GB/T 21709.14-2009
Active
T/CNPPA 3023-2023
Active
Group standards
T/CNPPA 3023-2023 Application guide for moist heat sterilization bag for pharmaceutical packaging materials
T/CNPPA 3023-2023 Application guide for moist heat sterilization bag for pharmaceutical packaging materials
Price:
$ 46.00
Basic Information
Standard Code:
T/CNPPA 3023-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
\nLogo, packaging, transportation, storage
ICS Name:
Pharmaceutical Science
Publish Date:
2023-10-07
Implement Date:
2023-10-07
Pages:
28 pages
Scope
This document provides the technical requirements, test methods, packaging, labeling, marking, and storage for wet heat sterilization packaging bags used for pharmaceutical packaging materials (hereinafter referred to as packaging bags). This document is applicable to packaging bags for wet heat sterilizable pharmaceutical packaging materials, including pre-sealed components, rubber seals, aluminum caps, and their components, etc.
Development Information
Referenced Standards
GB/T 451.2-2002 Paper and board—Determination of grammage
GB/T 454-2020 Paper—Determination of bursting strength
GB/T 455-2002 Paper and board determination of tearing resistance
GB/T 458-2008 Paper and board—Determination of air permeance
GB/T 2410-2008 Determination of the luminous transmittance and haze of transparent plastics
GB/T 4744-2013 Textiles—Testing and evaluation for water resistance—Hydrostatic pressure method
GB/T 6672-2001 Plastics film and sheeting—Determination of thickness by mechanical scanning
GB/T 6673-2001 Determination of length and width of plastics film and sheeting
GB/T 12914-2018 Paper and board—Determination of tensile properties—Constant rate of elongation method(20 mm/min)
GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes
YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer
YY/T 0681.4-2021 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
YY/T 0681.10-2011 Test methods for sterile medical device package—Part 10:Test for microbial barrier ranking of porous package material
T/CNPPA 3017-2021 Guidelines for the study of self-stability of plastic and rubber type drug packaging materials
中华人民共和国药典(2020年版)
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