Testing and Certification for Cleanrooms, Dry Cleanrooms, and Vacuum Environments

Why must products intended for manufacturing environments such as cleanrooms, dry cleanrooms, and vacuum environments be individually tested?

Clean and hygienic production areas are complex systems designed to prevent contamination in manufacturing processes and in the products being manufactured. These systems consist of the production rooms and the production equipment located within them. The various subsystems and components—such as ceilings, walls, floors, sealants, manufacturing equipment, transport systems, tools, and consumables—can be collectively referred to as “equipment” (see ISO 14644-14).

To ensure clean and hygienic production areas, the equipment used must meet the specific/industry-relevant cleanliness requirements. Metrological evidence is required for objective assessment. The respective production environments must be taken into account here, as they can have a significant influence on the test results:

  • Cleanroom
  • Dry room / dry cleanroom
  • Vacuum

 

What does Fraunhofer IPA offer, and what infrastructure is available?

Fraunhofer IPA currently offers customers more than 60 different test methods for determining cleanliness properties and maintains a specialized testing infrastructure. This includes:

  • various Class 1 reference cleanrooms (ISO 14644-1),
  • dry rooms with dew point temperatures down to -50°C,
  • combined dry-cleanrooms,
  • containers for high-vacuum applications
  • as well as a wide range of test benches and measurement equipment.

 

How are the test results documented?

Our test results are documented in detailed, scientific test reports. In conjunction with the “TESTED DEVICE®” or “Cleanroom Suitable Materials®” (“CSM®”) test marks, overview reports, qualification statements and qualification certificates are issued in addition to the test report. The overview reports, qualification statements and qualification certificate contain a condensed version of the essential information from the test report and, thanks to their high level of brand recognition, are specifically intended for customer communication.

 

How well-established are our testing services?

Our services are internationally established, with industrial customers in over 39 countries and more than 5,200 product tests. Our unique selling points include:

  • Internationally recognized test marks for products in clean/hygienic manufacturing areas
  • Specialized infrastructure featuring the world’s cleanest cleanroom
  • Expertise in contamination control

 

Where can the test results be listed?

On our online database Tested Device® / CSM®, our customers can publish their test results—including qualification statements, qualification certificates and company contact information—free of charge. With result overviews, filters, and a validation function, external users of the database have extensive research capabilities at their disposal.

Customer inquiries

Database

Fraunhofer TESTED DEVICE® & CSM®

Service description

CSM® Certification Cleanroom Suitable Materials

Service description

Equipment Certification Cleanroom, Dry-Room, Vacuum TESTED DEVICE®

What services do we offer?

We offer our customers purity and cleanroom suitability testing for a wide range of industrial products. This helps ensure product quality and supports customer communication and marketing activities.

 

For which applications and industries are purity and cleanroom suitability tests relevant?

Our customers include manufacturers and users of production equipment, measuring machines, transport systems, AGVs, robots, grippers, energy chains, cables, pneumatic components, lubricants, as well as a wide range of components used in cleanrooms, such as floor coverings, wall coatings, lighting systems, cable bushings, filters, ceiling panels, sealants, and various other products.

Our services take into account, among other things, the specific requirements of the semiconductor, optics, electronics, photovoltaics, aerospace, pharmaceutical, and biotechnology industries.

 

What are cleanrooms/clean areas?

Cleanrooms/clean areas are manufacturing environments in which the concentrations of airborne particles are defined or classified. Particulate air cleanliness is classified in ISO 14644-1 as Classes 1 through 9 and in EU GMP as Classes A through D. In addition to particles, viable particles and chemical contaminants are also taken into account, depending on the application.

The requirements for the components of production environments, manufacturing equipment, system components, consumables, and materials can be summarized by the terms “cleanroom suitability” and “cleanliness suitability.”

 

What does “cleanroom suitability” mean?

Cleanroom suitability (ISO 14644-14, VDI 2083 Part 17, VDI 2083 Part 9.1, VDI 2083 Part 9.2) describes particle emission behavior—or particle release behavior—in relation to suitability for the air cleanliness classes defined in ISO 14644-1.

 

What does cleanliness suitability mean?

