Cleanroom Certification

© Jens Krämer
Evaluation of cleanroom suitability

For the production of many products, cleanrooms are an indispensable infrastructure and a mandatory requirement for high quality and product safety. They are particularly relevant in the semiconductor, electronics, optics, aerospace, pharmaceutical and biotechnology industries.

The cleanliness relevant components within cleanrooms include filters, ceiling/wall systems, coatings, lighting and floor coverings. However, cleanrooms alone are no guarantee for a sufficiently clean production. The used equipment, system components and consumables also have a decisive influence on product cleanliness, as they are often used directly on the product or in its immediate surrounding. Furthermore, the materials used also have an influence.

In order to sufficiently ensure clean production areas, an objective, practicable and meaningful evaluation of the cleanliness relevant properties of all cleanroom components, equipment and consumables is particularly important.

Test labels Fraunhofer TESTED DEVICE® and CSM®

 

Fraunhofer IPA is an independent, public research institution and offers objective and internationally recognized certification services with the test marks »Fraunhofer TESTED DEVICE®« and »CSM®«.

»TESTED DEVICE®« exists since 1998 and is a registered trademark in the German Patent and Trademark Office (DPMA). Within 20 years, more than 2500 products and materials have been tested and certified for their cleanliness and cleanroom suitability for industrial partners in over 30 countries. All tests procedures are always carried out according to the latest technological standards. Fraunhofer IPA currently offers more than 60 different test procedures and has a unique testing infrastructure.

  • In order to ensure a holistic approach, we offer a comprehensive service portfolio:

    • Development of test and measuring methods for cleanliness control
    • Certification of systems, equipment, components, materials and environments for contamination-critical manufacturing
    • Testing for particle emission behaviour, outgassing, ESD properties, chemical and biological resistance, cleanability, antibacterial effectiveness, flow behaviour etc.
    • The qualification package includes:
      • Customer and market-oriented documentation
      • Individualized test mark»Fraunhofer TESTED DEVICE®« or »CSM®« incl. unique report number for traceability
      • Test report: Contains measurement data and detailed result analyses
      • Certificates

    Option to publish test results in database.

  • In addition to the certification service, the department of Ultraclean technology and micromanufacturing is also available to its customers as a technology partner. Depending on requirements, we develop holistic, detailed potential analyses for the optimization of systems, devices and components, design them in terms of cleanliness and carry out flow simulations and visualizations. Additionally, we also provide support in equiment and hygienic design.

  • Current research priorities in the field of cleanroom certification are the development of standardized, meaningful methods for the evaluation of cleanroom-suitable equipment and consumables as well as fundamental research on particle generation in a vacuum.

  • Our international customer group extends to over 30 countries. 70% are European customers, 30% are mainly spread over China, Korea, Japan, Canada and USA.
     

    VDE-Korea Cooperation

    In January 2018, the partnership with VDE Korea was established by a cooperation agreement for the next five years. Korea is regarded as one of the world's emerging high-tech nations, thus making VDE with its network is an important strategic partner.
    Further information can be found here.

Test procedures and measuring methods

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The surface roughness of a material results in different difficulties during cleaning. A fluorescence test is performed to check the cleanability. This test method is of great relevance, especially in the field of sterile process engineering. By applying a test liquid to the test object and performing a defined cleaning procedure, the residues on the product can be evaluated.

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Through regular disinfection procedures in a wide variety of industries, materials, products and substances must ensure chemical resistance to cleaning, process and disinfection reagents. In this test procedure a material is exposed to common disinfection chemicals in a defined period of time. The evaluation of the chemical resistance is based on the damage occurring after the process has been carried out.

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Airborne molecular contamination (ACC: airborne contamination by chemicals) can cause clouding of optics or corrosion of microchips during production. For the determination of volatile organic compounds (VOC/SVOC), the outgassing behavior is investigated with the aid of a (micro) emission chamber. With the help of a thermodesorber/gas chromatograph and a mass spectrometer the critical substances can then be determined.

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The sterilization of cleanrooms is often done by hydrogen peroxide gassing. For the subsequent use of the room, it must be ensured that there is no hydrogen peroxide gas in the room. A defined measuring procedure is used to check the extent to which the test material adsorbs hydrogen peroxide and how long its desorption lasts. The less gas is adsorbed and the shorter the desorption phase, the more suitable the material is for sterilization.

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Particle contamination can lead to defective microchips or displays during production. By using an optical particle counter, the concentration and size of the particles on the product is recorded and evaluated during particle emission measurement. This method can be used to determine the suitability of the product for the individual cleanroom classes.

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Downloads

Brochure

'Certification of cleanroom suitability TESTED DEVICE®'

Flyer

'Cleanability of surfaces – CSM Riboflavin test'

Flyer

'Range of services (extract)'