包装验证方案报告).docVIP

包装验证方案报告 编制： 日期： 审核： 日期： 批准： 日期： 1概述---------------------------------------------------------------------------------3 2 目的---------------------------------------------------------------------------------3 3 适用范围---------------------------------------------------------------------------3 4 验证参考资料---------------------------------------------------------------------4 5 验证小组成员及职责--------------------------------------------------------------4 6 包装材料选择评价-------------------------------------------------------------------4 7 包装成型工艺确认-------------------------------------------------------------------6 7.1 设备及材料-------------------------------------------------------------------------6 7.2 安装确认----------------------------------------------------------------------------6 7.3 运行确认----------------------------------------------------------------------------8 7.4 性能确认----------------------------------------------------------------------------9 8 异常情况处理程序--------------------------------------------------------------------11 9 再确认----------------------------------------------------------------------------------12 1. 概述是我公司采用技术，自主开发的，属于医疗器械，十万级净化厂房加工制作符合美国FDA食品接触标准。Tyvek（） Tyvek（）是美国杜邦公司生产，Tyvek作为无菌医疗器械的初包装运用有30年的历史，Tyvek（）具有高强度，高阻菌，寿命长，优异的抗微生物渗透能力，灭菌后撕口干净不带纸屑目的 。。 适用范围 本方案适用公司生产的。 ISO 11607-1：2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems. ISO 11607-2：2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes. EN868-1:2007 Packaging materials and systems for medical devices which are to be sterilized Part 1 General requirements and test methods. EN868-5: Packaging materials and systems for medical devices which are to be sterilized Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction—Requirement and test methods. GB/T 15171-1994软包装件密封性能试验方法。 ASTM F 1980-02 Stand