直接压缩连续制造设备的清洁,通过辅助剂来取代API残留物
Dhavalkumar S Patel1, Rafael Méndez2, Rodolfo J Romañach1
1Department of Chemistry, University of Puerto Rico at Mayagüez, Puerto Rico.
International journal of pharmaceutics
|January 24, 2024
概括
这项研究探讨了使用Prosolv®和Tablettose®等辅助剂来清洁制药设备,避免使用洗剂. 虽然有效去除布洛芬残留物,但仍然需要一些手动清洁.
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.
- 分析化学是一种分析化学.
背景情况:
- 传统的清洗方法往往涉及洗剂,并带来操作者暴露于活性药物成分 (API) 的风险.
- 连续的制造工艺需要高效和安全的清洁协议,以保持产品质量和操作员安全.
- 开发无洗剂的清洁方法对于可持续的制药生产至关重要.
研究的目的:
- 评估连续制造设备的无洗剂清洁工艺的可行性.
- 评估辅助剂 (Prosolv®和Tablettose® 70) 在去除活性药物成分 (API) 残留物的疗效.
- 调查使用过程分析技术 (PAT) 来监控清洗过程.
主要方法:
- 实施了使用Prosolv®和Tablettose® 70的清洁过程,以取代ibuprofen残留物.
- 分析了清洁辅助剂不同体积料速率的影响.
- 在线近红外 (NIR) 光谱和现场拉曼光谱用于监测API移位和残留检测.
- 主要组件分析 (PCA) 用于评估设备内的清洁进展.
主要成果:
- Prosolv®和Tablettose®证明有效地从各种设备部件中去除布洛芬残留物,包括排水器,料螺丝,混合器,轴和流量采样器.
- 过程分析技术 (PAT) 系统在清洗过程中成功检测到API的位移.
- 手动清洁和设备拆卸是必要的,以解决靠近旋转料螺丝和混合机的表面粘附的残留物.
结论:
- 以助剂为基础的清洁是一种可行的无洗剂方法,用于从特定制药制造设备组件中去除API残留物.
- 在线分析技术,如NIR和拉曼光谱,对清洁过程的实时监控非常有效.
- 需要进一步优化,以应对与去除复杂几何形状中的附着残留物相关的挑战,可能需要修改清洁策略或设备设计.
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