Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs - Webinar (Recorded)

Why Should You Attend:

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 processes play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated by 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.

Products that have historically been aseptically filled have relied upon the use of USP < 71> Sterility Tests to demonstrate sterility. However, since no more than 20 containers are tested per media regardless of the production lot size, the use of sterility tests does not provide a high degree of sterility assurance (SAL). Thus, media fills are now utilized to simulate the actual fills and to demonstrate at least a 10-3 sterility assurance level of no contamination. If the facility uses RABS or isolators, a SAL of 10-5 to 10-6 is even possible since the interactions with personnel and the environment decrease markedly.

Media fills are required during the commissioning of an aseptic operation within a new facility, when a new container configuration (volume or neck size) or other unique activities associated with aseptic filling occurs. Following the on-going performance of a new aseptic filling line, a requalification is required at six-month intervals.