Collection and Analysis of Bioburden Information in Pharmaceutical Clean Room
- VernacularTitle:药品洁净室生物负载信息的采集与分析
- Author:
Weisheng CHEN
;
Rongfeng ZHU
;
Qianming GUAN
- Publication Type:Journal Article
- Keywords:
Bioburden;
Clean room;
Risk assessment;
Microorganism identification
- From:
China Pharmacist
2015;(6):1046-1048
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To collect the bioburden information in clean room to understand the bioburden status, find out weak points and risks in microbial control and improve the management efficiency in clean room. Methods: According to GB/T 16293-2010 and the standard operation practice ( SOP) in our lab, the bioburden information was obtained by the collection and identification of air-borne microbe and surface bacteria in the four main areas of clean room ( microbial limit test room, sterile room 1 and 2, positive room) and on the person entered clean room. Results:The preliminarily established bioburden information indicated that the main mi-croorganism in clean room was Micrococcus and Staphylococcus. The detection rate of fungi was about 5% in clean room. Conclusion:The movement of people and goods in clean room should be strengthened, and samples should be with thorough disinfection.
