Table of Contents:

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Introduction

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 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.