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

Edward C. 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 C. Tidswell, Radhakrishna S. Tirumalai and Deborah D. Gross

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 348-357; DOI: https://doi.org/10.5731/pdajpst.2023.012855

Edward C. Tidswell

1Quality Assurance, Merck & Co., Inc., West Point, PA 19486; and

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For correspondence: edward.tidswell@merck.com

Radhakrishna S. Tirumalai

2Analytical R&D, Merck & Co., Inc., West Point, PA 19486

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Deborah D. Gross

2Analytical R&D, Merck & Co., Inc., West Point, PA 19486

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vol. 78 no. 3 348-357

DOI

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

PubMed

38942475

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Parenteral Drug Association (PDA)

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1079-7440

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1948-2124

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Published online June 28, 2024.

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previous version (December 19, 2023 - 03:26).
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Edward C. Tidswell^1,*,
Radhakrishna S. Tirumalai² and
Deborah D. Gross²

¹Quality Assurance, Merck & Co., Inc., West Point, PA 19486; and
²Analytical R&D, Merck & Co., Inc., West Point, PA 19486

↵* Corresponding Author: Merck & Co., Inc.; West Point, PA 19486; E-mail: 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 C. Tidswell, Radhakrishna S. Tirumalai, Deborah D. Gross

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 348-357; 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 C. Tidswell, Radhakrishna S. Tirumalai, Deborah D. Gross

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 348-357; DOI: 10.5731/pdajpst.2023.012855

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Keywords

Compendia
United States Pharmacopeia
Microbiological test methods
Microbial enumeration
Nonsterile products
USP <61>
Bioburden

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