Evaluation of ATP-Bioluminescence Detection as a Supportive Technology for Bioburden and Sterility Testing Processes

Madaisabel Arias; Ashley Osuna-Najarro; Scott Lute; Reyes Candau-Chaucon; Erika Pfeiler; Sarah Johnson; Talia Faison

doi:10.5731/pdajpst.2024.99905

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Evaluation of ATP-Bioluminescence Detection as a Supportive Technology for Bioburden and Sterility Testing Processes

Madaisabel Arias, Ashley Osuna-Najarro, Scott Lute, Reyes Candau-Chaucon, Erika Pfeiler, Sarah Johnson and Talia Faison

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 759-760; DOI: https://doi.org/10.5731/pdajpst.2024.99905

Madaisabel Arias

1CDER/OPQ/Office of Pharmaceutical Quality and Research-DPQRVI, Silver Spring, MD;

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For correspondence: madaisabel.fuentesarias@fda.hhs.gov

Ashley Osuna-Najarro

1CDER/OPQ/Office of Pharmaceutical Quality and Research-DPQRVI, Silver Spring, MD;

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Scott Lute

1CDER/OPQ/Office of Pharmaceutical Quality and Research-DPQRVI, Silver Spring, MD;

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Reyes Candau-Chaucon

2CDER/OPQ/Office of Pharmaceutical Manufacturing Assessment, Silver Spring, MD; and

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Erika Pfeiler

2CDER/OPQ/Office of Pharmaceutical Manufacturing Assessment, Silver Spring, MD; and

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Sarah Johnson

3OPQ/Office of Product Quality Assessment III, Silver Spring, MD

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Talia Faison

1CDER/OPQ/Office of Pharmaceutical Quality and Research-DPQRVI, Silver Spring, MD;

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vol. 78 no. 6 759-760

DOI

https://doi.org/10.5731/pdajpst.2024.99905

PubMed

39725486

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online December 26, 2024.

Author Information

Madaisabel Arias^1,*,
Ashley Osuna-Najarro¹,
Scott Lute¹,
Reyes Candau-Chaucon²,
Erika Pfeiler²,
Sarah Johnson³ and
Talia Faison¹

¹CDER/OPQ/Office of Pharmaceutical Quality and Research-DPQRVI, Silver Spring, MD;
²CDER/OPQ/Office of Pharmaceutical Manufacturing Assessment, Silver Spring, MD; and
³OPQ/Office of Product Quality Assessment III, Silver Spring, MD

↵* Corresponding Author: Madaisabel Arias, 10903 New Hampshire Avenue Silver Spring, MD 20993. E-mail: madaisabel.fuentesarias{at}fda.hhs.gov

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Evaluation of ATP-Bioluminescence Detection as a Supportive Technology for Bioburden and Sterility Testing Processes

Madaisabel Arias, Ashley Osuna-Najarro, Scott Lute, Reyes Candau-Chaucon, Erika Pfeiler, Sarah Johnson, Talia Faison

PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 759-760; DOI: 10.5731/pdajpst.2024.99905

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Evaluation of ATP-Bioluminescence Detection as a Supportive Technology for Bioburden and Sterility Testing Processes

Madaisabel Arias, Ashley Osuna-Najarro, Scott Lute, Reyes Candau-Chaucon, Erika Pfeiler, Sarah Johnson, Talia Faison

PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 759-760; DOI: 10.5731/pdajpst.2024.99905

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