ASTM E3469 : 26 New ASTM DRM Policy

1.1 Process validation of sterilizing filtration is required by industry standards and regulatory agencies to ensure that process fluid contact with the filter under actual worst-case process-use conditions (that is, time, flux, temperature, and pressure differential) do not adversely affect the composition of the filtered material, the retentivity and integrity of the filter, and the filtration process is capable of producing a sterile filtrate.

1.2 In this practice, guidance is provided for bacterial challenge validation of sterilizing-grade filters demonstrating the membrane filter’s ability to retain the challenge organism completely, typically Brevundimonas diminuta (ATCC 19146) or another suitable bacterium at a minimum challenge level of 1 × 10⁷ CFU/cm² of effective filtration area (EFA), under process-specific conditions using the actual process fluid or a surrogate fluid when necessary with the specified filter membrane material and composition.

1.3 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.