Research ArticleReview
A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
Kelly Waldron, Amanda McFarland, Hal Baseman and Maik Jornitz
PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 88-97; DOI: https://doi.org/10.5731/pdajpst.2024-003038.1
Kelly Waldron
1ValSource Inc, Downingtown, PA; and
Amanda McFarland
1ValSource Inc, Downingtown, PA; and
Hal Baseman
1ValSource Inc, Downingtown, PA; and
Maik Jornitz
2BioProcess Resources LLC, Manorville, NY

References
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- 17.↵Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT). Parenteral Drug Association Inc.: Bethesda, MD, 2020.
- 18.↵International Electrotechnical Commission. IEC 61025:2006 Fault Tree Analysis (FTA). IEC: Geneva, 2006.
- 19.↵Parenteral Drug Association Inc. Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations; Bethesda, MD, 2012.
- 20.↵Committee for Proprietary Medicinal Products. Note for Guidance on Manufacture of the Finished Dosage Form; CPMP/QWP/486/95; EMEA: London, 1996.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
Kelly Waldron, Amanda McFarland, Hal Baseman, Maik Jornitz
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 88-97; DOI: 10.5731/pdajpst.2024-003038.1
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