ECA新闻：新的模制玻璃缺陷评估表现在出版了

罗伊鲱

17.10.2018

New defectEvaluation List for Moulded Glass out now

Defect evaluation lists consist ofcomprehensive, detailed documents on pharmaceutical and cosmetics packagingtesting and are obligatory for efficient and systematic quality assurance. Thelists are based on GMP Rules, pharmacopoeias (Ph.Eur., USP, JP), and directivesand technical standards (ISO, ANSI Z1.4). They include a classification ofdefects, sampling tables and detailed descriptions of testing procedures tofacilitate practical work.

缺陷评估清单包括关于药品和化妆品包装测试的全面、详细的文件，并且是有效和系统的质量保证的必要条件。这些清单基于GMP规则、药典（EP、USP、JP）以及指令和技术标准（ISO、ANSI Z1.4）。它们包括缺陷分类、抽样表和测试程序的详细描述，以方便实际工作。

The bilingual (German - English) checklistsand instructions for use in the testing of containers made of glass have beencompletely revised and enlarged.

双语（德语和英语）清单和用于测试玻璃容器的说明已经全面修订和扩充。

·        Thebrand-new 2018 edition of the Defect Evaluation List for Containers Made ofMoulded Glass now includes an colored appendix on the determination of stressdue to cooling in containers made of moulded glass and an illustratedfour-colour appendix with photo examples for specific defect characteristics toillustrate the defect category.

·        全新的2018版《模制玻璃容器缺陷评估清单》现在包括一个彩色附录，用于确定模制玻璃容器中的因冷却引起的应力，以及图示的四色附录，附有具体缺陷特征的照片样板来说明缺陷类别。

·        The2016 edition of the Defect Evaluation List for Containers made of Tubular Glassincludes already defect characteristics for syringes and an illustratedfour-colour appendix with example images of specific defect characteristics.

·        2016版《管制玻璃容器缺陷评估清单》已经包括注射针筒的缺陷特征和图示的四色附录，附有具体缺陷特征的样板图像。

原文：http://www.gmp-compliance.org/gm ... ulded-glass-out-now
购书：http://www.ecv.de/Buecher/Fehler ... aus_H%C3%BCttenglas

罗伊鲱

Defect Evaluation Lists 现有21本：

12	Principles for the Defect Evaluation  Lists for Packaging Material, 5th ed. 2017
13	Secondary Packaging Materials, 6th ed. 2017
14	Containers Made of Moulded Glass, 4th ed. 2010
15	Aerosol Cans Made of Metal, 3rd ed. 1996
17	Injection-moulded Parts Made of Plastic: Boxes, Tubes, Turning and Sliding Mechanism. 1993
18	Plastic Stoppers, Desiccators and Caps, 1995
19	Containers Made of Tubular Glass, 5th ed. 2016
20	Rubber Parts, 3rd ed. 2007
21	Valves, Pumps and Adapters, 4th ed. 2007
22	Injection-moulded Parts Made of Plastic: Closures, Sealing Disks, Dosage Aids (Droppers, etc.). 2010
23	Blow-moulded Plastic Containers, 4th ed. 2014
24	Foils/Films, 2nd ed. 2001
25	Metal Closure Systems, 2nd ed. 2009
26	Medical Needles, 2009
34	Applicators and Measuring Devices Made of Plastic, 1989
35	Disposable Syringes and Needles, 1990
36	Delivery Packaging Materials Made of Corrugated Board, 3rd ed. 2008
37	Bags and Liners Made of Plastic and Plastic-containing Materials, 1995
38	Tins and Lids Made of Metall, 2006
39	Tubes Made of Aluminium, 4th ed. 2007
40	Tubes Made of Laminate and Plastic, 2001

补充内容 (2021-2-19 19:52):
39  Tuben aus Aluminium/Tubes Made of Aluminium, 5. A./5th ed. 2020

补充内容 (2021-2-19 21:17):
20  Rubber Parts, 4th ed.  2019

syhorchid

关注一下

罗伊鲱

第一次听老外要求按AQL取样是10年前了（可能是在PDA TR43第一次出版后），但一直不知道怎么确定缺陷等级和取样水平（PDA TR43之前也一直没有学习过），现在才知道这本书具体规定了怎么操作（是TR43的背景资料）。https://www.ouryao.com/thread-381046-1-1.html

Defect Evaluation Lists实际是一个系列，其中包括大多数药用包装材料。其中的Vol.35出版于1990年。

让我们出国看看老外的灯检、贴标设备http://biomanufacturing.org/uplo ... 7062-chapter-15.pdf

罗伊鲱

https://wenku.baidu.com/view/a0f205a5a417866fb94a8eaa.html
https://wenku.baidu.com/view/968ba88abe23482fb5da4c26

补充内容 (2019-7-10 22:36):
https://wenku.baidu.com/view/968ba88abe23482fb5da4c26

罗伊鲱

Defect Evaluation List for the quality assurance of rubber parts (节选)
http://docplayer.org/storage/29/ ... ohgLGg/13687053.pdf

懒虫9527

谢谢楼主分享

罗伊鲱

28.08.2019

New Defect Evaluation List for Rubber Parts

Defect evaluation lists consist of comprehensive, detailed documents including checklists and instructions for use in the testing of packaging materials and are obligatory for efficient and systematic quality assurance.

The lists are based on GMP Rules, pharmacopoeias (EP, USP, JP), statutory provisions and directives and technical standards EN ISO 2859-1 and DIN EN ISO 15378, ANSI Z1.4 (formerly MILSTD 105) and include a classification of defects, sampling tables and detailed descriptions of testing procedures to facilitate practical work.  

The brand new 2019 edition of the bilingual (German - English) Defect Evaluation List for Rubber Parts has been fundamentally revised according to the current state of knowledge and technology and adapted to the defined quality standard including an illustrated four-colour appendix with example images of specific defect characteristics.

Participants of ECA`s Conference on Plastic/Elastomeric Materials for Pharmaceutical Packaging and Production from 25-26 September 2019 in Barcelona, will exclusively receive the Defect Evaluation List for Rubber Parts, New Edition 2019, as a Free PDF-Download!

罗伊鲱

Defect Evaluation List for Foils/Films (Vol.24)

http://docplayer.org/55769393-De ... or-foils-films.html

补充内容 (2021-2-19 21:18):
http://docplayer.org/158635908-F ... h-edition-2019.html

小金库

不错，学习了