
Contamination and Cross Contamination Control in shared Facilities to protect the product, the operators, and the environment, especially working with highly potent/toxic sterile pharmaceutical substances. The session will cover the GMP and Occupational Safety Requirements for highly potent sterile products, Cleaning requirements for non-product contact surfaces as in filling line Isolators, room, and airlocks. Separation vs Segregation, Single Use System compared to CIP/SIP, Air Handling Unit as single pass compared to air recovery/ air recirculation, Facility design as well as personnel and material flow.