Electronic PDA Technical Reports

PDA Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1µm Mycoplasma Reduction Filters (single user digital version)

PDA's newly released Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1µm Mycoplasma Reduction Filters describes a consensus filter challenge test for standardizing test parameters across laboratories. This report educates users and filter manufacturers about best practices for mycoplasma reduction filtration and suggests the implementation of a specific filtration testing method and positive controls for establishing a manufacturer's claims of mycoplasma reduction.

This technical document recommends a consistent method that filter manufactures can use to test and rate the effectiveness of mycoplasma reduction filters. The consensus method also provides cultivation parameters for Acholeplasma laidlawii as a challenge microorganism, if a risk assessment determines that process-specific evaluation is appropriate.

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Format: PDF (1 file 474 KB)

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Table of Contents:

Click here to download >>> Detailed Table of Contents
  1. Introduction
  2. Glossary of Terms
  3. Mycoplasma Filtration Consensus Method
  4. Appendix I: Consensus Method Protocol
  5. Appendix II: Bubble Point Method
  6. References

Figures and Tables Index


Date of Publication: August 2016
ISBN Number: 9780939459919
Format: PDF
Number of Pages: 22
Binding: