howanautoclaveworks

• Subject : Introduce Systec company
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and autoclave
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• Presented by : Vahid Totonchi
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• Mehr 1393
The concept of sterilization
Astrylyzyasyvn or sterilization means elimination of all forms of life in or on a
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medium or substance. The different forms of living cells, bacteria and eukaryotes,
Andvspvr bacteria, spores, fungi, virus particles, smaller than the virus.
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Sterilization process is complete, meaning that it is sterile or non-sterile
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environment and a term or provision or part-sterile or nearly sterile there.
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Sterilization Methods
• Different sterilization procedures are performed in the microbiology laboratory can

be used in both physical and chemical methods.
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• Physical methods: incineration, autoclaving, use the oven (oven), filtration and
radiation
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Chemical methods: the use of chemical disinfectants and disinfectant Burning in
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the microbiology laboratory culture after culture and transfer using a wire loop or
ounces (needle) to catch and fry them on the flames killed the tools are sterile.
Sterilizing autoclave method
• An autoclave is a pressure chamber used to sterilize equipment and supplies by

subjecting them to high pressure saturated steam at 121 °C for around 15–20 minutes
depending on the size of the load and the contents.[1] It was invented by Charles
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Chamberland in 1879,[2] although a precursor known as the steam digester was
created by Denis Papin in 1679.[3] The name comes from Greek auto-, ultimately
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meaning self, and Latin clavis meaning key—a self-locking device.[4]
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• Other types of autoclave are used in the chemical industry to cure coatings, vulcanize
rubber and for hydrothermal synthesis, growing crystals under high temperatures and
pressures. Synthetic quartz crystals used in the electronic industry are grown in
autoclaves.
Systec Company
• Systec develops, produces and markets laboratory autoclaves

and devices for media preparation and handling worldwide
• The company was founded in 1994
• It employs about 115 persons
• Two main sites in Germany
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INTRODUCTION | company mission
• Systec is absolutely committed to the laboratory autoclave market
We make steam sterilization processes in laboratories

safe, accurate, reproducible and validatable
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• Systec educates the market, customers as well as distributors, about
state-of-the-art steam sterilization techniques and developments
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• Systec provides innovations in design, quality and solutions for various
steam sterilization applications in laboratories
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• We want to strengthen our position as a leading company in the global
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laboratory autoclave market
© Systec GmbH , Wettenberg | www.systec-lab.com 6

INTRODUCTION | product range
SYSTEC D-SERIES – BENCH-TOP, FRONT-LOADING AUTOCLAVES
• 7 models, 23 to 200 liter chamber volume
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SYSTEC V-SERIES – VERTICAL, TOP-LOADING AUTOCLAVES
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• Systec V-Series and D-Series autoclaves are available in three different

performance categories
– Systec DX|VX
For all laboratory applications even for state-of-the-art sterilization processes.
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With all possibilities to add options for process optimization to meet highest
process accuracy and to carry out validatable sterilization cycles.
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– Systec DE|VE
For basic laboratory applications and media sterilization. With limited
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possibilities to add additional options for process optimization.
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– Systec DB|VB
For simple process applications. No options available for process optimization.

SYSTEC H-SERIES – HORIZONTAL, FLOOR-STANDING AUTOCLAVES
• 16 models, 65 to 1.580 liter chamber volume
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SYSTEC H-SERIES 2D – DOUBLE-DOOR, PASS-THROUGH AUTOCLAVES
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INTRODUCTION | quality
• Further Directives:
– 2006/95 EC Low Voltage
Equipment
– 2004/108 EC Electromagnetic
Compatibility
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– 2006/42 EC Machinery Directive
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• All steam sterilizers and
mediapreparators come with CE
Mark
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• Marking permission for CE mark
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issued by a notified body proving
that pressure vessels are calculated
and checked by an independent
authority

INTRODUCTION | quality management
• Certified according to newest

ISO-Norm DIN EN ISO 9001:2008
• Certified for design, development,
production, sales and service for
laboratory autoclaves
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INTRODUCTION | a unique and reliable partner
• Systec offers the widest range of laboratory steam sterilizers and

mediapreparators in the world
– 73 autoclave models, 23 to 1.580 liter chamber volume

– 7 mediapreparator models, 10 to 120 liter chamber volume
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– Manual and fully automatic media dosing, filling and handling devices
– Modularity and a vast variety of options and accessories provide a maximum of
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flexibility and allows to meet even the highest customer’s requirements
– Custom solutions where applicable
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• A strong focus to steam sterilization applications in laboratories
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• About 20 years of experience in the design and construction of steam
sterilizers and mediapreparators
THIS MAKES SYSTEC A UNIQUE AND RELIABLE PARTNER

FOR YOUR STEAM STERILIZATION APPLICATIONS

INTRODUCTION | our customers
• Research laboratories at
universities and other research
institutes
– Medical science
– Biology
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– Environmental protection
– Biotechnology
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• Microbiological diagnostic
laboratories
– Human-Medicine
– Veterinary-Medicine
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• Cosmetic industry
– Research
– Quality Control
– Production / Pilot production
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• Biotech companies and

laboratories
– Research
– Quality Control
– Production
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• Service laboratories
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BASIC PRINCIPLES | steam sterilization in laboratories
STERILIZATION OF LIQUIDS (PREPARATION)
• Culture media in bottles to selectively grow specific

microorganisms
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STERILIZATION OF SOLIDS (PREPARATION)
• ra
Instruments
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• Empty glassware
• Tubes and hoses
• Pipettes, pipette tips
• Filters, Textiles

BASIC PRINCIPLES | steam sterilization in laboratories
STERILIZATION OF WASTE (DECONTAMINATION)
• Solid waste in waste bags

• Liquid waste in bottles
• Biohazard waste
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BASIC PRINCIPLES | what is steam sterilization?
Sterilization is a term referring to any process that eliminates or kills all forms of
microbial life, including transmissible agents (such as fungi, bacteria, viruses,
spore forms, etc.) present on a surface, contained in a fluid, in medication, or in
a compound such as biological culture media
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• Steam sterilization is carried out at
– a steam pressure of 1 to 5bar
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– a sterilization temperature between 100 to 150°C
– a sterilization time between 3 and 20 minutes
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• Commonly used steam sterilization parameters are
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– 121°C, 15 to 20 minutes
– 134°C, 3 to 5 minutes

BASIC PRINCIPLES | how is steam produced in steam sterilizers
STEAM GENERATION BY INTERNAL HEATING ELEMENTS
• Heating elements inside the pressure vessel of the

autoclave
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STEAM GENERATION BY SEPARATE STEAM GENERATOR
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• Steam is generated in a steam generator which is
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separated from the pressure vessel but integrated into
the housing of the autoclave

BASIC PRINCIPLES | how is steam produced in steam sterilizers
• For steam generation in a steam sterilizer, demineralized water must be used

