Merck

Bacterial Retention Testing

Durapore® membrane with Opticap® Capsules and OptiScale® Capsule Filters

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.

Challenging each membrane with worst-case experiments

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.

  • Brevundimonas diminuta (B. diminuta) is commonly used as a challenge microorganism. With appropriate justification from your bioburden characterization, we can also use other strains for testing.
  • Every lab strictly adheres to Parenteral Drug Product (PDA) guidelines and American Society for Testing and Materials (ASTM) standards.
  • A robust and compliant challenge consists of one lot of finished drug product or process fluid to be evaluated using three lots of MilliporeSigma sterilizing-grade, 47 mm membrane discs.
  • At least one membrane is included at or near the minimum integrity specification.
  • Size controls prove that the test organism has the appropriate size.
  • Preliminary studies are included, such as viability testing to select the appropriate challenge solution and a recovery test to ensure that any possible bacteria can be recovered on the collection filters.
  • Process conditions with your drug product are simulated to provides empirical evidence.

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Trust our Global Services Network

To learn more about our industry-leading validation services for biopharmaceutical manufacturers, look into these specialized capabilities performed at our laboratories worldwide.

  • Singe-Use and Filter Validation Services
  • Chemical Compatibility Testing
  • Filter Integrity Testing
  • Extractables and Leachables
  • Validation Services Consultancy
  • Validation Service Levels