基于重量计的技术辅助工作流程系统,用于注射抗癌药物化合物:设计和合格的原始权衡在一个隔离器内
Mélanie Brun1, Julien Fouque2, Hugo Palisson1
1Département de Pharmacie, Institut Curie, PSL Research University, Paris, France.
概括
针对可注射抗癌药物化合物的新称量表 (WS) 显示出高准确性和可靠性. 这项技术在制药生产中确保了精确的重力计控制 (GC),提高了患者的安全性.
科学领域:
- 制药技术 制药技术 制药技术
- 分析化学 分析化学
- 医疗器械验证 医疗器械验证
背景情况:
- 技术辅助制造,包括计算机辅助重量计控制 (CAGC),对于合成注射抗癌药物 (AD) 至关重要.
- 精确的过程中重力测量控制 (GC) 对于确保正确的剂量和可注射AD的有效性至关重要.
研究的目的:
- 为了验证一个创新的称量表 (WS) 设计用于在隔离器内注射AD化合物的工艺GC.
- 与标准模型相比,评估Cyto-TopControl® WS的性能和可靠性.
主要方法:
- 使用重量从1到2000g的Cyto-TopControl® WS的操作和性能合格.
- 使用Bland-Altman图表的新WS与Cytocontrol® WS的比较.
- 使用CAGC和新的WS.使用四种不同的抗癌药物的60个输液袋的复合.
- 分析控制 (AC) 用于验证GC结果.
主要成果:
- Cyto-TopControl® WS满足了所有性能标准,包括保真性,准确性,线性和精度,偏差低于既定限制.
- 来自Cyto-TopControl® WS的测量结果与标准的Cytocontrol® WS一致.
- 重力测量控制 (GC) 在复合药物制剂中达到0.19%的准确性.
结论:
- 创新的Cyto-TopControl®权衡表可靠用于注射抗癌药物合成过程中的重力测量控制.
- 这种经过验证的技术提高了用于癌症治疗的药物制造的准确性和安全性.
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