ISO 11040-8:2016
Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
ISO 11040-8:2016 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040‑4 or ISO 11040‑6, together with ISO 11040‑5, for parenteral injection preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods.
Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of ISO 11040-8:2016.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 User requirements
4.1 Definition of intended use
4.2 Risk management
4.3 Application of usability engineering
5 System characterization
5.1 Critical dimensions
5.2 Description of components and materials
5.2.1 General
5.2.2 Barrel
5.2.3 Plunger stoppers
5.2.4 Additional components
5.3 Description of the content of the finished prefilled syringe
6 Performance requirements
6.1 General
6.2 Break loose and extrusion forces
6.3 Burst resistance
6.4 Break resistance
6.5 Closure system forces and torques
6.6 Connectivity with fluid path connectors
6.7 Residual volume
6.8 Needle penetration force
6.9 Needle pull-out force
6.10 Sharps injury protection requirements
6.11 Liquid leakage beyond plunger
6.12 Markings
7 Pharmaceutical requirements
7.1 General
7.2 Drug-container interaction
7.3 Biological requirements
7.4 Container closure integrity
7.5 Deliverable volume
7.6 Particles (visible and subvisible)
8 Documentation
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 User requirements
4.1 Definition of intended use
4.2 Risk management
4.3 Application of usability engineering
5 System characterization
5.1 Critical dimensions
5.2 Description of components and materials
5.2.1 General
5.2.2 Barrel
5.2.3 Plunger stoppers
5.2.4 Additional components
5.3 Description of the content of the finished prefilled syringe
6 Performance requirements
6.1 General
6.2 Break loose and extrusion forces
6.3 Burst resistance
6.4 Break resistance
6.5 Closure system forces and torques
6.6 Connectivity with fluid path connectors
6.7 Residual volume
6.8 Needle penetration force
6.9 Needle pull-out force
6.10 Sharps injury protection requirements
6.11 Liquid leakage beyond plunger
6.12 Markings
7 Pharmaceutical requirements
7.1 General
7.2 Drug-container interaction
7.3 Biological requirements
7.4 Container closure integrity
7.5 Deliverable volume
7.6 Particles (visible and subvisible)
8 Documentation
Bibliography