• The water quality has a direct influence to the steam quality
• Normal tap water contains minerals, in particular carbonates, and other
ingredients which can contaminate the product during sterilization
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DIN 58951-2 Sterilization - Steam sterilizers for laboratory use
Part 2: Apparatus requirements, requirements on services and installation
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Demineralized water < 15 μS/cm
conductivity (at 20 °C) and Σ alkaline earth ions < 0.02 mmol/l
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BASIC PRINCIPLES | evaporation
• Kinetic heat energy (heat) is transferred from the heating elements into the
liquid (demineralized water)
• The liquid (demineralized water) has the tendency to evaporate due to the
kinetic energy (heat)
• As higher the kinetic energy the more molecules are released from the
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surface of the liquid due to evaporation
• The aggregate state changes from liquid to gaseous (steam)
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BASIC PRINCIPLES | condensation
• When steam condenses e.g. on cold surfaces, steam releases its kinetic
energy (heat)
• Due to condensation, the aggregate state changes from gaseous (steam) to
liquid
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BASIC PRINCIPLES | air release phase | internal heating elements vs. steam generator
Valve
Air
Water reservoir with heating element
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for steam generation
Air must be replaced by steam
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through air release valve
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Water
Heating element

valve open
air
Air removal by suppression
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against the natural gravitation
of the air
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Not an optimal process, as air is
steam
heavier than steam
ra Steam rises up and air gravitates

down
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heating of water
heating element

valve closed
steam
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sterilizing effect
if temperature is reached
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ra no sterilizing effect
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air
heating element

Steam created by a steam generator

outside of the sterilization chamber
Steam inlet from top
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Air release at the bottom with the
natural gravitation of the air
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Remaining air sediments down to
the bottom
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Steam-
Suppression of the remaining air
generator
and steam injection to sterilization
temperature / pressure

No remaining air left in the chamber
100% steam atmosphere (steam

pressure)
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Temperature equals exactly the
pressure depending boiling point
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The temperature depends only on the
ra steam pressure
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Steam-
Direct correlation between pressure
generator and temperature
Pressure and temperature monitoring

ensures a redundant process control

INTERNAL HEATING ELEMENTS STEAM GENRATOR
• Steam is generated directly in the • Steam is generated in a steam

pressure vessel of the autoclave generator outside pressure vessel
• Steam is created on the bottom of • Steam inlet from top of the
the chamber pressure vessel
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• Air must be suppressed to the top • Air is suppressed to the bottom of
of the chamber the pressure vessel
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• Suppression of air against its • Suppression with the natural
natural gravitation gravitation of the air
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• Air physically is heavier than steam
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and gravitates down while steam
rises up
Ineffective air release causes a Separate steam generator and steam

reduction of the biological efficiency generation outside the pressure vessel
of a steam sterilization process allows much better process control

INTERNAL HEATING ELEMENTS STEAM GENRATOR
• Heating elements on the bottom of • No heating elements on the

the pressure vessel bottom of the pressure vessel
• Dirty water swamp on the bottom • Not dirty water swamp on the
of the pressure vessel bottom of the pressure vessel
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Not easy to clean Easy to clean
the pressure vessel the pressure vessel
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STERILIZATION OF LIQUIDS | general
STERILIZATION OF LIQUIDS (PREPARATION)
• Culture media in bottles to selectively grow specific

microorganisms
• Steam sterilization can influence media quantity and
quality (e.g. heat sensitive additives)
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• Most critical sterilization process as far as safety, cycle
time and productivity are concerned
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STERILIZATION OF LIQUIDS | cycle phases
H: Heat-up
S: Sterilization
C: Cooling
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Blue: Pressure in
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the chamber
Red: Temperature
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STERILIZATION OF LIQUIDS | heat-up phase
• The pressure vessel of the

autoclave is heated by steam
• Steam condenses on the cold walls
of the bottles and releases its
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energy
• The heat radiates into the liquid
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   
   
   The liquid is heated up with a
ra delay time compared to the
pressure vessel of the autoclave
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H: Heat-up
S: Sterilization
C: Cooling
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Blue: Pressure in
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the chamber
Red: Temperature
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• When the autoclave is heated up to sterilization temperature, the liquids in the
bottles have by far not yet reached the wanted sterilization temperature
• The overall time required to attain equilibrium between chamber and liquids is
hence much longer

• Temperature must be measured in

a reference vessel using a PT-100
temperature load sensor
– To ensure that the wanted
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sterilization temperature is really
reached inside the liquid
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– To ensure a safe cooling
temperature
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large and the filling volume as
high as the volume of the biggest
vessel filled with culture media

H: Heat-up
S: Sterilization
C: Cooling
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Blue: Pressure in
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the chamber
Red: Temperature
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• Increased temperature in the pressure vessel during the heat-up time
• Improved heat transfer – Liquid media in the bottles heats up faster
• Heat-up time reduced by up to 50%

STERILIZATION OF LIQUIDS | cooling phase
• When sterilizing liquids, not only achieving the sterilization temperature in

the heat-up phase is important
• It is also important to cool the liquids to a save temperature before it is
allowed to open the autoclave
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TRB 402 – Technical Regulations for Pressure Vessels (clause 3.2.4)
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If there is a given danger of delayed boiling of the sterilization product, e.g.
when sterilizing liquids, it must be ensured that the pressure vessel can only be
opened when the temperature of the liquid is cooled well below the boiling
point
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DIN 58950 – Steam sterilizer for pharmaceutical products (clause 8.4)
The program control must be designed that opening of the door during
operation is not possible
When using a liquid sterilization program, it must be ensured that the
temperature in the product is lower than 0.8 times the boiling temperature

STERILIZATION OF LIQUIDS | cooling phase | delayed boiling
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STERILIZATION OF LIQUIDS | cooling phase | delayed boiling
• Delayed boiling can result in heavy injuries

• To prevent delayed boiling, it is to ensure that liquids in steam sterilizers are
cooled down to a temperature well below the boiling point at atmospheric
pressure
• A thermal protection has to ensure that the autoclave cannot be opened as
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long as the liquid is not cooled down to a save temperature
• The temperature has to be measured in the liquid (reference vessel)
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• A cooling temperature of 80°C is safe
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Because of the high risk of accidents
there should not be any compromise

STERILIZATION OF LIQUIDS | cooling phase
EVAPORATION COOLING
• Cooling by evaporation (boiling) of the culture media

in the cooling phase
Only for open vessels
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NON-EVAPORATION COOLING
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• Cooling without evaporation (boiling) of the culture
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media in the cooling phase
• Cooling by radiation
For open and hermetically closed vessels

STERILIZATION OF LIQUIDS | cooling phase | evaporation cooling
• Evaporation cooling is achieved by evaporation (boiling) of the sterilized

liquid
• Evaporation can only take place in open vessels - never in closed vessels as in
closed vessels a gas exchange is not possible
• Evaporation out of closed vessels cannot take place and the liquid does not
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cool off
• Caps of closed vessels must at least be vented
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How can it be assured that bottles are always open (caps
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are vented) given the fact that more and more bottles
with screw caps are used in laboratories nowadays?
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At the opening of the autoclave, the temperature of the liquid in closed
bottles is still above 100°C and the bottles are still under pressure
DANGER! GLASS BOMB

STERILIZATION OF LIQUIDS | cooling phase | conventional cooling
• Conventional cooling, no active

cooling system
• Slow steam release
• Boiling and evaporation of liquid
media out of the vessel due to
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pressure drop in the pressure
vessel
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• Cooling by evaporation down to
100°C / 100kPa
ra Liquid product loss of 3 to 5%

