浅谈非无菌制剂设备清洁SOP的编制

Simple Discussing the Preparation of The Cleaning SOP for Non-sterile Formulation Equipment

目的探讨非无菌制剂制药设备清洁标准操作规程(SOP)的制定,从程序设计上保证设备清洁后的残留物达到可接受标准,最大限度地保证消费者的用药安全。方法从《药品生产质量管理规范》(2010版)的基本要求入手,对污染物、清洁剂、消毒剂、清洁方法、产品分组进行了分类探讨,结合实例做简要介绍。结果与结论非无菌制剂设备清洁SOP应根据物料的特点、设备的特点分别制定,使其具有较强的可操作性、重现性、科学性、合理性。清洁人员必须严格按照批准的清洁SOP操作,防止人为因素导致的差错事故,从而保证清洁效果,保证药品质量。

Objective Dicussion of the preparation of The cleaning SOP for non-sterile formulation equipment to ensure that equipment residues after cleaning achieve acceptable standard at the level of program design in order to guarantee the consumer safety to the maximum. Methods Beginning with the basic requirements from （（ GMP ）） （ 2010 Edition）, we classified and discussed the pollution, cleaning agents, disinfectants, cleaning methods and product groups. We also used examples to give a brief introduction. Results and Conclusion The cleaning SOP for non-sterile formulation equipment should be drafted according to the characteristics of the material and equipment, to ensure the stronger maneuverability, reproducibility, scientificity and rationality. Cleaning personnel must follow strictly the approved cleaning SOP to exclude the accidents due to human factors to ensure the cleaning effect and the drug quality.