ISO 11040-6:2019
Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only.
This document also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Polymer barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.
Components to complete the subassembled syringe, such as plunger and rod, are not specified in this document.
Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.
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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 Dimensions and designation
5.1 Design including dimensions
5.2 Design requirements
5.2.1 Head design
5.2.2 Dead space
5.2.3 Functional testing of Luer cone/Luer lock connection
5.2.4 Flange breakage resistance
5.2.5 Syringe tip breakage resistance
6 Requirements
6.1 General
6.2 Material
6.2.1 General
6.2.2 Duty of notification concerning modifications to polymers
6.2.3 Needle
6.2.4 Closure system
6.2.5 Closure system integrity
6.3 Physical requirements
6.3.1 Sterilization
6.3.2 Clarity and transparency
6.3.3 Particulate contamination
6.3.4 Lubricants
6.4 Chemical requirements
6.5 Endotoxins and biological requirements
7 Graduation
8 Packaging and 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) Evaluation of syringe lubrication by glide force test method
Annex F (informative) Needle penetration test
Annex G (normative) Test methods for syringe closure systems
Annex H (informative) Dye solution tightness test
Annex I (informative) Guidance on materials
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 Dimensions and designation
5.1 Design including dimensions
5.2 Design requirements
5.2.1 Head design
5.2.2 Dead space
5.2.3 Functional testing of Luer cone/Luer lock connection
5.2.4 Flange breakage resistance
5.2.5 Syringe tip breakage resistance
6 Requirements
6.1 General
6.2 Material
6.2.1 General
6.2.2 Duty of notification concerning modifications to polymers
6.2.3 Needle
6.2.4 Closure system
6.2.5 Closure system integrity
6.3 Physical requirements
6.3.1 Sterilization
6.3.2 Clarity and transparency
6.3.3 Particulate contamination
6.3.4 Lubricants
6.4 Chemical requirements
6.5 Endotoxins and biological requirements
7 Graduation
8 Packaging and 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) Evaluation of syringe lubrication by glide force test method
Annex F (informative) Needle penetration test
Annex G (normative) Test methods for syringe closure systems
Annex H (informative) Dye solution tightness test
Annex I (informative) Guidance on materials
Bibliography