动物饮用水无菌验证.docx

性能确认Performance Qualification起草于2015年04月Prepared April 2015名称Title动物饮用水无菌确认Microbial levelqualification of laboratory animal drinking water房间号Room NoNA验证的仪器、设备或程序Instrument/Equipment/Procedure to be Validated设备供应商Supplied by: NA设备序列号Equipment Register: NA设备编号Equipment NumberNA验证方案的批准Approval of the Validation Protocol审核和批准了相关SOP、标准和日程表之后在下表签字Sign here after reviewing and approving the SOPs, standards and schedules头衔Title姓名Name签名Signature日期Date起草人Written By:验证负责人VD王海洋Haiyang Wang批准人Approved By:主管Supervisor王海洋Haiyang WangQA负责人QA Manager刘振超Zhenchao Liu机构负责人Test facility manager夏玉叶Yuye Xia目录Table of Contents1通用说明和先决条件General Instructions and Prerequisite31.1目的Objective31.2设备描述Equipment Description31.3术语和定义32责任43文件和标准操作规程Documents and Standard Operating Procedures43.1完成本文件Completion of this Document43.2文件列表Qualification Documents44使用的仪器和标准品Test Instrumentation and Standards Used in the Qualification65性能确认Performance qualification66缺陷报告附件列表Deficiency Report Attachments List77批准Approvals87.1临时批准Interim Approval87.2最终批准Final Approval8通用说明和先决条件General Instructions and Prerequisite目的Objective这份方案描述动物饮用水无菌的确认程序。This protocol will define the procedure to be followed for the Microbial level qualification of sterilized items in clean areas.方法描述Method Description未灭菌水：将SPF区域内的出水龙头用医用酒精擦拭后，打开水龙头，3 min后用灭过菌的饮水瓶取水，密闭备用。Unsterilized water: In SPF area, use medical alcohol to clean water tap first, then open the tap, after 3 minutes, collect water from the tap with a sterilized container, seal the container.灭菌水：按照1.2.1方法取水，取水后送到高压灭菌锅灭菌。Sterilized water: collect water according to the steps described in 1.2.1, then sterilize the water collected in the container in an autoclave.在超净工作台或生物安全柜内，取1 mL未灭菌水接种于营养肉汤培养基，然后将接种过的培养基放入生化培养箱培养。同样的方法取1 mL灭菌水接种于营养肉汤培养基，然后将接种过的培养基放入生化培养箱培养。In clean bench or biosafety cabinet, pipette 1 mL of unsterilized waterinto nutrient broth media, and thencultivate the inoculated nutrient broth mediain a biochemical incubator.And so does the sterilized water.在超净工作台或