GB/T 35594-2023Paper and board for pharmaceutical packaging (English PDF)

Foreword

This document complies with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Drafting:

This document replaces GB/T 35594-2017 "Medical Packaging Paper": Compared with GB/T 35594-2017, except for structural adjustment and editing In addition to the modifications, the main technical changes are as follows:

a) Changed the scope (see Chapter 1, Chapter 1 of the:2017 edition);

b) The classification has been changed (see Chapter 4, Chapter 4 of the:2017 edition);

c) Changes in raw material requirements (see Chapter 5, Chapter 5 of the:2017 edition);

d) Change "basic basis" to "quantitative deviation", "tear degree" to "tear index", "burst resistance" to "burst resistance index", "wet resistance" "Breaking Strength" is changed to "Wet Bursting Index", "Tensile Strength" is changed to "Tensile Index", "Wet Tensile Strength" is changed to "Wet Tensile Index" "number", and changed the requirements and corresponding test methods (see 6:1:1, 7:2, 7:5, 7:7~7:10, 5:4, 6:2, 6:4,:2017 edition 6:6~6:9);

e) Change the brightness (whiteness) indicator name to D65 brightness, and the fluorescence brightness (whiteness) indicator name to D65 fluorescence brightness:

The name of the chloride content indicator is changed to water-soluble chloride content, and the name of the sulfate content indicator is changed to water-soluble sulfuric acid:

Salt content, changed the D65 brightness, air permeability, water absorption, smoothness, microbial barrier properties technical index requirements (see 6:1:1, 5:3 and 5:4 of the:2017 edition), the test methods for water-soluble chloride content and water-soluble sulfate content have been changed (see 7:12, 7:13, 6:11 and 6:12 of the:2017 edition), the test method for microbial barrier properties has been added (see 7:18);

f) Added technical index requirements for decolorization performance, heavy metal content, and dust level (see 6:1:1) and their test methods (see 7:15, 7:17, 7:20);

g) Added the physical and chemical properties and test methods of cardboard for pharmaceutical packaging (see 6:1:2, 7:17, 7:21~7:24);

h) Added requirements for appearance quality, dimensional deviation and skewness index of paperboard for pharmaceutical packaging (see 6:3 and 6:4:2);

i) Added requirements for microbiological indicators of medical packaging paper and cardboard for pharmaceutical packaging (see 6:2) and their test methods (see 7:25);

j) The inspection rules have been changed (see Chapter 8, Chapter 7 of the:2017 edition);

k) Product identification has been changed (see 9:2 and 9:3, 8:2 and 8:3 of the:2017 version);

l) Added measurement methods for decolorization performance and crease stiffness (see Appendix A and Appendix B):

Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents:

This document is proposed by China Light Industry Federation:

This document is under the jurisdiction of the National Paper Industry Standardization Technical Committee (SAC/TC141):

This document was drafted by: Ningbo Asia Pulp and Paper Co:, Ltd:, Zhejiang Hengda New Materials Co:, Ltd:, Anhui Huabang Gulou New Materials Co:, Ltd:, Zhejiang Kaifeng New Materials Co:, Ltd:, Xianhe Co:, Ltd:, Asia Pacific Senbo (Shandong) Pulp and Paper Co:, Ltd:, Shandong Jinmai Material Technology Co:, Ltd:, Huabang Gulou New Materials Co:, Ltd:, China Pulp and Paper Research Institute Co:, Ltd:, Medium and Light Paper Products Inspection and Certification Ltd:

The main drafters of this document: Wang Xinting, Zhou Xuelin, Yi Fortune, Tang Shengde, Wang Junming, Hu Caiwei, Hu Jiangtao, Liu Xiangbo, Yang Heng, Zhao Xinmin, Huang Xueying, Ding Pengxiang, Men Junyan, Wang Gang, Yang Jianqing, Yang Gang, Hu Dinggen, Yasuda Tian, Zhang Qi, Wu Minzhe, Yuan Taojing, Feng Yafang, Wen Jianyu, Liu Yang:

The previous versions of this document and the documents it replaces are as follows:

— First published as GB/T 35594-2017 in:2017;

— This is the first revision:

Paper and cardboard for pharmaceutical packaging

1 Scope

This document stipulates the classification, raw material requirements, technical requirements, inspection rules and markings, packaging, transportation, storage and Describes the corresponding test methods:

This document applies to the production, inspection and sales of terminally sterilized medical packaging paper and cardboard for pharmaceutical packaging:

2 Normative reference documents

GB/T 450

GB/T 451

GB/T 451

GB/T 454

GB/T 455

GB/T 456

GB/T 457-2008

GB/T 458-2008

GB/T 462

GB/T 465

GB/T 465

GB/T 1540

GB/T 1541

GB/T 1545-2008

GB/T 2678

GB/T 2678

GB/T 2828

GB 4789

GB/T 6682

GB/T 7974

GB/T 10335

GB/T 10335

GB/T 10342

GB/T 10739

GB/T 12914

GB 14934

GB/T 19633

GB/T 22364-2018