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Analytical Method Validation STERILITY TEST
Analytical Method Validation STERILITY TEST
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OUTLINE
Introduction
Certificate of Analysis
Media Validation
Tests Methods
Method Validation
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Certificate of Analysis
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Media sterility
Negative Control - may be used to identify a “false
positive” test result
Incubate for 14 days prior to use, may be conducted
concurrently with test
30 - 35°C for Fluid Thioglycollate medium (FTM)
20 - 25°C for Soybean Casein Digest Medium (SCD/TSB)
Acceptance criteria:
Should be sterile, no growth observed
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Incubation
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Interpretation of results
Challenge organisms should clearly show visible growth
of bacteria within 3 days, and fungi within 5 days in
the test media containing product.
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Checklist
Results
Test Document Required Method (Raw
data)
1. Sterility Test √ √
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