Method Development and Validation for the Pharmaceutical Microbiologist

Feb 2017
PDA Item Number
Hardcover: 17339 | Digital: 18022
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The book primarily focuses on parenteral products and the excipients, but the methodology can transfer to other areas of microbiology as well. The book also provides advice on programs and special studies that might be performed in the pharmaceutical microbiology laboratory.

The purpose of this book is to inspire ideas and provide recommendations regarding method development and validation strategies for pharmaceutical microbiologists. The book may also aid microbiologists when starting new facilities or validating equipment.

This is a must have resource for anyone engaged in the many aspects of method development and validation in pharmaceutical microbiology.

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents


  1. Starting Up a Microbiology Laboratory
  2. Growth Promotion Testing
  3. Bioburden Testing
  4. Microbial Limits Testing
  5. Bacterial Endotoxin Testing
  6. Sterility Testing
  7. Understanding Container Closure Integrity Testing
  8. Antimicrobial Effectiveness Testing
  9. Understanding Particulate Testing for Injectable Parenteral Products
  10. Disinfectant Efficacy Testing
  11. The Microbiologist's Role in the Validation and Monitoring of Pharmaceutical Water Systems
  12. The Microbiologist's Role in Establishing and Maintaining a Compliant Environmental Monitoring Program
  13. Utilizing and Obtaining Microbial Identification Data
  14. Biological and Endotoxin Indicators
  15. Special Studies

About the Authors

About the Author

Crystal M. Booth, M.M., is an Independent Pharmaceutical Microbiology Consultant with Pharmaceutical Advisors, LLC. She earned her Bachelor's Degree in Biology from Old Dominion University and her Masters of Microbiology Degree from North Carolina State University. She has over 17 years of experience in Pharmaceutical Microbiology. She is a technical author and public speaker in the Microbiology Industry.

Crystal has developed and performed numerous method validations. Some of the methods include Microbial Limits Testing, Bacterial Endotoxins Testing, Particulate Testing, Sterility Testing, Pharmaceutical Water System Validations, Environmental Monitoring Programs, Surface Recovery Validations, Disinfectant Efficacy Studies, Minimum Inhibitory Concentration Testing, Antimicrobial Effectiveness Testing, Hold Time Studies, and various equipment validations (Autoclaves, Isolators, Vitek, Biolog, EM equipment, Conductivity Meters, pH Meters, Pipettes, PTS Unit, Endoscan, TOC equipment, Incubators, to name a few.). She also teaches aseptic gowning qualification classes.

Crystal has worked in both R&D and Quality Control Laboratories, including a start-up company. She has developed and validated methods for antibiotics, otic products, topical creams, topical ointments, oral solid dose products, oral liquid dose products, veterinary products, human parenterals, vaccines, biologics, aseptically filled products, and terminally sterilized products. She has experience working with global markets and regulatory bodies.