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Sterile products may be broadly classified into two main categories based on their production mode -- those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled, and then sealed. Aseptic Processing play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated through the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the volumes filled over a defined period.
Aseptic Processing involves risk assessment on an on-going basis because of the inherent risks due to consequences of management and process failure and challenges within the detection, isolation, control, and management of product contamination. Within aseptic processing, the severity of the consequences of a failure can be severe to the end user while detection through sterility testing remains rather limited because of the small number of final products tested.
The FDA and EMA require that any product that may be terminally sterilized be managed in that fashion. However, almost all large molecules and some small molecules can only be sterilized by aseptic processes, i.e., membrane filtration.
With membrane filtration, it is essential to establish acceptable levels of microbiological contamination to ensure both product safety and compliance. Meeting sterility claims for Phase 1, 2, 3 and commercial products in a timely and effective manner is important in avoiding costly delays. In addition, since aseptic processes are associated with endotoxin control, it too, must be managed to acceptable levels.
Seminar participants will learn the following: