New ISO Cleanroom Classification and Monitoring Standards

ISO 14644 Parts 1 and 2 have finally been approved!

Official notice from the IEST:

The Institute of Environmental Sciences and Technology (IEST) announces the international approval of the new revisions to the cornerstone cleanroom standards—ISO 14644, Cleanrooms and associated controlled environments, Part 1: Classification of air cleanliness by particle concentration and Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. IEST serves as the Secretariat organization for ANSI for ISO Technical Committee 209 (ISO/TC 209), which is responsible for the cleanroom standards’ development.

The revised 14644-1 and -2 Standards were approved by a significant majority of the 20 member nations participating in the ISO/TC 209 final vote. The International Standards will be available from IEST following editorial revision and international translation. ISO’s recent measures to bring standards to industry more quickly is expected to lead to published versions within a period of weeks. Cleanroom industry customers and suppliers are encouraged to check www.iest.org for updates on availability of the International Standards. IEST is offering several course options to educate stakeholders regarding the requirements and use of the new revisions.

ISO 14644-1 and -2 are so critical to the estimated $14 billion cleanroom industry that the revision efforts by the lead ISO/TC 209 Working Group lasted more ten years, with the ISO Technical Management Board providing a perhaps unprecedented second extension of the drafting period. The Standards are part of a concurrent adoption as American National Standards, which would take effect in tandem with the international publication.

ISO 14644-1 specifies classes of air cleanliness for the world’s cleanrooms and controlled environments in terms of the number of particles expressed as a concentration in air volume. To determine the class, a specified testing method is required, which includes selection of sampling locations. A major focus in revising ISO 14644-1 (1999) was development of a refined statistical approach regarding the selection and number of sampling locations. The underlying assumption in the 1999 version held that particle counts follow a similar distribution across the room. The new revision discards the previous assumption in order to allow more accurate sampling where particle counts may vary in a more complex pattern.

Another revision in ISO 14644-1 addresses the issues surrounding ≥ 5 μm particle limits for ISO Class 5 in the sterile products annexes of the EU, PIC/S, and WHO GMPs. An adaptation of the macroparticle descriptor is included in the Standard to accommodate the particle size.

ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to the execution or evaluation of the classification provisions of ISO 14644-1. The requirements of a monitoring plan are detailed, including additional guidance on risk assessment as part of an informative annex.

The mission of ISO/TC 209 is to develop international standards for cleanrooms and associated controlled environments encompassing standardization of equipment, facilities, and operational methods. The committee defines procedural and operational limits and testing procedures to achieve desired attributes to minimize contamination. IEST serves as the Secretariat for ISO/TC 209 and is also the Administrator for the United States Technical Advisory Group (US TAG) to ISO/TC 209. ISO Standards and IEST Recommended Practices for cleanrooms and controlled environments are available through IEST at www.iest.org.

Posted by Tim Sandle