Glass Syringe Testing per ISO 11040-4
Pre-filled glass syringes are most commonly tested to ISO 11040-4 standards. As glass syringes are more susceptible to failure than plastic syringes, a wider variety of tests are required to be performed on them. Within ISO 11040-4 there are a total of 10 annexes, each requiring a different mechanical test. The annexes in ISO 11040-4 are as follows: Annex C.1 for flange breakage resistance, Annex C.2 for Luer cone breakage, Annex E.1 for glide force, Annex F.1 for needle penetration, Annex G.1 for needle pull-out force, Annex G.2 for liquid leakage testing, Annex G.3 for Luer lock collar pull-off, Annex G.4 for Luer lock collar torque, Annex G.5 for Luer tip cap unscrewing torque, and Annex G.6 for pull-off force of the needle shield.
ISO 11040-4 includes testing requirements for both glass syringes with needles adhesively bonded and glass syringes that utilize a Luer mechanism for attaching needles. While glass syringe manufacturers and pharmaceutical companies need only to test the annexes that are applicable to their end product, many companies are required to follow all of them. To simplify the test system required to perform both axial and torsional tests, and to simplify the number of fixtures required to meet all annex requirements, we offer the Torsion Add-On for all 6800 Series table model universal testing systems in addition to several modular fixtures that can be combined to meet all testing requirements in ISO 11040-4. Given the brittle failure of glass, we also offer a sleek protective shield that can be integrated into all fixtures for tests that require the glass syringe be taken to failure.