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Rapid methods for testing the efficacy of sterilization-grade filter membranes.


ABSTRACT: The validation of sterilization-grade membranes is integral to ensuring the efficient and safe use of microfiltration systems. Here validation refers to the production of sterile filtrate for sterilizing-grade membranes under challenge test conditions. Current validation methods require 48 h of culture for results to become available, which creates time delays within the manufacturing process and quality control (QC) backlogs. This work compares four methods for the production of filter challenge test data, to the desired test sensitivity, within 24 h using bioluminescent and fluorescent recombinant strains of the test organism Brevundimonas diminuta. These methods should provide a way to implement more rapid QC test regimens for filters.

SUBMITTER: Griffiths MH 

PROVIDER: S-EPMC92167 | biostudies-literature | 2000 Aug

REPOSITORIES: biostudies-literature

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Rapid methods for testing the efficacy of sterilization-grade filter membranes.

Griffiths M H MH   Andrew P W PW   Ball P R PR   Hall G M GM  

Applied and environmental microbiology 20000801 8


The validation of sterilization-grade membranes is integral to ensuring the efficient and safe use of microfiltration systems. Here validation refers to the production of sterile filtrate for sterilizing-grade membranes under challenge test conditions. Current validation methods require 48 h of culture for results to become available, which creates time delays within the manufacturing process and quality control (QC) backlogs. This work compares four methods for the production of filter challeng  ...[more]

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