Bacterial Retention Testing

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“Worst Case” Experiments Challenge Each Membrane

Required by all regulatory bodies worldwide, bacterial retention testing (BRT) is a critical step in filter validation. To ensure a “best case” outcome, we conduct BRT using each client’s “worst case” processing conditions and drug product.

Highly skilled Validation Specialists perform microbial retention tests in a controlled laboratory using calibrated equipment and methods that are governed by a robust quality system:

• Each lab strictly adheres to Parenteral Drug Product (PDA) guidelines and American Society for Testing and Materials (ASTM) standards
• BRT is conducted using the candidate pharmaceutical under simulated processing conditions to validate sterilizing-grade filter performance.
• To correctly challenge each membrane, one lot of finished drug product or process fluid is evaluated using three lots of Merck sterilizing-grade, 47 mm membrane discs
  • Including the low bubble point challenges the least retentive membrane
  • Size controls prove that the test organism is the appropriate size
  • Viability tests are performed prior to testing to assure no interference from the drug product
  • Simulated process conditions in drug product provide empirical evidence

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