What happened to our Air Change Rate Table in the new ISO 14644-4:2022? Rethinking Cleanroom Design The new ISO 14644-4 was published in November of last year and addresses design, construction, and start-up of Cleanrooms. But why has the Air Change Rate table from Annex B.2 disappeared? Well, because no one size fits all; the old table led to over-design in many cases and a lack of focus on understanding the process and contamination risks. The new and revised Annex 1 places the focus on QRM (Quality Risk Management) and CCS (Contamination Control Strategy) instead. The ISO/TC 209 working group, composed of subject matter experts from nearly 20 countries (including Ireland, UK, France, Germany, Switzerland, The Netherlands, Italy, Sweden, Norway, Denmark, Romania, Russia, China, Japan, Australia, Philippines, Korea, Brazil, and the USA) decided there was a better way – good engineering practice (GEP) and good science would prevail!
The Evolution of ISO 14644 Standards
Back in the late 1990s when the first version (2001) was being developed the experts at the time agreed, that as part of the “first generation” of the new ISO 14644 standard series of dashes, they would include some general guidance. They put the Air Change Rate table in the Informative Annex purely as a backup plan, to be used in the event of no other information being available. Unfortunately, lots of people, both users and designers adopted the Air Change Rate table, which was often cross referenced in the URS. The need for compliance in a heavily regulated industry paved the way for this approach and this became the norm over time.
To make matters worse, from a Life Science perspective the language and guidance was driven by the Microelectronics Industry, which at the time was operating at very low particle thresholds and was heavily reliant on unidirectional airflows and high concentrations of HEPA filtered air. So, when we look at ISO 7 and ISO 8 in the context of Life Science and Sterile Medicines in Annex 1, terms like “Service Zones” and “Surface Treatment” meant nothing.
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