Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test
J Pharm Innov
;
13(1)2018.
Article
in English
| LILACS, CONASS, ColecionaSUS, SES-SP, SESSP-IALPROD, SES-SP
| ID: biblio-1426032
ABSTRACT
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.
Full text:
Available
Index:
LILACS (Americas)
Main subject:
Aptitude
/
Culture Media
/
Environmental Pollution
/
Infertility
Language:
English
Journal:
J Pharm Innov
Year:
2018
Type:
Article
Institution/Affiliation country:
Discipline of Pharmacy/BR
/
Institute Adolfo Lutz/BR
/
NKBR College of Pharmacy & Research Centre/BR
/
São Paulo University/BR
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