Pharmaceutical Technology - May 2021

Pharmaceutical Technology - Biologics and Sterile Drug Manufacturing - May 2021

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4 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Manufacturing P oint-of-use sterilizing grade filtration has been used reli- ably for years to achieve sterile f luid fill. It is currently the only alternative for biologics, which would be dam- aged by heat sterilization. Over the years, the depend- ability of this critical aseptic processing step has been improved with the introduction of new filter materials and designs, and the adop- tion 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 f low, 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: • Pre-use/pre-sterilization • Pre-use/post-sterilization (PUPSIT) • Post-use. The post-use test is a requirement of most regulatory agencies. But the PUPSIT test is also an expectation of many regulatory agencies. Because all sterilizing grade filters are integrity tested before they are released from the filter manufacturer and there is difficulty in testing pre-sterilized filter in single use systems, many filter users do not test the integrity before the filtration process. Less common and of more concern are PUPSIT integrity test activi- ties, because they require that operators manipulate the sterile filtrate side of the filter, which can pose a higher process risk. Thus, many regulatory authorities request the integrity test of the sterilizing grade filter after the filtration, post-use, but only recommend an integrity Sterile Filtration: Reducing Risk, Ensuring Safety Maik W. Jornitz A task force established by PDA and BioPhorum is establishing scientific data for integrity test activities. Maik W. Jornitz is CEO of G-CON Manufacturing, Inc. IVAN TRAIMAK - STOCK.ADOBE.COM

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