ISO 11040-4:2015
Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
ISO 11040-4:2015 applies to
- tubing-glass barrels (single-chamber design) for injection preparations, and
- sterilized subassembled syringes ready for filling.
It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only.
Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040‑4:2015.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Quality systems
4.2 Testing
4.3 Documentation
5 Syringe barrel
5.1 Design including dimensions
5.2 Functional testing of Luer connection
5.3 Material
5.4 Performance requirements
5.4.1 Hydrolytic resistance
5.4.2 Annealing quality
5.4.3 Lubrication of the inner surface
5.4.4 Flange breakage resistance
5.4.5 Luer cone breakage resistance
6 Sterilized subassembled syringes ready for filling
6.1 General
6.2 Sterility
6.3 Pyrogenicity/endotoxins
6.4 Particles
6.5 Additional requirements to specific components of sterilized subassembled syringes ready for filling
6.5.1 Barrel
6.5.2 Needle
6.5.3 Closure system
6.6 Closure system barrel integrity
7 Packaging
8 Labelling
Annex A (informative) Examples of types of sterilized subassembled syringes ready for filling
Annex B (informative) Head designs
Annex C (normative) Test methods for syringe barrels
Annex D (informative) Sample preparation for endotoxin and particulate determination
Annex E (informative) Glide force test method to evaluate syringe lubrication
Annex F (informative) Needle penetration test
Annex G (normative) Test methods for closure systems
Annex H (informative) Dye solution tightness test
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Quality systems
4.2 Testing
4.3 Documentation
5 Syringe barrel
5.1 Design including dimensions
5.2 Functional testing of Luer connection
5.3 Material
5.4 Performance requirements
5.4.1 Hydrolytic resistance
5.4.2 Annealing quality
5.4.3 Lubrication of the inner surface
5.4.4 Flange breakage resistance
5.4.5 Luer cone breakage resistance
6 Sterilized subassembled syringes ready for filling
6.1 General
6.2 Sterility
6.3 Pyrogenicity/endotoxins
6.4 Particles
6.5 Additional requirements to specific components of sterilized subassembled syringes ready for filling
6.5.1 Barrel
6.5.2 Needle
6.5.3 Closure system
6.6 Closure system barrel integrity
7 Packaging
8 Labelling
Annex A (informative) Examples of types of sterilized subassembled syringes ready for filling
Annex B (informative) Head designs
Annex C (normative) Test methods for syringe barrels
Annex D (informative) Sample preparation for endotoxin and particulate determination
Annex E (informative) Glide force test method to evaluate syringe lubrication
Annex F (informative) Needle penetration test
Annex G (normative) Test methods for closure systems
Annex H (informative) Dye solution tightness test
Bibliography