ISO 11040-4:2024 PDF

Overview

ISO 11040-4:2024 - Prefilled syringes, Part 4 specifies requirements for glass barrels for injectables and sterilized subassembled syringes ready for filling. It covers materials, dimensional and design requirements, quality and performance criteria, and relevant test methods. The standard applies to single‑use tubing‑glass barrels (single‑chamber design) and sterilized subassembled syringes delivered to pharmaceutical manufacturers for filling. Components needed to complete the subassembled syringe (e.g., plunger stopper, plunger rod) are outside its scope. National/regional pharmacopeial rules (Ph.Eur., USP, JP) can also apply.

Key topics and technical requirements

• Design & dimensions: Specifies Luer slip/Luer lock front‑end dimensions and staked‑needle (SN) front ends to ensure interchangeability and compatibility with needles and adapters.
• Material & surface: Requirements for glass type and inner‑surface properties, including hydrolytic resistance, annealing quality and lubrication (including performance requirements for non‑lubricated syringes).
• Mechanical performance: Tests and limits for flange breakage resistance, front‑end (cone) breakage resistance, and specific requirements for staked needle syringes.
• Functional testing: Luer connection performance, glide/force characteristics, needle penetration and front‑end component tests, tightness and leakage assessments.
• Sterile subassembly requirements: Sterility, pyrogenicity/endotoxin limits, particulate matter control, documentation of raw materials and assembly, and additional component‑specific checks (needle, closure systems).
• Packaging & labelling: Requirements for sterile barrier systems (nests/tubs and sealing lids), packaging integrity, and labelling information for delivery to filling operations.
• Test methods & annexes: Normative and informative annexes provide test methods (Annex C, G), glide‑force, needle penetration, tightness, sample preparation for endotoxin and particulates, and examples of subassembled syringe types.

Applications and users

• Primary users: glass barrel manufacturers, syringe and component suppliers, and sterilized subassembly producers.
• Secondary users: pharmaceutical companies (filling/assembly lines), quality assurance/regulatory teams, and equipment manufacturers for filling and automated injectors.
• Practical uses: product design/specification, supplier qualification, quality control testing, regulatory compliance, and ensuring compatibility with filling/closure systems.

Related standards

• ISO 720; ISO 4802‑1 / 4802‑2 (hydrolytic resistance)
• ISO 7864 (hypodermic needles)
• ISO 8871‑1 (elastomeric parts)
• ISO 9626 (needle tubing)
• ISO 10993‑1, ISO 10993‑7 (biological evaluation, EtO residuals)

Keywords: ISO 11040-4:2024, prefilled syringes, glass barrels, sterilized subassembled syringes, injectables, Luer, staked needle, hydrolytic resistance, sterility, test methods.