Bacterial Retention Testing
“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:
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- 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