Contamination Control 101 in Pharmaceutical, Biotech, and Medical Device Clean rooms

"Controlling a cleanroom environment is critical to get the best product yield. Do you know enough to avoid common mistakes that cost big bucks?"

Fact: Cleanroom contamination can result in downtime and burgeoning production costs. The billion-dollar Hubble Space Telescope did not perform as designed because of a particle smaller than 0.5 microns.

This online training will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs. The end user will get a complete overview of the basics of how to control the cleanroom environment and how to get the best possible product yield.

The basics of personnel practices, and cleaning and disinfection will be discussed. The most common source of contamination in the cleanroom is people; it is thus important to cover common mistakes in behavior and gowning. Facility design and conditions will be addressed as well since these are also a contributor to contamination.

Areas Covered in the seminar:

• Review the most common mistakes people make in cleanrooms that lead to contamination.
• Learn how to develop a successful contamination control program.
• Learn ways to improve facility design and maintenance.

Who will benefit:

This webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs, including companies in the Pharmaceutical, Biotech, and Medical Device fields. The employees who will benefit include:

• 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

Instructor Profile:

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 Veteran.

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