Speakers:
Conor Murray, Chair of the Irish Cleanrooms Society
Main discussion topics:
ANNEX 1 OVERVIEW & IMPLICATIONS
Annex 1 Overview and link to Pharma 4.0
Where the new Annex 1 fits in with other Annexes . Annex 11 on Data Integrity, Annex 15 on Q&V, and other GMPs, e.g. ATMPS and Short Shelf Life products
Fundamental principles of QRM and CCS. What does this mean in practice and what do I need to do in order to comply with the new Annex 1?
ISO Standards and the Link to Annex 1. Classification as part of Qualification vs Ongoing EM
Annex 1 and link to the new NP ISO 14644-20 on Microbiological Contamination Control). Engineering Controls + People Gowning & Behavior + Ongoing Cleaning & Disinfection
Annex 1 and link to ISO 14644-4 (Design, Construction & Start Up) and -16 (Energy Management) in terms of Cleanroom Design and Initial Qualification
Challenges in Automation and Robotics in RABS/Isolators
Continuous EM and ARMM
FACILITIES DESIGN & QUALIFICATION
Cleanroom design and adopting ISO 14644-4:2022 and ISO 14644-16:2019 for Lean Cleanroom operations
Approach to upgrade existing facilities.
Initial cleanroom classification: Is both “cleanup” and “recovery” test validation vise mandatory.
Qualify cleanup/ recovery time for both 5µm as well as 0,5µm particles?
Cleanroom and clean air equipment qualification is the overall process of assessing the level of compliance of a classified cleanroom or clean air equipment with its intended use
The re-qualification of cleanrooms and clean air equipment should be carried out periodically following defined procedures (Aseptic process Vs Terminally sterilized)