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No cooling effect on
hermetically closed vessels
Risk of over boiling – protein

containing liquid can foam over

• Below 100°C/100kPa, evaporation

cooling discontinues
• Atmospheric pressure is reached,
no more pressure that can be
released from the pressure vessel
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• Further cooling to 80°C by
radiation through the stainless
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steel and insulation of the pressure
vessel and the autoclave housing is
ra very slow
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All heat that radiates out of the
autoclave is given to the room in
which the autoclave is installed and
heats the room – special air condition
in the room might be needed

CLOSED VESSEL (1000ml water) OPEN VESSEL (1000ml water)
nd
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ra
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• Hermetically closed and open

vessels in autoclave chamber
• Both, the closed and the open
vessels, are filled with 1000ml of
water
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ra
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H: Heat-up
S: Sterilization
C: Cooling
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Blue: Pressure in
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the chamber
Red: Temperature
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• Cooling by evaporation down to 100°C is reasonably fast
• Further cooling by radiation down to 80°C is very slow
Cooling time up to 10 hours (depending on load volume)

STERILIZATION OF LIQUIDS | cooling phase | ambient air ventilation
• Cooling by ambient air ventilation

• Condensation of steam at the cold
spot causes a pressure drop
• Boiling and evaporation of liquid
media out of the vessel due to
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pressure drop in the pressure
vessel
• Down to 80°C = vacuum ~ 50 kPa
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Liquid product loss of 7 to 10%
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Heat radiates into the room
where the autoclave is installed

CLOSED VESSEL (1000ml water) OPEN VESSEL (1000ml water)
nd
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ra
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• Hermetically closed and open

vessels in autoclave chamber
• Both, the closed and the open
vessels, are filled with 1000ml of
water
nd
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ra
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H: Heat-up
S: Sterilization
C: Cooling
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Blue: Pressure in
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the chamber
Red: Temperature
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• Cooling by evaporation down to 80°C
Cooling time between 1 hour and 5 hours (depending on load volume)

STERILIZATION OF LIQUIDS | cooling phase | water cooling
• Cooling by water cooling with

cooling coils around the pressure
vessel
  • Condensation of steam at the
 
 
cooled walls of the pressure vessel
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  • Quick pressure drop
 
  • Fast Boiling and evaporation of
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
 liquid media out of the vessel




• Effective down to 80°C
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No cooling effect on

STERILIZATION OF LIQUIDS | cooling phase | water cooling with support air pressure
• Cooling by water cooling with

cooling coils around the pressure
vessel
• Prior to cooling, replacement of
steam pressure by sterile filtered
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air pressure (support air pressure)
• Air is a non-condensable gas ,
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pressure remains throughout the
whole cooling phase
ra • Cooling by radiation of heat to the

cooled walls of the pressure vessel
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Non-evaporation cooling
No boiling of the liquids
Effective for hermetically

closed vessels

H: Heat-up
S: Sterilization
C: Cooling
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Blue: Pressure in
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the chamber
Red: Temperature
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• Non-evaporation cooling down to 80°C
Cooling time between 30 minutes and 3 hours (depending on load volume)

STERILIZATION OF LIQUIDS | cooling phase | water cooling systems
DOUBLE JACKET (MANTLE COOLING) COOLING COILS
nd
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STERILIZATION OF LIQUIDS | cooling phase | water cooling systems
DOUBLE JACKET (MANTLE COOLING) COOLING COILS
• Double jacket is produced by point • Half-pipe cooling coils to increase

welding two metal sheets and the cooling surface
inflating these by air pressure • Cooling water is led all around the
• Double jacket has very tiny pressure vessel
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capillaries through which the • Cooling coils provide a bigger
cooling water is led diameter compared to the
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• Using tap water or softened water capillaries of a double jacket which
for cooling would block the reduces the risk of blocking the
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capillaries with carbonates cooling system by carbonates
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Because of the tiny capillaries, Inexpensive tap water or
expensive demineralized water softened water can be used
has to be used for cooling

• Add-on: Radial Ventilator

• Internal ventilator for further
reduction of the cooling time
• Supports water cooling with
support air pressure by ventilation
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forced convection of the heat to
the cooled walls of the pressure
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vessel
ra Does not reach into the chamber,

does not reduce the usable space
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(except Systec V-40 and V-55)

H: Heat-up
S: Sterilization
C: Cooling
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Blue: Pressure in
the chamber
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Red: Temperature
in the media
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• Water cooling with support air pressure and Radial Ventilator
Cooling time between 20 minutes and 2 hours (depending on load volume)

• Add-on: Ultra Cooler

• Additional heat exchanger for
further reduction of the cooling
time
• Supports water cooling with
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support air pressure and radial
ventilator
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ra Does not reach into the chamber,
does not reduce the usable space
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(except Systec V-40 and V-55)

H: Heat-up
S: Sterilization
C: Cooling
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Blue: Pressure in
the chamber
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Red: Temperature
in the media
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• Water cooling with support air pressure, Radial Ventilator and Ultra Cooler
Cooling time between 10 minutes and 60 minutes (depending on load volume)

STERILIZATION OF LIQUIDS | cooling phase | spray cooling
• Spray cooling
• Heating by steam
• Steam is condensed in the cooling
phase and recirculated through a
heat exchanger as cooling water
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• Cooling by spraying cold water to
the vessels
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• Includes support air pressure
ra Non-evaporation cooling
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Only for hermetically

closed vessels

STERILIZATION OF LIQUIDS | cooling phase | spray cooling with laminar plate
• Spray cooling with laminar plate

• Laminar plate prevents direct
spraying of water to the bottles
nd
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ra Non-evaporation cooling
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Only for hermetically

closed vessels

STERILIZATION OF LIQUIDS | cooling phase | spray cooling
H: Heat-up
S: Sterilization
C: Cooling
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Blue: Pressure in
the chamber
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Red: Temperature
in the media
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• Spray cooling with or without laminar plate
Cooling time between 5 minutes and 20 minutes (depending on load volume)

STERILIZATION OF LIQUIDS | cooling phase | evaporation vs. non-evaporation cooling
EVAPORATION COOLING NON-EVAPORATION COOLING
• Conventional cooling (no active • Water cooling with support air

cooling system) pressure
• Ambient air ventilation • Spray cooling with support air
• Water cooling without support air pressure
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pressure
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ra
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STERILIZATION OF LIQUIDS | cooling phase | evaporation vs. non-evaporation cooling
EVAPORATION COOLING NON-EVAPORATION COOLING
• Cooling without support air • Cooling with support air pressure

pressure • Replacement of steam pressure by
• Boiling of liquids during cooling sterile filtered air pressure for
phase cooling (support air pressure)
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– Loss of liquid out of vessels due to • Non evaporation cooling
boiling process – No boiling, no product loss
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– Risk of over boiling – No risk of over boiling
– Danger of delayed boiling – No risk of delayed boiling
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Not effective on Effective on open and
hermetically closed bottles hermetically closed vessels

STERILIZATION OF LIQUIDS | closed bottles
• Closed bottles and cans, etc. must always be sterilized with support air
pressure in the cooling phase
• There is danger of explosion without support air pressure as the
temperature and pressure in closed bottles drops much slower than in the
pressure vessel of the autoclave when using a cooling system without
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support air pressure
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How can it be assured that bottles are always open (caps
are vented) given the fact that more and more bottles
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with screw caps are used in laboratories nowadays?
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Systec strongly recommends to use a cooling system
with support air pressure for safety reasons!!!

