Validation of an Amplified-ATP Bioluminescence Method for the Rapid Detection of Contamination in a Betamethasone Suspension

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Validation of an Amplified-ATP Bioluminescence Method for the Rapid Detection of Contamination in a Betamethasone Suspension

2012

American Pharmaceutical Review, Fresh Perspectives 2012 | Thomas H. Chrzanowski and Ronald L. Smith

The equivalence of two test methods that detect microbiological contamination was evaluated by comparing the rate of positive and negative results obtained from identical samples. The methods were a rapid Amplified-ATP bioluminescence (ATP+) method and the compendial plate count method. The study measured the degree to which the methods agreed when performed repeatedly on multiple lots of the same product. The accuracy, precision, specificity and sensitivity of the ATP+ method (alternate method), expressed in terms of the relative rates of discordant outcomes using standardized low-level inocula, were computed and tested against an acceptance criteria of 70%. This performance qualification was based onthe United States Pharmacopoeia 32 General Chapters <1223>“Validation of Alternative Microbiological Methods” [1] and European Pharmacopoeia 6.0, Chapter 5.1.6 “Alternative Methods for Control of Microbiological Quality” [2].

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