基本信息General Information:
参照号Reference Number：产品编号Part Number:
产品名称
Part Name:
批号LOT Number
数量Quantity: 日期Date:
灭菌方法Sterilization Method:
辐照Irradiation / 环氧乙烷Ethylene Oxide
样品识别（按SPS里规定样品数量）
Sample Identification (Sample Quantities As Specified In SPS):
样品Sample 数量Quantity 有否正确标签Are the Samples Correctly Labeled? 热源测试Pyrogen Test 是Yes /否No
性能测试Performance Test 是Yes / 否No
存档Archive 是Yes / 否No
灭菌样品Sterile Sample 是Yes / 否No
样品批准Sample Approval:
样品符合包装标签及特定的要求？
Samples conform to packaging label and specific requirements? 是Yes / 否No
包装外箱上的标签信息是否正确？
Container and Transit Container labeled correctly? 是Yes / 否No
品质工程师批准Quality Engineer to Sign: 日期Date:
灭菌采购订单准备Sterilization Purcha Order Preparation:
采购订单号Purcha Order Number:
灭菌过程规格编号
Sterilization Process Specification Number:
采购经理批准Purchasing Manager to Sign: 日期Date:
灭菌后接收检验Post Sterilization Receiving Inspection:
接收数量Number of Packs received:
包装&货盘是否可接收Packaged & Palletid Acceptable：是Yes / 否No
交货文件符合性Delivery Documentation Suitable: 是Yes / 否No
货盘隔离且产品状态清晰标示
是Yes / 否No Pallets gregated and product status clearly labeled:
发烧头晕灭菌证书参照号
Sterilization certificate reference number:
是Yes / 否No
包装箱数量符合订单
Number of transit boxes tallies with PO:
样品回收Samples recovered: 是Yes / 否No
污染Contamination: 是Yes / 否No缅怀历史
物理损坏Physical damage: 通过Pass / 不合格Fail 封箱胶纸安全Tape curity: 通过Pass / 不合格Fail 所有灭菌点都是标识为已灭菌All sterile dot marked as sterilized 通过Pass / 不合格Fail 样品外观检查Sample visual inspection: 通过Pass / 不合格Fail 品质工程师批准Quality Engineer to Sign: 日期Date:
热源样品交货Pyrogen Sample Delivery:
采购订单号Purcha Order Number: 交货日期Date of delivery:
*制成采购订单并按要求出货热源样品
The purcha order has been created and pyrogen samples delivered according to requirements.
分娩阵痛品质经理签字Quality Manager to Sign: 日期Date:
性能测试，样品分配，存档Performance Test, Sample Allocation and Archiving
接受性能测试结果Performance test results received: 是Yes / 否No
性能测试评估Asssment of performance test 通过Pass / 不合格Fail 接受热源测试结果Pyrogen test results received: 是Yes / 否No
热源测试报告参照号Pyrogen test report reference number:
热源测试评估Asssment of Pyrogen test 通过Pass / 不合格Fail 灭菌样品保存Sterile sample archived: 是Yes / 否No借月抒情的诗句
如产品灭菌为辐射灭菌，填写以下信息
老人星赋Fill in below when sterilization conducted with irradiation
接受最小剂量Minimum do received: kGy
辐射剂量评估Asssment of satisfactory irradiation do: 通过Pass / 不合格Fail 接受辐射测试结果Irradiation test results acceptable: 是Yes / 否No
如产品灭菌为环氧乙烷灭菌，填写以下信息没有英文怎么写
Fill in below when sterilization conducted with Ethylene Oxide
通过Pass / 不合格Fail 确认纪录的环氧乙烷灭菌过程的参数跟环氧乙烷灭菌过程规格表相
同
图片识图Confirmation that the data recorded during routine processing meet
sterilization process specification;
确认生物指示剂没有生长
是Yes / 否No Confirmation of no growth of the test organism from any biological
indicator (if ud).
as的六种用法品质经理批准Quality Manager to sign: 日期Date:
*当所有选项都完成才能批准产品发行
*Only when all ctions are complete and product is approved for relea.
品质经理Quality Manager
名称Name:
签名Signature: 日期Date:
