PDA TR22（中英文）-2011 无菌工艺模拟.pdf

1 Technical Report No. 22 (Revised 2011) 2 Technical Report No. 22 (Revised 2011) Table of contents 目录 1.0 Introduction 简介 1.1 Scope 范围 1.2 Previous PDA Publications 先前的PDA 出版物 1.3 reason for revision 再版的理由 1.4 purpose 目的 2.0 Glossary of terms 术语表 3.0 process simulation concepts and principles 工艺模拟的概念和原理 3.1 number and frequency of simulations 模拟的次数和频率 3.2 worse case 最差条件 3.3 risk assessment 风险评估 3.4 ongoing evaluation 持续评估 4.0 process simulation for sterile dosage forms 无菌制剂的工艺模拟 4.1 aseptic compounding activities 无菌混合 4.2 solutions 液体 4.3 lyophilized products 冻干产品 4.3.1 simulated load/unload with shortened hold time 模拟进/ 出箱的最短保留时间 4.3.2 simulated lyophilization 模拟冻干 4.3.3 special considerations unique to the production of lyophilized products 冻干产品特殊考虑的事项 freezing of media 培养基的冷冻 3 Technical Report No. 22 (Revised 2011) vacuum levels and duration 真空度和持续时间 anaerobic conditions 厌氧条件 4.4 suspensions 混悬剂 4.5 ointments/creams/emulsions/gels 软膏/乳膏/乳剂/凝胶 4.6 powder 粉针剂 4.6.1 liquid medium filled by the powder filling equipment 使用固体灌装设备进行液体培养基的灌装 4.6.2 dry powder filler with supplementary liquid fill capability 增加液体灌装能力的干粉灌装机 4.6.3 on-line liquid fill followed by on-line powder fill 在线的液体灌装然后在线的粉末灌装 4.6.4 on-line powder fill followed by on-line media fill 在线的粉末灌装然后进行在线的液体灌装 4.6.5 special considerations unique to the simulation of aseptic filling of sterile powder