct materials of construction.
For similar reasons, when ordering Tuchenhagen equipment the ordering number must begin with
U 1, followed by the typical equipment number.
FFPM (Simriz) is resistant to concentrated caustic acids and solvents and can withstand temperatures
between -10 and 200°C.
The Sisto-C valve is suitable as isolating valve for sterile processes and e.g. sampling systems.
APV DEU 35
Tuchenhagen type Y..L
Südmo D 630 U
(hygienic)
Tuchenhagen type X
(hygienic)
spray
APV Rosista Type M4.. connection
(aseptic)
Description.
As shown above, flow diversion valves are available in various configurations and number of ports.
Double-seat flow diversion valves have one double seal between the upper and lower part of the valve. The
space between the seals is open to the atmosphere to allow any leakage, to drain without any pressure
build up. Mixproof or double-seat valves have the disadvantage that during switching product enters the
leakage or barrier space. Dependent on the pressure and product viscosity this leakage can vary a lot in
volume. For this reason low-leaking or non-leaking valves have been developed.
Most valves can be provided with an extra CIP connection to clean the barrier space and/or be provided
with an extra actuator which can lift one seat over a very short distance enabling seat cleaning and barrier
cleaning during CIP of the valve.
Remarks:
If for pasteurizers, flowdiversion is applied the valve has to be equipped with an extra barrier to avoid cross
contamination. This can be achieved with one double-seat valve or two valves in series (see also 6.2.1).
When ordering APV Rosista valves the ordering number must begin with 009, followed by the typical valve
number.
For similar reasons, when ordering Tuchenhagen equipment the ordering number must begin with U 1,
followed by the typical equipment number.
Description:
The valves are available as stop valve with two or three ports. They can be supplied with recommended
food grade seals such as NBR, HNBR, FPM or silicone elastomer.
Remarks:
The valves are not bacteria-tight, but can be easily cleaned in-place. Accumulation of soil on the outside
of the shaft must be avoided.
The type of elastomer seal must be clearly specified, as in many cases manufacturers supply EPDM
as standard seal.
The Johanson valve should not be ordered with PTFE seal because dirt accumulates behind the seal,
making cleaning in-place impossible.
Südmo type D 620, low leakage, APV Rosista DE3, low leakage, LKM SMP-SC
waterhammer proof waterhammer proof spillage free
Description:
Mixproof valves are designed to separate process lines which contain different incompatible fluids, or to
separate cleaned and uncleaned parts of a plant. The valves have in closed position a double seal
between the upper and lower part of the valve. The space between the seals is open to the atmosphere
to allow any leakage to drain without pressure build up in the leakage chamber. Mixproof or double-seat
valves have the disadvantage that during switching product enters the leakage or barrier space.
Dependent on the pressure and product viscosity this leakage can vary a lot in volume. For this reason
low-leaking or non-leaking valves have been developed.
All valves can be provided with an extra CIP connection to clean the barrier space and/or be provided
with an extra actuator which can lift both seats independently over a very short distance enabling seat
cleaning and barrier cleaning during CIP of the valve. To prevent unwanted opening (water hammer) of
the valve during cleaning, pressure resistant mixproof valves have been developed. Mixproof valves are
also available as flow diversion valve.
Remarks:
For food product lines the valves have to be equipped with an extra actuator for independent seat
cleaning. In those cases where the valve is opened and closed during production the extra CIP
connection have to be used, to avoid drying out of product (which is later very difficult to remove) and to
avoid that micro-organisms can multiply in the barrier space and subsequently contaminate production.
The valves are cleanable in-place. The space between the valve seats, however, requires a long time to
be cleaned effectively.
To prevent unwanted opening of the valve due to pressure differences (water hammer) in the CIP system
the connection of the CIP supply line must be opposite the closing direction of the valve, or water
hammer proof (balanced types) should be used.
To avoid dead ends in vessels there are tank bottom double-seat valves that can be welded directly into
the bottom of the tank.
When ordering APV Rosista valves the ordering number must begin with 009, followed by the typical
valve number.
When ordering Tuchenhagen equipment the ordering number must begin with U 1, followed by the
typical equipment number.
Description:
The valves mentioned on this sheet are not recommended for hygienic or aseptic processing as they have
crevices which cannot be cleaned and disinfected in-place.
Overpressure protection devices are fitted in process lines to protect equipment against excessive
pressures.
The designs used in the food industry often do not meet hygienic standards. They are not designed for
easy cleaning, certainly not for cleaning in-place. There are two basic types: the relief valve and the
bursting disk (see 5.1).
In general the construction of relief valves is rather complex, and the seal is not designed to prevent
penetration of micro-organisms. They may leak slightly after having been opened once. Micro-organisms
may multiply in the leaking valve and cause infection of the line through backgrowth.
Overpressure protection devices should be designed and mounted in such a way that dead spaces are
reduced to a minimum, as such spaces complicate cleaning and inactivation of micro-organisms and gives
them the opportunity to multiply. To remove product residues, the atmospheric side of the device must be
cleanable as well, and thus be provided with two connections. During processing potable water or steam
must be used only at the atmospheric side, so that contamination of the product-side with detergents is
not possible.
Description:
The Het Stempel valve is provided with a Nitrile rubber membrane
and can withstand steam sterilisations at 140°C. The housing is
made from stainless steel AISI 304 and is available for pipe sizes
of 1" - 2 1/2" inner diameter.
A springclosed type can withstand pressures up to 45 bar, the
pneumatic type is suitable for pressures up to 80 bar. At the non-
product side there is a CIP connection with a Saunders
membrane valve.
From a hygienic point of view the APV membrane relief valve is similar to the APV Rosista membrane valve
(see 5.14.2.3).
They are made from stainless steel AISI 304 and are available for pipe sizes of 25-100 mm inner diameter.
Port positions can be made as desired. The valve is particularly suited for lines in which the valve is
frequently opened and closed.
Remarks:
The valve is bacteria tight, sterilizable and cleanable in-place provided flow of the cleaning liquid is directed
towards the membrane.
The pneumatically closed version is to be preferred as it can be opened easily for cleaning in-place.
The APV valve is easily cleanable. The membrane arrangement is bacteria-tight. To ensure cleaning of the
valve seat, the valve must be opened during cleaning in-place of the process line. It is recommended also
to install valves with two ports at the atmospheric (non-product) side, so that it is possible to flush product
away after opening during processing. (This should be done with potable water or steam, but not with
chemicals as product and cleaning liquid are only separated by a single seal!).
The valve must be mounted in such a way that it is self-draining and should be ordered with hygienic
couplings (see 5.5.2 Pipe Couplings).
The diaphragm should be inspected regularly, depending on conditions of use.
If the valve type number from the APV Rosista catalogue is preceeded by "009-", APV Rosista will
recognize that the Unilever execution is required, i.e. all valves will be inspected and checked for
smoothness (surface roughness 0.8µm Ra).
The construction of most non-return valves is such that cleaning in-place is impossible. An Example of
such an incorrectly-designed valve is shown below. To improve cleanability, the inside of non-return valves
should be streamlined and the number of moving parts be as small as possible.
The non-return valves described on the next page has only one moving part and its seals are as close as
possible to the product side.
Description:
The stainless steel non-return valves are designed such that there are no dead spaces and seals are
mounted as closely as possible to the product side.
They are available for various pipe diameters. The one inch version has a stainless steel ball, the larger
types have a stainless steel cone (see picture).
Remarks:
The valves can be cleaned and sterilized in-line.
Sub-Paragraph
Mandoors are available in various executions and can be mounted on top or in the wall of a vessel.
Size, shape and pressure rating varies on the application of use.
In selecting hygienic/aseptic mandoors the following should be checked:
- suitability for cleaning in-place
- elastomer seal should be as close as possible to the product side
- during opening of the lid, dirt from the non product side may not enter the vessel.