STERILIZATION OF LIQUIDS | standard features and recommended options
STANDARD FEATURES RECOMMENDED OPTIONS
• Temperature and pressure • Water cooling with cooling coils

dependent door-locking device and support air pressure
prevents opening of the door – Add-on: Radial ventilator
whilst there is too high – Add-on: Ultra Cooler
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temperature or pressure
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• PT-100 temperature load sensor • Compressor
for measuring the temperature in a for support air pressure if on-site
reference vessel
ra compressed air supply is not
available
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STERILIZATION OF SOLIDS | general
• All kind of tools and utilities that are needed for

research
– Instruments
– Empty glassware (bottles, cans, …)
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– Tubes and hoses
– Pipettes, pipette tips
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– Filters, Textiles
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• Critical process as far as the biological efficiency is
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concerned

STERILIZATION OF SOLIDS | preconditions
• Important factors
– Temperature
– Time
– Most important: Sterilization agent (steam)
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• Steam contains 3600 times more heat energy than dry air at the same
temperature
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• Important for the biological efficiency of a steam sterilization process is not
only the temperature but particularly the heat capacity of the sterilizing
agent (steam)
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An accurate, reproducible and validatable sterilization can only be ensured
if the steam penetrates to all outer and inner surfaces of the product

STERILIZATION OF SOLIDS | heat-up phase | inefficient air release
• Air displacement by simple heat-up

• Steam atmosphere in the pressure
vessel
• Air inside the product (pipette tip
nd
box)
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ra
Fa
No sterilizing effect in
the pipette tip box
Air Steam

• Two pipette tip boxes

• In both boxes, temperature sensors
and bio-indicators are placed
nd
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ra
Fa

• Pipette tip box wrapped with

aluminum foil
nd
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ra
Fa

• Pipette tip boxes and two empty

bottles placed into the autoclave
• Each box and bottle contains a
temperature sensor and a bio-
indicator
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• Temperature mapping and using
bio-indicators in the pressure
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vessel of the autoclave and in the
product itself during the
ra sterilization cycle allows to exactly

determine the biological efficiency
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of the process in different areas of
the autoclave and the load

STERILIZATION OF SOLIDS | general
• All kind of tools and utilities that are needed for

research
– Instruments
– Empty glassware (bottles, cans, …)
nd
– Tubes and hoses
– Pipettes, pipette tips
ya
– Filters, Textiles
ra
• Critical process as far as the biological efficiency is
Fa
concerned

STERILIZATION OF SOLIDS | preconditions
– Temperature
– Time
nd
temperature
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agent (steam)
ra
Fa


vessel
• Air inside the product (pipette tip
nd
box)
ya
ra
Fa
No sterilizing effect in
the pipette tip box
Air Steam

STERILIZATION OF SOLIDS | heat-up phase | fractionated / pulsed pre-vacuum
First pre-vacuum
- air removal 90-95%
First steam injection

- remaining air gravitates down
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Second pre-vacuum
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Second steam injection
ra - remaining air gravitates down

Fa
Third pre-vacuum
Steam-
- air removal 100%
generator
Third steam injection

- heat up to sterilization temperature
and start of sterilization time

• Efficient air release by

fractionated / pulsed pre-vacuum
• Steam can penetrate to all inner
and outer surfaces of the product
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• Steam atmosphere in both, the
pressure vessel and the product
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• No remaining air inside the product
(pipette tip box)
ra
Fa
Sterilizing effect in
the pipette tip box
Air Steam

• Pipette tip boxes and two empty

bottles placed into the autoclave
• Each box and bottle contains a
temperature sensor and a bio-
indicator
nd
ya

Fa

Location of bio-indicator Test result

Chamber No growth
10L bottle No growth
1L bottle No growth
nd
pipette tip box 1 No growth
pipette tip box 2 No growth
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ra
Fa

STERILIZATION OF SOLIDS | steam release phase
• When sterilizing solids, after

sterilization, the steam will be
released from the pressure vessel
• It is allowed to open the autoclave
as soon as atmospheric conditions
nd
are reached in the pressure vessel
• During steam release, steam
ya
condenses in the product
• The product is wet after
ra sterilization
Fa

STERILIZATION OF SOLIDS | drying
• Surface drying by opening the door

of the autoclave after the
sterilization cycle is finished
• Not a good drying result, still much
nd
condense in the products
ya
Standard feature: Systec autoclaves
ra provide an automatic door-opening
Fa
at the end of the sterilization cycle
(triggered through a parameter)

• Drying with fractionated post-

vacuum
• During vacuum, the boiling point is
lowered which causes that the hot
nd
condense evaporates
• As much as the condenses cools
ya
off, the drying effect gets less
• Not a good drying result, still much
ra condense in the product especially
on difficult products (such as
Fa
textiles) and high load volumes

• Drying by fractionated post-

vacuum and Suprdry
• Drying by fractionated post-
vacuum
nd
• Additional heating by Superdry
heating coils
ya
• Heating adds energy to the
pressure vessel which keeps the
ra condense hot
• Ensures an optimal drying result
Fa
even for difficult products and high
load volumes

STERILIZATION OF SOLIDS | standard features and recommended options
• Temperature and pressure • Vacuum system

dependent door-locking device – Fractionated pre-vacuum for
prevents opening of the door efficient air removal
whilst there is too high – Fractionated post-vacuum for
nd
temperature or pressure drying
ya
• Separate steam generator • Superdry
(Systec VX, DX and HX autoclaves) for efficient drying even on difficult
ra loads and high load volumes
Fa

STERILIZATION OF WASTE | general
STERILIZATION WASTE (DECONTAMINATION)
• Solid waste in waste bags

• Liquid waste in bottles
• Biohazard waste
nd
ya
ra
Fa

STERILIZATION OF WASTE | preconditions
– Temperature
– Time
nd
temperature
ya
agent (steam)
ra
Fa

STERILIZATION OF WASTE | heat-up phase | inefficient air release

vessel
• Air inside the waste bag
nd
ya
ra
Fa
No sterilizing effect
in the waste bag
Air Steam

• Waste bag with petri dishes placed

into the autoclave
• Three temperature sensors with
each a bio-indicator in different
levels in the waste bag
nd
ya

Fa


Chamber No growth
Waste bag top Growth
Waste bag middle Growth
nd
Waste bag bottom Growth
ya
ra
Fa

• Air displacement by steam through simple heat-up is not sufficient to ensure

a 100% steam atmosphere not only in the pressure vessel of the autoclave
but also in the product that should be sterilized
• If air is left inside the product that should be sterilized, the air will prevent
that steam can penetrate to all surfaces of the product
nd
• Remaining air inside the product reduces the biological efficiency of the
sterilization process considerably
ya
ra
Fa

