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1、Medical Packaging Standards医疗包装标准,Ichiro Ikeda 池田一郎Regional Regulatory Affairs Manager亚太区法规事务经理DuPont Protection Technology杜邦防护科技,Overview 概览,Goal:Safe and Efficacious Product目标：安全和有效的产品,Global Medical Packaging Standards全球医疗包装标准,ISO EN 11607-1:2006,Packaging for terminally sterilized medical device
2、s-Part 1:Requirements for materials,sterile barrier systems and packaging systems.最终灭菌医疗器械的包装 第一部分：材料，无菌屏障系统和包装系统的要求PART 1 DEALS WITH MATERIALS AND DESIGN 第一部分 关于材料和设计,ISO EN 11607-2:2006,Packaging for terminally sterilized medical devices Part 2:Validation requirements for forming,sealing and assem
3、bly processes.最终来菌医疗器械的包装 第2部分:成形、密封和装配过程的确认要求PART 2 DEALS WITH PROCESSES 第二部分 关于加工过程,Source:,ISO EN 11607 Global Status 全球顺应现状(1/2),US 美国,Adopted as American National Standard without revision被美国国家标准采用，无修订“Recognized”by the FDA Centers for Devices and Radiological Health(CDRH)被FDA器械与体外诊断中心所认可,Europ
4、e 欧洲,Both documents approved as European Norms 被批准成为欧洲标准Compliance can be demonstrated using EN 868-1 or ISO EN 11607 until May of 2007 when ISO EN 11607 must be used 在2007年5月当ISO EN 11607 成为强制性标准前，符合性可以由EN868-1或ISO EN 11607来证明Current products already demonstrating compliance with EN 868-1 do not ha
5、ve to demonstrate compliance with ISO EN 11607 现有产品已经证明符合EN868-1标准不必再通过符合ISO EN11607的证明,ISO EN 11607 Global Status 全球顺应现状(2/2),Japan 日本,Japanese versions available from Japanese Standards Association(JSA)日本版的标准可从日本标准协会获得Adopted as JIS T 0841 as a Japanese National Standard in Sep.2009.It is a IDT tr
6、anslated standard.在2009年9月被采用成日本国家标准JIS T 0841。这是等同采用的标准。,China 中国,Previous version adopted as National Standard 之前的版本已被国标所采用 Current versions undergoing adoption as Chinese National Standard 当前的版本正在被采用为新版国标的过程中 Part of EN 868 parts 2-10 adopted as Industry standard(YY)EN868标准的第2-10部分被行业标准所采用Selecte
7、d ASTM testing methods adopted or will be adopted as Industry standard(YY)选用部分ASTM测试方法被采用或将被采用成为行业标准,Compliance 符合,Must meet the requirements dictated by every“Shall”statement 必须符合标准中所指示的每个“应该”的要求ISO EN 11607-1 has eighty-two“shall”statements 第1部分有82个“应该”的规定ISO EN 11607-2 has forty-eight“shall state
8、ments 第2部分有48个“应该”的规定Eleven of these“shall”statements are identical in the two documents 其中11个“应该”的规定在二个部分文档中是一致的Therefore one must document compliance with one hundred and nineteen“shall”statements 因此一个必需的文档包含符合119个“应该”的规定Many have multiple parts 许多有多重含义“shall consider”“必须考虑”,ISO EN 11607-1 Section
9、s 1-3 章节1-3,Section 1.Scope 章节1.范围Includes healthcare facilities 包括医疗诊所 Section 2.Normative references 章节2.标准化参考Annex C(normative)ISO 5636-5:2003 Paper and Board Determination of air performance and air resistance Part 5 Gurley method 附录C（标准）-ISO 5636-5：2003 纸和纸板-空气动力与空气阻力的判定-第5部分 格里方法 Section 3.Ter
10、ms and definitions(new definitions)章节3.术语和定义（新的定义）Pre-formed sterile barrier system 预成型无菌屏障系统Sterile barrier system无菌屏障系统Protective packaging 保护性包装Packaging system 包装系统,Formal quality system 正式的质量体系3rd party certification not required 对第三方认证没有作要求Sampling plan 取样计划Based upon statistically valid ratio
11、nale 基于统计上来验证其合理性Test method validation 测试方法验证Documentation 文件归档,ISO EN 11607-1 Section 4 General Requirements 第4章 通用要求,General Requirements 通用要求4.2 Quality systems Tyvek production facilities are ISO 9001:2000 certified 质量体系 特卫强 生产工厂是ISO 9001:2000 认证的4.3 Sampling Sampling plans in place,ISO 9001:20
