A Holistic Approach for Fill volume Variability Evaluation and Control with Statistical Tool

Mingyang Hei; Qingqing She; Quanmin Chen; Zhaowei Jin; Chunmeng Sun; Jiasheng Tu; Jeremy Guo

doi:10.5731/pdajpst.2023.012867

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A Holistic Approach for Fill volume Variability Evaluation and Control with Statistical Tool

Mingyang Hei, Qingqing She, Quanmin Chen, Zhaowei Jin, Chunmeng Sun, Jiasheng Tu and Jeremy Guo

PDA Journal of Pharmaceutical Science and Technology June 2024, pdajpst.2023.012867; DOI: https://doi.org/10.5731/pdajpst.2023.012867

Mingyang Hei

1 Drug Product Development Department, WuXi Biologics;

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For correspondence: hei_mingyang@wuxibiologics.com

Qingqing She

2 Drug Product Development Department, WuXi Biologics; State Key Laboratory of Natural Medicines, NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, and Department of Pharmaceutics, School of Pharmacy, China Pharm;

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For correspondence: she_qingqing@wuxibiologics.com

Quanmin Chen

1 Drug Product Development Department, WuXi Biologics;

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For correspondence: chen_quanmin@wuxibiologics.com

Zhaowei Jin

1 Drug Product Development Department, WuXi Biologics;

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For correspondence: jin_zhaowei@wuxibiologics.com

Chunmeng Sun

3 State Key Laboratory of Natural Medicines, NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, and Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University

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For correspondence: suncmpharm@cpu.edu.cn

Jiasheng Tu

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For correspondence: jiashengtu@cpu.edu.cn

Jeremy Guo

1 Drug Product Development Department, WuXi Biologics;

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For correspondence: jeremy_guo@wuxibiologics.com

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 2

March/April 2025

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A Holistic Approach for Fill volume Variability Evaluation and Control with Statistical Tool

Mingyang Hei, Qingqing She, Quanmin Chen, Zhaowei Jin, Chunmeng Sun, Jiasheng Tu, Jeremy Guo

PDA Journal of Pharmaceutical Science and Technology Jun 2024, pdajpst.2023.012867; DOI: 10.5731/pdajpst.2023.012867

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A Holistic Approach for Fill volume Variability Evaluation and Control with Statistical Tool

Mingyang Hei, Qingqing She, Quanmin Chen, Zhaowei Jin, Chunmeng Sun, Jiasheng Tu, Jeremy Guo

PDA Journal of Pharmaceutical Science and Technology Jun 2024, pdajpst.2023.012867; DOI: 10.5731/pdajpst.2023.012867

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Keywords

Peristaltic pump
fill volume variability
Filling accuracy
Filling accuracy optimization
high concentration filling

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Parenteral Drug Association, Inc.