STERILIZATION OF WASTE | heat-up phase | over pressure pulses / pulsed heat-up
• Heat-up and air release through

over pressure pulses, pulsed heat-
up
• Steam pulses are given into the
nd
followed by releasing the steam
again
ya
ra
Fa

STERILIZATION OF WASTE | heat-up phase | over pressure pulses / pulsed heat-up
• Some water must be added into

the bag to support the air release
out of the destruction bag
• By evaporation out of the
destruction bag during steam
nd
release the air release will be
improved
ya
• Difficult to standardize – in
particular when the out gassing
ra plastic suppresses the steam out of

the destruction bag.
Fa
• Over pressure pulses procedure is
better than simple heat up but it is
H20
not a reproducible or validatable
method
Air Steam

STERILIZATION OF WASTE | heat-up phase | fractionated / pulsed pre-vacuum
First pre-vacuum
First steam injection

- remaining air gravitates down
nd
Second pre-vacuum
ya
Second steam injection
ra - remaining air gravitates down

Fa
Third pre-vacuum
Steam-
- air removal 100%
generator
Third steam injection

- heat up to sterilization temperature
and start of sterilization time

• Efficient air release by

fractionated / pulsed pre-vacuum
• Steam can penetrate to all inner
and outer surfaces of the product
nd
• Steam atmosphere in both, the
pressure vessel and the waste bag
ya
• No remaining air inside the waste
bag
ra
Fa
Reproducible and validatable
sterilizing effect in the waste bag
Air Steam

• Waste bag with petri dishes placed

into the autoclave
• Three temperature sensors with
each a bio-indicator in different
levels in the waste bag
nd
ya

Fa


Chamber No growth
Waste bag top No growth
Waste bag middle No growth
nd
Waste bag bottom No growth
ya
ra
Fa

STERILIZATION OF WASTE | air exhaust filtration
steam
nd
ya
air
ra
Fa
• Air leaving the autoclave is filtered through a 0.2µm HEPA-filter

• Condense is kept in the pressure vessel and steam is injected to the
condense to ensure sterility of the condense prior to draining

STERILIZATION OF WASTE | air exhaust filtration
steam
nd
ya
air
ra
Fa
• Filter is inline sterilized during the sterilization process by steam injection

• Temperature in the filter controlled by PT-100 temperature sensor
• Filter can be exchanged by operator, no service intervention needed

STERILIZATION OF LIQUIDS | standard features and recommended options
• Temperature and pressure • Vacuum system

dependent door-locking device – Fractionated pre-vacuum for
prevents opening of the door efficient air removal
whilst there is too high – Single post-vacuum to reduce bad
nd
temperature or pressure smell of the waste
ya
• Separate steam generator • Air exhaust filtration
(Systec VX, DX and HX autoclaves) for save sterilization of even
• Over pressure pulses

ra biohazard waste
Fa

SYSTEC AUTOCLAVES | Systec V-Series
nd
ya
• Vertical, top-loading autoclaves
ra
Fa

nd
ya
Systec V-40 V-55 V-65 V-75 V-95 V-100 V-120 V-150
Chamber dim.
Ø x depth (mm)
344x450
ra
344x600 400x500 400x600 400x750 500x500 500x600 500x750
Fa
Chamber volume
45/40 60/65 70/65 80/75 100/95 110/100 130/120 160/150
total / nominal (l)
Heating (kW) 3.6 3.6 9.0 9.0 9.0 9.0 9.0 9.0
Link: Technical Drawings

• Optimized loading capacities

• Slim housing, small footprint
• Extended chamber dimensions
• Excellent loading capacities
Systec V-95 and Systec V-150 optimized for three
nd
layers of 1 liter Schott bottles
ya
ra
Fa

SYSTEC AUTOCLAVES | Systec D-Series
nd
ya
• Horizontal, bench-top autoclaves
ra
Fa

SYSTEC AUTOCLAVES | Systec D-Series
nd
ya
Systec D-23 D-45 D-65 D-90 D-100 D-150 D-200
Chamber dim.
Ø x depth (mm)
260x420
ra
344x500 400x500 400x700 500x500 500x750 500x1000
Fa
Chamber volume
total / nominal 25/23 50/45 70/65 95/90 110/100 160/150 210/200
(l)
Heating (kW)
DX 2.8 2.8 9.0 9.0 9.0 9.0 9.0
DE and DB 2.3 3.0 4.5 4.5 4.5 7.25 7.25

SYSTEC AUTOCLAVES | Systec V- and D-Series | performance categories
• Systec V-Series and D-Series autoclaves are available in three different

performance categories
– Systec DX|VX
For all laboratory applications even for state-of-the-art sterilization processes.
nd
With all possibilities to add options for process optimization to meet highest
process accuracy and to carry out validatable sterilization cycles.
ya
– Systec DE|VE
For basic laboratory applications and media sterilization. With limited
ra
possibilities to add additional options for process optimization.
Fa
– Systec DB|VB
For simple process applications. No options available for process optimization.

nd
ya
• Systec VX and DX autoclaves with steam generator
ra
• Steam generator separates the heating (steam generation) from the
Fa
• Steam generator integrated into the housing of the autoclave

nd
ya
• Systec VE|VB and DE|DB autoclaves with heating elements inside the
ra
• Steam generator inside the pressure vessel of the autoclave
Fa

SYSTEC AUTOCLAVES | Systec H-Series
nd
ya
• Horizontal, floor-standing autoclaves
ra
• 16 models, 65 to 1.580 liter chamber volume
Fa

nd
ya
Systec HX-65 HX-90 HX-100 HX-150 HX-200
Chamber dim.
Ø x depth (mm)
400x500
ra 400x700 500x500 500x750 500x1000
Fa
Chamber volume
70/65 95/90 110/100 160/150 210/200
total / nominal (l)
Heating (kW) 9.0 9.0 9.0 9.0 9.0

nd
ya
Systec HX-210 HX-320 HX-430 HX-540 HX-650
Chamber dim.
Ø x depth (mm)
740x500
ra 740x750 740x1000 740x1250 740x1500
Fa
Chamber volume
280/210 385/320 495/430 602/540 710/650
total / nominal (l)
Heating (kW) 18.0 18.0 18.0 18.0 18.0

nd
ya
Systec HX-580 HX-780 HX-980 HX-1180 HX-1380 HX-1580
Chamber dim.
Ø x depth (mm)
1000x750
ra
1000x1000 1000x1250 1000x1500 1000x1750 1000x2000
Fa
Chamber volume
755/580 950/780 1150/980 1345/1180 1541/1380 1735/1580
total / nominal (l)
Heating (kW) 36.0 36.0 36.0 36.0 36.0 36.0

SYSTEC AUTOCLAVES | Systec H-Series 2D
nd
Unsterile side Sterile side
ya
• Double-door, pass-through autoclaves
•
• ra
Build into a wall between to divide a sterile and an unsterile area
For clean-rooms and biological safety laboratories
Fa

nd
ya
Systec HX-90 2D HX-150 2D HX-200 2D
Chamber dim.
Ø x depth (mm)
400x750
ra 500x750 500x1000
Fa
Chamber volume
98/95 155/150 205/200
total / nominal (l)
Systec HX-320 2D HX-430 2D HX-540 2D HX-650 2D