Unacceptable mandoor cover in open and Acceptable mandoor cover in open and
closed position closed position
Sub-Paragraph
Description:
Alfa-Laval as well as Zimmerling offer round and oval mandoors for both pressure and non pressure
applications in stainless steel 304 and 316L.
Hygienic/Aseptic mandoor
Sub-Paragraph
mechanical
product out medium out seal
product
in medium
in
scraper medium in medium product in
blade
All heat exchangers should be fully cleanable in-place and preferably drainable and accessible for
inspection.
Dead ends or crevices should not be present at the product side.
There must always be two gaskets between the product and heating or cooling medium, and it must be
impossible to build up pressure between these two gaskets.
Vibrations or resonance must be prevented to avoid screwed connections to be loosened.
Vents must be avoided.
Plates, tubing, welds in contact with product should be regularly checked for mechanical damage.
Internal bearings must be cleanable.
For aseptic processing double mechanical seals (with an ABS system) must be present.
Information about pasteurization and sterilization can be found in the EHEDG publications (see 9.1.2)
Sub-Paragraph
Description:
The Contherm is a vertically mounted scraped surface heat exchanger which can easily be inspected by
lowering of the rotor by means of a hydraulic lift. Working temperatures are between -35 and +150 °C.
The Contherm can be supplied with a Huhnseal double mechanical seal (see 5.9.3).
The Cartrix tubular heat exchanger has no seals between product and other media. It consists of a number
of cartridges with spiral shaped product ducts which fit in each other.
The hygienically improved Perfector of Gerstenberg & Agger is a scraped surface heat exchanger with one
double mechanical seal at the inlet side. The blades can easily be exchanged without removal of the
rotor. The Perfector can withstand pressures up to 120 bar.
Incapsa manufactures a corrugated multi tube heat exchanger in length up to 6 m. and are connected to
each other with pipe couplings. Materials of construction: AISI 304, 316 and 316L.
The Terlet Terlotherm is a vertical scraped surface heat exchanger capable to handle viscous products and
products with particles.
It has an inner and an outer jacket which are both scraped to improve heat transfer. The inner jacket is
welded to the bottom plate and has on top a shaft passage with a mechanical seal to which a cage
construction is welded which serves as support for the scraper blades.
Sub-Paragraph
vessel 2
steam
steam connection
supply tube
vessel 1 tank valve
A1
stop valve
B1 vessel 2
T temp. probe
E B2
vessel 1
A2 shuttle
valve
T Fig. 2
C
D
Fig. 1
product
A1
A2
B1 B2
Fig. 3 D
Sub-Paragraph
An antimicrobial barrier system (ABS) is any system which has been designed to prevent:
a) Migration of micro-organisms between two separate spaces.
b) Product build up at the non product side in which micro-organisms can grow and cause contamination.
c) The emission of micro-organisms into the environment for safety reasons.
For movable shafts, double mechanical seals are applied to protect a production batch from contamination.
Dependent on the product to be processed, the space between the seals is usually flushed which can be
done with steam, sterile condensate, hot (potable) water, food grade glycerol (low temperature applications),
edible oil, or an antimicrobial liquid.
Steam is used when the micro-organisms need to be inactivated. Condensate is used to prevent build up of
micro-organisms.
For aseptic applications the barrier must be pre-sterilized with steam, whereafter it is flushed with sterile
condensate of about 80 °C to destroy any vegetative micro-organism that enters the barrier space. Figure 1
shows a mechanical seal for steam and condensate flushing.
For hygienic applications and to lubricate the seal, hot water, an antimicrobial liquid, a food grade oil can be
used, or the space can be filled with a food grade grease.
The oil or antimicrobial liquid is circulated as shown in figure 2. The oil, anitimicrobial liquid or grease must,
depending on fouling, be refreshed at regular time intervals.
However, for many products, seal flushing can be done with potable hot water (figure 3). The hardness of the
potable water should be checked to control fouling.
The use of water with 0.3 % citric acid and 0.1 % potassium sorbate has proven to be an adequate
antimicrobial barrier liquid. The liquid is circulated and refreshed at regular time intervals.
The pressure in the ABS circuit must be lower than in the production line.
The Hygienic Processing team would be grateful if companies would inform us about any experience with
ABS they apply.
steam
water
ABS
cooling liquid
Sub-Paragraph
Remarks:
T2
To reduce the risk of contamination, the plates in
the regeneration section have to be checked on
flow diversion valves
the absence of pinholes at regular time intervals.
strainer If a double-seat valve is used, the barrier space
has to be flushed after each change-over (see also
Fig. 2 8.1.4.) to avoid product built-up.
balance tank
Design Requirements for Safe Continuous Pasteurisation Using Plate Heat Exchangers can befound on
our intranet site “http://vlisis.vl.u2488.unilever.com:8100/micropres/man_hyg/”
A special note highlights the main points to be considered using plate heat exchanger with flowdiversion.
In animations is shown how both above mentioned flowdiversion systems work.
In the EHEDG publications (see 9.1.2) also information about pasteurization can be found.
Sub-Paragraph
It is as easy to construct hygienic tanks as it is to construct tanks that are not hygienic. Long-term
experience has shown that hygienic requirements with respect to tank design has no influence on the
production costs.
Hygienic design:
Basic elements in hygienic tank design are the avoidance of dead spaces, sharp corners and narrow
recesses. In addition measures should be taken to prevent the entrance of dirt, foreign bodies, etc., see
Fig. 6.4.1. For cleaning in-place, the position, capacity and number of spray devices are important . Self-
evidently, tanks must be completely drainable and - to facilitate cleaning - have a smooth surface (0.8 µm
Ra; see 4.4).
Aseptic design:
For aseptic tanks, there are two additional requirements (as with all aseptic equipment), viz.
- sterilisability / pasteurisability
- imperviousness to micro-organisms.
Whether a tank must be pasteurisable or sterilisable depends on the application. In case steam-
sterilisability is needed, the tank must of course be sufficiently pressure and vacuum resistant.
In most cases, the tank will be subjected to approval by regulatory authorities.
Tanks may be obtained either or not vacuum-resistant. If not vacuum-resistant, it is essential to install an
underpressure safety device. Care must be taken that the supply of air to the tank in case of a sudden
vacuum is sufficient to indeed prevent a fatal low pressure inside the tank.
The following pages give examples of hygienic and aseptic tanks and suitable fittings. The necessity of
various fittings shown depends on the required duty of the tanks.
Fig. 6.4.1. VESSELS SHOULD BE DESIGNED AND POSITIONED such that the product is not
contaminated by dirt etc.
WRONG CORRECT
GOOD
Fence
BETTER
sealed
BEST mandoor
Powder
Venturi
Make-up Vessel
Sub-Paragraph
product
inlet (6.3.6)
shaft seals
mandoor (5.9.)
(5.15.2)
sightglass
(5.8.6.2) vent pipe (6.3.5)
sprayball
(5.10.2)
load cell
(5.8.3.1)
level
probe
(5.8.3.3)
insulation
(6.3.11)
baffle
(6.3.8) jacket
thermo
pH pocket
impeller (5.8.7.2)
probe (5.12.4)
(5.8.4.2)
Tuchenhagen
double-seat valve
(5.14.2.6)
LKM double-seat
bottom valve
(5.14.2.6)
load cell
(5.8.3.1)
Sub-Paragraph
overpressure
pressure gauge
safety valve
(5.8.5.2/6.3.7)
bursting disk (5.1.1)
double mechanical
seal (5.9.3) air filter
4 6
2 8
0 10 (5.3.1.2)
sightglass
(5.8.6.2)
spray ball
inlet valve (5.10.2) jacket
(5.14.2.3)
insulation
(6.3.11)
baffle
(6.3.8)
thermo
pocket
pH probe
(5.8.7.2)
(5.8.4.2) bottom
bearing
(6.3.9)
bottom valve
(5.14.2.3)
Sub-Paragraph
agitator drive
spray ball
connection
product
inlet
vent pipe
light-
lifting lug sightglass
man door
Sub-Paragraph
An U-bend can be used for the ventilation of hygienic tanks, preventing objects falling into the product. To
prevent insects entering the tank, an insect proof screen should then be installed at the outlet of the
ventilation pipe (see figure 6.4.6.1). The upstand of the venthole must be as short as possible to ensure
effective cleaning during CIP. The pipebend must be removed for manual cleaning.
