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

Adriana Bugno; Adriana Aparecida Buzzo Almodovar; Deborah Pita Sanches Saes; Rajendra Awasthi; Daniela Dal Molim Ghisleni; Marina de Souza Braga; Wesley Anderson de Oliveira; Kamal Dua; Terezinha de Jesus Andreoli Pinto

doi:10.1007/s12247-018-9344-y

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

Adriana Bugno
, Adriana Aparecida Buzzo Almodovar
, Deborah Pita Sanches Saes
, Rajendra Awasthi
, Daniela Dal Molim Ghisleni
, Marina de Souza Braga
, Wesley Anderson de Oliveira
, Kamal Dua
, Terezinha de Jesus Andreoli Pinto

Instituto Adolfo Lutz
Amity University, Noida
Universidade de São Paulo
University of Technology Sydney
University of Newcastle

Research output: Contribution to journal › Article › peer-review

6 Scopus citations

Abstract

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.

Original language	English
Pages (from-to)	152-158
Number of pages	7
Journal	Journal of Pharmaceutical Innovation
Volume	14
Issue number	2
DOIs	https://doi.org/10.1007/s12247-018-9344-y
State	Published - 15 Jun 2019
Externally published	Yes

Keywords

Celsis AKuScreen™ Advance™
Performance
Rapid microbiological method
Sterility test

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10.1007/s12247-018-9344-y

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Bugno, A., Almodovar, A. A. B., Saes, D. P. S., Awasthi, R., Ghisleni, D. D. M., de Souza Braga, M., de Oliveira, W. A., Dua, K., & de Jesus Andreoli Pinto, T. (2019). Evaluation of an Amplified ATP Bioluminescence Method for Rapid Sterility Testing of Large Volume Parenteral. Journal of Pharmaceutical Innovation, 14(2), 152-158. https://doi.org/10.1007/s12247-018-9344-y

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abstract = "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{\texttrademark} Advance{\texttrademark} 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{\texttrademark} Advance{\texttrademark} 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{\texttrademark} Advance{\texttrademark} 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.",

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author = "Adriana Bugno and Almodovar, \{Adriana Aparecida Buzzo\} and Saes, \{Deborah Pita Sanches\} and Rajendra Awasthi and Ghisleni, \{Daniela Dal Molim\} and \{de Souza Braga\}, Marina and \{de Oliveira\}, \{Wesley Anderson\} and Kamal Dua and \{de Jesus Andreoli Pinto\}, Terezinha",

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AU - Bugno, Adriana

AU - Almodovar, Adriana Aparecida Buzzo

AU - Saes, Deborah Pita Sanches

AU - Awasthi, Rajendra

AU - Ghisleni, Daniela Dal Molim

AU - de Souza Braga, Marina

AU - de Oliveira, Wesley Anderson

AU - Dua, Kamal

AU - de Jesus Andreoli Pinto, Terezinha

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AB - 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.

KW - Celsis AKuScreen™ Advance™

KW - Performance

KW - Rapid microbiological method

KW - Sterility test

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

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Keywords

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