一种通过设计的质量 (QbD) 方法来验证微生物保留:海报在2025年PDA周发布
Annie Leahy1, Jennifer Juneau2, Corinne Miller3
1Process Solutions, MilliporeSigma, Burlington, MA, USA; and annie.leahy@milliporesigma.com.
PDA journal of pharmaceutical science and technology
|August 1, 2025
概括
设计质量 (QbD) 可以消除对消毒过器的产品特定微生物保留测试的需要,特别是对于早期产品. 这种方法通过分析过程和产品参数如何影响微生物保留来简化测试.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 过技术过技术的使用
- 微生物学 微生物学
背景情况:
- 消毒过器需要根据监管标准对产品进行特定的微生物保留测试.
- 早期的产品往往缺乏足够的材料来进行高效的测试.
- 当前的测试方法可能是资源密集的.
研究的目的:
- 实施设计质量 (QbD) 方法用于微生物保留测试.
- 建立一种模式,消除对特定产品进行测试的需求.
- 评估工艺和产品参数对过器性能的影响.
主要方法:
- 不同的关键过程参数 (如压力,流速).
- 调整了产品的关键特性 (如粘度,pH).
- 在不同条件下评估微生物保留效率.
主要成果:
- 确定了影响微生物保留的关键参数.
- 证明QbD原理可以预测不同条件下的过器性能.
- 建立了一个数据驱动的方法来验证过器的有效性,而不需要产品特定的测试.
结论:
- 一个QbD方法是可行的验证消毒过器微生物保留.
- 这种方法减少了早期开发阶段产品特定测试的负担.
- 优化的流程和产品参数提高了过器的可靠性和监管合规性.
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