Practical Approaches to Sterility Test Validation: Overcoming difficult products

Duration: 60 Minutes
This webinar examines some practical approaches to sterility test method validation, in relation to the pharmacopeia described culture based method. Method validation is important because products must be shown to be non-inhibitory to the recovery of any microorganisms that may be present in the sample. The main concerns here are with products not being validated due to problems with the method or, more seriously, the risk of a false-negative where a product is released when it appears to pass the sterility test whereas it actually contains microorganisms. The webinar also addresses the significance and risks in relation to sterility test failures.
Sterility Test Validation
Instructor: Tim Sandle
Product ID: 507625
Objectives of the Presentation
Key learning points:
  • How important is the sterility test anyway?
  • How to validate difficult products?
  • What to do if products won't pass through a membrane filter?
  • What to do with turbid products?
  • How to write a method validation protocol and report?
  • How to select appropriate neutralizers?
  • How to assess test failures?
  • How to prepare the sterility test validation data?
Why Should you Attend
To understand how sterility test validation can be approached in relation to culture media, stasis tests, in general (for regulatory filings) and in relation to new, modified or challenging products.

Areas Covered
  • How to test culture media
  • Media concerns with isolators
  • Fundamentals of the sterility test methods
  • How to perform the end of incubation stasis test
  • Examples of potentially difficult products, which will include:
    • Mercurial compounds
    • Antibiotics
    • Turbid samples
    • Medical devices
    • Oily samples
    • Catgut
    • Radiopharmaceuticals
    • Cell lines
  • Significance of sterility test failures
  • Risk factors to account for with validation and preparing for regulatory filings
Who will Benefit
  • Microbiologists
  • Method development
  • Validation
  • Quality Control
  • Quality Assurance
  • Production
  • Academia
  • Compounders
  • Pharmacists
  • Regulators
Topic Background
Sterility testing is an important activity, but it can prove challenging to validate different products and to present this data to regulators. Given the multitude of different types of sterile products on the marketplace, this webinar will consider some general practical examples for the sterility testing of 'difficult' products. The focus will be on common product types and widely used techniques. The webinar will provide a framework for considering the appropriate steps to take when developing an alternative method (such as attempting membrane filtration first, exploring rinsing and neutralization second, and so forth). The webinar will also consider how to assess sterility test failures.
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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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