FOCUS ON

CLEANLINESS

Testing laboratory for technical cleanliness,

medical technology and environmental analysis
 "Our vision is to offer our customers first-class
support in their processes and challenges
through innovative products and services."

Volker Burger
CEO

CleanControlling stands for comprehensive services in the fields of technical,

medical and environmental cleanliness for surfaces, materials and media. In
addition to cleanliness testing and documentation, it offers consultation, training
and a specialist product range for the definition, achievement and maintenance of
technical cleanliness. It also focuses on the preservation of human health in
connection with product cleanliness and the absence of pollutants in water,
soil and waste.

Through our customer-oriented services, we embrace our commitment to

supporting and assisting our customers as a helpful, competent and transparent
partner. A trusting, cooperative relationship with employees and fair collaboration
with suppliers and service providers lie at the very heart of this. For us,
regulation- and law-compliant business is a matter of course.

Technical Cleanliness Biological and chemical cleanliness

Chemical film-type cleanliness Environmental Analysis
Locations

CleanControlling GmbH, - Technical cleanliness testing

Emmingen-Liptingen - Material determination of particles
- Testing of chemical film-type cleanliness
- Manufacture and sale of products for technical cleanliness
- Training and consultation on technical cleanliness
- DAkkS accreditation Reg.-Nr. D-PL-18040-01*

CleanControlling GmbH, - Technical cleanliness testing

Dresden - DAkkS accreditation Reg.-Nr. D-PL-18040-01*

CleanControlling Medical - Testing of the biological and microbiological hygienic cleanliness of medical products
GmbH & Co. KG, - Testing to determine the bio-compatibility of medical products
Emmingen-Liptingen - Testing for the validation of reprocessing instructions for medical products
- DAkkS accreditation Reg.-Nr. D-PL-19887-01*

CleanControlling Medical - Examination of organic and inorganic cleaning and manufacturing

GmbH & Co. KG, residues on medical devices
Leipferdingen - Examination of water, wastewater, soil, waste or recycling
materials for pollutants
- Special analyses for the determination of unknown compounds
- DAkkS accreditation Reg.-Nr. D-PL-19887-02*

*Companies accredited by DAkkS according to DIN EN ISO/IEC 17025:2018. The accreditation is valid
for the scope of accreditation listed in the annex to the certificate. The scope of accreditation and the
documents can be found at www.cleancontrolling.com.

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 Construction of an air extraction test bench
for air-conducting components in accordance
First trade fair appearance with VDA 19.1 as the world's first laboratory
at “parts2clean” in Stuttgart service provider

First product catalog

Technical Cleanliness

Workforce
Establishment of the Consulting division 2006 5
2010 10
Series production and market 2015 40
First conference on the
topic Technical Cleanliness
launch of the new particle 2018 55
2
suction extraction system C PS 2020 80
2021 100

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Accreditation in Acquisition of
Foundation of CleanControlling
compliance with Expansion of the Chemisches Labor Becker
Medical GmbH & Co. KG
DIN EN ISO/IEC 17025 biology laboratory Total area of 2000 m2
Total area of 1500 m²

Laboratory extension in
new premises Relocation to new company building Inauguration of
Total area of 300 m² Total area of 1000 m² Dresden laboratory

Development of first
Accreditation of CleanControlling
particle trap generation
Medical according to
DIN EN ISO/IEC 17025

Foundation of CleanControlling GmbH

GLP recognition of
with premises measuring 30 m²
CleanControlling Medical

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TECHNICAL CLEANLINESS

As an internationally leading specialist in the field of technical

cleanliness, CleanControlling GmbH sets globally
renowned standards in laboratory analysis, consulting
throughout the entire product development process and a
specialist product range.
Particulate analysis

In the field of particulate analysis, we evaluate the particulate component cleanliness of your
products and help you to determine the particle source or assess the damage potential through
particle material determination.

Particulate cleanliness testing

Cleanliness tests in accordance with VDA 19.1 / ISO 16232:2018 as well as

over 1,000 specific customer standards for all types of components (small
parts, large parts, air-conducting components, battery components, etc.)

