注射剂灭菌器验证探讨  

Approach in Validation on Sterilizer of Injection

作　　者：黄新兰[1] 何建荣[1] 张丽君[1] 陈琴华[1] 季红兰[1] 

机构地区：[1]扬子江药业集团,泰州225321

出　　处：《中国药事》2010年第9期906-907,共2页Chinese Pharmaceutical Affairs

摘　　要：目的探讨大容量注射剂、小容量注射剂产品灭菌器温度、时间等指标验证的标准。方法比较标准,发现其中差别。结果与结论灭菌器的验证标准应结合灭菌程序确定。Objective To approach index such as temperature and time of sterilizer of large volume for injection and small volume for injection,and validate on qualified standard. Methods Compare with the standard to find the difference. Results and Conclusion Standard of validation on sterilizer should be determined combined with sterilize process.

关 键 词：灭菌器 验证 标准 

分 类 号：R954.2[医药卫生—药学]