Cleanliness suitability encompasses all individual cleanliness requirements relevant to a manufacturing process. Key cleanliness requirements include: particle emission behavior, outgassing behavior (ISO 14644-15, VDI 2083 Part 17), electrostatic properties (charging behavior SEMI E78-0222, electrical resistance IEC 61340-2-3, -4-1, -5-1), cleanability (VDMA Information Sheet), chemical resistance (ISO 2812-1 or -4, ISO 4628-1), biological resistance (ISO 846), antibacterial efficacy (ISO 22196), hydrogen peroxide absorption/desorption (VDI 2083 Sheet 20), and clean air flow characteristics (VDI 2083 Sheet 16.2).

Contact

Dipl.-Ing. FH Marion Schweizer

 

Tel: +49 711 970-1509

Contact

Dipl.-Ing. Eileen Junghans

 

Tel: +49 711 970-1558

Contact

Dr.-Ing. Frank Bürger

 

Tel: +49 711 970-1148

Fraunhofer TESTED DEVICE® & CSM® database

in German

»Certification of equipment, devices and consumables«

Data Sheet

TESTED DEVICE®/CSM®

What services do we offer?

We offer our customers testing to determine the suitability of a wide variety of industrial products for dry environments and dry cleanrooms. This helps ensure product quality and supports customer communication and marketing activities.

 

For which applications and industries is this relevant?

Our customers include manufacturers and users of transport systems, AGVs, robots, energy chains, cables, pneumatic components, lubricants, and a wide range of components used in cleanrooms, such as floor coverings, wall coatings, lighting systems, cable glands, sealants, and various other products.

Our services take into account, in particular, the specific requirements of battery production.

 

What are dry rooms?

Dry rooms are controlled manufacturing environments that often have dew point temperatures ranging from -30°C to -50°C. Since, in addition to humidity, the concentrations of airborne particles are frequently specified or classified, these environments are referred to as dry cleanrooms. Particulate air cleanliness is classified in ISO 14644-1 into classes 1 through 9. The cleanliness levels specified in VDA Volume 19, Part 2 are also used.

The requirements for components in production environments, manufacturing equipment, system components, consumables, and materials can be summarized by the terms “dry room suitability” and “dry cleanroom suitability.”

 

What does “dry cleanroom suitability” mean?

Dry cleanroom suitability (VDI-EE 2083 Part 4.3) describes particle emission behavior under dry conditions in relation to suitability for the air cleanliness classes defined in ISO 14644-1.

 

What does “dry suitability” mean?

Dry suitability (VDI-EE 2083 Part 4.3) encompasses all properties relevant to the production process in a dry cleanroom. These include system properties and material properties (mostly plastics). Examples include: shrinkage behavior, mechanical strength, corrosion resistance, moisture absorption and release (hygroscopicity), diffusion tightness, chemical resistance, outgassing, particle release behavior, and electrostatic properties.

 

What are the specific characteristics?

Due to the drying effect, the properties of tribological systems (wear behavior) and materials are often not transferable from normal humidity conditions to dry conditions. The drying effect can also lead to accelerated aging of production equipment.

Contact

Dipl.-Ing. FH Marion Schweizer

 

Tel: +49 711 970-1509

Contact

Dipl.-Ing. Eileen Junghans

 

Tel: +49 711 970-1558

Contact

Dr.-Ing. Frank Bürger

 

Tel: +49 711 970-1148

What services do we offer?

We offer our customers vacuum compatibility testing for a wide variety of industrial products. This helps ensure product quality and supports customer communication and marketing activities.

 

For which applications and industries is this relevant?

Our customers include manufacturers and users of vacuum locks, valves, manipulators, bearings, and material pairings.

Our services take into account the specific requirements of the semiconductor, display, photovoltaic, optics, elementary particle research, aerospace (space robotics, satellites), and quantum computing industries.

 

What testing services do we offer?

Our testing services for particle release and particle dispersion include:

  • Testing and evaluation of tribological systems and various industrial components
  • Tests under various conditions: temperature, vacuum pressure, purge gases
  • Parameters for particle release: number, size distribution, volume, release rate
  • Parameters for particle dispersion: velocity, direction, spatial distribution

 

What is meant by a vacuum?

A vacuum is defined as rarefied gases or corresponding states in which the pressure or density is lower than that of the surrounding atmosphere (ISO 3529-1 (ISO 3529-1:1981-12 1981), DIN 28400-1 (DIN 28400-1:1990-05 1990)). A distinction is made between the pressure ranges of rough vacuum, fine vacuum, high vacuum, and ultra-high vacuum (Jousten 2010).