Method - Liquid extraction (spraying, rinsing, ultrasonic, shaking)

- Air throughflow extraction
- Manual air extraction (air jet)
- Suction extraction – robot-guided
- Light analysis – stereomicroscope, material microscope
- Gravimetric determination of particle mass

Further analyses

Material determination to localize particle origin and assess the

damage potential

Method - SEM/EDX scan – particle measurement with

element determination
- Correlative SEM/EDX analysis in connection with
stereomicroscopic evaluation
- IR-FTR analysis of organic particles

Particles in oils & lubricants

Determination of particulate contamination in oils and greases

Method - Microscopic analysis in accordance

with ISO 4406 / ISO 4407
- Quantitative determination in accordance with DIN 51813

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F I L M -T Y P E C L E A N L I N E S S

Chemical analysis

We determine chemical film-type and ionic component cleanliness with targeted procedures to
evaluate the specified limit values. Statements can also be made on substance composition and
possible sources of contamination.

Organic contamination

The identification of organic production residues, such as oils, greases,

corrosion protection, cooling lubricants or cleaning agents to evaluate
film-type component cleanliness.

Method
- Gravimetric analysis
- Determination of surface tension
- Determination of organic compounds (IR)
- Determination of water-soluble total organic carbon (TOC)
- Identification of film-type contamination (GC-MS)

Ionic contamination

Determination of ionic, salt-containing contaminants from soldering and

galvanic process residues.

Method
- Determination of residue conductivity (ROSE)
- Qualitative and quantitative determination – ion-exchange
chromatography (IC)
- Fluoride and residual contamination testing (e.g. cooling systems)

Special analyses – unknown contamination

Characterization of unknown organic and inorganic substances and

compounds in combination with various testing procedures.

Method
- SEM/EDX analysis
- IR spectroscopy
- Gas chromatography (GC-MS)
- Ion chromatography (IC)
 C O N S U LT I N G

Consultation, training and vocational training

We advise you in all areas of technical cleanliness throughout the product

creation process and offer staff training all the way up to specialized
training workshops, seminars and expert conferences.

Consultation

We accompany you all the way from the early concept phase, advising you through the entire
product creation process and helping you to fulfill your cleanliness requirements in a targeted,
optimized manner

- Production cleanliness assessment

- Environmental cleanliness analysis
- Process chain analysis
- Concept assessment of assembly systems
- Product design assessment
- Laboratory planning, laboratory assessment, laboratory audit

Training

A comprehensive range of training, conferences and congresses on technical cleanliness

supports you in qualifying your employees and raising awareness amongst them.

- Basic training courses on technical cleanliness

- Assembly cleanliness training
- Training and sensitization of production employees
- Cleanliness test execution training

Vocational training

We offer vocational training to qualify your employees as

- Qualified employee of Technical cleanliness

- Technical cleanliness specialist
- Technical cleanliness auditor

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 PRODUCTS – TECHNICAL CLEANLINESS

Mobile system for particle suction extraction

A new, non-destructive and mobile testing method using dry suction extraction for economical and
application-focused particle extraction on large components or directly in the process environment –
ideal for the execution of cleanliness tests on HV vehicle batteries and battery components.

C PS2 Basic
- Fast, application-focused particle extraction
- Mobile and process-related extraction on-site

C PS2 ESD
- Full ESD capability, electronic components
can be returned to the production batch
after extraction
- For mobile and process-related use on
production lines in the ESD field, extraction on-site

C PS2 robotics
- Robot-guided suction extraction with high
repeat accuracy
- Collaborative concept – allows direct
proximity to employees
- Rapid and simple induction, even of
complex 3D geometries
- Can be integrated into production lines
for inline testing

Videos
Tried-and-tested equipment and accessories

The product range in our e-shop offers a comprehensive selection of accessories for technical
cleanliness. All products have been examined for technical efficacy and tested in practice. You benefit
from the knowledge and experience of our cleanliness experts.

Particle monitoring

Monitoring accessories for assessing particle appearance in the

production environment, including using particle traps or stamps.

- The particle trap collects collects particles sendimenting in

the work environment
- The particle stamp collects particles from the surface
to be analyzed

Assembly cleanliness

Clean areas as room concepts are supported through special

products and systems. e.g. with

- Glove cleaning system for the removal of micro-particles

- Clean mats for the reduction of particle
entry by personnel
- Barrier/marking tape for the identification of clean zones

Laboratory equipment

The right laboratory equipment and accessories are decisive for

the results of the cleanliness test. CleanControlling offers
laboratory technology matched to the needs of a cleanliness
laboratory.

- Vacuum filtration unit for the separation of extracted

particles on analysis filters
- Tweezers and clips for clean and safe filter and
component handling
- Cleanroom coats and hoods to protect the clean room
- Filter membranes and microscopy accessories

e-Shop

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As an accredited and ZLG- and GLD-recognized testing
laboratory, CleanControlling Medical GmbH & Co. KG is
your partner for the biological and microbiological
hygienic testing of medical products. In the field of
environmental analysis, we use accredited testing
methods to examine water, soil and recyclable
construction waste for pollutants.
 M E D I C A L T E C H N O LO GY T E ST I N G

Medical products – clean and safe

As an accredited and recognized testing laboratory, CleanControlling

Medical checks the biological, microbiological and hygienic cleanliness and
safety of medical products.

