Personnel Practices, Hand Washing, and Solutions for Addressing Microbial Contamination in Process Equipment

This webinar will cover a risk-based approach to contamination control in cleanroom operations.  Case studies will be covered on microbial control in cleanrooms, personnel practices, and effective hand washing. An effective contamination control program is essential to prevent microbial contamination in cleanrooms, controlled environments and of sterile drug products.

This second part of this presentation will focus on critical elements that have been effective in troubleshooting and correcting microbial contamination in processing equipment. One element is a review of cleaning parameters to ensure effective residue removal. A simplified laboratory screening process will be discussed along with specific examples on how information generated from these studies can be used to develop effective cleaning strategies. Another element is a review of the surface and equipment design. Surface and design issues may include materials of construction, crevices, and drainability. Surface and equipment design issues can lead to ineffective cleaning and sanitization. Finally, a third element is sterilization/disinfection practices which include multiple alternatives depending on the industry. 

Who Should Attend the Webinar

  • Validation Managers
  • Quality Control Managers
  • Quality Assurance Managers
  • Lean Managers
  • Operations Managers
  • Cleanroom Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Industry Auditors

Instructors

Jim Polarine

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty 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.  He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection and microbial control in cleanrooms.   Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control.  He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators and the pharmaceutical, biotech, 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’s Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course.  Mr. Polarine is currently President Elect for the PDA Missouri Valley and Technical Coordinator 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 coordinator 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.

Elizabeth Rivera

Elizabeth Rivera is a technical service manager for the Scientific Division of STERIS Corporation (Mentor, Ohio). Currently, she provides technical assistance in the areas of selection of detergents, disinfectants and sterilization assurance products including the application and use of these in the pharmaceutical, biopharmaceutical, cosmetics, medical devices, dietary supplements and related industries. In addition, she offers conferences and exhibits on educational technical forums such as IPA, Interphex, ExpoFYBI, ETIF, PDA, ISPE, Expofarma, Pharma Expo, Executive Conference and more. Also, she has published articles related to cleaning and microbial control. She has a bachelors and masters degree in chemical engineering from the University of Puerto Rico.

Elizabeth has over 15 years of experience and travels to places in North America, Latin America and elsewhere to support customers in various aspects of cleaning and decontamination. Previously, she held positions at companies such as BMS and Eli Lilly. She has extensive experience in cleanup of active pharmaceutical programs. She has worked in the preparation, implementation and support of cleaning processes including protocols, validation, qualification of spray devices, master plans, standard operational procedures, training staff, and post-construction cleaning. Other industrial experiences include qualification of equipment, process validation, batch records, investigation of discrepancies, and corrective and preventive actions, according to good manufacturing practices (GMP) for pharmaceutical industries.

Date

May 28, 2020
1 - 2:30 p.m. Central Time
Registration closes May 27


Pricing

Complimentary