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Bacterial Retention Testing for Validation of Ster

11.24.2020

 

According to current regulations (ASTM838; PDA 26# ect.); Daily’s Filter Validation Laboratories conduct testing at lab scale using scaled-down processing conditions. Testing is conducted using worst-case processing conditions to determine the ability of a sterilizing-grade filter to retain a minimum challenge of 107 cells of Brevundimonas diminuta (B. diminuta; ATCC 19146) per cm2 of filter area. One batch of filter fluid is evaluated using three batches of 0.2 µM sterilizing-grade 47 mm membrane discs. A 0.45 µM membrane is also used in paralleled as positive control. Size controls are run with each test to prove that the test organism is the appropriate size. Reused filter bacterial retention ability also can be tested by similar procedure.