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1、微生物微生物实验实验室通室通则则 1.0Purpose/目的To define and describe the steps necessary to ensure proper control of the microbiology laboratory, including equipment monitoring, handling of samples, nonconforming product and documentation and review. 定义和描述针对合理控制微生物实验室的必要措施，包括设备监测、样品处理、不合格产品、 文件及其审核。2.0Scope/范围This
2、procedure applies to all personnel involved directly with the microbiology laboratory and associated support personnel. 本程序适用于所有直接涉及微生物实验室的人员以及相关辅助人员。3.0Associated Materials/相关材料3.1 QA-LAB-041 Sampling and Testing of the Purified Water System QA-LAB-041 纯化水系统取样和检验 3.2QA-LAB-005 Handling of Microbiol
3、ogy Laboratory Waste QA-LAB-005 微生物实验室废弃物处理 3.3QA-LAB-011 General Laboratory Procedure QA-LAB-011 实验室通则 3.4QA-LAB-023 Laboratory Investigation Procedure QA-LAB-023 实验室调查程序 3.5FM-QA-00024Test Report FM-QA-00024 检验报告 3.6FM-QA-00025Data Sheet FM-QA-00025 原始记录 3.7FM-QA-00054 Micro Test Log FM-QA-00054 微
4、生物检验登记表 3.8FM-QA-00043Laminar Flow Bench/Biosafty Cabinet Operational Form FM-QA-00043 超净台/生物安全柜使用记录 3.9FM-QA-00044Instrument Temperature Record FM-QA-00044 设备温度记录 3.10FM-QA-00045Autoclave Performance Check Form FM-QA-00045 高压灭菌器运行确认记录 3.11 FM-QA-00125Instrument Using LogFM-QA-00125 设备使用记录 3.12FM-QA
5、-00047Microbiology Lab Cleaning/Disinfection Form FM-QA-00047 微生物实验室清洁/消毒记录4.0 Responsibility/职责4.1 It is the responsibility of the analyst to ensure that the procedure is followed as written. 分析人员的职责是严格按照以下所写程序操作。 4.2 It is the responsibility of the Microbiology Lab Supervisor to assess any deviati
6、ons from the written procedure. 微生物实验室主管的职责是评估任何来自所写程序的偏差。4.3 It is the responsibility of the Lab Manager to assess the competence of the analyst performing the test.实验室的职责是评估分析人员执行此程序的能力。5.0Procedure/程序5.1Wearing Apparel 着装5.1.1Laboratory smocks must be worn whenever any microbiological activity is
7、 engaged. When going to the clean room in microbiology laboratory, must put on the sterile clothes. 任何时候进行微生物操作都必须穿实验室工作服。当进入微生物实验室洁净 区时，必须要穿上无菌衣物。5.1.2Non-sterile gloves disinfected with 70% IPA or other suitable disinfectant are to be worn during any testing or handling of cultures. The wearing of
8、 sterile gloves is optional. 检验或者处理培养基的过程中，必须穿戴消毒过的非无菌手套，可以用 70% 异丙醇或其他合适的消毒剂消毒。也可选择无菌手套。5.2Safety 安全5.2.1All personnel must wash their hands before and after performing any microbiological activity. 在进行与微生物有关的工作前后，操作人员必须洗手。5.2.2Personnel with open sores and rashes must exercise extreme caution whil
9、e working in the microbiology laboratory. 有开放性伤口或者皮疹的人员在微生物实验室工作时必须额外小心。5.2.3Eating, drinking, smoking and applying cosmetics is strictly prohibited in the microbiology laboratory. 微生物实验室内禁止进食、饮水、吸烟和化妆。5.2.4Aseptic technique must be practiced at all times to prevent contamination of samples, culture
10、s, and sterile culture media. Aseptic technique may involve using sterilized (autoclaved) utensils such as forceps or splints, disinfecting metal utensils using 70% IPA and flaming prior to use, using sterile sample cups, working in a laminar flow hood, using an open flame near the weight scale whil
11、e dispensing samples, wearing sterile or disinfected garment or gloves, disinfecting all work surfaces, etc. 任何时候都要坚持无菌操作，以避免对样品、培养物和无菌培养基介质的污 染。无菌操作可包括使用灭菌（经高压灭菌）的器具比如钳子或夹板、使用金 属器具前用 70% IPA 和火焰进行消毒、使用无菌样品杯、在超净台中操作、 分配样品时在天平附近使用明火、穿戴无菌服或消毒手套和消毒工作台面等。5.3General Guidelines 常规要求5.3.1Disinfection/Decon
12、tamination 消毒/净化5.3.1.1Treat bench tops and work surfaces with 70% isopropyl alcohol before and after each use. 用 70% 异丙醇处理使用前后的椅子和工作台面。5.3.1.2All potentially infectious agents must be disposed of in a disposal bag, details see SOP QA-LAB-005. This includes inoculated media, bacterial cultures, glas
13、sware and disposable instruments. 具有潜在传染性的物品必须用废弃物处理袋处理，详见 SOP QA-LAB-005。这些包括接种培养基、菌种、玻璃器具和一次性器 具。5.3.1.3Daily, weekly and monthly tasks for disinfection (using 70% IPA or other recognized disinfection agent) of the lab and equipment is to be performed and documented according to FM-QA-00047. 执行 FM
14、-QA-00047 的规定并记录实验室及设备的每天、每周和 每月的消毒工作（使用 70% 异丙醇或其他认可的消毒剂）Daily: Disinfect all lab bench top surfaces, laminar hood work surface and balance prior to use. 每日：使用前对实验室的所有台面、超净台工作表面以及天平进 行消毒。Weekly: Autoclave all microbiology laboratory micropipettors in use. Disinfect interior chamber and shelves of a
15、ll incubators. 每周：对微生物实验室使用微量移液枪灭菌消毒。对培养箱的内 胆和架子进行消毒。Monthly: Disinfect interior chamber and shelves of refrigerator. Clean water bath and replenish with fresh water. 每月：对冰箱的内胆和架子进行消毒。清洁水浴锅，并换水。FM-QA-00047is to be initialed in the appropriate space as tasks are completed. Completed form is to be rev
16、iewed. 完成任务后，应在 FM-QA-00047 中记录，完成的记录表应被复 核。5.3.2Equipment Monitoring and Operation 设备监测和操作5.3.2.1Record the equipments temperatures on the appropriate forms, or record the running status on the appropriate forms: 将设备的温度并记录在对应的监测记录上，或者将设备的运行状 态记录在相应的记录上：Laminar flow hood and Biosafety cabinet 超净台和生物安全柜台 FM-QA-00043 Incubator 培养箱 FM-