Chamber dim.
740x750 740x1000 740x1250 740x1500
Ø x depth (mm)
Chamber volume
370/320 480/430 590/540 700/650
total / nominal (l)

nd
ya
Systec HX-580 2D HX-780 2D HX-9802D
Chamber dim.
Ø x depth (mm) ra
1000x750 1000x1000 1000x1250
Fa
Chamber volume
670/580 870/780 1070/980
total / nominal (l)
Systec HX-1180 2D HX-1380 2D HX-1580 2D

Chamber dim.
1000x1500 1000x1750 1000x2000
Ø x depth (mm)
Chamber volume
1270/1180 1470x1380 1670x1580
total / nominal (l)

SYSTEC AUTOCLAVES | control panel Systec V- and D-Series
• LCD Screen with multi-function keys

• Displays all relevant sterilization parameters in
real-time
• Shows the cycle stage
• Customizable sterilization parameters for each
nd
program
• Four access levels secured by numeric code
ya
ra
Fa

SYSTEC AUTOCLAVES | available programs Systec V- and D-Series
Available programs VX|DX Available programs VE|DE Available programs VB|DB

1-3 Solids 1-3 Solids 1 Solids
4-5 Waste in waste bags 4-5 Waste in waste bags 2 Waste in waste bags
6 Liquid waste with 6 Liquid waste with 3 Liquids with
regulated steam regulated steam regulated steam
nd
exhaust for cooling exhaust for cooling exhaust for cooling
7 Liquid waste with 7 Liquid waste with self
self cooling cooling
ya
8-10 Liquids with 8-10 Liquids with
regulated steam regulated steam
11
exhaust for cooling
Liquids with self
cooling
ra 11
exhaust for cooling
Liquids with self
cooling
Fa
12 Cleaning 12 Cleaning
13 Vacuum-Test**
14 Bowie-Dick-Test**
15-25 Free for individual
programming
**Requires the optional vacuum system

SYSTEC AUTOCLAVES | touch-screen
• Standard for Systec H-Series, optional for Systec

VX autoclaves from 65 liter chamber volume
• Full color touch-screen
• Up to 100 sterilization programs self-
programmable
nd
• Self-programmable description for each program
in the program list
ya
• Sterilization parameters customizable for each
program
ra • Displays all relevant sterilization parameters as
well as the cycle stage in real-time
Fa
• Real-time graph view
• User administration
– User names
– Passwords
– Access and operating rights

SYSTEC AUTOCLAVES | standard features
TEMPERATURE AND PRESSURE RANGE X|E|B
• Maximum temperature 140°C

• Maximum pressure 4bar
• Systec D-23: 136°C, 3.8bar
nd
ya
OPTIONAL EXTENSION OF TEMPERATURE AND PRESSURE X|E
• ra
Maximum temperature 150°C
Fa
• Maximum pressure 5bar
• For autoclaves from 65 to 650 liter chamber volume and more
• Later upgrade possible

SAFETY DOOR-LOCK X|E|B
• Temperature and pressure dependent door-lock

• Prevents opening of the door whilst there is too high temperature or
pressure in the autoclave
nd
ya
AUTOMATIC DOOR OPENING X|E|B
ra
• Automatic door opening at the end of the sterilization cycle
Fa
• Programmable for each program individually

ADJUSTMENT OF STERILIZATION TIME X|E
• Sterilization time adjustable between 1 and 300 minutes

• Programmable for each program individually
nd
ya
START BY CLOCK X|E
ra
• Programmable timer for automatic, delayed start of a sterilization cycle
Fa

TEMPERATURE AND PRESSURE REGULATION X|E|B
• Class A PT-100 temperature sensor

• Electronic pressure sensor
• Redundant process control of both, temperature and pressure
nd
ya
STEAM EXHAUST CONDENSATION X|E
ra
• Water cooled steam exhaust condensation to protect drain against high
Fa
temperature
• Thermostatic controlled

SYSTEC AUTOCLAVES | standard features and options | steam generation
STANDARD FEATURE: AUTOFILL X|E
• Autofill, connection to demineralized water line for automatic filling of

demineralized water
• Systec DX-23 and 45: build-in tank filled automatic or manual
• Systec DE-23 and 45: build-in tank filled manual (optional automatic)
nd
ya
MANUAL FILLING E|B
ra
• Manual filling of demineralized water direct into the pressure vessel of the
Fa
autoclave
• Systec DB-23 and 45: manual filling of demineralized water into build-in tank

STANDARD FEATURE: LOW WATER LEVEL PROTECTION X|E|B
• Protection against low water level in steam generator (X autoclaves)

• Protection against low water level in chamber (E and B autoclaves)
nd
ya
STANDARD FEATURE: FULL PARAMETER LIMIT CONTROL X|E|B
• Over-heating protection ra
Fa
• Over-temperature protection
• Over-pressure protection

OPTION: DEMINERALIZATION CARTRIDGES X|E
• Produces demineralized water from tap water

• Demineralized water quality consistently checked
by conductivity meter
nd
ya
OPTION: FEED WATER VESSEL AND CONDENSATE COLLECTION VESSEL X
ra • Feed water vessel for feeding demineralized
Fa
water from a separate (external) vessel
• Condensate collection vessel to collect condense

SYSTEC AUTOCLAVES | standard features and options | sterilization of liquids
STANDARD FEATURE: CONTROLLED MEDIA TEMPERATURE X|E|B
• Flexible PT-100 temperature probe for reference

bottle
• Start of sterilization time depending on the
temperature of the media
nd
ya
STANDARD FEATURE: F0-CALCULATION X|E
• Calculation of F0-Value ra
Fa
• To reduce the sterilization time for heat sensitive culture media

OPTION: COOLING OF LIQUIDS X|E
• Ambient air ventilation

(without support air pressure)
nd
ya
OPTION: COOLING OF LIQUIDS X|E
ra • Water cooling
Fa
(without support air pressure)

OPTION: FOR FAST AND SAFE COOLING OF LIQUIDS X|E
• Water cooling
(with support air pressure)
nd
• Addon: Radial ventilator
ya
• Addon: Ultra Cooler
OPTION: FAST AND SAFE COOLING OF LIQUIDS X|E

ra • Spray cooling
Fa
(with support air pressure)

OPTION: FOR FAST AND SAFE COOLING OF LIQUIDS X|E
• Closed cooling circuit for water cooling
nd
ya
OPTION: MAGNETIC STIRRER X|E
ra • Magnetic stirrer for homogeneous mixing of
Fa
culture media in big flasks

FURTHER OPTIONS FOR WATER COOLING SYSTEMS X|E
• Feed water softener

Needed if tap water used for cooling is harder than 300µS / 10°dH
• Compressor for support air pressure if on-site compressed air is not available
nd
– Silent 40 for autoclaves Systec V- and D-Series up to 50 liter chamber volume
– Silent 50 for autoclaves Systec V- and D-Series from 65 to 200 liter chamber and
ya
Systec H-Series 65 to 200 liter chamber volume
– Silent 200 for autoclaves Systec H-Series 210 to 1580 liter chamber volume
ra
Fa

