The practice will find wide applicability among pharmaceutical manufacturers and regulators.

May 13, 2026

ASTM International’s manufacture of pharmaceutical and biopharmaceutical products committee (E55) has approved a new standard practice for validating end-user sterilizing filtration of pharmaceutical,  biopharmaceutical, and biological products (E3469) that will help to ensure sterilization processes during the drug manufacturing process are effective and contribute to patient safety.

According to ASTM member Russell Madsen, the new standard will provide guidance for bacterial challenge validation of sterilizing-grade filters, demonstrating the membrane filter’s ability to completely retain the challenge organism. The organism is typically a suitable bacterium under process-specific conditions, using the actual process fluid, or a surrogate fluid when necessary, with the specified filter membranes material and composition.

“Process validation of sterilizing filtration is required by industry standards and regulatory agencies," says Madsen." It works to ensure that process fluid contact with the filter under worst-case process-use conditions does not adversely affect the composition of the filtered material or the retentivity and integrity of the filter."

Madsen says that E3469 should find wide applicability among pharmaceutical, biopharmaceutical, and biological product manufacturers that require sterilizing filtration at various steps in their processes. Additionally, regulatory bodies should find the proposed standard useful as a basis for understanding how and why manufacturers use and validate sterilizing filtration processes.

ASTM welcomes participation in the development of its standards. Join ASTM.

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