Fraunhofer Institute for Manufacturing Engineering and Automation IPA
Fraunhofer Institute for Manufacturing Engineering and Automation IPA

Guidelines and Standardization

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Committee and standardization work is essential to ensure the quality of products and services.

Relevance of commitee work for cleanness technology

Committee and standardization work is essential to ensure the quality of products and services. In this context, the cross-national elaboration, finding and agreeing on uniform procedures as well as the establishment of common values are important in global competition. The Fraunhofer IPA plays a leading role in the field of ultraclean technology and micromanufacturing. We address the cleanliness-related concerns and challenges of our industrial and research pairtners and develop proposals for solutions. In cooperation with the standardization and committee members, we bring these to a common, consensual level and overcome the administrative hurdles.

In our functions as experts, members and chairpersons of various committees, we bring together the various interests of the cleanroom world and represent them on a national and international level. We consider, for example, the aspects of cleanliness-compliant plant construction, cleanroom-suitable materials, as well as production planning and the operation of cleanrooms. Furthermore, we also support our customers in the development of internal company guidelines.

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International standardization contributes significantly to safeguarding technical developments in the field of German industry and research. Due to the multitude of international interests and a necessary consensus, ISO regulations are usually less detailed and more technically abstract than national regulations. A harmonization between national and international sets of rules takes place in order to avoid contradiction.

In the past years, scientists at the Fraunhofer IPA have taken part in the development of a large number of ISO regulations. These include: 

  • ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start up
  • ISO 14644-9:2012 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
  • ISO 14644-10:2013 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
  • ISO 14644-8:2013 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
  • ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
  • ISO 14644-14:2016 Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration 
  • ISO 14644-15:2017 Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration
  • ISO 14644-12:2018 Cleanrooms and associated controlled environments - Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration

The elaboration of common and standardized procedures, evaluations, concepts and even simple descriptions of the facts are key components of the committee work at the VDI (Verein Deutscher Ingenieure e.V. - Association of German Engineers). The guidelines on the topic of cleanroom and cleanliness technology are characterised not only by regulatory aspects but also by a more detailed, engineering-scientific depth. Often, technical explanations are included that explain the motivation and details of a specific regulatory approach in a plausible manner. 

In the past years, scientists at the Fraunhofer IPA have been involved in the development of various VDI guidelines:

  • VDI 2083/1.1 Cleanroom technology - Particulate air cleanliness classes for nano-scaled particles (ACnP)
  • VDI 2083/9.1 Cleanroom technology - Compatibility with required cleanliness and surface cleanliness
  • VDI 2083/9.2 Cleanroom technology - Consumables in the cleanroom
  • VDI 2083/15 Cleanroom technology - Personnel at the clean work place
  • VDI 2083/16 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
  • VDI 2083/17 Cleanroom technology - Compatibility of materials with the required cleanliness
  • VDI 2083/18 Cleanroom technology - Biocontamination control
  • VDI 2083/20 Cleanroom technology - Determination of the desorption kinetics of materials after fumigation
  • VDI 2083/21 Cleanroom technology - Cleanliness of medical devices in the manufacturing process

As the superordinate body, DIN (Deutsches Institut für Normung - German Institute for Standardisation) is the bridgehead for worldwide standardization. Standards that are already established in various German technical committees are often transferred by DIN through the corresponding mirror committees and serve as a proposal for transnational standardisation. DIN standards represent the state of the art and generally have the character of recommendations. The expertise of the Fraunhofer IPA in the field of cleanliness and cleanroom technology is often incorporated into internationally recognised DIN standards by taking over and technically managing working groups.

The ECSS (European Cooperation for Space Standardisation) has set itself the goal of transferring the standardization efforts of individual national space agencies into pan-European regulations. This standardization, primarily in the area of product assurance and space technology, but also of the different processes and phases of space projects, is intended to strengthen Europe's competitiveness in international aerospace. The ECSS standards, which have also been recognised as EN standards for several years, were originally initiated by the ESA (European Space Agency). The Fraunhofer IPA plays an important role in the development and transfer of cleanliness-related process sequences for the space industry. We also contribute to the standardized planning, design and implementation of space-specific, contamination-controlled assembly, handling and manufacturing processes.

Scientists at Fraunhofer IPA have been involved in the development of »ECSS-Q-ST-70-54 Space Product Assurance – Ultra Cleaning of Flight Hardware«.

At the VDA (Verband der Automobilindustrie - German Association of the Automotive Industry), reference works have been created through the very comprehensive and detailed regulations on technical cleanliness and the transfer of the interests of industrial associations in the automotive industry, which have received worldwide attention and recognition. A large part of the content of the VDA regulations on technical cleanliness was initiated and elaborated by the Fraunhofer IPA in cooperation with major representatives of the automotive industry operating worldwide. The international establishment of the VDA regulations was achieved by transferring them to corresponding ISO standards.

  • VDA Volume 19 Part 1, Inspection of Technical Cleanliness - Particulate Contamination of Functionally Relevant Automotive Components
  • VDA Volume 19 Part 2, Technical cleanliness in assembly - Environment, Logistics, Personnel and Assembly Equipment
  • ISO 16232:2018-12 Road vehicles - Cleanliness of components and systems

The Fraunhofer IPA is also a member of the European Hygienic Engineering and Design Group (EHEDG). It is an association of research institutes, public health facilities, food manufacturing equipment suppliers and food processing companies. The aim of the EHEDG group is to develop guidelines for hygiene measures in the production and packaging of food. These guidelines serve as an aid for companies and enable a uniform EU-wide concept for action, taking into consideration international and national regulations.