Case study
BS ISO 11040-4Pre-filled Syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
This part of ISO 11040 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. Relevant mechanical strength testing methods include: Syringe Barrel tests (C.1 Flange Breakage Resistance C.2 Luer Cone Breakage Resistance), E.1 Glide Force Test to evaluate syringe lubrication, F.1 Needle Penetration Test, G.1 Needle Pull-out Force, G.2 Closure system Liquid Leakage Test using compression tester, G.3 Luer-lock Adaptor Collar Pull-off Force and G.4 Torque Resistance, G.5 Luer-lock rigid tip cap Unscrewing Torque, G.6 Pull-off force of the tip cap or the needle shield
