A Disinfectant Field Trial that Meets Annex I Guidance
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Speaker : JIM POLARINE JR., MA.
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When : Monday, May 19, 2025
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Time : 01 : 00 PM EST
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Mr. Polarine is a Principal Consultant, Technical Services at STERIS Corporation. He has been with STERIS Corporation for twenty-five years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient and the 2024 PDA Service Appreciation Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. Mr. Polarine is a frequent international industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the prestigious PDA’s Scientific Advisory Board (SAB). He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection, Technical Report #88 on Microbial Deviations, and the COVID Points to Consider. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, ATMP, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is the current past President for the PDA Missouri Valley Chapter and Vice President of Membership for the IEST. He is the PDA Chapter Council Vice Chairperson and President Elect for the IEST.
Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research manager with the Department of Veterans Affairs in St. Louis, MO 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.
In this informative webinar, we will explore the key elements of a Contamination Control Strategy (CCS) implemented in a recent biopharma disinfectant field trial, following Annex I guidance. The case study highlights the use of a ready-to-use quaternary ammonium disinfectant and a hydrogen peroxide/peracetic acid sporicide to control bioburden in a new cleanroom operation post-construction.
This webinar is ideal for professionals in the biopharma, regulatory, and cleanroom management sectors, offering valuable knowledge on disinfectant field trials, contamination control, and regulatory compliance. Don't miss this opportunity to gain a deeper understanding of how to design and execute field trials that meet Annex I guidance for disinfectant effectiveness and safety.
Areas Covered
This seminar will cover key components of CCS (Contamination Control Strategy) in a recent biopharma disinfectant field trial. The case study utilized a ready-to-use quaternary ammonium disinfectant and a hydrogen peroxide/peracetic acid sporicide to control bioburden in a new cleanroom operation post-construction. Material flow, engineering controls, utility supplies, and operational procedures will be discussed. In-depth field trial environmental monitoring data will be covered. This CCS case study has recently been published in a peer-reviewed industry journal.
Who Should Attend
- Validation Managers
- Quality Control Managers
- Quality Assurance Managers
- Lean Managers
- Operations Managers
- Cleanroom Managers
- Regulatory Affairs Managers
- Production Managers
- Quality Systems Managers
- Sustainability Managers
Why Should You Attend
By attending this webinar, you'll gain essential knowledge from a real-world case study on how to successfully conduct disinfectant field trials in alignment with Annex I guidance. Learn from in-depth environmental monitoring data, proven strategies, and the practical lessons that will help you ensure your trials meet regulatory requirements, minimize risks, and safeguard product quality.
Don’t risk falling behind or making costly mistakes. This webinar will provide the clarity, expertise, and actionable insights you need to stay compliant and stay ahead of industry standards. Secure your spot and ensure your contamination control strategy is up to par.
Topic Background
In the biopharma industry, maintaining contamination control is essential for ensuring product safety, efficacy, and adherence to regulatory standards. Cleanrooms, critical in pharmaceutical production, must be meticulously managed to prevent bioburden and other contaminants that could affect product quality. Implementing effective contamination control strategies (CCS) is vital to meet the stringent requirements of these controlled environments.
Annex I guidance, set by the European Medicines Agency (EMA), lays out strict regulations for the manufacture of sterile medicinal products, focusing on microbial contamination control in cleanrooms. This guidance stresses the need for disinfectants and sporicides to be tested for their effectiveness in reducing bioburden while meeting safety and environmental standards.
Field trials are crucial for evaluating the performance of disinfectants under real-world conditions. The field trial discussed in this webinar utilized a ready-to-use quaternary ammonium disinfectant and a hydrogen peroxide/peracetic acid sporicide to control bioburden in a newly constructed cleanroom. The trial was designed in line with Annex I guidance to ensure both regulatory compliance and operational effectiveness.
This background underscores the importance of thorough contamination control strategies and well-executed field trials to ensure the proper functioning of cleanrooms in biopharma manufacturing.
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$199.00
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