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- Published online June 1, 2022.
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- previous version (September 16, 2021 - 08:01).
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© PDA, Inc. 2022
Author Information
- 1Merck, West Point, PA 19486;
- 2Agalloco & Associates Inc., PO Box 899, Belle Mead, NJ 08502-0899; and
- 3U.S. Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-1790
- ↵*Corresponding Author: Merck & Co., West Point, PA 18486 Telephone (224) 931-9059, E-mail: edward.tidswell{at}merck.com.
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- Article
- Abstract
- Introduction
- Sterility Assurance—Current State
- Current US Legislation Governing Sterility and Sterility Testing
- Testing Sterility
- Sterility Assurance—Evolution of a New Perspective
- Sterility Assurance–Future State
- Principles Governing Parametric Release
- 1. Quantification of Assurance of Sterility
- 2. Process Parameters and Critical Process Parameters
- 3. Risk Assessment and Microbial Control Strategy
- Summary
- Conflict of Interest Declaration
- References
- Figures & Data
- References
- Info & Metrics
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