Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom

Why Should You Attend:

Training on personnel practices and microbial control of non-sterile manufacturing areas and process equipment are a critical part of your facility operations and overall control program to meet FDA, EMA, IMB, and MHRA regulations. This process involves updated personnel training and having a validated cleaning and disinfection program to control microbes on both product and non-product contact process equipment and cleanroom surfaces.

This 90-minute presentation will cover all the necessary components that will allow end users to be in compliance with FDA, MHRA, IMB, and EMA regulations.

Areas Covered in the Webinar:

• General oral solid dose (OSD) manufacturing considerations
• Addressing bioburden and cleaning and sanitization or process equipment
• Discussing the most current methods for applying disinfectants, sanitizers, and sporicides on process equipment and in the cleanroom
• Control of bioburden with a validated cleaning and disinfection program
• Effective methods for controlling residues
• Necessary components will be discussed that will allow end users to be in compliance with FDA and EMA/European regulatory agencies

Who Will Benefit:

This webinar will provide valuable assistance to all FDA and EMA/European regulated manufacturers that need to validate their cleaning and disinfection programs, including manufacturers in the Pharmaceutical, Biotech, Medical Device, and Oral Solid Dose fields. Employees who will benefit include:

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

Jim Polarine
Technical Service Specialist , STERIS Corporation

Mr. Polarine, is a technical service manager at STERIS Corporation. He has been with STERIS Corporation for over eleven 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 cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and has worked on several books and article publications related to cleaning and disinfection and contamination control. He is currently co-authoring several articles and is a co-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 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, SWE, and Barnett International on cleaning and disinfection and contamination control. Mr. Polarine also frequently presents global industry webinars on Cleaning and Disinfection including one that he co-presents with Carole Genovesi (Cleanroom Director at Genentech).

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 Veteran’s 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 tornado safety.

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