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Risk Mitigation of Plunger-Stopper Displacement Under Low Atmospheric Pressure by Establishing Design Space for Filling-Stoppering Process of Prefilled Syringes: A Design of Experiment (DoE) Approach
- Source :
- Journal of Pharmaceutical Sciences. 111:2038-2048
- Publication Year :
- 2022
- Publisher :
- Elsevier BV, 2022.
-
Abstract
- There is a concern that low atmospheric pressure typically encountered during shipment could result in plunger-stopper displacement in prefilled syringes impacting sterility and container closure integrity (CCI) of drug product.
- Subjects :
- Vacuum
Infertility
Syringes
Humans
Pharmaceutical Science
Glass
Drug Packaging
Subjects
Details
- ISSN :
- 00223549
- Volume :
- 111
- Database :
- OpenAIRE
- Journal :
- Journal of Pharmaceutical Sciences
- Accession number :
- edsair.doi.dedup.....e8c62e0af26c1e68925e78d0c278d69e