Transcription of Preservation Efficacy Testing
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Preservation Efficacy Testing
10/21/20111 Preservation Efficacy TestingScott Sutton, in this presentation is copyright 2011 Microbiology Network Inc. All rights reserved38 Overview 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 data210/21/20112 Antimicrobial 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 survivors3 USP 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 categories of products410/21/20113 Consensus Antimicrobial Effectiveness TestEffort of the European Pharmacopoeia, Japanese pharmacopeia , and united states pharmacopeia to come to a harmonized , SVW and D Porter.
10/21/2011 3 “Consensus” Antimicrobial Effectiveness Test Effort of the European Pharmacopoeia, Japanese Pharmacopeia, and United States Pharmacopeia to
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