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Updated: Jun 22, 2025

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Design and Optimization Strategies of a High-Performance Vented Box
Published on: June 9, 2023
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用统计工具填充体积变量评估和控制的整体方法
Mingyang Hei1, Qingqing She1,2, Quanmin Chen1
1Technology Transfer Center of Excellence, Drug Product Development Department, WuXi Biologics, 299 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, 200131; and.
PDA journal of pharmaceutical science and technology
|June 28, 2024
概括
这项研究量化了影响生物制药制造业周围填充变量的因素. 像粘度和设置这样的关键参数显著影响填充精度,从而实现了优化过程控制.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 工艺工程是过程工程.
- 生物技术是生物技术.
背景情况:
- 环静脉对于生物制药生产中的瓶子和注射器填充至关重要.
- 控制填充量变化对于药物产品的安全性,有效性和一致性至关重要.
- 对影响填充变化的因素的定量理解是有限的.
研究的目的:
- 用准确性,能力和精度标准来评估周围静止填充性能.
- 调查液体特性和参数对填充体积变化的影响.
- 开发一个用于优化和控制填充量变化的预测模型.
主要方法:
- 使用了带有环静电和高精度平衡的长椅系统.
- 使用相对误差平均值,Cpk ≥1.33,相对标准偏差和相对移动范围平均值来评估填充性能.
- 采用最终选设计来分析因素相互作用和影响.
主要成果:
- 粘度,目标体积,管道尺寸,转速,加速度/减速和吸回显著影响了填充的可变性.
- 确定了影响填充体积一致性的关键因素及其相互作用.
- 开发并验证了流程优化的预测模型.
结论:
- 建立了一种逐步的方法来优化和控制环静止填充量变化.
- 模型适用于粘度为1-23 cP,体积为0.2-2.0 mL的药物溶液.
- 为增强无菌填充工艺提供了定量框架.
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