杜邦医疗包装升级项目2013进展报告中文版.pdf

DuPont™ Tyvek® Medical Packaging Transition Project 2013 Progress Report ™ ® 杜邦 特卫强 医疗包装升级项目 2013年进展报告 June 2013 8/28/2013 Agenda 目录 Transition Project Overview 项目概述 Regulatory Update 法规进展 Technical Milestones Reached as of June 2013 截至2013年6月项目在技术层面的主要进展 Preparing for Full Commercialization 为全面商业化生产所做的准备 Closing Remarks 备注 QAs 问答 8/28/2013 2 Project Objective – To Ensure Continuity and Flexibility of Future Supply 项目目的: 确保未来产品供应的连续性和灵活性 Goal of the Transition Protocol is to demonstrate functional equivalence 升级方案的目标是证实功能一致性 Functional equivalence means that the attribute you are measuring may be different, even statistically, but it still meets functional and performance requirements, so that it will perform similarly to current Tyvek® in your process and applications 功能一致性 表示：测试的参数也许不同，甚至在统计学上有差异，但是仍然满足 功能和性能的要求，所以在制程和应用中，与现有的特卫强® 具有一致性表现 More than $30 Million investment by DuPont covering: 杜邦3千万项目投资包含 : • Global regulatory and industry support 全球法规及行业支持 • Raw materials for multiple line and polymer testing 针对不同生产线和不同聚 合物产生的原材料的测试 • Developmental package creation and testing 研发型包装的制成与测试 • Transition Protocol package creation and testing 升级项 目包装的制成与测试 • Third-party laboratory testing 第三方实验室的测试 • Phantom Protocol 幻影计划测试 • Product Stewardship 产品体系管理 8/28/2013 3 Components of DuPont™ Tyvek® Medical Packaging Transition Project (MPTP) 杜邦医疗包装升级项目组成部分 U.S. Food and Drug Administration (FDA) Transition Protocol 美国食品与药物管理局 (FDA)杜邦升级项目方案 Phantom Protocol 幻影计划