Bacterial Retention Testing (BRT) ensures that filters will produce a sterile effluent even when loaded with bacteria, making it a critical step in filter validation for biopharmaceutical manufacturers. This study is required by all regulatory bodies worldwide, including the United States Food and Drug Administration (FDA), European Union, Japan, and China Good Manufacturing Practices.
BioReliance® Validation Services testing is conducted in compliance with FDA’s Guidance on Sterile Drug Products Produced by Aseptic Processing, as well as testing parameters established by the Parenteral Drug Association’s (PDA) Technical Report 26. All bacterial retention tests are performed in controlled laboratories with calibrated equipment and methods governed by our robust quality system.
Our test approach is to utilize end-user worst-case processing conditions to determine the ability of a sterilizing-grade filter to retain a minimum challenge of 107 bacteria per cm2 of filter area. By using this worst-case approach, we ensure a best-case outcome for you.
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To learn more about our industry-leading validation services for biopharmaceutical manufacturers, look into these specialized capabilities performed at our laboratories worldwide.