ASTM International approves sterilizing filtration validation standard for drug manufacturing

ASTM International’s committee on pharmaceutical and biopharmaceutical product manufacturing has approved a new standard intended to support sterilizing filtration validation in drug manufacturing processes.

The new standard, ASTM E3469, provides guidance for bacterial challenge validation of sterilizing-grade filters. According to ASTM member Russell Madsen, the standard is designed to demonstrate a membrane filter’s ability to fully retain challenge organisms during filtration under process-specific conditions.

The validation process typically uses a suitable bacterium along with the actual process fluid or a surrogate fluid when necessary. The testing also considers the specified membrane filter material and composition.

Madsen said process validation of sterilizing filtration is required by industry standards and regulatory agencies to confirm that fluid contact with the filter under worst-case operating conditions does not negatively affect the filtered material, filter integrity, or retention performance.

According to ASTM International, the E3469 standard is expected to be applicable across pharmaceutical, biopharmaceutical, and biological product manufacturing operations that rely on sterilizing filtration during production. The organization also said regulatory agencies may use the standard to better understand sterilizing filtration validation practices used by manufacturers.