STERIS WORKSHOP - Disinfectant Validation and Efficacy Testing

24 Feb 2022
9.30-11.00 am SGT | Online

This presentation covers:

  • Current debates in the industry regarding disinfectant coupon testing.  
  • PDA Technical Report No. 70 and USP 43 <1072> in relation to current industry disinfectant efficacy testing. 
  • Recent FDA Warning Letters and 483s highlighting regulator expectations in disinfectant efficacy testing.
  • Data will be presented on the importance of disinfectant efficacy testing with specific bacterial spores which can be more difficult to kill than ATCC strains.  
  • Both sides of the debate on disinfectant validation detailed with emphasis on current FDA, MHRA, ANVISA, ANSM, CFDA, and HPRA regulatory expectations and reducing the costs for testing. 
  • The recent PDA Technical Report No. 70 recommendations on DET. 

Speakers:

• Jim Polarine Jr. MA., Senior Technical Service Manager at STERIS
With STERIS Corporation for 20 years, Jim’s current technical focus is microbial control in cleanrooms and other critical environments. 
A frequent industry speaker, he has published several PDA book chapters and articles related to cleaning and disinfection and contamination control. 
Active on PDA’s COVID-19 and Microbial Excursions Task Forces, Jim co-authored PDA’s Technical Report #70 on Cleaning and Disinfection. He teaches regulators from FDA, MHRA, HPRA, ANVISA, and ANMAT as well as the pharmaceutical, biotech, and medical device industries. Jim is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST.

• Richard Chai, Technical Service Manager at STERIS
Based in Singapore, Richard has been providing technical support and training to customers related to bioburden control for cleanrooms, as well as cleaning and cleaning validation for product contact surfaces. 
He is also a frequent industry speaker at industry events such as ISPE and PDA, and co-author of PDA book chapter. 
Richard has been with STERIS for 5 years. Prior to joining STERIS, he has 16 years of manufacturing, validation and consultancy experience working in dry powder inhaler plant, biotech sterile fill and finish plant, medical device and biopharmaceutical facilities.

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