12、00 compliant 取样 具有适当的取样计划，符合ISO 9001:2000 4.4 Test Methods Validated test methods used to show compliance for 测试方法 经验证的测试方法用于证明符合性:Air permeability,Unit weight,Delamination,Hydrostatic head,Thickness,Tensile(MD&CD)透气性，单位重量，分层力，静水压，厚度，张力 Procedures in place for calibration of test equipment 恰当的程序用于测试
13、设备的检验 Tyvek in-area lab uses CUSUM to monitor repeatability 特卫强 地区间实验室采用CUSUM来监控可重复性4.5 Documentation All documents that illustrate the compliance of Tyvek with ISO 11607-1:2006 are retained for a specific period of time 文件归档 所有文档关于阐明特卫强符合ISO 11607-1:2006的都被保存一个特定的时间段,DuPont Tyvek Compliance to ISO
14、11607-1:2006,ISO EN 11607-1 Section 5 Materials and Preformed Sterile Barrier Systems 第五章 材料和预成型无菌屏障系统,Addresses required physical,chemical,environmental and biological requirements of materials used in the manufacture of sterile barrier systems and compatibility with the sterilization process.阐述用于制
15、作无菌屏障系统的材料所需具备的物理，化学，环境的和生物学的要求以及与灭菌过程的相容性Many of these requirements may be met by suppliers of materials and pre-formed sterile barrier system.这些要求中的很多项是可以由材料和预成型无菌屏障系统的供应商来满足的DuPont is able to supply compliance data for packaging material(TYVEK)杜邦能够为包装材料提供符合性报告（特卫强）,How to comply section 5(for exa
16、mple)如何符合第五章（举例),5.1.4 As a minimum,the following shall be considered作为最低要求，以下条目必须被考虑temperature range 温度范围pressure range 压力范围humidity range 湿度范围maximum range of the above,where necessary 以上项目的最大范围，哪里是必须的exposure to sunlight or UV light 暴露于日光或紫外线cleanliness 清洁Bioburden 初始污染菌electrostatic conductivit
17、y 静电传导,DuPont Tyvek Compliance to ISO 11607-1:2006杜邦TM特卫强 Tyvek 符合ISO 11607-1:2006,Materials and Preformed Sterile Barrier Systems 材料和预成型无菌屏障系统5.1.4 As a minimum the following shall be considered 至少必须要考虑以下各项:a)temperature range 温度范围.Toughness and flexibility are retained down to 100F(73C).When expos
18、ed to heat,Tyvek begins to shrink at approximately 270F(132C).Steam sterilization must be limited to a maximum of 125oC 材料的韧性和柔软性能保持低至73C.当被加热处理时，特卫强在接近132C时开始发生收缩.在蒸汽灭菌时必须控制温度最高不超过125oCb)pressure range 压力范围.Tyvek performs over a range of pressures and allows 特卫强能承受一定的压力范围并允许for the equilibration of
19、 pressure differentials across a sealed sterile barrier system(SBS)通过闭合的无菌屏障系统来平衡压力差c)humidity range 湿度范围.Tyvek is not affected by moisture特卫强不受湿气影响.d)maximum rate of change of temperature,pressure and humidity.温度，压力和湿度的最大变化率 These elements must be considered once Tyvek becomes part of an SBS.这些因素在特
20、卫强成为无菌屏障系统的组成部分时必须加以考虑,DuPont Tyvek Compliance to ISO 11607-1:2006杜邦TM特卫强 Tyvek 符合ISO 11607-1:2006,5.1.4e)exposure to sunlight or UV light 经日照或紫外线.Physical properties are degraded by exposure to direct sunlight(UV)暴露于日光（紫外线）直射下，材料的物理属性会发生退化.f)cleanliness 清洁.Tyvek is composed of essentially continuou
21、s fibers and does not generate a significant amount of lint particles under conditions of ordinary use.特卫强基本构造是由长丝纤维所组成并且在正常的使用条件下不会产生大量的落屑颗粒,DuPont Tyvek Compliance to ISO 11607-1:2006杜邦TM特卫强 Tyvek 符合ISO 11607-1:2006,-5.1.4-g)bioburden 生物负担.The process of manufacturing Tyvek allows only short perio
