Understanding Disinfection and Cleanroom cleaning in a FDA Regulated Environment

Why Should You Attend:

Designing an effective cleaning and disinfection program is a critical part of your facility operations and contamination control program to meet FDA, EMA, and MHRA regulations. This process involves selecting the most effective products against your isolates, rotating these products, and having a safe and effective method to apply these products. Today end users typically struggle with how often to rotate products and determining exactly which products to rotate.

This 90-minute presentation will cover all the necessary components that will allow end users to be in compliance with FDA and EMEA.

Areas Covered in the Webinar:

• Effective ways to rotate disinfectants.
• The need to control bioburden involves a sound cleaning and disinfection program.
• The most current industry methods for applying disinfectants.
• Effective methods for controlling residues.
• All the necessary components will be discussed that will allow end users to be in compliance with FDA and EMEA.

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
• 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.

Topic Background:

Recently regulators have been placing a larger emphasis on companies using both a disinfectant to address daily routine cleaning and a sporicide to address mold and bacterial spores. Currently the majority of the pharmaceutical, biotech, and medical device industries use phenolics, quats, or quat mixes for routine disinfection. Therefore, rotation of a disinfectant and a sporicide is common in the industry today. Certain regulations such as USP 29 NF-24 <1072> Disinfectants and Antiseptics and the Aseptic Processing Guide (2004) support the use a disinfectant and sporicide as a rotational program. Typically tacky rollers and HEPA vacuums are used to remove larger debris on the floors before the implementation of the cleaning and disinfection program. The application equipment used is also critical to successful cleaning and disinfection and most end users will us a two or three bucket system for routine cleaning and disinfection and they will conduct a fogging or triple clean for extraordinary events. Extraordinary events would be at a facility shut down, power failure, construction event, after a hurricane or after any lengthy downtime period. Fogging would typically be conducted with a sporicidal agent such as Hydrogen Peroxide/Peracetic Acid blends, Hydrogen peroxide, or Chlorine Dioxide. The triple clean generally means conducting the cleaning and disinfection program including the sporicidal application three times. Cleanroom wipes are also a routine part of the cleaning and disinfection program for cleaning equipment, windows, and walls. Following several applications of disinfectant and sporicide end users typically will rinse the walls and floors with Water for Injection and rinse equipment and windows with 70% Isopropyl Alcohol to remove the residual build up. Rinsing is typically based on visual observation and is carried out once a week, once a month, or once a quarter depending on the levels of residues. To summarize a sound cleaning and disinfection program consists of choosing the most effective products against your microbial isolates as well as the most effective technologies to apply the disinfectants and sporicides. Additionally, a rinsing step has really become standard best practice in the industry following several applications of products.

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