SYSTEC AUTOCLAVES | standard features and options | sterilization of solids and waste
STANDARD FEATURE: STEAM GENERATOR X
• Separate steam generator integrated into the

housing of the autoclave
• For optimized fractionated pre-vacuum
nd
ya
STANDARD FEATURE: OVER-PRESSURE PULSES X|E|B
ra • Over-pressure pulses, pulsed heat-up for
Fa
improved displacing of air out of waste bags

OPTION: VACUUM SYSTEM X

• Vacuum system for reproducible and validatable
steam sterilization of solids and waste in waste
bags
– Fractionated pre-vacuum for optimal air
nd
displacement
– Fractionated post-vacuum for drying
ya
OPTION: SUPERDRY X
ra • Superdry heating for drying of solids
Fa
• For an optimal drying result even on difficult
loads and high load volumes

OPTION: AIR EXHAUST FILTRATION X
• Air exhaust filtration for save sterilization of

biohazard waste
• Protects the environment aginst possible
contamination
nd
ya
ra
Fa

SYSTEC AUTOCLAVES | standard features and options | documentation
STANDARD FEATURE: RS232 INTERFACE X|E
• RS232 Interface for connection of a Windows PC

• Compatible for documentation over a network
nd
ya
STANDARD FEATURE: INTERNAL STORAGE X|E
ra • Internal storage for documentation of up to 500
Fa
sterilization cycles

OPTION: PRINTER X|E|B
• Printer with standard paper (no thermal paper)

• Integrated into the housing of the autoclave
nd
ya
OPTION: PC SOFTWARE X|E
ra • Systec ADS for control, parameterization and
Fa
documentation of up to 6 Systec autoclaves
• Either by direct RS232 connection or through a
network
• Numerical and graphical processing of the data

OPTION: DOCUMENTATION SD X|E
• Documentation on 1GB SD-Card

• For documentation of up to 10.000 sterilization
cycles
nd
ya
ra
Fa

SYSTEC AUTOCLAVES | standard features and options | qualification & validation
STANDARD FEATURE: VALIDATION PORT X|E|B
• Validation port for introducing independent temperature sensors into the

nd
ya
OPTION: VALIDATION SET X|E|B
ra • For validation port to introduce independent
Fa
temperature sensor gastight

SYSTEC AUTOCLAVES | optional accessories
• Support tables for Systec D-Series autoclaves
nd
ya
ra
Fa

• Wire-mesh baskets for liquids and solids

• Closed baskets for waste in waste bags
nd
ya
ra
Fa

don't use closed baskets use wire mesh baskets
nd
ya


 ra 


Fa
 

don't use wire mesh baskets use closed baskets
nd
ya
ra
Fa
 

• Racks for Systec D-Series and

Systec H-Series
nd
ya
ra
Fa

nd
ya
ra
Fa
• Transport and Loading carriages for Systec D-Series and Systec H-Series
• For easy laoding and unloding even of heavy goods

• Lifting device for Systec V-Series autoclaves
nd
ya
ra
Fa

SPECIAL APPLICATIONS | hot water recirculation
• Heating and cooling by spraying of water

• Water is continuously recirculated
• Additional air pressure can be selected over the whole sterilization cycle
nd
ya
ra
Fa

SPECIAL APPLICATIONS | hot water recirculation
• Temperature and pressure • Hot water recirculation

dependent door-locking device • Includes: Spray heating and spray
prevents opening of the door cooling
whilst there is too high – Includes: Support pressure over
nd
temperature or pressure the whole sterilization cycle
– Includes: Temperature and
ya
pressure extension to 150⁰C/5bar
• PT-100 temperature load sensor
(for autoclave 65 liter to 650 liter)
for measuring the temperature in a
reference vessel
ra • Compressor
Fa
for support air pressure if on-site
compressed air supply is not
available

SYSTEC MARKETING | custom products and solutions
• Custom products and solutions

available on request
• 2x Systec DX-2D double-door

autoclave built into one housing
nd
ya
ra
Fa


• 2x Systec HX-650 2D double-door

autoclave built into one housing,
nd
completely made from stainless
steel
ya
ra
Fa


• Systec autoclave – support table

and transport carriage customized
nd
to sterilize heavy loads of soil
ya
ra
Fa


• Change door opening for

Systec D-Series and Systec H-Series
nd
ya
ra
Fa


• Changed door opening for

Systec D-Series and Systec H-Series
nd
ya
ra
Fa


• Waste water collector
nd
ya
ra
Fa

QUALIFICATION & VALIDATION | Resistance of microorganisms
80°C 100°C 121°C 134°C

Plasmodia
Flagellates
Viruses
1-5 min.
Bacteria without spores
nd
Yeasts
Moulds
Spores of yeast and moulds 5-10 min. 1 min.
ya
Spores of germs with low
1-60 min.
resistance
Spores of germs with higher
resistance (e.g. Bacillus
ra 15-20 min. 1-3 min.
Fa
Stearothermophilus)
Because of its high temperature resistance, Bacillus Stearothermophilus

is considered to be the reference indicator for qualification and
validation of steam sterilization processes

QUALIFICATION & VALIDATION | procedure
• Qualification
A qualification process is used to verify whether or not a device is suitable
for its intended use
• Validation (definition according to U.S. FDA)
nd
(...) the process of demonstrating, through the use of specific laboratory
investigations, that the performance characteristics of an analytical
ya
method are suitable for its intended analytical use
ra
• GMP / GLP (Good Manufacturing Practice / Good Laboratory Practice)
It is required in governmental GxP regulations that (in particular in the
Fa
pharmaceutical industry) devices with influence on the product quality
must be validated

• DQ – Design Qualification
– User defines his requirements to a device or a process
– According to these requirements a design of the device that fulfills the
requirements will be developed
nd
• IQ – Installation Qualification
– Verification whether the device is manufactured and installed according to the
ya
requirements developed in DQ
ra
• OQ – Operational Qualification
– Verification whether the device operates without product according to the
Fa
• PQ – Performance Qualification
– Verification whether the device operates with product according to the

IQ OQ
nd
Installation Qualification Operational Qualification
(carried out once) (carried out periodic)
VALIDATION
ya
ra
Fa
PQ
Performance Qualification
(carried out periodic)

• All steps of IQ, OQ and PQ follow a predefined qualification test plan in

which the characteristics of the device, the characteristics of the product as
well as the acceptance criteria of the various tests are defined
• All results of the tests carried out must be documented according to the test
plan and it must be verified whether the results are within the defined
nd
acceptance criteria
• The documentation must be verified and signed by the manufacturer and
ya
the user of the device
ra
Aim of Qualification and Validation is to have a documented
Fa
proof that a device is qualified for its intended use

QUALIFICATION & VALIDATION | validation of steam sterilization processes
• IQ/OQ templates available from

Systec as
– IQ/OQ Standard
Basic IQ/OQ procedure suitable for
nd
most laboratory customers
ya
– IQ/OQ Extended
Advanced IQ/OQ suitable for e.g.
the pharmaceutical industry
ra
Fa
Link: IQ/OQ templates