Testing within the scope of

- Biocompatibility – chemical characterization and

toxicological evaluation
- Validation of the final cleaning of medical devices
- Validation of instructions for the reprocessing/sterilization of reusable
medical products
- Sterilization container validation
- End-of-life tests: simulation of preparation and sterilization
cycles and the implementation of associated tests for the preservation
of biocompatibility

Tests within the scope of routine monitoring of washer-disinfectors (WD)

The preparation and evaluation of validation sets with bio-indicators for the
validation of washing and disinfection devices (WD)

Hygienic environmental cleanliness testing

Microbiological hygienic testing of surfaces (contact plates) and air

(sedimenting airborne germs on sedimentation plates)

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M E D I C A L T E C H N O LO GY T E ST I N G M E T H O D S

Medical technology analysis

CleanControlling Medical has a comprehensive portfolio of biological, chemical and particulate

analysis methods for testing medical products.

ANALYSIS METHODS

Biological analysis methods

- In-vitro cytotoxicity tests

- Determination of bioburden
- Endotoxin test (LAL test)
- Sterility tests
- Incubation and evaluation of contact or sedimentation plates
- Manual and mechanical processing (cleaning and
disinfection) for testing for reprocessing instruction validation
- Steam sterilization for testing for sterilization
instruction validation
- Determination of residual protein concentration

Particulate analysis method

- Direct count of particles in the extraction medium using

optical particle counter (OPC)
- Microscopic analysis of the analysis filter, automatic
count and measurement of particles

Chemical analysis method

- Chemical analyses for organic/inorganic contaminants

or discharges (TOC, THC, GC-MS, ICP-MS, LC-MS, Headspace)
- Surface testing SEM/EDX, XPS
 E N V I R O N M E N TA L A N A LY S I S

Environmental analysis / chemical special analysis

With its highly qualified chemical analysis laboratory in Leipferdingen, CleanControlling not only offers
purity analyses for medical products, but also chemical analyses in the area of environmental analysis.
Special analyses for the determination of unknown compounds is also one of our strengths.

The environment and pollutants – chemical analysis

The range of services offered in the area of environmental analysis

covers physical, physico-chemical and chemical laboratory analyses
for testing of water (groundwater, demineralized water, wastewater),
aqueous eluates, sludge and sediment as well as soil and waste or
materials for recycling (e.g. recycled building materials) for the
presence of pollutants (PAH/PCB, volatile halogenated hydrocarbons
(CHC)/BTEX, mineral oil hydrocarbons, heavy metals, asbestos, etc).

Special analysis – determination of unknown substances

We use a variety of chemical methods and analysis to carry out the

targeted examination of complex questions with the determination of
unknown substances and compounds in order to provide informative
answers and results. Many years of specialist expertise are combined
with cutting-edge, comprehensive methods and devices in the
execution of the tests.

Chemical/physico-chemical methods

- Gas chromatography (GC) for the separation of organic substances

- Liquid chromatography (LC or HPLC) for the separation of organic
substances Detection via UV/VIS, FID, DAD, MS, MS/MS, etc.
- Ion chromatography (IC), for ion separation
- UV/VIS spectroscopy, for the determination of organic substances
- Atomic absorption spectrometry (ICP/OES + ICP/MS), for the
determination of heavy metals

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Testing laboratory for technical cleanliness,
medical technology and environmental analysis

www.cleancontrolling.com

CleanControlling GmbH CleanControlling Medical GmbH & Co. KG

Headquarters Headquarters
Gehrenstraße 11a Gehrenstraße 11a
78576 Emmingen-Liptingen 78576 Emmingen-Liptingen
Germany Germany

Phone +49 74 65 / 92 96 78-0 Phone +49 74 65 / 92 96 78-0

Fax +49 74 65 / 92 96 78-10 Fax +49 74 65 / 92 96 78-10
info@cleancontrolling.com info@cleancontrolling.com

Dresden branch Leipferdingen branch

Dresden
Lockwitzgrund 100 Kellhofstraße 6
Gestaltung: www.revoLUZion.de September 2021

01257 Dresden 78187 Leipferdingen

Germany Germany

D
Leipferdingen

Emmingen-Liptingen

CH A