Validation of Microbial Identification Systems (single user digital version)

Sep 2004
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This booklet covers the below chapter is taken from PDA's best selling Laboratory Validation, and offers a complete overview of a specific topic and provides practical advice for anyone interested in current aspects of laboratory validation.

Validation of Microbial Identification Systems

There are numerous different technologies available for the characterization and identification of microorganisms. Some companies choose to use the term 'characterization' when the organism is identified to genus, but not necessarily to species and use identification to mean both genus and species. Other systems use gas chromatography. Regardless of the type of system used, the general principles of validation for these systems are consistent. The specific technology employed may require that additional tests be performed. This booklet discusses the general principles for validating these systems and provides examples of protocols for one type of available technology.

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Format: PDF (1 file - 4.08 MB)

Paper version is not available

Table of Contents

Table of Contents :

I. Introduction
II. Qualification of the Identification System
III. Installation Qualification Testing
IV. Operational Qualification Testing
V. Performance Qualification Testing

  • Accuracy/Precision Testing
  • Repeatability Testing - Cultures
  • Repeatability Testing - Analysts
  • Range of Testing
  • Other
  • Stress Testing
    VI. Conclusion
    VII. References
    VIII. Appendix A
    IX. Appendix B

  • About the Authors

    About the Author

    Jeanne Moldenhauer is a Pharma Consultant with Vectech Pharmaceutical Consultants, Inc. She has over 25 years of experience in sterile process validation, regulatory affairs, and microbiology. She is an interest group leader for microbiology and environmental monitoring at PDA, chair of the Rapid Microbiology User's Group, and a member of the Scientific Advisory Board of PDA.