紫外传递窗表面消毒性能验证.docxVIP

性能确认Performance Qualification起草于2015年04月Prepared April 2015名称Title紫外传递窗-表面消毒性能确认UV delivery window–Bacteria ChallengeTest on the surface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: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33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 Qualification45性能确认Performance qualification56缺陷报告附件列表Deficiency Report Attachments List57批准Approvals67.1临时批准Interim Approval67.2最终批准Final Approval6通用说明和先决条件General Instructions and Prerequisite目的Objective这份方案描述KPB型电子连锁传递窗的灭菌性能确认程序。将会确认设备在正常操作条件下，关键变量能在允许的公差范围内持续稳定的重现。This protocol will define the procedure to be followed for the Bacteria Challenge Test on the surface of theUV delivery window. It will verify that the variables, critical to the operation, consistently operate within a specified tolerance range when operated under normal conditions.设备描述Equipment Description设备的型号是KPB，由XXXXXXXXXXX有限公司提供。其使用目的是对进入SPF级动物房的物品进行表面消毒。Model of the equipment isKPB, it’s supplied byXXXXXXXXXXXXCo., Ltd.It is used to sterilize surfaces of the items to be used in SPF area.术语和定义关键缺陷-在关键缺陷项目被（解决）完成之前，验证工作不能签署通过。Critical Deficiency – Validation may not be signed off until the item is closed out.非关键缺陷-验证工作可以签署通过，可是继续使用没有被缺陷影响的项目。Non–Critical Deficiency – Validation may be signed off and (continued) use of the item is not impacted by the deficiency.责任活动Activity责任方Responsible Party起草和批准方案Prepare and approve protoc