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3 modules9 lessons~8 h

Sterility Testing Masterclass

Membrane filtration, direct inoculation, isolators and real invalidation case studies.

What you'll be able to do

  • ✓ Set up a sterility test that rarely gives false positives
  • ✓ Perform and document method suitability
  • ✓ Run isolator-based testing with proper controls
  • ✓ Investigate a positive and decide on invalidation with evidence

Syllabus

  1. MODULE 1FoundationsWhy the test exists and why it fails.
  2. MODULE 2Environment and controlsIsolators, LAF and monitoring.
    • Isolators and decontamination
    • Controls and environmental monitoring in the suite
  3. MODULE 3Suitability and investigationsMethod suitability and positives.
    • Method suitability
    • Investigating a positive
    • Rapid sterility methods
    • Final exam

Questions

Does it cover isolators?

Yes, including decontamination, glove integrity and aeration.

Are there case studies?

Yes, the investigation module walks through real-world style cases.