Manufacturing and Production

Sterile Manufacturing and Aseptic Processing

Sterility cannot be tested into a product, because the test examines a tiny fraction of a batch and would miss contamination in almost every unit, so assurance has to come from the process itself. This course builds that assurance. Delegates work through the difference between terminal sterilisation and aseptic processing, and the decision tree that determines which a product must use. Sterilisation methods are covered across moist heat, dry heat, filtration, irradiation and gas, with the validation each requires. Sterile filtration is addressed including integrity testing before and after use. Aseptic technique is treated in operational detail: gowning, behaviour, intervention discipline and the fact that people are the principal contamination source. Media fill simulations and their acceptance criteria follow. Isolators and restricted access barriers are covered. Environmental monitoring is addressed, including trend interpretation and excursion response. The course closes on contamination investigation, on sterility assurance level and on regulatory expectations for sterile facilities.