To remove steam, hazardous gasses and other vapours , the installation of a fan as shown in the
arrangement below (figure 6.4.6.2) may be used.
Because of a positive flow through the fan and continuous ventilation of the head space via the spray ball or
a filter, fall of condensation in the tank may be prevented.
Figure 6.4.6.2 Sealed Mandoor with ventilation U-bend connected to a fan; example only:
To be able to clean the U-bend in-place, a spray device can be installed in the top of the U-bend to spray
the cleaning fluid on the internal surfaces of the bend. The bend can be cleaned in-place intermittently
during tank cleaning.
The following steps are shown in figure 6.4.6.3 below:
a. production
b. tank cleaning and
c. intermittent U-bend cleaning
CIP+
Figure 6.4.6.3 Arrangement for cleaning in-place of the pipebend and venthole
Sub-Paragraph
Sub-Paragraph
4
2 6
0 8
±28 mm
Sub-Paragraph
Inside diameter D
+- 0.1 D
10 - 30 mm
Uninterupted
welding around
baffle attachement
Sub-Paragraph
elastomer
seals
sleeve
bush
elastomer seals
location
pin
elastomer
seals
Sub-Paragraph
Varivent flange
Aseptic‘flowthrough’
valve with metal bellows
Sub-Paragraph
Insulation of tanks must be sealed with stainless steel cladding, preferably fully welded to prevent the
occurrence of crevices.
To detect leakage due to weld failures it is advisable to install a leak warning system.
WRONG CORRECT
WELD
Sub-Paragraph
To control microbiological hazard within the production area, the factory lay-out should
be designed according to the principles of risk separation.
For each production step the required level of hygiene must be determined and the lay-out of
production area should be based upon the physically separation of areas, according to the
microbiological risks during the different process steps.
The factory logistics must be in-line with the risk segregation.
Construction materials:
Materials in production areas must be smooth, easy to clean, impermeable and not transmit toxic
substances to food .
Any coating system must allow for differential expansion of the building structure.
Any glass that has to be used must be shatterproof or effectively shielded and comply with the unilever
glass policy
When selecting construction materials, specifications and performance should be clear,
compare supplier specifications
Plant layout:
Walls:
Paint coating
Cladding sheets, stainless steel, plastic faced
Ceramic Tiles with epoxy grouting
Process Floors:
Sub-Paragraph
Description:
Stainless steel floor drains and drainage channels of the above mentioned manufacturers guaranty a high
level of hygiene.
Drainage is achieved by laying the floor to falls. In general a slope of 1 in 80 is used.
The drains should have a removable basket to retain debris and have a water trap.
Drains should be embedded in the flooring system with a shrink free epoxy mortar and be sized to handle
the expected cleaning flowrates to avoid flooding.
Waste water should run from clean to other areas.
Drains should be cleaned at regular time intervals whereafter it can be filled with a disinfectant which is
flushed away after a few hours.
Sub-Paragraph
In food processing often there is a high level of reverberant noise due to concrete or tiled walls, ceilings and
floors, combined with noise producing machinery.
Acoustic absorption materials may be mounted to the walls or ceilings or suspended as baffles from the
ceilings.
To avoid the creation of microbiological problems, the materials must be cleanable and should not absorb
moisture or soil.
From a hygienic point of view, mounting of acoustic materials on walls is to be preferred. The use of baffles
or not fully sealed suspended ceilings is not recommended.
Although for maximal noise reduction, mounting of acoustic materials should be at some distance from
walls, to avoid the creation of places where insects, pests, etc. may proliferate, mounting directly on the
walls is preferred.
Acoustic panels will often be mounted on some sort of frame which could be made of hard plastic, painted
metal, aluminum alloy or possibly also galvanized steel. These panels will be cleaned in situ and as a
consequence, the frame must be resistant to the cleaning agent used, but also be hermetically sealed to
avoid the ingress of liquids. (for cleaning see 8.3.4).
Sub-Paragraph
Food conveyor belts are a constant source of contamination of the product and the difficulties of
maintaining them in a clean hygienic condition are well known.
Synthetic Material
A microscopic examination of synthetic conveyor belt material gives a good indication of its cleanability; this is
confirmed by the good correlation obtained between the bacteriological and microscopic assessment. Belting
having a smooth, impervious surface may be cleaned easily but belting made of canvas or cotton is most
difficult to clean (1).
Whilst many belts recommended for use in the food industry may be cleaned satisfactorily on the contact
surface, the edges often present problems.
Natural rubber
Natural rubber is also used in belting compounds, sometimes blended with other polymers (if in
compliance with the FDA requirements). Use temperatures of these in prolonged use conditions is
normally limited to 80°C.
Formulations:
The conveyor belting formulations are typical of the complexity of compounded rubber materials. A range of
components are included in such formulations each with a specific purpose. Certain components (cure
activators and accelerators) bring about controlled vulcanization (cross linking) of the polymer on heating at
processing temperatures. Other additives ensure processibility during mixing and curing. Reinforcing fillers are
included to increase the strength of the compounds. Anti-oxidants are present to prevent oxidation both during
processing and also during the use of the belting. Antiozonants are also added to provide protection of the
surface of the compound against attack by atmospheric ozone (ozone cracking). This can be a problem with
natural rubber and also nitrile rubber compounds.
The Malaysian Rubber Producers Research Association (MRPRA) has produced guidelines for the formulations
for natural rubber conveyor belts.
Remarks
Reinforcement of conveyor belt materials should never come in contact with product (see figure below).
HYGIENE RISK CORRECT
Reinforcement
As manufacturers may modify the design of their belts, it is recommended to ask for evidence of good
performance of belts currently offered and to inspect surfaces (top, bottom and edges) of samples
microscopically. Users are kindly requested to report adverse experience to the Hygienic Processing Team
at URL Vlaardingen.
Sub-Paragraph
Wooden pallets should not be used in production areas to avoid contamination as they support
growth of micro-organisms (moulds). In addition wooden pallets can generate splinters. Pallets originating
from a palletpool system can only be used to transport packed raw or packaging materials or packed
finished goods. Pallets must be inspected for damage and visible dirt (microbial growth) upon entering the
side.
As alternative for wood there are pallets on the market which are made from plastic, aluminum, galvanized
steel or stainless steel.
selection criteria for hygienic pallets are:
- solid design, without raised borders
- smooth surface (seamless welded)
- open structure, accessible for cleaning
- resistant to the required working temperature
Remarks:
To clean aluminum pallets a mild caustic detergent on base of silicates, e.g. SU 937 from Diversey-Lever
is recommended.
Stainless steel pallets are heavy in weight.
Section 8 Cleaning
Sub-Paragraph
The mean velocity of flow of the cleaning solution in a clean in-place system should be about 1,5 m/s. This
has been found to be the optimum velocity (1) for effective cleaning irrespective of pipe size in the range
generally used for the food industry.
It is important to ensure that the fluid velocity is maintained throughout the system by determining the flow
for the largest cross-section where practical. The benefits of using velocities greater than 1,5 m/s are
marginal because tests have shown that soil removal rates are almost at a maximum at this velocity; a
slight reduction in cleaning time which would result from using higher velocities is unlikely to justify the
higher capital and running costs of larger pumps.
Fluid velocity and the pump sized after establishing friction losses may be obtained from next pages, in
addition to allowances for the static head and pressure losses of components in the system.
