Validation of Microbial Recovery – Method Suitability Studies

Webinar to be presented Thursday, March 8 at 2 pm EST

Abstract

Microbiological assays require recovery and growth of microorganisms. While the Sterility Tests and the Microbial Limit Tests have the “validation” or “method suitability” studies are part of the procedure, many tests do not. USP Chapter <1227> was designed to provide information on the design of these studies, and to provide information on the limitations of the plate count method. This webinar will review USP <1227> with emphasis on how it can be used to strengthen all assays in the QC microbiology laboratory.

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Scott Sutton, Ph. D.

Dr. Scott Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). With over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical and personal products industries, he now consults through Microbiology Network, Inc. Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses. Laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest. He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000. He operates the Pharmaceutical Microbiology Forum with its monthly newsletter (http://www.microbiologyforum.org) and serves as a reviewer for several peer-reviewed journals. Dr. Sutton also operates an information source on the internet – The Microbiology Network (http://www.microbiol.org) that provides services to microbiology related user’s groups. This service also supports three Email lists, the first devoted to pharmaceutical microbiology, the second devoted to pharmaceutical stability and the third to cleanrooms and controlled environments.

Key Topics

  • Influential Factors
  • Methods of Neutralizing Antimicrobial Properties
  • Validation of Neutralization Methods – Recovery Comparisons
  • Recovery of Injured Organisms
  • Specific Tests
    • Sterility Test
    • Microbial Limits: Enumeration
    • Microbial Limits: Absence of Specified Organisms