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洁净室微生物群落综述:类型、趋势和模式。

A review of cleanroom microflora: types, trends, and patterns.

作者信息

Sandle Tim

机构信息

Pharmaceutical Microbiology Interest Group, U.K.

出版信息

PDA J Pharm Sci Technol. 2011 Jul-Aug;65(4):392-403. doi: 10.5731/pdajpst.2011.00765.

Abstract

UNLABELLED

Cleanroom microflora are of importance for microbiologists and quality control personnel in order to assess changes in trends. Shifts in the types of microflora may indicate deviations from the "norm" such as resistant strains or problems with cleaning practices. Given the few published studies of the typical microflora, this paper uniquely reviews over 9000 microbial isolates from a range of different grades of cleanroom. The paper concludes that the typical flora are primarily those associated with human skin (Gram-positive cocci), although microorganisms from other sources such as the environment (Gram-positive rods) and water (Gram-negative rods) are also detected, although in lower numbers.

LAY ABSTRACT

It is of importance that pharmaceutical manufacturers and healthcare pharmacies review the types and numbers of microorganisms found within their clean areas. Such examination should be carried out over a long period of time so that the complete picture can be revealed. This is important in order to understand if certain species are being recovered pose a product or environmental risk and to check if the cleaning and sanitization practices are effective.

摘要

非标签说明

洁净室微生物群落对于微生物学家和质量控制人员评估趋势变化具有重要意义。微生物群落类型的转变可能表明偏离了“正常”情况,例如耐药菌株或清洁操作存在问题。鉴于已发表的关于典型微生物群落的研究较少,本文独特地回顾了来自一系列不同等级洁净室的9000多个微生物分离株。本文得出结论,典型菌群主要是那些与人类皮肤相关的菌群(革兰氏阳性球菌),尽管也检测到了来自其他来源的微生物,如环境中的(革兰氏阳性杆菌)和水中的(革兰氏阴性杆菌),但数量较少。

摘要

制药制造商和医疗保健药房审查其洁净区域内发现的微生物类型和数量非常重要。这种检查应该在很长一段时间内进行,以便能够揭示全貌。这对于了解回收的某些物种是否构成产品或环境风险以及检查清洁和消毒措施是否有效很重要。

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