Section 8 Cleaning
Sub-Paragraph
Title 8.1.2 Fluid Velocity Versus Flow Rate for Stainless Steel Pipes
2
A B C D E F
3
0 10 20 30 40 50 m /h
Flow rate
0 0.002 0.004 0.006 0.008 0.010 0.012 0.014
A B C D E F
(mm) 25.4 x 1.2 38.2 50.8 x 1.2 63.5 x 1.6 76.2 x 1.6 101.6 x 1.6
(inch) 1.0 x 0.048 1.5 x 0.048 2.0 x 0.048 2.5 x 0.064 3.0 x 0.064 4.0 x 0.064
Section 8 Cleaning
Sub-Paragraph
m3/h m3/s (mm) 25.4 x l.2 38.l x l.2 50.8 x l.2 63.5 x l.6 76.2 x l.6 101.6 x l.6
(inch)1.0 x 0.048 1.5 x 0.048 2.0 x 0.048 2.5x 0.064 2.5x0.064 4.0 x0.064
0.5 .00013 0.0076 0.0010 0.0003
1.0 .00027 0.0274 0.0033 0.0008
1.5 .00042 0.0579 0.0069 0.0016
2.0 .00055 0.0986 0.0117 0.0027
2.5 .00069 0.1488 0.0176 0.0041 0.0013 0.0005
3.0 .00083 0.2084 0.0245 0.0057 0.0018 0.0007
3.5 .00097 0.2770 0.0326 0.0076 0.0024 0.0009
4.0 .00111 0.3545 0.0416 0.0098 0.0031 0.0012
4.5 .00125 0.4406 0.0516 0.0121 0.0039 0.0015
5.0 .00139 0.5351 0.0062 0.0147 0.0047 0.0018 0.0004
7.5 .00208 1.1321 0.1322 0.0309 0.0100 0.0039 0.0009
10.0 .00278 0.2242 0.0524 0.0171 0.0066 0.0015
12.5 .00347 0.3377 0.0789 0.0259 0.0100 0.0022
15.0 .00417 0.4721 0.1103 0.0364 0.0141 0.0031
17.5 .00486 0.6267 0.1463 0.0486 0.0188 0.0042
20.0 .00555 0.8009 0.1869 0.0623 0.0241 0.0053
22.5 .00625 0.9944 0.2320 0.0776 0.0300 0.0067
25.0 .00694 1.2067 0.2815 0.0944 0.0366 0.0081
30.0 .00833 0.3933 0.1326 0.0515 0.0114
35.0 .00972 0.5218 0.1768 0.0687 0.0151
40.0 .01111 0.6665 0.2268 0.0881 0.0194
45.0 .01250 0.8273 0.2824 0.1099 0.0241
50.0 .01389 1.0036 0.3437 0.1338 0.0293
55.0 .01528 1.1953 0.4106 0.1599 0.0351
60.0 .01667 0.4829 0.1682 0.0411
65.0 .01805 0.5606 0.2185 0.0477
70.0 .01944 0.6436 0.2510 0.0548
75.0 .02083 0.7319 0.2856 0.0623
87.5 .02430 0.7319 0.3810 0.0829
100.0 .02777 0.4891 0.1063
112.5 .03125 0.6045 0.1312
125.0 .03472 0.7423 0.1609
137.5 .03819 0.8872 0.1921
150.0 .04166 1.0439 0.2258
ISO bends (radius = 11/2 x pipe diameter): equivalent length of straight pipe = 1 00 x pipe diameter Tees:
equivalent length of straight pipe = 1 00 x pipe diameter
Section 8 Cleaning
Sub-Paragraph
The use of double-seat valves in Unilever food factories is strongly increasing. Correct application of this type of
valve in a product line guarantees a safe separation between circuits which contain different, incompatible
materials (e.g. cleaning liquid and product), or between cleaned and uncleaned circuits (see SHEACO 10,
Cleaning in-Place Principles).
In general, double-seat valves (see 5.14.2.6, Mixproof Valves) have an 'atmospheric leakage chamber'
between the two valve seats to prevent pressure build-up in case one of the seats should leak and to allow
such leakage to be observed. Most types of double-seat valves have the disadvantage that during opening
and closing some product enters the atmospheric chamber. Irrespective of the quantity (which depends
on the type of valve, the viscosity of the product and the pressure in the process line), this is an
undesirable situation from a microbiological viewpoint if this product is allowed to stagnate. Therefore
double-seat valves are usually provided with constructions that enable cleaning of this atmospheric
chamber. Basically there are two possibilities:
A standard CIP connection enables cleaning of the chamber when the valve is fully open or fully closed.
That means that one or more valve seat contact surfaces are not cleaned at all. This might be
acceptable in certain applications, e.g. in a part of a process upstream of a decontamination step.
An extra actuator which can move both valve seats independently over a very short stroke. In that case it
is possible to lift one single valve seat during cleaning of the line and thus to flush cleaning liquid through
the open valve seat via the atmospheric chamber to drain. This option is strongly recommended when
the valve is used in the sector of a line downstream of a pasteurization step. (*)
In all cases it is preferred to rinse the atmospheric chamber immediately after each opening or closing via
the extra CIP-connection to avoid drying out of the spilled product residues, which would hamper cleaning
in a later stage. Depending on the product and the maximum length of the production run this could be
done with cold water, hot water or even with cleaning agent. A prerequisite is that the valve is
constructed in such a way that also during such procedures pressure build-up in the atmospheric
chamber is not possible. Within Unilever there is positive experience concerning this criterion with the
Varivent Mixproof valve from Tuchenhagen, APV, etc (Mixproof Valves for more information and drawings).
Remark
Product in the atmospheric leakage chamber of double-seat valves should preferably be rinsed out after
each operation of the valve and should be regularly cleaned together with the process line (as part of
the CIP procedure).
(*) The usual types of hygienic double seat valves are not suitable for aseptic processing. For
these processes aseptic double seat valves are required (see 5.14.2.6)
Section 8 Cleaning
Sub-Paragraph
For open plant cleaning a number of detergent types can be used. Commonly used in unilever food
companies is cleaning with foam or gel.
However, foam cleaning is not a miraculous cleaning method, that solves every cleaning problem in the
food industry. Its main advantage (it strongly appeals to the operators) is of a psychological rather than of a
technical nature and therefore very difficult to quantify (it should, however, not be under-estimated).
Provided that care is taken to prevent feelings of false security, foam cleaning can be a useful tool to
make work for the cleaning staff more pleasant and to reduce labour costs compared to manual
cleaning.
Foam cleaning is a process, that involves applying detergent to a dirty surface as a foam. Provided that the
foam is stable and not too wet, it will cling to the surface for a relatively long time (5-10 min.) during which
physical/chemical attack can soften the soil. The foam and loosened dirt are then rinsed away from the
surface. This is preferably done with a high pressure jet, provided that there is no danger of spraying
electrical switch gear or similar water sensitive equipment. In this case, a low pressure spray or
occasionally vacuum can be used for removal of the foam.
Application
---------------
Foam cleaning is particularly useful for cleaning the outside of complex machinery (e.g. votators), walls
and other large surfaces, as these surfaces can be easily and quickly covered with a foam layer.
A range of detergents from strongly alkaline to acidic and all suitable for foam cleaning is available, so that
most soiling in the food industry can be dealt with. Foam cleaning is typically not suited for surfaces
covered in a thick soil layer (> 1 mm) as the foam will not be able to penetrate thick layers completely and
reach the surface.
Section 8 Cleaning
Sub-Paragraph
A newly developed cleaning method is gel cleaning. Gel cleaning detergents are chemicals which are of
low viscosity as a 100% product. On dilution however, they gel and by this they will increase the
contacttime of the detergent on the soil (5 min. for foam, 20-30 min. for gels).
This prolonged contact time gives a much stronger effect and therefore better cleaning results, or equal
results with rinsing at reduced pressure (5-20 bar). Rinsing at reduced pressure offers the advantage of
less damage to equipment and less aerosol.