22、ds of time when the sheet is subject to airborne particulates and microbes;therefore,the bioburden on the surface of the Tyvek is very low特卫强的生产过程中只有很短的时间段片材会接触到悬浮微粒和微生物，所以特卫强表面的生物负担水平是很低的.The typical bioburden of all Tyvek medical packaging styles is less than 100 colony forming units(cfu)per ft2.典
23、型的特卫强生物负担水平是低于100CFU/每平方英尺-h)electrostatic conductivity 静电传导性.Tyvek may generate static electricity 特卫强可以产生静电.(styles intended for medical packaging do not contain an antistatic agent.用于医疗包装的型号不含有抗静电剂),ISO EN 11607-1 Section 6 Packaging Systems Design and Development 对包装系统设计与开发,General Requirements通
24、用要求Performance of the packaging system 包装系统的性能Introduction of“product family”and“worst case configuration”“产品族”和“最差状况的设定”的介绍Design considerations that must be considered to develop a safe and effective packaging system 设计所需考虑的事项必需被评估用于开发一个安全和有效的包装系统Packaging system performance testing 包装系统的性能测试Stabi
25、lity testing(aging)稳定性测试（老化）,Changes in Air Pressure 气压的变化,Air pressure inside package vs.outside package包装内外的气压对比 Non breathable materials cant adjust to changes in air pressure.非透气性材料不能适应气压的改变 Design your packaging to meet the challenges of the distribution environment设计你的包装以应对运输环境的挑战,实验室模拟运输测试/验证
26、 Laboratory transportation testing/validationRefer to ISTA or ASTM D4169 for testing protocol 测试方案参考ISTA 或 ASTM D4169,运输测试 Transportation Testing,振动 VibrationProgrammed spectra for truck,air or rail frequencies and intensity,挤压 CompressionWarehouse or vehicle stacking,跌落 DropSeverity and frequency o
27、f impact,Test Methods 测试方法,Part 1 Annex B lists many test methods.All must be validated in the laboratory conducting the testing 第一部分附录B列出了许多测试方法.所有的方法必须经实验室的测试操作来验证确认.Seal Strength 封合强度ASTM F88Package Integrity 包装完整性ASTM F1886 Visual Inspection 目测ASTM F1929 Dye Penetration 染剂渗透ASTM F2096 Internal P
28、ressurization 内部增压ASTM F2338 Vacuum Decay 真空衰减Microbial Barrier of Porous Materials 多孔性材料的微生物阻隔F1608 F2638,ISO EN 11607-1 Section 7 Information to be Provided提供的信息,New requirement in ISO 11607 needed for European compliance.ISO11607中用于欧盟法规符合性所需的新要求Specifies the information that must be provided for
29、materials,preformed sterile barrier systems and sterile barrier systems 明确规定必须提供的有关材料，预成型无菌屏障系统和无菌屏障系统的信息NOT intended to be supplied with every order but rather must be available(MSDS)不必按批次提供来信息但必须是有可获取的（物料安全数据表）,ISO EN 11607-1 Annexes 第一部分的附录,Annex 附录A(参考性Informative)Guidance on medical packaging 医
30、疗包装指南Annex 附录B(参考性Informative)Standardized test methods 标准测试方法Can use ANY validated test method,this list is for informational purposes 可以使用任何经确认的测试方法，这个目录是提供信息为目的的 Criteria for inclusion:must be commercially available from a standards development organization or trade association 入选的标准：必须是由一个标准开发组织
31、或贸易协会正式发布的，可以在市场上获得的New criteria for next revision 新的入选标准会用于下一个修订版Annex 附录C(标准性Normative)Test method to determine if a material is impermeable 用于判别材料是否是非透气性的测试方法Gurley-Hill for 1 hour without deflection of the cylinder 葛尔莱 1小时无柱面改变,Points of Discussion 论点,Test method validation 测试方法的确认Introduction o
32、f“product family”and“worst case configuration”“产品族”和“最差状况的设定”的介绍Packaging system performance testing 包装系统的性能测试Stability testing(aging)稳定性测试（老化）Process for manufacture of preformed sterile barrier systems and sterile barrier systems must be validated预成型无菌屏障系统和无菌屏障系统制造流程必需被验证确认,Product family and Wors
