Global Best Practices for Cleaning and Disinfection of Cleanrooms and Disinfection Validation

Duration: 60 Minutes
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Cleaning and disinfection of cleanrooms is of great importance as part of a contamination control strategy. For this to be effective, correct disinfectants need to be selected, rotation between biocides must in place, a sporicidal agent needs to be selected, disinfectants need to be qualified cleaning frequencies need to be established, and appropriate training given. This is hampered by the lack of a global approach to satisfy regulatory agencies. This webinar provides an overview of the focal points required to achieve a global approach for cleanroom disinfection.
Best Practices for Cleaning and Disinfection
Instructor: Tim Sandle
Product ID: 505381
Objectives of the Presentation
  • What is cleaning and disinfection?
  • How to select disinfectants?
  • Global guidelines for disinfection in cleanrooms
  • EU GMP (& draft Annex 1), USP <1072>, FDA aseptic processing guidance, PIC/S
  • How to use disinfectants effectively
  • Points for success
  • Approaching disinfectant validation: Differences between European and U.S. standards
  • Practical approach to disinfectant validation: what is best for pharma?
  • Legal requirements for disinfectants: Europe and U.S.
Why Should you Attend
To understand the concerns expressed by regulators in relation to cleaning and disinfection and to consider how application and qualification of detergents and disinfectants can be approved in order to satisfy competing regulatory demands, that is to identify the key features of a global approach for cleaning and disinfection of cleanrooms and disinfection validation.

Areas Covered
  • Differences between types of disinfectants
  • Disinfectant efficacy testing
  • Regulatory citations
  • Latest laws and regulations
  • Cleaning and disinfectant policy and procedure points
  • Developing global standards
Who will Benefit
  • Microbiologists
  • Quality Assurance
  • Quality control
  • Production
  • Regularity
  • Procurement
  • Students
  • Academia
Topic Background
In recent years there have been a number of regulatory citations relating to cleaning and disinfection practices, in terms of techniques and inadequate qualification. In addition, companies operating globally face a problem of how to meet the differing international standards. This webinar provides an opportunity to understand the GMP deficiencies and to develop a qualification approach to meet global regulatory expectations.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
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