KVR040023尿杯吸塑包装验证报告(1).docVIP

文件名称File Name 吸塑包装验证报告 Specimen Container form- fill – Seal packaging Validation Report 文件编号REF# 版本Version A Page 6 APPROVAL We have reviewed the requirements of the Validation protocol. All of the requirements have been met and this Protocol is considered to be complete. Drafter By: Originator Date Approved By: Amsino –Product Engineer Date Amsino – Quality Date Amsino - Deputy General Manager Date 1.目的PURPOSE 本确认方案用于确认 杭州圣合医疗器械成套有限公司提供的吸塑包装机，在使用医用透析纸,和PP/PE复合膜分别作为盖材和底膜时，在吸塑包装时能够达到天宇的生产要求. 本次确认的样品为 . 范围Scope 2.1设备Equipment： 本次确认的目标设备是用于吸塑成型－填充－热合—切割的全自动软吸塑包装机，产地为中国，型号为PZB-40，工厂内部编号是. 模具编号： The validation object is the FFP machine which is made in Switzerland, model number is ECO-C460; equipment ID number coded in plant is . mould NO.. 2.2材料Materials： 本次确认使用的包装材料为63G 医用透析纸和PP/PE复合医用膜，具体的材料信息如下： The validation is for FFS process that uses iatrical dialysis paper （63G） as coated paper and PP/PE compound film. The detail information of the two materials as below: 2.2.1 盖材Top Web： a. 供应商Supplier b. 规格 Spcification：width (415mm) 2.2.2 a. 供应商Supplier：, b. 规格Specification：421mmX0.12mm c. 货号Item：XPP 0.1mm 职责RESPONSIBILITIES 3.1技术部门Technology department: 负责提供技术支持、设备安装和检测、设定工艺参数和确认目标值,审批方案和报告；指导设备操作培训并主持考核。需尽快制定MPS吸塑包装机的操作规范SOP. Provide technical support, equipment installation and test, set up process parameter and validation purpose value. Review and approve this validation protocol and final report；Lead relative operating training and examining. 3.2质量部门Quality department: 提供检验方案、接受标准并负责实施检验事项,起草和审批检验方案和实施校准仪器。 Provide inspection method, criteria and handle this action. Draft the validation protocol and get all instruments calibrated。 3.3生产部门Manufacture department: 实施完整确认过程并据此编辑标准生产操作程序（SOP）审批方案，协助相关人员培训。 Calibrate instrument, execute validation protocol and when it successfully be finished, set up the SOP (standard operation process) for production.