The pharma and biotech industry has seen an increase in the number and species of bacterial endospores and mold spores found in facilities. This presentation focuses on ways to limit bacterial and mold spore contamination from incoming items into cleanrooms, and limit other sources of spore contamination. The speaker discusses sporicidal products and their efficacy, and presents data which can be used to address bacterial spore issues, also reviewing current sporicide regulation in the US and Europe.

The presentation covers current issues in the industry and provides a better understanding of how to prevent outbreaks. Registrants hear about industry experiences, and troubleshooting methods for bacterial spore contamination issues. The presentation is designed to provide a better understanding of how personnel practices, transferring items into cleanrooms, facility design, construction, and sporicidal chemistries are critical to developing a successful contamination control program.

This audio conference covers:

• Effective methods for addressing contamination in biotech and pharmaceutical operations
• The latest technology for cleaning and disinfection
• Increasing awareness of elements that make cleaning and disinfection successful
• The latest regulations surrounding disinfectant validation
• Real-world cases studies on how to control bioburden and contamination

About the speaker:

Jim Polarine is a technical service specialist at STERIS Corporation. He has been with STERIS for over 10 years, and his current focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Asia, Latin America, and Puerto Rico and presented at numerous industry events on issues related to cleaning and disinfection in cleanrooms.

Mr. Polarine is a frequent industry speaker and has worked on several books and articles related to cleaning and disinfection and contamination control. He is currently co-authoring several articles and is an author of the PDA technical report on cleaning and disinfection. He is also currently active on the PDA task force on cleaning and disinfection. He is part of the faculty at the University of Tennessee Parenteral Medication course. He has presented at key industry events for PDA, ISPE, AALAS, IVT, University of Tennessee and SWE on cleaning and disinfection and contamination control.

Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology, and is a member of the PDA, ISPE, IEST, ASM, AALAS, ASTM, AAAS, AOAC, and ACS. He previously worked as a clinical research coordinator with the Department of Veterans Affairs and as a biology and microbiology instructor at the University of Illinois.

Who should attend?

• Regulatory Affairs
• Quality Control and Quality Assurance
• Validation Managers
• Production Managers
• QAL Managers
• Technical Services Managers
• Operations Managers
• Environmental Monitoring Managers