The Importance of Pre-Use Integrity Testing in Sterilizing Filtration - Pharmaceutical Technology

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The Importance of Pre-Use Integrity Testing in Sterilizing Filtration
Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the integrity-test specification established during filter-validation studies.

Pharmaceutical Technology

Russell E. Madsen* is president of the Williamsburg Group, LLC, 18907 Lindenhouse Rd., Gaithersburg, MD 20879, tel. 301.938.4266,
Maik W. Jornitz is group vice-president of global product management, bioprocess of Sartorius Biotech Inc. Theodore H. Meltzer is a consultant for Capitola Consulting Company. Madsen and Meltzer are also members of Pharmaceutical Technology's Editorial Advisory Board.

*To whom all correspondence should be addressed.

Keywords: filtration, integrity testing. sterilization


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