T/SHBX 011-2021 Active Group standards

T/SHBX 011-2021 Bioprocessing high-barrier, puncture-resistant plastic multilayer film for use in biotechnology

Publish Date: 2021-12-22 Implement Date: 2021-12-30 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SHBX 011-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Plastic profiles

ICS Name: Films and sheets

Publish Date: 2021-12-22

Implement Date: 2021-12-30

Pages: 12 pages

Scope

This document sets out the production and technical requirements for the membrane materials used in single-use systems in biotechnology processes, including single-use storage systems, single-use dosing systems, single-use aseptic sampling systems, and single-use formulation filling systems.
This document is applicable to the production and quality control of membrane materials for single-use systems in biotechnology processes.

Development Information

Word Count: 20 Thousand words Pages: 12 pages

Referenced Standards

GB/T 2828.1-2003 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 2828.1-2012 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 6672-2001 Plastics film and sheeting—Determination of thickness by mechanical scanning YBB 00082003-2015 Test for Gas Transmission YBB 00092003-2015 Test for Water Transmission YBB 00112003-2015 Test for Tensile Properties YBB 00122003-2015 Test for Welding Strength T/CNPPA 3005-2019 Guidelines for Quality Management of Drug Package Materials Production 中华人民共和国药典　2020年版四部化学药品注射剂生产所用的塑料组件系统相容性研究技术指南(试行)(国家药监局药审中心　2020年第33号) ISO 10993-4 ISO 9001 ASTM D-5026 ASTM D-882 ASTM F-1306 ASTM F-392 USP〈87〉 USP〈88〉 USP〈661〉 BPOG生物制药一次性使用系统浸出物风险评估最佳规范指南 BPOG一次性组件可提取物研究最佳规范指南