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-Reference-Cited by-同舟云学术

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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

Published:2022-07 Issue:7 Volume:111 Page:2038-2048
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Mehta Shyam B.^ORCID,Cook Joseph,Liu Wei,Brisbane Charlene

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference30 articles.

1. A rational approach to determining the maximum allowable gas bubble inside a pre-filled syringe to minimize stopper movement and protect product sterility;Kinney;Drug Deliv Technol,2009

2. International conference on Harmonization Q8(R2) Pharmaceutical Development,2022

3. Design of experiments (DoE) in pharmaceutical development;S;Drug Dev Ind Pharm,2017

4. Quality by design for biopharmaceuticals;Rathore;Nat Biotechnol,2009

5. Jerkins J. Integration of QbD risk assessment tools and overall risk management;Kelley;Biologicals,2016

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Industry perspective on a holistic container closure integrity approach to parenteral combination products;European Journal of Pharmaceutics and Biopharmaceutics;2024-01

2. Container Closure Integrity of a Glass Prefillable Syringe in Deep Frozen Storage Conditions;Journal of Pharmaceutical Sciences;2023-12

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