33、t case configuration 产品族和最差状况的设定,A product family is also a group of similar preformed sterile barrier systems manufactured under the same process conditions.一个产品族也是一组经相同加工过程制造出的相类似预成型无菌屏障系统Example举例:Pouches made of the same materials 同样材料制成的管袋5.0 cm x 10.0 cm5.0 cm x 15.0 cm4.5 cm x 30.0 cmWhat is
34、the product family and worst case?什么是产品族和最差状况？Using this approach the pouch manufacturer does not need to validate every size.采用这个方法，管袋的制造商不需要去确认每个不同尺寸的产品,Accelerate aging study 加速老化试验,The accelerated aging factor is calculated based on the difference between the accelerated aging temperature and th
35、e expected storage temperature加速老化因数是基于加速老化测试温度和预期储存温度的差异来计算的,Ts Ka=Q10(Ta-Ts)/10Normal warehouse storage temperatures could be quite warm.正常的仓储温度可能是非常暖和的 If Q10=2;Ts=35C;Ta=55C,then Ka=2(55-35)/10=4The number of days to simulate 1 year of aging is 用于模拟老化一年所需的时间天数是 365 days/4=92 days,Summary 总结(1/2)
36、,ISO EN 11607 in conjunction with AAMI TIR 22 provide a framework for ensuring that the sterile barrier system will meet the requirements of maintaining the device in an acceptable form for use in a healthcare setting.ISO EN 11607通过AAMI TIR22的导读配合，提供了一个框架用于确保无菌屏障系统能符合保持医疗器械能适用于医疗使用的要求 Compliance wit
37、h the ISO/EN standards is required for new devices in the European market.新的医疗器械进入欧盟市场必须符合 ISO EN 11607 Without adequate packaging,all the sophisticated technology of a device and the sterilization processing is worthless.没有恰当的包装，各种医疗器械所含的高端技术和相关灭菌过程都将是没有价值的。,Summary 总结(2/2),Section 7:Information to
38、 be provided 所需提交的信息文件1)Pkg material 包装材料:similar documents as Tyvek(r)类似于特卫强的技术文档2)Pkg(including pre-formed SBS):包装（包括预成型无菌屏障系统）seal strength 封合强度测试pkg integrity testing 包装完整性测试,特卫强的价值 Value of Tyvek,Notes,Source:,特卫强的强度是相同克重医用纸的6-8倍,Generic description of the 6 factors,特卫强材料的细菌阻隔能力是纸的100倍，具有优异的微生物
39、阻隔性能,更高的保护性更容易符合ISO 11607-1:2006,特卫强材料透气性能,国际先进水平减少包装在环氧乙环灭菌过程中包装的破损和有助于减少环氧乙环的残留,减少被微生物污染的机会，延长产品的无菌保质期，可提供5年以上的灭菌保质期,降低在运输和储存过程中产品包装的破损,Higher Protection for Easier Compliance with ISO 11607-1:2006 更高的保护性更容易符合ISO 11607-1:2006 ISO 11607:2006 Part 1 Key SectionsGeneral RequirementsMaterials and pref
40、ormed sterile barrier systems5.1 General requirements5.2 Microbial barrier properties5.3 Compatibility with the sterilisation process5.4 Compatibility with the labelling system5.5 Storage and transport,特卫强的价值 Value of Tyvek(1/4),特卫强的强度是相同克重医用纸的6-8倍 The strength of Tyvek is 6-8 times vs.paper at the
41、same gsm降低在运输和储存过程中产品包装的破损Lower the risk of packaging fail during distribution,特卫强的价值 Value of Tyvek(2/4),特卫强材料的细菌阻隔能力是纸的100倍，在现有的多孔材料中是最好的微生物阻隔性能 The microbial barrier of Tyvek is about 100 times over paper减少被微生物污染的机会，延长产品的无菌保质期，可提供5年以上的灭菌保质期,特卫强的价值 Value of Tyvek(3/4),特卫强材料透气性能 The permeability of
42、 Tyvek is good enough for ETO sterilization and keep its physical properties after sterilization 减少包装在环氧乙环灭菌过程中包装的破损和有助于减少环氧乙环的残留,特卫强的价值 Value of Tyvek(4/4),特卫强的价值 Value of Tyvek,更高的保护性更容易符合ISO 11607-1:2006,特卫强的强度是相同克重医用纸的6-8倍,降低在运输和储存过程中产品包装的破损,特卫强的价值,特卫强材料的细菌阻隔能力是纸的100倍，在现有的多孔材料中是最好的微生物阻隔性能.减少被微生物
43、污染的机会，延长产品的无菌保质期，可提供5年以上的灭菌保质期,特卫强材料透气性能减少包装在环氧乙环灭菌过程中包装的破损和有助于减少环氧乙环的残留,在国内的联系方式 Contacts in China 钱军 Park Qian 021 38622201,U.S.A Global Technology Centerin Richmond,VA,JAPANTechnical Service Center-Tokyo,CHINARegional Technology Center Shanghai,EUROPEGlobal Technology Center in Luxembourg,Here to Help杜邦医疗包装 DuPont Medical Packaging,
