Innovation and Compliance: Pharmaceutical Clean Rooms according to the new rules of Annex 1 and ISO 14644-21:2023


annex 1

LOCATION: Politecnico di Milano c/o Department of Energy



9:30 a.m. Welcome and introduction to the day

9:45 a.m. Cleanroom and regulatory aspects: the influence of new changes from design to management Dr. Francesco Romano – Researcher, Energy Department, Politecnico di Milano

10:15 AM The 14644-4:2022 new requirements on how to design, build and start a Clean Room in the Pharmaceutical sector Gilberto Dalmaso – Technical & Scientific Director – Palladio Consulting

11:15 a.m. coffee break

11:45 a.m. Pipe leakage at sampling points and new ISO/TR 14644-21:2023, Airborne Particle Sampling Techniques Dr. Kurt Jaecques – Global aseptic Technologies Lead Monitoring & Control – GSK, Global Quality Assurance

13:00 Buffet lunch

2:30 p.m. Calibration according to ISO 21501-4:2018 of optical particle counters Petrone – CEO QSGroup, Technical Director Altiorlab 3:30 p.m. Microbiological monitoring in Annex 1, concepts of Microbiological Efficiency Kiel Rehn – Gethin Jones, Clean Air Monitoring Solutions

4:30 p.m. Presentation of the clean room of the Politecnico di Milano: tests that are performed, methods of use and innovations

5:00 p.m. end of work and final aperitif

Places are limited, book now!


09:00 – 20/11/2023