ISO 21881:2019
Sterile packaged ready for filling glass cartridges
This document specifies the characteristics of sterile and ready for filling empty glass cartridges for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system
4.1 General
4.2 Testing
5 Process description and requirements
5.1 Washing
5.2 Drying
5.3 Lubrication
5.4 Capping and crimping
5.5 Plunger insertion
5.6 Packaging
5.7 Sterilization
6 Requirements for glassware
6.1 General
6.2 Material
6.3 Dimensions
6.4 Particles
6.4.1 Visible particles
6.4.2 Sub-visible particles
6.5 Bacterial endotoxin level
7 Requirements for packaging system
7.1 General
7.2 Nest and tub configuration
7.3 Tray configuration
7.4 Nest
7.5 Tub and tray
7.6 Insert liner
7.7 Sealing lid
7.8 Protective bag
7.9 Information to be provided by the manufacturer
8 Marking of the tub or tray
9 Labelling
Annex A (informative) Design of tub
Annex B (informative) Design of nest
Annex C (informative) Design of tray
Annex D (normative) Glide force test method to evaluate cartridge lubrication
Annex E (informative) Schematic illustrations of examples for the orientation of tubs or trays within the protective bag
Annex F (normative) Closure systems liquid leakage
Annex G (informative) Sample preparation for endotoxin and particulate determination
Annex H (informative) Product and packaging configuration
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system
4.1 General
4.2 Testing
5 Process description and requirements
5.1 Washing
5.2 Drying
5.3 Lubrication
5.4 Capping and crimping
5.5 Plunger insertion
5.6 Packaging
5.7 Sterilization
6 Requirements for glassware
6.1 General
6.2 Material
6.3 Dimensions
6.4 Particles
6.4.1 Visible particles
6.4.2 Sub-visible particles
6.5 Bacterial endotoxin level
7 Requirements for packaging system
7.1 General
7.2 Nest and tub configuration
7.3 Tray configuration
7.4 Nest
7.5 Tub and tray
7.6 Insert liner
7.7 Sealing lid
7.8 Protective bag
7.9 Information to be provided by the manufacturer
8 Marking of the tub or tray
9 Labelling
Annex A (informative) Design of tub
Annex B (informative) Design of nest
Annex C (informative) Design of tray
Annex D (normative) Glide force test method to evaluate cartridge lubrication
Annex E (informative) Schematic illustrations of examples for the orientation of tubs or trays within the protective bag
Annex F (normative) Closure systems liquid leakage
Annex G (informative) Sample preparation for endotoxin and particulate determination
Annex H (informative) Product and packaging configuration
Bibliography