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Challenges on rapid microbiological methods validation: sterility test based on carbon dioxide detection

Grant number: 12/05898-2
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): June 01, 2012
Effective date (End): May 31, 2013
Field of knowledge:Health Sciences - Pharmacy - Medicines Analysis and Control
Principal researcher:Terezinha de Jesus Andreoli Pinto
Grantee:Wesley Anderson de Oliveira
Home Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Nowadays, the sterility test methods described on main pharmacopoeias used requires an incubation period of 14 days. During this period the product stays on quarantine waiting the result for release, which demands warehousing and inventory costs. By the other hand, the method based on carbon dioxide detection is already used in clinical analysis laboratories and has as principle the detection of culture media color change due to carbon dioxide release by microorganisms metabolism, which according to literature references, in low levels of contamination the detection could be done until one week. Regarding regulatory perspectives, there is a great resistance to accept non pharmacopoeial methods usage due to be a critical issue. In these cases, non pharmacopoeial methods were only accepted after showing of many evidences that they were equivalent or superior than pharmacopoeial methods. Given the above, this work has the objective of evaluate comparatively the time of detection of large parenteral volume samples intentionally contaminated with low levels of challenge microorganisms in order to prove the method is equivalent or superior than pharmacopeial methods and to contribute to greater regulatory acceptance.

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