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  • 微生物检查室和无菌室怎么设置?
    来源:http://www.jnyhrs.com 浏览: 发布日期:2020-12-17
    1、微生物检查室的环境条件
    1. Environmental conditions of microbiological laboratory
    微生物检查室是用来检查非规定灭菌制剂及其原料、辅料受微生物污染程度的场所。微生物检查指物品中允许含规定合格范围内的活的微生物。《中国药典》2010版附录规定微生物检查应在环境洁净度10000级以下,局部洁净度100级的单向层流空气区域内进行。
    Microbial examination room is used to check the microbial contamination of non prescribed sterilization preparations and their raw materials and accessories. Microbiological examination means that the articles are allowed to contain living microorganisms within the specified qualified range. According to the appendix of Chinese Pharmacopoeia (2010 Edition), microbiological examination should be carried out in the unidirectional laminar air area with environmental cleanliness below 10000 and local cleanliness of 100.
    大型设备:冰箱、超净工作台、培养箱、干燥箱、恒温水浴锅、烘箱、纯水机、离心机等
    Large scale equipment: refrigerator, super clean table, incubator, drying oven, constant temperature water bath pot, oven, pure water machine, centrifuge, etc
    小型设备:天平、显微镜、分光光度计、酸度计、电导仪和浊度仪、折光仪、杂质度过滤机等
    Small equipment: balance, microscope, spectrophotometer, acidity meter, conductivity meter, turbidity meter, refractometer, impurity filter, etc
    其他:玻璃器皿、试剂(营养琼脂、牛肉膏蛋白胨、氯化钠、氢氧化钠)等
    Others: Glassware, reagents (nutrient agar, beef extract peptone, sodium chloride, sodium hydroxide), etc
    微生物检查室和无菌室的设置
    Setting of microbiological examination room and aseptic room
    2、无菌检查室的环境条件
    2. Environmental conditions of aseptic examination room
    无菌检查室是用来检查注射剂、用于无菌制剂中的原料、辅料的检验场所。以无菌保证水平(SAL)表述。因此,无菌室的环境十分关键,对样品的检测结果的准确性干扰很大。
    无菌室装修
    Aseptic examination room is used to check injections, raw materials and excipients in sterile preparations. It was expressed as sterility assurance level (SAL). Therefore, the environment of aseptic room is very important, which greatly interferes with the accuracy of sample test results.
    设备:超净工作台、集菌仪
    Equipment: ultra clean working table and bacteria collecting instrument
    3、阳性对照室的环境条件
    3. Environmental conditions of positive control room
    阳性对照室是制备阳性对照菌种及转接种等场所。阳性对照室应为洁净度局部100级的单向层流空气区域内,背景环境洁净度10,000级,室内空气经过滤装置处理后直排室外,一般都在生物安全柜内操作。
    The positive control room is a place to prepare positive control strains and transfer strains. The positive control room should be a unidirectional laminar air area with local cleanliness of 100 grade, and the background environment cleanliness of 10000 level. The indoor air is directly discharged to the outside after being treated by the filter device, and is generally operated in the biological safety cabinet.
    设备:生物安全柜、混合器
    Equipment: biosafety cabinet, mixer
    4 无菌室、微生物限度实验室和阳性对照室的设置管理
    4. Setting and management of aseptic room, microbial limit laboratory and positive control room
    实验室布局设计应避免交叉污染,有利于清洁和日常维护。人和物是洁净区的污染源,实验室要分别设置人流和物流的通道,并有明确的标识。3个实验室要分别设置更衣通道,避免交叉污染,环境的着装要与药品生产相一致,无菌检查试验时的洁净衣都经过高压灭菌。进入的物流要与人流分开,每个实验室要都单独的传递窗传递试验样品和器具,所有样品都要用75%乙醇擦拭消毒,无菌检测所用器具等皆需进过灭菌处理送入无菌检查室;灭菌的效果要进行验证确认,传递窗必须安装紫外灯,并定期对其消毒效果进行确认评价,及时更换紫外灯。
    The layout design of laboratory should avoid cross contamination, which is conducive to cleaning and routine maintenance. People and things are the biggest pollution source in clean area. The laboratory should set up the channel of people flow and logistics respectively, and have clear identification. The three laboratories should set up changing channels to avoid cross contamination. The environmental clothing should be consistent with the drug production. The clean clothes in the sterility test should be sterilized by high pressure. The incoming logistics should be separated from the flow of people. Each laboratory should have a separate transfer window to transfer test samples and instruments. All samples should be wiped and disinfected with 75% ethanol. All instruments used for sterility test should be sent to the sterile examination room after sterilization treatment; The sterilization effect should be verified and confirmed. The transmission window must be equipped with ultraviolet lamp, and its disinfection effect should be confirmed and evaluated regularly, and the ultraviolet lamp should be replaced in time.
    阳性对照室中的操作多为有菌操作,其对操作人员及操作环境污染的可能性更大,建议用生物安全柜操作。由此认为,无菌室、微生物限度实验室本身都应当确保检测环境对实验样品不得产生污染,而影响检验数据的准确性。在无菌检查的同时要同步对检验环境进行检测,洁净程度仍然满足洁净要求。因此,3个实验室在检测结束后的清场、清洗等强度不同,但更终都是以满足10000洁净要求及100级洁净要求为可接受的标准。
    The operation in the positive control room is mostly bacterial operation, which is more likely to pollute the operator and the operating environment. It is recommended to use the biological safety cabinet for operation. Therefore, the sterile room and microbial limit laboratory should ensure that the test environment does not pollute the experimental samples, which will affect the accuracy of the test data. At the same time, the test environment should be tested at the same time, and the cleanliness still meets the requirements of cleanliness. Therefore, the intensity of site cleaning and cleaning of the three laboratories are different after testing, but the final acceptable standard is to meet the requirements of 10000 cleanliness and 100 grade cleanliness.