Speakers:
Conor Murray, Chair of the Irish Cleanrooms Society
Main discussion topics:
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 ISO 14644-4 (including the new ISO 14644-20 on Microbiological Contamination Control), in terms of Cleanroom Design - Engineering Controls + People Gowning & Behaviour + Ongoing Cleaning & Disinfection
Challenges in Automation and Robotics in RABS/Isolators - Continuous EM and ARMM
Through active discussions, the participants searched for solutions and a suitable approach to the implementation of Annex 1 on the following topics:
QRM and Annex 1
Challenge of Preparing a CCS in accordance with Annex 1
Annex 1- and 5,0-micron particle size Classification vs EM
Continuous EM in Aseptic Production
Challenges to upgrade Traditional Viable EM (LIMS and Automatic Plate Counters)
Role of Airflow Viz in Annex 1
Annex 1 and RABS vs Isolators
Recovery time test vs Clean up test
Overview of ARMM and application to Annex 1
Application of Real-time ARMM as per Annex 1