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Millipore Technical Publications


SDS1009EN00.pdf
DS- SDS1009EN00

Bacterial Retention Testing for Validation of Sterilizing-Grade Membrane or Quantification of Bioburden Reduction

Lit No:SDS1009EN00
Year:12/2008


Bacterial retention testing is required to validate retention of Millipore sterilizing-grade membrane filters with specific process fluids at the chosen filtration conditions. Millipore’s Validation Sciences Laboratories conduct testing at lab scale using scaled-down processing conditions. First, a standard test protocol is submitted to the client. Then, project specific parameters are determined by scaling down by filter area. Millipore will perform preliminary studies to determine the best test method for your process fluid and process conditions. These will require process fluid samples and may include viability, flush, flow or recovery studies. Millipore and the client sign the project specific test protocol prior to the start of testing. A standard report summarizing testing data is submitted to the client at the completion of testing.

  • Determine the correct testing for your process
  • Recommend process parameters to be mimicked or scaled down
  • Provide test protocols, reports and customized test systems when necessary
  • Maintain raw data files
  • Ensure confidentiality

Click the PDF above for the full document.