药品生产设备表面微生物取样及微生物限度检查的方法研究

Establishment of a Method for Microbial Swab Wiping and Recovery Rate Confirmation on the Surface of Pharmaceutical Production Equipment

目的:建立一个可重现的设备表面微生物取样方法,为药品生产设备清洁验证过程中的微生物取样及限度检查提供依据。方法:由不同人员对不锈钢材质使用棉签模拟擦拭,分别进行3次独立试验,并与对比样品值相对照。结果:棉签擦拭取样回收率及微生物限度检查方法试验组与阳性对照组比值均在0.5~2之间,表明棉签擦拭法取样法适用于设备表面的微生物取样,有利于开展微生物限度检查。

Objective:Establish a reproducible method for surface microbial sampling of equipment,providing reference for surface microbial sampling methods in the cleaning and validation process of pharmaceutical production equipment.Methods:Three independent tests were conducted by different personnel using cotton swabs to simulate wiping of stainless steel materials,and compared with the values of the comparative samples.Results:The recovery rate of cotton swab wiping sampling and the applicability of microbial limit inspection method were tested.The ratio of the experimental group to the positive control group was between 0.5 and 2,indicating that this sampling method is suitable for daily surface microbial sampling.This inspection method is suitable for microbial limit inspection of cotton swabs after sampling using cotton swab wiping method.