Kruse R H, Puckett W H, Richardson J H
MEDI, Inc., Lexington, Kentucky 40576-1486.
Clin Microbiol Rev. 1991 Apr;4(2):207-41. doi: 10.1128/CMR.4.2.207.
The biological safety cabinet is the one piece of laboratory and pharmacy equipment that provides protection for personnel, the product, and the environment. Through the history of laboratory-acquired infections from the earliest published case to the emergence of hepatitis B and AIDS, the need for health care worker protection is described. A brief description with design, construction, function, and production capabilities is provided for class I and class III safety cabinets. The development of the high-efficiency particulate air filter provided the impetus for clean room technology, from which evolved the class II laminar flow biological safety cabinet. The clean room concept was advanced when the horizontal airflow clean bench was manufactured; it became popular in pharmacies for preparing intravenous solutions because the product was protected. However, as with infectious microorganisms and laboratory workers, individual sensitization to antibiotics and the advent of hazardous antineoplastic agents changed the thinking of pharmacists and nurses, and they began to use the class II safety cabinet to prevent adverse personnel reactions to the drugs. How the class II safety cabinet became the mainstay in laboratories and pharmacies is described, and insight is provided into the formulation of National Sanitation Foundation standard number 49 and its revisions. The working operations of a class II cabinet are described, as are the variations of the four types with regard to design, function, air velocity profiles, and the use of toxins. The main certification procedures are explained, with examples of improper or incorrect certifications. The required levels of containment for microorganisms are given. Instructions for decontaminating the class II biological safety cabinet of infectious agents are provided; unfortunately, there is no method for decontaminating the cabinet of antineoplastic agents.
生物安全柜是实验室和药房中唯一一种能为人员、产品和环境提供保护的设备。从最早公布的实验室感染病例到乙肝和艾滋病的出现,阐述了医护人员防护的必要性。对I级和III级安全柜的设计、构造、功能及生产能力进行了简要描述。高效空气微粒过滤器的发展推动了洁净室技术的进步,在此基础上演变出了II级层流生物安全柜。水平气流洁净工作台的制造推动了洁净室概念的发展;它在药房中因能保护产品而在静脉输液配制中流行起来。然而,如同感染性微生物和实验室工作人员一样,个体对抗生素的敏感性以及危险抗肿瘤药物的出现改变了药剂师和护士的观念,他们开始使用II级安全柜来防止人员对药物产生不良反应。描述了II级安全柜如何成为实验室和药房的主流设备,并深入探讨了美国国家卫生基金会标准第49号及其修订版的制定过程。介绍了II级安全柜的工作操作,以及四种类型在设计、功能、风速分布和毒素使用方面的差异。解释了主要的认证程序,并列举了不当或错误认证的例子。给出了微生物所需的防护级别。提供了对II级生物安全柜进行感染性因子去污的说明;遗憾的是,没有对抗肿瘤药物进行去污的方法。