Section 8 Cleaning
Sub-Paragraph
It is important that detergent products are not corrosive to the acoustic panel system. Most of the panels
are resistant to the chemicals normally used in detergents. Some of the materials used for the frame,
however, may be adversely affected by highly alkaline products. Therefore such products, although highly
effective detergents, cannot be used. Final choice of product will depend on the construction materials
used.
Cleaning methods
Manual cleaning
For manual cleaning a detergent containing a mixture of anionic and nonionic surfactants at (near) neutral
pH is recommended (Lever Industrial Recommended Formulation TC/CI-a2).
Manual cleaning is a possibility, but in most cases this will be far too time consuming and therefore too
expensive to be acceptable in practice.
Mist cleaning
In mist cleaning, a detergent solution is sprayed onto the panels by a low energy jet. For treating ceiling
panels, an extra long application lance would enable the job to be done from ground level, thus eliminating
the need to use a scaffold or steps. After a few minutes, during which time the detergent should soften the
soil, detergent and soil are removed by a high pressure fan jet.
The detergent developed for this application by Diversey Lever is SU 166 (Titan Pressure Wash;
Recommended Formulation S/CI-b7). User's concentration: 1-2% v/v. If the soiling is not too heavy, low
pressure rinsing may be sufficient.
Foam cleaning
In foam cleaning a detergent is applied to a dirty surface as a foam. Provided that the foam is stable and
not too wet, it will cling to the surface for a relatively long time (about 5 min.) during which chemical attack
can soften the soil. The foam and loose soils are then rinsed away from the surface. This is preferably
done with a high pressure fan jet.
Sub-Paragraph
The booklet Hygienic Plant Engineering Requirements, SHE 8, has been produced by the Hygienic
Processing Team in cooperation with Corporate Manufacturing & Engineering Group (CM&EG) and
Advanced Manufacturing Technology Group (AMTG) for the Safety Health & Environment Advisory
Committee (SHEACO). It has been produced for the use of equipment manufacturers, suppliers and
contractors working in Unilever plants and may be used as part of equipment specifications, engineering
contracts, etc. It discusses the minimum requirements for hygienically acceptable process plant. Copies
are available in the English, German, Spanish and Portuguese language.
Copies are available from the Hygienic Processing Team, Microbiology & Preservation Unit, Unilever
Research. Vlaardingen, The Netherlands.
CONTENTS
INTRODUCTION
DEFINITIONS
DESIGN PRINCIPLES
MATERIALS OF CONSTRUCTION
SURFACE FINISH
TEST PROCEDURES
CIVIL
Sub-Paragraph
The European Hygienic Equipment Design Group (EHEDG) is publishing minimum requirements for
food processing equipment. The following guidelines and test methods have been published in Trends
in Food Science & Technology, from Nov. 1992 to March 1997.
European Hygienic Equipment Design Group (EHEDG) Vol. 3(11), 1992 (pp. 277)
The EC Machinery Directive and food-processing equipment Vol. 4(5), 1993 (pp. 153-154)
Welding stainless steel to meet hygienic requirements Vol. 4(9), 1993 (pp. 306-31 0)
Hygienic design of closed equipment for the processing of liquid food Vol. 4(11), 1993 (pp. 375-
379)
Hygienic design of valves for food processing Vol. 5(5), 1994 (pp. 169-1 71)
Hygienic design of equipment for open processing Vol. 6(9), 1995 (pp. 305-31 0)
A method for assessing the in-place cleanability of food-processing equipment Vol. 3(12), 1992
(pp. 325-328)
A method for the assessment of in-line pasteurization of food-processing equipment Vol. 4(2),
1993 (pp. 52-55)
A method for the assessment of in-line steam sterilizability of food-processing equipment Vol.
4(3), 1993 (pp. 80-82)
A method for the assessment of bacteria tightness of food-processing equipment Vol. 4(6),
1993 (pp. 190-192)
Microbiologically safe continuous pasteurization of liquid foods Vol. 3(11), 1992 (pp. 303-307)
The microbiologically safe continuous-flow thermal sterilization of liquid foods Vol. 4(4), 1993
(pp. 11 5-121)
The continuous or semicontinuous flow thermal treatment of particulate foods Vol. 5(3), 1994
(pp. 88-95)
Experimental test rigs are available for the EHEDG test methods Vol. 6(4), 1995 (pp. 132-134)
Obtaining copies of the publications is strongly recommended. Reprints of the above mentioned
articles can be obtained from the Hygienic Processing Team, Unilever Research Laboratorium,
Vlaardingen, The Netherlands.
A compendium of the above mentioned EHEDG guidelines and test methods reprinted from Trends in
Food Science & Technology can be purchased from:
Editorial Office, TIFS, Elsevier Trends Journals, 68 Hills Road, Cambridge CB2 1LA, UK
Fax: +44-1223-464430. E-mail: TIFS@elsevier.co.uk
Avesta Sheffield, P.O. Box 16377, Vasagatan 8, S-103 27 Stockholm, Sweden. Tel:+ 46 8 6133600, Fax:+ 46
8 208481
Ahlström Corp. Salo Mixer Factory, Sokerikatu 1, FIN-24100 Salo, Finland. Tel:+358 2777 1200; Fax:+358
2777 1299
Alfa-Laval AB, S-221 86 Lund , Sweden. Tel:+ 46-46-367000; Fax:+ 46-46 394958
Alfa-Laval LKM, Box 802, DK 6000 Kolding, Denmark. Tel: + 45 79 322200, Fax: + 45 75 535222
American Air Filters (AAF), 215 Central Avenue, Louisville, KY 40232-5690, USA. Tel: + 1 502 6370011, Fax:
+ 1 5026370520
Ammeraal International B.V., P.O. Box 38, 1700 AA Heerhugowaard, The Netherlands. Tel: + 31 72-5751212.
Fax: + 31 72-5743364
Anderol, Punterweg 21A, 6222NW Maastricht, The Netherlands. Tel:+ 31 43 3524190, Fax:+ 31 43 3524199
Anderol, 215 Merry Lane, East Hanover, NJ 07936, USA.Tel:+ 1 973 887 7410, Fax:+ 973 887 8404
Anisa, P.O.Box 96, 8330, Huningue, France. Tel:+ 33 896 92000, Fax:+ 33 896 79545
APV Crepaco,395 Fillmore Avenue, Tonawanda New York 14150, USA. Tel: +1 716 692 3000, Fax: + 1 716
692 1715
APV Fluid Handling Corporate, Ternevej 61-63, DK-8700 Horsens, Denmark. Tel: int + 45-756-437-37. Fax: int
+ 45-756-487-33.
APV Fluid Handling, Zechenstrasse 49, D-59425 Unna -Konigsborn, Germany. Tel:+ 49-2303-1080; Fax: + 49-
2303-108162
APV plc-Group, PO Box 4, Gatwick Road, Crawley, West-Sussex, RH10 2QB, United Kingdom. Tel: +44-
1293-527777; Fax: +44-1293-552640.
APV Homogenizers, 8 Roholmsvej, DK 2620 Albertslund, Denmark. Tel:+ 45 42649300, Fax:+ 45 42640330
Armaturenbau GmbH, Manometerstrasse, D-46487 Wesel-Ginderich, Germany. Tel: + 49 2803 9130-0. Fax;+
49 2803 1036
Bel-Ray Company inc., P.O. Box 526, Farmingdale, New Jersey, USA. Tel:+ 1 732 938 2421, fax:+ 1 732 938
4232
Bran & Luebbe GmbH, , Werkstrasse 4 D-22844 Norderstedt, P.O. Box 1360 D-22803 Norderstedt, Germany.
