Integrity Testing of Sterilizing-Grade Filters: Efficient Measures for Increasing Reliability

摘要

Integrity testing of sterilizing-grade filters is necessary to reliably prevent damage to these sterile barriers from compromising the production of biopharmaceuticals. Documented integrity test results are essential to a manufacturing audit trail forreleasing pharmaceutical products (l, 2). Accordingly, problems encountered during this testing can lead to considerable financial damages and substantial delays or even entirely prevent a production lot from being released to the market. Therefore, filter integrity testing is a critical step with high economic importance for biopharmaceutical companies.Daily operations show time and again, however, that unnecessary problems can occur during and after integrity testing due to use errors and failure to comply with necessary basic conditions of the process. Essentially avoidable errors in data recording also can occur. Here I describe some measures that can significantly increase the reliability of filter integrity testing.