Manufacturing of sterile pharmaceutical products (4 credits)
Prof. Bice Conti
Contents: General aspects of sterile pharmaceutical products. Sterility assurance: design and qualification of aseptic areas in compliance with regulatory requirements (GMP). Technology transfer of sterile pharmaceutical products. Risk assessment in sterility assurance. Microbiologic control assessment. “Process simulation testing” applied to aseptic processes. Isolators and containment. Learning check: written examination.