5种洗剂类医疗机构制剂微生物限度检查方法验证

Validation of microbial limit test for 5 kinds of hospital preparation with lotions

目的建立5种洗剂类医疗机构制剂微生物限度检查法。方法细菌、真菌和酵母菌计数方法的验证分别采用平皿法、培养基稀释法和薄膜过滤法;控制菌检查法的验证分别采用直接接种法、培养基稀释法和薄膜过滤法。结果 1种洗剂的细菌、真菌和酵母菌计数可采用培养基稀释法,控制菌检查可采用直接接种法。另4种洗剂的细菌、真菌和酵母菌计数和控制菌检查均需采用薄膜过滤法。结论 5种洗剂类医疗机构制剂微生物限度检查法均通过验证。

Objective To establish a method of microbial limit test for 5 kinds of hospital preparation with lotions.Methods The validation on plate count method,culture medium diluting method and membrane filtration method was conducted in accordance with bacterium count,total combined molds and yeasts count. The validation on routine method,culture medium diluting method and membrane filtration method was conducted in accordance with absence of specified microorganisms. Results The one kind can be tested with culture medium diluting method on bacterium count,total combined molds and yeasts count,and can be tested with routine method on absence of specified microorganisms. The other 4 kinds can be tested with membrane filtration method on bacterium count,total combined molds and yeasts count,and absence of specified microorganisms. Conclusion The validation results of microbial limit tests of 5 kinds of hospital preparation with lotions met the requirement.