IQ Standard IQ Extended
Documentation User manual User manual
Declaration of Conformity RI-Schematic
Wiring diagram
Declaration of Conformity
nd
RI-Schematic Check whether options are Detailed check of all
present as confirmed in mechanical connections
order confirmation against a custom RI-
ya
Schematic
Wiring diagram n/a Detailed check of all
ra electrical connections
against a custom wiring
Fa
diagram
Electrical test n/a Test according to VDE 0701
Software test Check of installed software Check of installed software
version version
Number of protocols 3 (7 pages) 6 (16 pages)

OQ Standard OQ Extended
Temperature calibration 121⁰C 105, 121 and 134⁰C
Pressure calibration 210kPa 122, 210 and 305kPa
Time calibration n/a Yes, during a test run
nd
Failure messages n/a Yes, 7 messages
Log book n/a Check whether available
ya
Check of access rights n/a Yes
Vacuum test Yes Yes
(only for Systec VX, DX and HX with
optional vacuum system)
Test run Instrument

ra
1 runs with an instruments 3 run with an instruments
Fa
(empty chamber with program program
temperature/pressure mapping
and bio-indicators)
Test run Liquids n/a 3 runs with a liquids

(empty chamber with program
temperature/pressure mapping
and bio-indicators)
Number of protocols 4 (15 pages) 9 (34 pages)

• IQ/OQ templates need to be

adapted to the customers need
(together with the customer!)
• Typically IQ/OQ documentation
nd
includes
– Description of the device tested
ya
– Test description
– Description of the instruments
ra used to carry the test out (e.g.

temperature sensors)
Fa
– Acceptance criteria
– Test result
– Signature of the person who did
the tests (e.g. service engineer)
and the customer to document
that the results are approved

• PQ – Performance Qualification
– Qualification of the sterilization process with the product that is to be sterilized
– Definition of load schemes for each product / sterilization cycle (customer!)

• Simple load
nd
• Medium load
• Worst case load
ya
– Temperature sensors and bio-indicators are placed into the chamber of the
autoclave and into the product that is to be sterilized
ra
• Definition of the critical areas
Fa
– Carrying out of three sterilization runs per program and load scheme
– Documentation and verification of temperature/pressure mapping and bio-

indicators
• Verification of bio-indicators either by customer or by accredited test
laboratory

• Which bio-indicator has to be used for which application?
nd
ya
ra
Fa

SPORE STRIPS ONY FOR STERILIZATION OF SOLIDS AND WASTE IN WASTE BAGS
• Spore strips to be used only for sterilization of solids

and waste in waste bags
• Spore strips placed into the critical areas of the load
give indication whether steam was in place or not
nd
• Spore strips will only be inactivated if steam was in
place to transfer the heat energy needed for the
ya
biological efficiency of the steam sterilization process
ra
Fa

• Right placing of bio-indicator

• Bio-indicator and temperature
sensor placed in the critical area of
the load
nd
ya
ra
Fa


• Bio-indicator and temperature
sensor placed in the critical area of
the load
nd
ya
ra
Fa


• Bio-indicators and temperature
sensors placed in the critical areas
of the load
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Reference
• Systec Documentation
• en.wikipedia.org/wiki/Autoclave
• http://www.astell.com/howanautoclaveworks
• en.wikipedia.org/wiki/Sterilization
•
nd
en.wikipedia.org/wiki/Sterilizationen.wikipedia.org/wiki/Sterilization_(micro
biology)
• getenotes.weebly.com/uploads/1/4/1/9/.../2.1.pptx
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• ksupc.com/.../Sterilization%20methods%20and%...
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nd
• Thanks For Attention
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• Subject : Introduce Systec company

Astrylyzyasyvn or sterilization means elimination of all forms of life in or on a

• Different sterilization procedures are performed in the microbiology laboratory can

• An autoclave is a pressure chamber used to sterilize equipment and supplies by

• Systec develops, produces and markets laboratory autoclaves

• Systec is absolutely committed to the laboratory autoclave market

We make steam sterilization processes in laboratories

© Systec GmbH , Wettenberg | www.systec-lab.com 6

SYSTEC D-SERIES – BENCH-TOP, FRONT-LOADING AUTOCLAVES

• 7 models, 23 to 200 liter chamber volume

© Systec GmbH , Wettenberg | www.systec-lab.com 7

• Systec V-Series and D-Series autoclaves are available in three different

© Systec GmbH , Wettenberg | www.systec-lab.com 8

SYSTEC H-SERIES – HORIZONTAL, FLOOR-STANDING AUTOCLAVES

• 16 models, 65 to 1.580 liter chamber volume

© Systec GmbH , Wettenberg | www.systec-lab.com 9

© Systec GmbH , Wettenberg | www.systec-lab.com 10

• Certified according to newest

© Systec GmbH , Wettenberg | www.systec-lab.com 11

• Systec offers the widest range of laboratory steam sterilizers and

– 73 autoclave models, 23 to 1.580 liter chamber volume

THIS MAKES SYSTEC A UNIQUE AND RELIABLE PARTNER

© Systec GmbH , Wettenberg | www.systec-lab.com 12

© Systec GmbH , Wettenberg | www.systec-lab.com 13

© Systec GmbH , Wettenberg | www.systec-lab.com 14

© Systec GmbH , Wettenberg | www.systec-lab.com 15

• Biotech companies and

© Systec GmbH , Wettenberg | www.systec-lab.com 16

© Systec GmbH , Wettenberg | www.systec-lab.com 17

STERILIZATION OF LIQUIDS (PREPARATION)

• Culture media in bottles to selectively grow specific

© Systec GmbH , Wettenberg | www.systec-lab.com 18

STERILIZATION OF WASTE (DECONTAMINATION)

• Solid waste in waste bags

© Systec GmbH , Wettenberg | www.systec-lab.com 19

© Systec GmbH , Wettenberg | www.systec-lab.com 20

STEAM GENERATION BY INTERNAL HEATING ELEMENTS

• Heating elements inside the pressure vessel of the

© Systec GmbH , Wettenberg | www.systec-lab.com 21

• For steam generation in a steam sterilizer, demineralized water must be used

© Systec GmbH , Wettenberg | www.systec-lab.com 22

© Systec GmbH , Wettenberg | www.systec-lab.com 23

© Systec GmbH , Wettenberg | www.systec-lab.com 24

© Systec GmbH , Wettenberg | www.systec-lab.com 25

ra Steam rises up and air gravitates

© Systec GmbH , Wettenberg | www.systec-lab.com 26

© Systec GmbH , Wettenberg | www.systec-lab.com 27

Steam created by a steam generator

Steam inlet from top

© Systec GmbH , Wettenberg | www.systec-lab.com 28

No remaining air left in the chamber

100% steam atmosphere (steam

Pressure and temperature monitoring

© Systec GmbH , Wettenberg | www.systec-lab.com 29

INTERNAL HEATING ELEMENTS STEAM GENRATOR

• Steam is generated directly in the • Steam is generated in a steam

Ineffective air release causes a Separate steam generator and steam

© Systec GmbH , Wettenberg | www.systec-lab.com 30

INTERNAL HEATING ELEMENTS STEAM GENRATOR