Tel: +49 40 522 02-0; Fax: +49 40 522 02 444
Broadley-James,19 Thomas, Irvine, CA 92618 USA. Tel:+ 1 714 8295555, Fax:+ 1 714 8295560
BS&B safety systems, Centre House, 68 Sheen Lane, London SW14 8LP, England. Tel: + 44 81 392 1333,
Fax: + 44 81 876 0573
Burmah-Castrol Ltd, Burmah Castrol House, Pipers Way, Swindon Wiltshire SN3 1RE, England, Tel: + 44
1793 511521. Fax: + 44 1793 513506.
Caldic, Am Karlshof 10, D-40231 Düsseldorf, Postfach 101816 Düsseldorf, Germany . Tel:+ 49 211 7346-0,
Fax:+ 49 211 7346 200
Cartrix, Unterer Dammweg12, 76149 Karlsruhe, Germany. Tel: + 49 721 788464, Fax: + 49 721 700537
Chemineer, Kenics, P.O. Box 1123, Dayton, Ohio 45401, USA. Tel:+ 1 513 454 3200, Fax:+ 1 513 454 3379
Cole-Palmer,625 East Bunker Court, Vernon Hills, IL 60061-1844 USA. Tel:+ 1 847 549 7600, Fax:+ 1 847
5491700
Controlotron,155 Plant Avenue, Hauppauge, New York, USA. Tel:+ 1 516 231 600, Fax:+ 1 516 231 3334
Clextral, 1 Rue du Colonel Riez, P.O. Box 10, 42702 Firminy Cedex, France, Tel: + 33-77403131: Fax:+ 33-
77403123
Combifit Int. B.V., Postbus 378, 2700 AJ Zoetermeer, The Netherlands Telephone: + 31 79-3614 929; Telefax:
+ 31 79-3614 791
Dimetrics Inc (Liburdi), 404 Armour Street, P.O. Box 339, Davidson North Carolina 28036, USA. Tel:+ 1 704
892 8872, Fax:+ 1 704 892 4713
Dimitrics Int, Gelreweg 5, 3843 AN Harderwijk, the Netherlands. Tel:+ 31 3414 188899, Fax:+ 3414 24153
Diversey Lever, P.O. 10, 3600 AA Maarssen, The Netherlands. Tel: +31 30 2476922. Fax:+31 30 2476319.
DEPA, 4000 Düsseldorf, P.O. Box 110341, Monschauer strasse 7, Germany. Tel:+ 49 211 507077
DMT (Burdosa) Fischbach 3, 35418 Buseck, Germany. Tel:+ 40 6408 900342, Fax:+ 49 6408 900345
Dockweiler, Dutton Road, Redwither Complex, Wrexham Industrial Estate, Wrexham, Clwyd LL13 9UL,
England. Tel:+ 44 1978 660330, Fax:+ 44 1978 660157
Dockweiler GmbH, Meessen 10, D-22113 Oststeinbek, Germany. Tel:+ 49 40 71304280, Fax:+ 49 40
71304222
Domnick Hunter Ltd, Dukesway, Team Valley trading Estate, Gateshead, Tyne & Wear NE11 0PZ, England.
Tel:+ 44 191 4029000. Fax:+ 44 191 4821613
Dresser Mono Pumps, P.O. Box 14, Martin street, Audenshaw, Manchester M34 5QD, England. Tel:+ 44 161
339 9000, Fax:+ 44 161 343 1253
Ecomax Acoustics, Gomm Road, High Wycombe, Bucks HP13 7DJ, England. Tel:+ 44 494 436345, Fax:+
44 494 465274
Ecophon AB, Box 500, S-260 61 Hyllinge, Sweden. Tel:+ 46 42 179900, Fax:+ 46 42 225555
Endress + Hauser, D-79689 Maulburg, Hauptstrasse 1, Germany. Tel: + 49 7622 28-0. Fax: + 49 7622 28438
Engelhard-CLAL, 28 rue Michel-Le-Comte, 75003 Paris, France. Tel:+ 33 1 4461 3000, Fax:+ 33 1 44 61 3001
Eriks B.V., Voormeer 33, 1813 SB Alkmaar, The Netherlands. Tel: + 31 72-5141 911; Fax: + 31 72-5155 645
ESAB AB, Herkulesgatan 72, Box 8004, SE-40277, Göteborg, Sweden. Tel:+ 46 31 50 9500, Fax:+ 46 31 50
9222
Fabidor B.V., Noordhoek 33, 3350 AA Papendrecht, The Netherlands. Tel:int+ 31 78 150044. Fax:int+ 31 78
154948
Fagersta Stainless AB, Box 508, 73725 Fagersta, Sweden. Tel:+ 46 223 45500, Fax:+ 46 223 45748
Flowguard, 9009 North Loop East, Suite 230, Houston, Texas 77029, USA. Tel:+ 1 713 673 5161, Fax:+ 1
713 673 5113
Foulds Ltd., Parkwood street, Keighly BP 21 4PL, West Yorkshire, England. Tel:int+ 44 535 667015. Fax:int+
44 535 610250
Fristam Pumpen KG, Kampchaussee 55, 21033Hamburg (Bergedorf), Germany. Tel:+ 49 40 725560. Fax:+
49 40 72556166.
Garlock , 1977 Kindred st. , Houston, Texas 77049, USA. Tel:+ 1 281 459 7200, Fax:+ 1 282 459 7224
GEA Aktiengesellschaft, D-44809 Bochum, Germany. Tel: + 49 234 980 1081, Fax: + 49 234 980 1087
GEA Tuchenhagen GmbH, Am Industriepark 2-10, Box 1140, D-21514 Büchen, Germany, Tel: int.+49-4155
492402; Fax: int.+49-4155 492428
GAE Tuchenhagen Scanflow Am Industriepark 2-10, Box 1140, D-21514 Büchen, Germany, Tel: int.+49-4155
492402; Fax: int.+49-4155 492428
GEA Westfalia, Postfach 3720, D-4740 Oelde 1 Westfalen, Germany. Tel: + 49 2522 770, Fax:+ 49 2522
772488
Gelman Sciences, Brackmills Business Park, Caswell Road, Northampton NN4 7EZ, England. Tel:+ 44 1604
765141, Fax:+ 44 1604 761383
Gerstenberg & Agger 19 frydendalsvej, Frederiksberg C , DK 1809 Copenhagen, Denmark. tel:+ 45 31312839,
Fax:+ 45 31313025
Goodville Engineering, La Foie, 49520 Noellet, France Tel:+ 33 241 943800, Fax: + 33 241 943900
U.K: Tel: +44 1424 812516
Guichon, P.O. Box 401, 73104 Aix-Les-Baines, Cedex, france. Tel:+ 33 479 61 4000, Fax:+ 33 479 35 2402
GWT Global Weighting Technologies GmbH, Meiendorferstrasse 205, 22145 Hamburg. Tel: +49 40 679600,
Fax: +49 40 67960383
Haenni & Cie. A.G., CH 3303 Jegensdorf, Switzerland. Tel:+ 41-31-96 00 11; Fax: +41-31-96 26 85
HBM (Hottinger Baldwin Messtechnik) GmbH, Postfach 4235, Im Tiefen See 45, D-6100 Darmstadt 1,
Germany. Tel: + 49 151 8080. Fax: + 49 6151 894896.
Heraeus Instruments, Postfach 1563, 6450 Hanau 1, Germany. Tel: + 49 6181 35-413. Fax: + 49 6181 35749
Herbert Industrieglas, Gewerbeschulstrasse 72, 42289 Wuppertal, Germany. Tel:+ 49 202 590064-66, Fax:+
49 202 597837.
