LOCATION: Politecnico di Milano c/o Department of Energy
Program
9:00 AM REGISTRATIONS
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
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