中国药物评价2024，Vol.41Issue(2)：128-131,4.
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
吴斌 1陈耀娣 1陈俊 1罗秀媚1
作者信息
- 1. 润尔眼科药物(广州)有限公司,广东广州 510530
- 折叠
摘要
Abstract
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 af-ter sampling using cotton swab wiping method.关键词
微生物限度检查/擦拭法/回收率Key words
Microbial limit tests/Wipe/Rate of recovery分类
药学引用本文复制引用
吴斌,陈耀娣,陈俊,罗秀媚..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[J].中国药物评价,2024,41(2):128-131,4.
