Annex 1 |
September 15, 2023
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...
Annex 1 |
April 4, 2023
Imagine a scenario where your organization is gearing up for a regulatory audit and you have been tasked with supporting their preparation of a Cleanroom Contamination Control Strategy (CCS). The CCS outlines the key decisions and scientific rationales for...
Annex 1 |
January 11, 2023
The presence of 5 micron and greater particles in Cleanrooms and in particular ISO 5 UDAF environments has been a source of much discussion and contention over many decades. Essentially the arguments have been over the significance and importance of the measurement...
Annex 1 |
October 28, 2022
Finally the new Annex 1 is published, after 7 years. The challenge is how best to apply good science and GEP (good engineering practice), as the goal is to improve product quality and ultimately patient safety and wellbeing. The deadline for coming into...
