摘要
药品在生产过程中与原粉直接接触的生产设备会留下残留,设备的清洁方法用于防止出现能够对下一次生产产品的安全性和质量带来不利影响的污染。设备清洁验证是采用试验检测手段证明设备的清洁操作规程的合理性、科学有效性。介绍了口服固体制剂设备的清洁操作规程、清洁验证方案思路,阐述了清洁方法的确定验证方案的编写原则,提出在设备清洁验证结束后,应按验证方案中规定的清洗方法定期对清洗方法进行监控,以保证日常生产中清洁操作规程的有效性,该设备清洁验证法为口服生产设备的清洁方法及验证思路提供参考。
In the drug production process, production equipments will leave residue after the direct contact of drugs and raw powder, equipment cleaning method is used to prevent the pollution that will effect the safety and quality of the next production products. Equipment cleaning validation is used to prove the rationality and scientific validity of the cleaning operation procedures by detection means. Cleaning operation procedures and cleaning validation plan of oral solid preparation equipments were introduced, the compiling principles of the determination plan of the cleaning method were expounded. At the end of the equipment cleaning validation, according to the cleaning method which specified in the validation plan, the cleaning method at regular intervals should be monitored so as to ensure the effectiveness of the cleaning operation procedures in daily production. This equipment cleaning validation method provides a reference for the cleaning method and verification method of the oral preparation equipment production.
出处
《煤炭与化工》
CAS
2016年第2期152-153,160,共3页
Coal and Chemical Industry
关键词
口服固体制剂
残留
设备
清洁验证
oral solid preparation
residual
equipment
cleaning validation
作者简介
赵春妹（1984-），女，河北昌黎人，助理工程师。E—mail：563568066@qq．com
