Cleanroom Microbiology – A Foundational Introduction

Date: April 27, 2017
Time: RECORDED SESSION
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!

Course Description:

Microbial control is critical in cleanrooms environments.  Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths.  In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood.  The importance of cleanroom sterility cannot be understated.  In 2016 alone, FDA made over 350 microbial, sterility, cleaning, and related form 483 observations during inspections of drug manufacturers.

Whether you need a foundation for cleanroom microbiology or are looking for a refresher, this course will outline critical components and current best practices.  Join our interactive online training course where we will discuss:

  • An introduction to cleanroom microbiology
  • Guidance documents and some regulatory observations
  • Sources of microbial contamination in cleanrooms
  • Basics of cleanroom design
  • Proper material transfer
  • Cleanroom gowning
  • Environmental monitoring
  • Disinfectant efficacy and the importance of proper cleaning

This course will be of benefit to anyone involved in cleanroom activities including: maintenance, management, monitoring, or operations. 

Crystal Booth is an Independent Pharmaceutical Microbiology Consultant for Pharmaceutical Advisors, L.L.C.  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 17 years of experience in Pharmaceutical Microbiology. 

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, Container Closure Integrity Testing, and various Equipment Validations (Autoclaves, Isolators, Vitek, Biolog, EM equipment, Conductivity Meters, pH Meters, Pipettes, PTS Unit, Endoscan, TOC equipment, Incubators, etc.).  

Crystal has worked in both R&D and Quality Control Laboratories, including a Start-up Company. She has developed and validated methods for Antibiotics, Otics, Topical Creams, Topical Ointments, Oral Solid Dose Products, Oral Liquid Dose Products, Veterinary Products, Human Parenterals, Aseptically Filled Products, and Terminally Sterilized Products.  She has experience working with global markets and regulatory bodies.