Chapter 13 - Post Aseptic Fill Sterilization and Lethal Treatment

Abstract

Due to inherently greater risks of nonsterility, aseptic processes are considered inferior to terminal sterilization processes from a Sterility Assurance perspective. However, post aseptic fill sterilization and post aseptic lethal treatment processes can be performed as the terminal step of the manufacturing process to significantly reduce the risks of nonsterility for aseptic processes. Accordingly, incremental beneficial considerations could be achievable for these products and processes, including a reduction in environmental monitoring, a reduction in aseptic process simulation frequency, and/or a reduction or elimination of the finished product sterility test. Full compliance with current parametric release requirements would be a prerequisite to support the reduction or elimination of the finished product sterility test.