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GMP & OCCUPATIONAL EXPOSURE REQUIREMENTS TO MANUFACTURE HIGH POTENT STERILE PRODUCTS IN SHARED FACILITIES

February 23, 2021
USA
SHARESHARESHARE
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.