Evaluation of an Amplified ATP Bioluminescence Method for Rapid Sterility Testing of Large Volume Parenteral

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

Evaluation of an Amplified ATP Bioluminescence Method for Rapid Sterility Testing of Large Volume Parenteral

Bugno, A Almodovar, AAB Saes, DPS Awasthi, R Ghisleni, DDM de Souza Braga, M de Oliveira, WA Dua, K

de Jesus Andreoli Pinto, T

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Publication Type:: Journal Article
Citation:: Journal of Pharmaceutical Innovation, 2019, 14 (2), pp. 152 - 158
Issue Date:: 2019-06-15

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Field	Value	Language
dc.contributor.author	Bugno, A	en_US
dc.contributor.author	Almodovar, AAB	en_US
dc.contributor.author	Saes, DPS	en_US
dc.contributor.author	Awasthi, R	en_US
dc.contributor.author	Ghisleni, DDM	en_US
dc.contributor.author	de Souza Braga, M	en_US
dc.contributor.author	de Oliveira, WA	en_US
dc.contributor.author	Dua, K https://orcid.org/0000-0002-7507-1159	en_US
dc.contributor.author	de Jesus Andreoli Pinto, T	en_US
dc.date.issued	2019-06-15	en_US
dc.identifier.citation	Journal of Pharmaceutical Innovation, 2019, 14 (2), pp. 152 - 158	en_US
dc.identifier.issn	1872-5120	en_US
dc.identifier.uri	http://hdl.handle.net/10453/135243
dc.description.abstract	© 2018, Springer Science+Business Media, LLC, part of Springer Nature. The sterility test described in pharmacopeial 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 Celsis AKuScreen™ Advance™ system, is particularly interesting because it allows a reduced incubation period and higher efficiency. The present study was aimed to evaluate and compare the performance of Celsis AKuScreen™ Advance™ system with the pharmacopeial sterility test. There was no significant difference between the ability of detection of microbial contamination observed within pharmacopeial method and test method. The Celsis AKuScreen™ Advance™ system allowed a faster 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/s12247-018-9344-y	en_US
dc.subject.classification	Pharmacology & Pharmacy	en_US
dc.title	Evaluation of an Amplified ATP Bioluminescence Method for Rapid Sterility Testing of Large Volume Parenteral	en_US
dc.type	Journal Article
utslib.citation.volume	2	en_US
utslib.citation.volume	14	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	2	en_US
pubs.publication-status	Published	en_US
pubs.volume	14	en_US

Abstract:

© 2018, Springer Science+Business Media, LLC, part of Springer Nature. The sterility test described in pharmacopeial 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 Celsis AKuScreen™ Advance™ system, is particularly interesting because it allows a reduced incubation period and higher efficiency. The present study was aimed to evaluate and compare the performance of Celsis AKuScreen™ Advance™ system with the pharmacopeial sterility test. There was no significant difference between the ability of detection of microbial contamination observed within pharmacopeial method and test method. The Celsis AKuScreen™ Advance™ system allowed a faster 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/10453/135243