Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test

Bugno, A; Saes, DPS; Almodovar, AAB; Dua, K; Awasthi, R; Ghisleni, DDM; Hirota, MT; de Oliveira, WA; de Jesus Andreoli Pinto, T

Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test

Bugno, A Saes, DPS Almodovar, AAB Dua, K

Awasthi, R Ghisleni, DDM Hirota, MT de Oliveira, WA de Jesus Andreoli Pinto, T

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Publication Type:: Journal Article
Citation:: Journal of Pharmaceutical Innovation, 2018, 13 (1), pp. 27 - 35
Issue Date:: 2018-03-01

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Field	Value	Language
dc.contributor.author	Bugno, A	en_US
dc.contributor.author	Saes, DPS	en_US
dc.contributor.author	Almodovar, AAB	en_US
dc.contributor.author	Dua, K https://orcid.org/0000-0002-7507-1159	en_US
dc.contributor.author	Awasthi, R	en_US
dc.contributor.author	Ghisleni, DDM	en_US
dc.contributor.author	Hirota, MT	en_US
dc.contributor.author	de Oliveira, WA	en_US
dc.contributor.author	de Jesus Andreoli Pinto, T	en_US
dc.date.issued	2018-03-01	en_US
dc.identifier.citation	Journal of Pharmaceutical Innovation, 2018, 13 (1), pp. 27 - 35	en_US
dc.identifier.issn	1872-5120	en_US
dc.identifier.uri	http://hdl.handle.net/10453/128328
dc.description.abstract	© 2017, The Author(s). 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.	en_US
dc.relation.ispartof	Journal of Pharmaceutical Innovation	en_US
dc.relation.isbasedon	10.1007/s12247-017-9303-z	en_US
dc.subject.classification	Pharmacology & Pharmacy	en_US
dc.title	Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	13	en_US
utslib.for	1115 Pharmacology and Pharmaceutical Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Graduate School of Health
utslib.copyright.status	closed_access
pubs.issue	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	13	en_US

Abstract:

© 2017, The Author(s). 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.

Please use this identifier to cite or link to this item:

http://hdl.handle.net/10453/128328