在医院药房中对肠外产品进行视觉检查方法的比较:在可靠性,成本和操作员培训考虑之间
Alexandre Jambon1, Marie Forat1, Chloé Marchand1
1Service Pharmaceutique, Plateforme FRIPHARM, Groupement Hospitalier Centre, Hôpital Edouard Herriot, Place d'Arsonval, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France.
概括
手动和半自动视觉检查方法有效检测无菌制药制剂 (P2S) 中的可见颗粒,性能优于自动化方法. 这些发现对于确保医院生产中的P2S质量和安全至关重要.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 质量控制 质量控制 质量控制
背景情况:
- 由于COVID-19大流行,医院需要生产无菌药物制剂 (P2S),以应对药物短缺问题.
- 视觉检查是P2S的关键释放控制,目前的方法需要广泛的人员培训.
- 现有的药典视觉检查方法 (例如,欧洲药典2.9.20,美国药典1790) 是非自动化的.
研究的目的:
- 为了比较手动视觉检查 (MVI),半自动视觉检查 (SAVI) 和自动视觉检查 (AVI) 的可靠性和速度,用于检测P2S中的可见粒子.
- 评估这些方法在预生产和生产阶段识别颗粒污染源的有效性.
主要方法:
- 三名药房技术人员对41个无菌药物制剂瓶进行了视觉检查.
- 使用的方法包括手动视觉检查 (MVI),半自动视觉检查 (SAVI) 和自动视觉检查 (AVI).
- 瓶子含有各种污染物 (玻璃颗粒,塞片,织纤维) 或是在不同的生产前条件下制备的 (ISO 8 和 ISO 9).
主要成果:
- 手动视觉检查 (MVI) 和半自动视觉检查 (SAVI) 实现了100%的可见颗粒检测,包括织纤维.
- 自动视觉检查 (AVI) 仅检测到28%的可见颗粒,并且在识别织纤维方面存在缺陷.
- 所有方法都正确地识别了没有可见颗粒的瓶子,但MVI和SAVI对在ISO 8条件下制备的瓶子比AVI更令人满意.
结论:
- 手动视觉检查 (MVI) 和半自动视觉检查 (SAVI) 在检测P2S中的可见颗粒方面比自动视觉检查 (AVI) 更有效和可靠.
- 在成本,培训和实施方面,MVI和SAVI提供了更具竞争力的投资.
- 这些发现强调了敏感和可靠的视觉检查方法的重要性,以确保医院生产的无菌药物制剂的质量和安全.
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