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

Aug 2016
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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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Table of Contents

Table of Contents:

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  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