Het Stempel B.V., Fruiteniersstraat 18, 3334 KA Zwijndrecht, The Netherlands. Tel: + 31 78-6104 055; Fax: +
31 78-6104 010
Hilge GmbH, P.O. Box 60, D-6501 Badenheim/Mainz, Germany. Tel: + 49 6135 750. Fax: + 49 6135 1737
Hobart TAFA Technologies P.O. Box 8144, 1005 AC Amsterdam, The Netherlands. Tel:+ 31 20 6114981,
Fax:+ 31 20 6119503
Holledge (Instruments) Ltd. Sandy Lane, Crawley Down, Sussex RH10 4HS, England. Tel:+ 44-342-716 411;
Fax:+ 44-342-716 418
Honeywell Inc, Honeywell Plaza, Minneapolis, Mn55440, USA. Tel: +1 612 951 1000
Hovap Hogeveen BV, Postbus 163, 8600 AD Sneek, The Netherlands. Tel:+ 515 418445, Fax:+515 420441
Huhnseal AB, Postbox 288, Enoch Thulinsväg 1, SE-261 23, Landskrona, Sweden Tel:+46-418-449940; Fax:
+46-418-449969
Incapsa, Alejandro Seiquer 4, 30001 Murcia, Spain. Tel:+34 68212140, Fax:+ 34 68211978
Innova, Rozendaalseweg 101, B 8900 Ieper, Belgium. Tel:+ 32 572 19266, Fax:+ 32 572 19227
ITT Jabsco, Bingley Road, Hoddesdon, Hertforshire EN11 0BU, England. Tel:+ 44 1992 450145, Fax:+ 44
1992 467132
J.M. Canty, 590 Young street, Buffalo, New York 14150, USA. Tel:+ 1 716 693 3953, Fax:+ 1 716 693 1774
Janz, Lütjenburgerstrasse 84, D-23714 Malente/Holstein, Germany.Tel:+ 49 4523 3319. Fax: + 49 4523 6968.
Johansons Metallfabrik AB, Box 26, S-73040 Kolbäck, Sweden. Tel:+ 46 220 40320. Fax: + 46 220 40523
Johnson Pumps, Edison Road, Eastborne, East Sussex BN23 6PT, England. Tel:+ 44 1323 509211, Fax:+
44 1323 507306
Jongia Machinefabriek B.V., James Wattstraat 8, 8901 AS Leeuwarden, The Netherlands. Tel: + 31 58-2139
715; Fax:+ 31 58-2129 787
Kaptech Hose Ltd., Huddersfield, West Yorkshire HD2 1UR, England. Tel:+ 44 484 512284, Fax:+ 44 484
432423
KDG Instruments, Crompton Way, Crawley West Sussex RH10 2YZ, England. Tel: + 44 293 25151.
Keofitt A/S, Snaremosevej 27, DK-7000 Fredericia, Denmark. Tel: +45- 75 941344, Fax: +45 75 941377
Keystone, Anderson Greenwood, Corrie Way, Bredbury Industrial Estate, Stockport SK6 2ST, England. Tel:+
44 161 494 5363, Fax:+ 44 161 494 5672
Klay Instruments, P.O.Box 13, 7990 NA Dwingeloo, The Netherlands. Tel:+ 31 521 591550, Fax:+ 31 521
592046
Klüber Lubrication, Geisenhausenetstrasse 7, D- 81379, Postfach 701047, D-81310 München, Germany. Tel:
+ 49 89 78 76-0, Fax: + 49 89 78 76333.
Krohne Messtechnik, Ludwig-Krohne-Strasse 5, P.O. Box 100970 D-4100 Duisburg Germany, Tel: + 49 203
301-0; Fax: + 49 203 301389
KSB AMRI, 40 rue Jean-Jaures, 93176 Bagnolet Cedex, France. Tel: + 33-1 43 622900. Fax: + 33-1 43
621920
KSB, Johann Klein Strasse 9, D 76227 Frankental, Pfalz, Germany. Tel:+ 49 6233 863373, Fax:+ 49 6233
863400
Kusel, Watertown, Wisconsin 53094-0087, USA. Tel:+ 1 414 261 4112, Fax:+ 1 414 261 3151
Labom Mess- und Regeltechnik GmbH, P.O. Box 1262, D-27795 ,Langenbergerstrasse 24, D-27798 Hude,
Germany. Tel:+49-4408-804-0; Fax: +49-4408-804 85
Ladish Co. Tri-Clover Division, 8 South Michigan Ave, Chicago, Illinois 60603, USA
Tri-Clover, 9201 Wilmot Road Kenosha, Winconsin 53141-1413, USA. Tel:+ 1 414 6973170, Fax:+ 1 414
6948188
Le Carbone-Lorraine, Tour Manhattan, Cedex 21, F-92095 Paris, La Defense 2, France. Tel: + 33 147 62
8800. Fax:+ 33 147 75 9610
Leder Benelux B.V., P.O. Box 7002, 5605 JA Eindhoven, The Netherlands. Tel: + 31 40 513975. Fax:+ 31 40
528985.
Lewa Herbert Ott GmbH, Ulmerstrasse 10, Leonberg, Telex 7-24153, Germany
Lightnin Mixers Ltd. Poynton. Stockport, Cheshire SK12 1LH, England. Tel:+ 44 1625 876421, Fax: + 44
1625 872324
Lubrication Engineers, P.O.Box 7128, 3851 Airport Freeway, Fort Worth, Texas 76111, USA. Tel:+ 1 817 834
6321
Machinefabriek Breda, Speelhuislaan 173, 48 15 CD Breda, The Netherlands. Tel: + 31 76 571 227, Fax: + 31
76 571 227
Magnaflux Ltd., South Dorcan Industrial Estate, Swindon, Wiltshire SN3 5HE, England. Tel:+ 0793 524566.
Fax: + 0793 619498
Maso Dickstoff Pumpen, Pestalozzistrasse 8, D 7107, Untergruppenbach, Germany. Tel:+ 49 7131 70878,
Fax:+ 49 7131 702131
Metas, Flodvej 13, DK-1765 Smorum, Denmark. Tel:+ 45 42 975133, Fax:+ 45 42 974466
Mettler Toledo GmbH, CH-8902 Urdorf, Switserland. Tel: + 41 17362211, Fax: +41 17362636
Microflow, Walworth Road, Andover, Hants SP10 5AA, England. Tel:+ 44 1264 835810, Fax:+ 44 1264
835801
Micro Motion, 7070 Winchester Circle boulder, CO 80301 USA,. Tel:+ 1 303 530 8400, Fax:+ 1 303 530 8209
Millipore Intertech, 80 Ashbey Road, P.O. Box 9125, Bedford, Massachusetts 01730, USA Tel: + 1-617 275-
9200, fax:+ 1 617 275 5550
Mouvex Blackmer, 1809 Century Avenue, Grand Rapids, MI, USA. Tel: +1 616 241 1611, Fax:+ 1 616 241
3752
Mouvex, 5 Rue du Sahel F 75012 Paris, France. Tel: + 33 1 44 731212, Fax: + 33 1 43 412458
Naue GmbH, Am Rotböll 5, 6108 Weiterstadt 2, Germany. Tel: + 49 6150 82568. Fax: + 49 6150 7018.
Nertzsch, P.O. box 1120, D-84464 Waldkraiburg, Germany. Tel:+ 49 8638 63-0, Fax:+ 49 8638 67981
Neumo GmbH, Henry Ehrenberg Platz, D 7134 Knittingen, Germany. Tel:+ 49 7043 360, Fax:+ 49 7043 3630
Niro Soavi , (GEA) Via M. da Erba Edoari, 29/A, 43100 Parma, Italy, Tel:+ 39 521965411, Fax:+ 39 521242819
NovAseptic, Rodjanvag 7, S-449n34 Nodinge, Sweden. Tel:+ 46 303 96075, Fax:+ 46 303 96079
Optac Weltin GmbH, Postfach 1210, 6074 Rödermark 2, Germany. Tel: + 49 6074 912-0. Fax:+ 49 6074 912-
12
Pall Process Filtration Ltd, Europe House, Havant Street, Portsmouth, Hants PO1 3PD, England. Tel: + 44-
1705-303303; Fax: + 44-1705-302510
Palletower, Earl Road, Stanley Green, Ceadle Hulme, Cheadle/Ceshire SK8 6QD England. Tel:+ 44 161 486
1241, Fax:+ 44 161 486 1248
Papenmeier, P.O. Box 1620, D-58211 Schwerte, Germany. Tel:+ 49 2304 205-0, Fax:+ 49 2304 205 205
Penko Engineering Wageningselaan 54, 3903 LA Veenendaal, The Netherlands. Tel: + 31 318 525630. Fax: +
31 318 529715.
