Part
1
1.1
实验设备
图1 振动驱动粉末灌装系统示意图
1.2
实验材料
表1 吸入级乳糖样品物性
1.3
样品制备与处理
1.4
灌装剂量分析
Part
2
2.1
流量控制机理
2.2
灌装剂量均一性
图2 累加剂量与下料时间的关系
图3 Lactohale®100 单剂剂量分布
表2 不同样品目标剂量为5.5 mg的灌装结果
图4 气泡和阻塞现象对Respitose®ML003 单剂剂量分布的影响
2.3
振动电压对粉体平均灌装剂量的影响
2.4
振动时间对粉体平均灌装剂量的影响
Part
3
参考文献
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撰稿人 | 刘环、陈岚、李宗齐、陈东浩 上海理工大学学报
责任编辑 | 胡静
审核人 | 何发
2024-07-16
2024-06-20
2024-06-24
2024-06-27
2024-07-13
2024-06-27
2024-06-12
随着敏捷开发和 AI 技术逐渐融入制药行业的合规管理,软件系统的定制化要求越来越高。本文主要从法规指南角度分析和评价定制软件验证的有效性。指导制药行业通过更加科学的风险管理手段开展验证,以实现系统选项、实施及测试过程的风险管控,保证后续运行阶段的 GXP 符合性。同时也满足《药品生产质量管理规范(2010 年修订)》计算机化系统 [1] 和《药品记录与数据管理要求(试行)》的要求 [2-3]。
作者:赵延武 程静 张文标 王军 张永秉
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