Cleanroom standard series ISO 14644

The globally recognized standard for the classification of cleanrooms is "ISO 14644 – cleanrooms and associated cleanroom areas". In addition to the classification, the series of standards covers all important topics from planning, construction, commissioning, test methods and the operation of cleanrooms.

The responsible Technical Committee 209 (TC) of the International Standard Organization (ISO) is currently revising some parts of the series of standards. In this process, in addition to formal corrections, the following points, among others, are being revised:

• Test methods for filter leakage tests (ISO 14644-3 – publication 2020)
• Requirements for the phases of a project (life cycle) and modernization (ISO 14644-4 publication 2021/2020)
• Complete revision of the standard for the operation of cleanrooms (ISO 14644-5, start of revision in Nov. 2019)
• Revision and adjustment, as well as clarification that the standards ISO 14644-8, 9 and 10 are not additional cleanroom classification (Publication 2020/2021)

In addition, two new standards are added to the standards series:

1. ISO 14644-17 "Particle Deposition Rate Applications"
   Describes methods for minimizing the risk of contamination on critical surfaces using the particle deposition rate (currently available as draft version, publication 2020/2021)
2. Working title: ISO 14644-18 "Consumables"
   Describes requirements for cleanroom consumables (proposal in preparation, publication unknown)

Valicare GmbH, daughter of Syntegon Technology GmbH, has extensive experience in the field of clean room qualification and GMP-compliant operation. Our services are always oriented towards the state of the art.

We would be pleased to support you in clean room projects and advise you in advance by telephone.

Find out more about our GMP-compliant services