粉针剂无菌分装模拟验证  

Simulated Validation about the Powder Medicine of Injection Sterilized Shipment

作　　者：贾宝艳[1] 赵颖[1] 姜丽红[1] 

机构地区：[1]哈药集团制药总厂,150086

出　　处：《黑龙江医药》2007年第3期240-241,共2页Heilongjiang Medicine journal

摘　　要：目的:为确保粉针无菌分装生产整个过程对产品不产生污染,保证粉针生产药品质量,我们采取一系列验证试验。方法:我们采取无菌分装模拟验证,而且每年做一次。结果:通过此次验证,观察14天乳糖培养情况,我们可知试验乳糖合格率达到100%,染菌率0%。结论:此次验证对乳糖没有造成污染,保证了无菌分装,为粉针剂无菌分装提供了可靠的数据。Objective： In order to avoid contamination and ensure quality. Methods： We take a set of validation experi- ments in sterilization - room every year during the powder medicine of injection producing. Results： Through observing the lactose cultivation for 14 days ,we know the rate of quanlifed experiment lactose is 100% ,the rate of contaminated experiment lactose is 0%, Conclusion： The lactose is uncontaminated. The experiments ensure sterilized shipment and is reliable.

关 键 词：粉针剂 无菌分装 模拟验证 

分 类 号：TQ460.69[化学工程—制药化工]