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A task force established by PDA and BioPhorum is establishing scientific data for integrity test activities.
Point-of-use sterilizing grade filtration has been used reliably for years to achieve sterile fluid fill.It is currently the only alternative for biologics, which would be damaged by heat sterilization.Over the years, the dependability of this critical aseptic processing step has been improved with the introduction of new filter materials and designs, and the adoption of single-use technology in closed unit operations.Moreover, the sterilizing grade filters and related processes are validated to test their performance under process conditions to help ensure that they perform as specified (1–3).Nondestructive tests (e.g., bubble point, diffusive flow, or pressure decay), which have been in use since the mid-1970s, are typically used for filter integrity assessments, which can be done in the following ways:
Maik W. Jornitz is CEO of G-CON Manufacturing, Inc.
eBook: Biologics and Sterile Drug Manufacturing, May 2021
When referring to this article, please cite it as M. W. Jornitz, “Sterile Filtration: Reducing Risk, Ensuring Safety," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2021).