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Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test.
Journal of Pharmaceutical Innovation ( IF 2.6 ) Pub Date : 2017-12-05 , DOI: 10.1007/s12247-017-9303-z Adriana Bugno 1 , Deborah Pita Sanches Saes 1 , Adriana Aparecida Buzzo Almodovar 1 , Kamal Dua 2, 3, 4 , Rajendra Awasthi 5 , Daniela Dal Molim Ghisleni 6 , Marici Tiomi Hirota 1 , Wesley Anderson de Oliveira 6 , Terezinha de Jesus Andreoli Pinto 6
Journal of Pharmaceutical Innovation ( IF 2.6 ) Pub Date : 2017-12-05 , DOI: 10.1007/s12247-017-9303-z Adriana Bugno 1 , Deborah Pita Sanches Saes 1 , Adriana Aparecida Buzzo Almodovar 1 , Kamal Dua 2, 3, 4 , Rajendra Awasthi 5 , Daniela Dal Molim Ghisleni 6 , Marici Tiomi Hirota 1 , Wesley Anderson de Oliveira 6 , Terezinha de Jesus Andreoli Pinto 6
Affiliation
The sterility test described in pharmacopoeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the BacT/Alert® 3D system, is particularly interesting, because it allows a reduced incubation period and lower associated costs. Considering that the BacT/Alert® 3D system offers several culture media formulations developed for this microbial detection system, the present study was aimed to evaluate and compare the performance of BacT/Alert® 3D with the pharmacopoeial sterility test. There was no significant difference between the ability of the culture media to allow detection of microbial contamination. However, the rapid sterility testing method allowed a more rapid detection of the challenge microorganisms, which indicates that the system is a viable alternative for assessing the sterility of injectable products.
中文翻译:
快速无菌测试方法与药典无菌测试性能比较。
药典中描述的无菌测试需要14天的孵育期才能获得有效的分析结果。因此,使用替代方法(例如BacT /Alert®3D系统)来评估药物的无菌性特别有趣,因为它可以缩短孵育时间并降低相关成本。考虑到BacT /Alert®3D系统提供了为该微生物检测系统开发的几种培养基配方,因此本研究旨在评估BacT /Alert®3D的性能并与药典无菌性测试进行比较。培养基允许检测微生物污染的能力之间没有显着差异。但是,快速无菌测试方法可以更快地检测出挑战性微生物,
更新日期:2017-12-05
中文翻译:
快速无菌测试方法与药典无菌测试性能比较。
药典中描述的无菌测试需要14天的孵育期才能获得有效的分析结果。因此,使用替代方法(例如BacT /Alert®3D系统)来评估药物的无菌性特别有趣,因为它可以缩短孵育时间并降低相关成本。考虑到BacT /Alert®3D系统提供了为该微生物检测系统开发的几种培养基配方,因此本研究旨在评估BacT /Alert®3D的性能并与药典无菌性测试进行比较。培养基允许检测微生物污染的能力之间没有显着差异。但是,快速无菌测试方法可以更快地检测出挑战性微生物,