On 3rd November 2022, our CCN Chairman, Tim Triggs, presented on the 'ISO14644 Cleanroom Standards and Annex 1 GMP Cleanrooms' at the annual PHSS QP Forum, hosted in Wales, UK.
Tim's presentation included the ISO14644 family of standards (Parts 1-20), some insights into the imminent Part 4 revision on Cleanroom design and construction, the new 2022 Annex 1 regulations for making sterile and aseptic pharmaceuticals and the Cleanroom-related requirements and an announcement about the intention of ISO to revise Part 7 on Separative Devices.