Aseptic Processing – Achieving Sterility By Design

“In an aseptic process, the drug product, container, and closure are first subjected to sterilization methods separately, as appropriate, and then brought together. Because there is no process to sterilize the product in its final container, it is critical that containers be filled and sealed in an extremely high-quality environment. Aseptic processing involves more variables than terminal sterilization.”

FDA, Aseptic Processing Guidance 2004

“Handling sterile materials in a controlled environment, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels.”

PDA, TR# 22, 2011 revision

Sterility assurance is easy to define, but no easier to quantify:

• In sterilization, it is estimated using a PNSU (or SAL) for each process. Actual sterilization process performance is much better than the minimum expectation of 1x10-6.
• In aseptic processing, process simulation demonstrates a maximum contamination rate from a point-in-time evaluation.