Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount. 

Why Should You Attend: 

The industry has seen an increase in the number and species of bacterial endospores and mold spores found in their facilities. This presentation will focus on ways to limit bacterial and mold spore contamination from incoming items into cleanrooms and limit other sources of spore contamination. Sporicidal products will be discussed and data will be presented which can be used to address bacterial spore issues. Current industry regulation in the US and Europe will be discussed related to sporicides.

This presentation will convey a robust approach to addressing bacterial spores by covering personnel practices, incoming items into cleanrooms, facility design and conditions, and the products used to address bacterial and mold spores as well as more resistant bacterial spore species. The audience will get a flavor of the current issues in the industry with bacterial spore outbreaks and develop a better understanding of how to prevent outbreaks. The audience will also see sporicidal data and hear industry experiences which will allow them to better address contamination control programs. The presentation will provide troubleshooting skills and experiences for bacterial spore contamination issues.

Areas Covered in the Seminar:

• Developing effective ways to address spore excursions.
• Troubleshooting real world experiences.
• Developing preventative action plans.
• Learn ways to improve facility design and maintenance.
• The most effective sporicidal chemistries will be discussed in detail.
• Cleaning and Disinfection Methods will be addressed.
• Warning Letters and 483’s from FDA will be discussed and addressed.

Who Will Benefit:

• QA and QC Managers
• Disinfectant Validation Managers
• Operations Managers
• Cleanroom Managers
• Personnel and contractors that clean and disinfect cleanrooms
• Regulatory Compliance Managers & Environmental Monitoring Managers
• Production Managers
• Cleanroom Operators

Jim Polarine, is a technical service specialist at STERIS Corporation. He has been with STERIS Corporation for over eight years, where his current technical focus is microbial control in Cleanrooms and other critical environments. He has lectured in North America, Europe, Asia, Latin America, and Puerto Rico on issues related to disinfection and sanitation in Cleanrooms. Mr. Polarine is a frequent industry speaker and has worked on several book article publications related to cleaning and disinfection and contamination control. He is currently co-authoring several articles and is an author on the PDA technical report on cleaning and disinfection. He is also currently active on the PDA task force on cleaning and disinfection. He has presented at key industry events for PDA, ISPE, AALAS, IVT, University of Tennessee, SWE, and Barnett International 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. His main hobby is storm chasing and is very active in tornado research and safety.