Standard Practice for Validating End-User Sterilizing Filtration of Pharmaceutical, Biopharmaceutical, and Biological Products

Importancia y uso:

4.1 This practice may be used to evaluate the microbial retentivity of any membrane filter used for liquid sterilization where validation is required in the manufacturing of pharmaceutical, biopharmaceutical, and biological products or their intermediates (where applicable). These processes may include, but are not limited to, cell culture media, buffers, intermediate holds in aseptic process, bulk, and sterile filtering.

4.2 In this practice, a framework for the development of an appropriate bacterial retention testing strategy based on applicable scientific and regulatory considerations is described. Alternative approaches may also be acceptable provided they are supported by sound scientific rational and risk assessments.

4.3 This practice was developed with certain assumptions in mind such as completion of appropriate investigative or testing activities, or both, for filter selection including chemical compatibility, active ingredient and preservative binding, and particle shedding before pursuing process-specific bacterial retention testing. Test methods and guidance for filter selection, therefore, are not included in this practice. Additionally, process bioburden should be sufficiently studied to support the rationale for determining the most appropriate challenge organism for use in bacterial retention testing.

4.4 This practice conforms to sterile filtration recommendations established by PDA TR 26, Test Method F838, FDA Guidance for Industry, EU GMP Annex 1, and ISO 13408-2.

Subcomité:

E55.13

Volúmen:

14.01

Palabras clave:

bacterial challenge validation testing; bacterial retention characteristics; BCT; B. diminuta; Brevundimonas diminuta; sterilizing filtration; sterilizing-grade membrane filters;