Improving the Environmental Monitoring Program
Webinar to be presented Thursday, May 3 at 2 pm EST
Abstract
Environmental monitoring in pharmaceutical production areas is performed to demonstrate the state of control of the facility. Methods used for environmental monitoring should therefore be accurate and precise, allowing clear and unambiguous interpretation. Unfortunately, the methods available to us are anything but clear and unambiguous.
There are several types of sampling used in a modern EM program, primarily sampling of surfaces, air, utilities and personnel. While some of these incorporate a physical component, all have a microbial component and this will be the focus of the presentation. We will look at the ability of these methods to provide a realistic evaluation of the state of control of the facility, and opportunities for alternate microbiological methods to help in this program.
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
- What’s the Point of the Program?
- Components of the Program
- Potential Improvements to the Program
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