The requirements for vacuum systems and components used under vacuum conditions can be summarized by the term “vacuum compatibility.” Due to the demands placed on production systems, it is often necessary to consider the suitability of system components with regard to particle release as well.

 

What Does Vacuum Suitability Encompass?

The vacuum suitability of materials includes, for example, corrosion resistance, mechanical strength, gas tightness, thermal shock resistance, surface cleanliness, chemical resistance, and outgassing behavior (Jousten 2010).

Suitability regarding particle release refers to system components in production facilities subject to tribological stress. In addition to the number of particles released, their size distribution must also be taken into account.

 

What are the specific characteristics?

Due to the low levels of oxygen and moisture, wear processes under vacuum conditions differ significantly from those under atmospheric conditions. Particle dispersion in production facilities depends on the vacuum pressure and vacuum pressure differentials and can vary greatly.

Our testing services include:

  • Testing and evaluation of particle release and spread on tribological systems
  • Testing under different conditions: temperature, pressure, etc.
  • Target variables for particle release: number, size distribution, volume, release rate
  • Target variables for particle spread: speed, direction, spatial distribution

Contact

Dr.-Ing. Frank Bürger

 

Tel: +49 711 970-1148

Contact

Dipl.-Ing. Florian Lehnert

 

Tel: +49 711 970-3525

What services do we offer?

We provide our customers with simulation services for a wide range of industrial applications. These services help ensure product quality (VDI 2083 Part 16.2, SEMATECH Guideline: Integrated Minienvironment Design Best Practices) and support customer communication and marketing activities.

 

For which applications and industries is this relevant?

Our customers include manufacturers and users of cleanrooms, mini-environments, and various manufacturing facilities. 

Our services take into account the specific requirements of the semiconductor, display, and optics industries.

 

What testing services are offered?

Our testing services include:

  • Testing of airflow patterns and pressure distribution
  • Testing and evaluation of clean air quality in manufacturing systems based on CAD files
  • Testing of particle dispersion as a function of particle size and material density
  • Calculation of air cleanliness classes (according to ISO 14644-1)

 

Why is a controlled clean air flow important in cleanrooms and manufacturing facilities?

Controlled clean air flow must be ensured in an increasing number of cleanroom areas and manufacturing facilities. For this reason, manufacturing facilities are often equipped with mini-environment or isolator technology. The objectives here are to create robust pressure barriers against the ingress of unwanted contaminants and to continuously remove airborne contaminants that arise within the high-purity areas. These include, for example, process-generated chemical substances and wear-induced particles on robots, linear guides, positioning systems, and end effectors.

 

What requirements apply to clean air flow and particle transport in manufacturing facilities?

The requirements for clean air flow include the flow pattern, flow velocity, flow direction relative to particle sources, and the ability to transport particles without them entering critical areas of the facility. Forces such as gravity and electrostatic forces must be taken into account. These requirements also apply in confined spaces and under highly dynamic conditions.

 

How are clean air flow and particle dispersion tested?

For industry-oriented testing of systems, we use our customers’ CAD files and incorporate appropriate turbulence models into our calculations. In addition, we integrate into our computational models metrologically determined (ISO 14644-14) or assumed particle release rates from system components, taking into account different particle size distributions and materials.

 

Contact

Dr.-Ing. Frank Bürger

 

Tel: +49 711 970-1148

Contact

Marija Nikolic

 

Tel: +49 711 970-3677

Contact

Dipl.-Ing. Florian Lehnert

 

Tel: +49 711 970-3525

In a production process where clean conditions are maintained, even the smallest contamination can have a damaging impact. We test and certify your production environments, systems, components and materials for your specific industry using selected testing procedures.
 

Our testing services include:

  • Analysis of contamination: on surfaces, in the air, in liquids
  • Laboratory testing using analytical methods for recording a wide range of impurities

Contact

Dipl.-Ing. FH Marion Schweizer

 

Tel: +49 711 970-1509

Contact

Dipl.-Ing. Eileen Junghans

 

Tel: +49 711 970-1558

Contact

Dr.-Ing. Frank Bürger

 

Tel: +49 711 970-1148