Preservation Efficacy Testing

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10/21/20111Preservation Efficacy TestingScott Sutton, in this presentation is copyright 2011 Microbiology Network Inc. All rights reserved38Overview of Presentation What is the Antimicrobial Effectiveness Test? What it can do What it can t do AET (PET) Topics Packaging Effects Formulation Effects Phoenix Phenomenon Linear Regression Unique Microorganisms FDA s Role in this Use of contract labs for generation of PET data210/21/20112Antimicrobial Efficacy TestUSP <51>/ISO11930 Designed to demonstrate the ability of a multidose product to withstand microbial challenge. High-level challenge, frequent sampling of the challenge suspension for survivors3USP Antimicrobial Efficacy Test Finished product test in US, development test in Europe Required for multi-dose presentations, anhydrous ointments that contain preservative Method basically harmonized, criteria not Different criteria for different cat

10/21/2011 4 CTFA Guidelines • 13. Determination of Preservative Adequacy in Cosmetic Formulations • 14. Preservation Testing of Eye Area Cosmetics