PermaBond Ltd., Woodside Road Easleigh, Hants SO5 4EX, England, Tel: + 44 703 629628. Fax: + 44 703
629629.
Pförtner, Oheweg 3-5, D-3306 Lehre 4, Germany. Tel: + 49 5309 8052 Fax:+ 49 5309 8065
Pierre Roch GmbH, Route de Lausanne, CH-1180 Rolle VD, Switzerland. Tel:+ 41 21 751785
Pomac, P.O. Box 32, 9356 ZG Tolbert, The Netherlands. Tel:+31 594 512877, Fax:+ 31 594 517002
Rank Taylor Hobson, P.O. Box 36, 2 New Star Road, Leicester LE4 7JQ, England. Tel:+ 44 533 763771
Realm Engineering, 8-28 Milton Ave, Croydon, Surrey CR9 2JP, England Tel:int+ 44 181 6895521. Fax: int+
44 181 6890245
Rembe GmbH, P.O.Box 1540, D-599918 Brilon, Germany, Tel:+ 49 2961 740510, Fax:+ 49 2961 50714
Pal-con Plastics, P.O.Box 824, 7301 BB Apeldoorn, The Netherlands. Tel:+ 31 55 427293, Fax:+ 31 55
423263
Rockfon, Wern Tarw, pencoed, Bridgend, Mid Glamorgan CF35 6NY, England. Tel:+ 44 1656 864696,
Fax:+44 1656 864549
Rollin Inc., P.O. Box 308, Stroudsburg, Pennsylvania 18360, USA. Tel: + 1-717 424 2632
Rubert & Co. Ltd., Demmings Road, Cheadle, Cheshire SK8 2PG, England. Tel + 44 61 428 6058. Fax: + 44
61 428 1146
Sartorius GmbH, Postfach 3243, D 3400 , Weender Landstrasse 94,Goettingen, Germany. Tel:+ 49 551 308
0, Fax:+ 49 551 289
Saunders Alfa Laval, Grange Road Cwmbran, Gwent, NP44 3XX, England. Tel:+ 44 1323 412555, Fax:+ 44
1323 730495
Scaba, Zum Wirtsberg 12, D-5133 Gangelt-Stahe, Germany. Tel:+ 49 2454 2768, Fax:+ 49 2454 2665
Schenck, D-64273 Darmstadt, Germany. Tel:+49 6151 381028, Fax:+ 49 6151 323846
Schneider, In den Kirchenmatten 52, D 7800 Freiburg-Lehen, Germany. Tel:+ 49 761 88506-0, Fax:+ 49 761
8850 625
Schröder, Tetra Laval, falkenstrasse 51, D23564 Lübeck 1, Germany. Tel:+ 49 451 3709-0, Fax:+ 49 451
3709200
Schwarze-Robitec GmbH, Olpener Strasse 460-474, 5000 Köln 91 (Merheim), Germany. Tel: + 49 221
892081. Fax + 49 221 892085.
Schwarze-Robitec GmbH, Rudolf Diesel Strasse 6, D-53919 Weilerswist, Germany. Tel:+ 49 2254 9405-0,
Fax:+ 49 2254 940540
Seepex, P.O. Box 101564, D-46215 Bottrop, Germany. Tel:+ 49 2041 9960, Fax:+ 49 2041 96200
Sensycon, Leipzigerstrasse 10, D-6450 Hanau 1, Germany. Tel: + 49 6181 369-02. Fax: + 49 6181 369-240
Shell Nederland, Hofplein 20, 3032 AC Rotterdam, The Netherlands. Tel:+ 31 10 4696911, Fax:+ 31
104116828
Siegling Nederland BV, Watermolenweg 3, 3961 NG Wijk bij Duurstede, The Netherlands. Tel:int+ 31 343
574574. Fax:int+ 31 343 576059.
Silverson, Waterside, Chesham, Bucks HP5 1PQ, England. Tel:+ 441494 786331, Fax:+ 44 1494791452
Sisto Armaturen S.A. (KSB), 37, rue de la Gare, P.O. Box 44, L-7501 Mersch, Luxemburg. Tel: + 352 32 50
85 235, Fax: + 352 32 89 56
Stelzer, P.O.Box 1367, Speckgraben 20, D 3530 Warburg, Germany. Tel:+ 49 5641 903-0, Fax:+ 49 5641
90350
Stiko, Industrieweg 5, 9301 LM Roden, The Netherlands. Tel:+ 31 50 5013813. Fax: + 31 50 5013824
Stork, P.O. Box 759, 1000AT, Ketelstraat 2 1021 JX , Amsterdam, The Netherlands. Tel:+ 20 6348911, Fax:+
20 6348603
Südmo GmbH, D-73469 Riesbürg , Germany. Tel: + 49 9081 803-0; Fax: +49 9081 803158
Swagelock, Abbott Valve & Fittings, 6090 Cochran Road, Solon, OH 44139, USA. Tel:+ 1 440 248 6515,
Fax:+ 1 440 248 2734
Syspal, Cockshuft Lane, Broseley, Shropshire TF125 JA, England. Tel:+ 44 952 883188, Fax:+ 44 952
884093
Terlet, P.O.Box 62, 7200 AB, Oostzeestraat 6, 7202 CM Zutphen, The Netherlands. Tel:+ 575 541643, Fax:+
575 518083
Toftejorg A/S, P.O. Box 1149, Baldershoej 19, DK-2635 Ishoej 19, Denmark. Tel: + 45-4252 8666; Fax: + 45-
4252 7552
Ultrafilter GmbH, Büssingstrasse 1, D-42781 Haan, Germany. Tel: + 49 21 29569-0, Fax: + 49 21 29569100
Van den Berg, Koperstraat 19, 8211 AK , Postbus 74 , 8200 AB Lelystad, The Netherlands. Tel: + 31 3200
26157, Fax: + 31 3200 44039
Van Leeuwen Stainless BV, P.O. Box 1, 3330 AA Zwijndrecht, The Netherlands. Tel:+ 31 78 252525, Fax:+
31 78 194444
Variantsystemet AS, Fynsvej 60, DK 5500 Middelfart, Denmark. Tel:+ 45 64 412044, Fax:+ 45 64 413144
Vega Grieshaber, P.O.Box 1142, 77757 Schiltach, Germany. Tel:+ 49 78 3650-0, Fax:+ 49 78 50201
Verder, Whitehouse street, Hunslet, Leeds LS10 1AD, England. Tel:+ 44 1132220250, Fax:+ 44 113 2465649
Waukesha, Cherry Burrell, 611 Sugar Creek Road, delavan, Wisconsin 53115, USA. Tel:+ 1 414 728 1900,
Fax:+ 1 414 728 4646
Wiedemann GmbH, Siemensstrasse 16-18, 25813 Husum, Germany. Tel: + 49 4841 778-0, Fax: + 49 4841
1687
Wilhams, 309-311 Harold Road, Hastings,East Sussex TN35 5NE, England. Tel:+ 44 1424 425694, Fax:+ 44
1424 721314
Ytron, Osternacher Strasse 50, D-83209 Prien am Chiemsee, Germany. Tel:+49 8051 1457. Fax:+ 49 8051
1637
Zimmerling, P.O.Box 54, 7805 Bötzingen, Germany. Tel:+ 49 7663 50001, Fax:+ 49 7663 4858
Section 10 Index