Clarifications on the Intended Use of USP &lt;61&gt; Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Edward Charles Tidswell; Radhakrishna S Tirumalai; Deborah D Gross

doi:10.5731/pdajpst.2023.012855

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Clarifications on the Intended Use of USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Edward Charles Tidswell, Radhakrishna S Tirumalai and Deborah D Gross

PDA Journal of Pharmaceutical Science and Technology December 2023, pdajpst.2023.012855; DOI: https://doi.org/10.5731/pdajpst.2023.012855

Edward Charles Tidswell

1 Merck;

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For correspondence: edward.tidswell@merck.com

Radhakrishna S Tirumalai

2 Merck & Co. Inc;

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For correspondence: radhakrishna.tirumalai@merck.com

Deborah D Gross

3 Merck & Co. Inc.

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For correspondence: deborah_gross@merck.com

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pdajpst.2023.012855

DOI

https://doi.org/10.5731/pdajpst.2023.012855

PubMed

38942475

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received April 10, 2023
Accepted November 22, 2023
Published online December 19, 2023.

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Edward Charles Tidswell1,4 (edward.tidswell{at}merck.com),
Radhakrishna S Tirumalai2 (radhakrishna.tirumalai{at}merck.com) and
Deborah D Gross3 (deborah_gross{at}merck.com)

¹ Merck;
² Merck & Co. Inc;
³ Merck & Co. Inc.

↵* Corresponding author; email: edward.tidswell{at}merck.com

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Clarifications on the Intended Use of USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Edward Charles Tidswell, Radhakrishna S Tirumalai, Deborah D Gross

PDA Journal of Pharmaceutical Science and Technology Dec 2023, pdajpst.2023.012855; DOI: 10.5731/pdajpst.2023.012855

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Clarifications on the Intended Use of USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Edward Charles Tidswell, Radhakrishna S Tirumalai, Deborah D Gross

PDA Journal of Pharmaceutical Science and Technology Dec 2023, pdajpst.2023.012855; DOI: 10.5731/pdajpst.2023.012855

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Keywords

bioburden
Compendia
Microbial enumeration
Microbiological test methods
Non-sterile products
United States Pharmacopoeia

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