Standardization in cleanroom technology

As interest in cleanroom technology grew across countries and industries, the need for a uniform definition of cleanroom standards and norms also increased. Due to the far-reaching and complex development progress of cleanroom technology across a wide range of areas, numerous standards and guidelines existed before uniform standardisation. In our blog post, we outline the historical development of standardisation in the field of cleanroom technology and give an insight into the current status quo of the most important guidelines.

Development of cleanroom technology and their standardisation

The exact emergence of cleanroom technology is disputed among experts. The only thing that is known is that it initially focussed on a relatively narrow field of application and only really became relevant from the beginning of the 1960s. Initially, cleanroom technology was only used in a few sectors and was largely limited to the semiconductor industry in the USA. However, medical facilities in Switzerland also discovered the decisive advantages of cleanroom technology, even before other industries utilised the new technology. While the technology was initially still purely a ‘niche product’, interest grew more extensively, particularly as a result of developments in space technology at the time and the global arms race for the first moon expedition.

With growing interest in the cleanroom concept, the first standardisation for the criteria of cleanroom technology was created in 1963 by the US Federal Standard 209 (FS 209). From this point onwards, efforts to establish a standardised set of cleanroom standards and guidelines gained momentum and have been continually optimised and adapted to new challenges over the years.

As the requirements for products and the associated manufacturing processes have changed significantly and increased continuously over time, production under cleanroom conditions has also become necessary for an increasing number of companies and industries. Due to the significant growth of a wide variety of companies and research departments from all over the world within just a few years, a global standard for cleanroom technology criteria had to be found in order to ensure uniform, comprehensive and high-quality categorisation. However, it took until 29 November 2001 before a uniformly applicable standard could be defined and become fully valid worldwide.

Current Standards in cleanroom technology

Today, the concept of cleanliness has become indispensable in many industries. Whether it is microelectronics, optics, biotechnology, semiconductor production, pharmaceuticals or nanotechnology – they all rely on cleanroom technology concepts to manufacture their products. This is the only way to set up flawless processes and fulfil highly demanding customer and market requirements.

A globally unified standard for cleanroom technology criteria has been in use since November 2001. The Institute of Environmental Sciences and Technology (IEST) compiles the various standards and guidelines that have been developed across countries and industries worldwide into a uniform, internationally recognised ISO standard: ISO 14644. In addition to cleanroom requirements, the standard also includes guideline values for air quality and qualification. ISO 14644 was also the first step towards the consistent use of SI units.

The ISO standard for modern cleanliness concepts has been continuously developed by the responsible ISO technical committee and adapted to the latest research findings and technical advances. By continuously optimising the ISO 14644 guidelines, current questions and problems relating to the planning of cleanrooms and clean areas, their operation or specific cleanliness-related challenges can also be considered.

The development of cleanroom technology and the associated standards and guidelines have therefore come a long way, with a number of challenges behind and much more ahead. This is because the technological advances in today's economic and industrial landscape in particular ensure regular innovations and thus new requirements on the market at ever shorter intervals. Only if the standards of cleanroom technology are adapted to modern conditions can the cleanliness concept be developed further in a meaningful way.

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