The market for pre-filled syringes is growing steadily. This development is reflected in the growth of biological and complex active ingredients as well as in the increasing requirements of patients and nursing staff. Experts estimate that this market will double to approximately 6 million units by 2024.* The increasing production numbers also affect quality control. The pharmaceutical industry is increasingly looking for reliable testing solutions that are also economical.
ZwickRoell offers a special test fixture in conjunction with a semi-automatic feeding system for testing such pre-filled syringes. This test fixture is used to determine the breakaway force and glide force of syringes, syringe cartridges, and similar dosimeters. The test is based on the following standards: DIN EN ISO 7886 -1, DIN EN ISO 11499 and ISO 11040-4. The breakaway force and glide force are important parameters used to select the most suitable syringe. These forces may not exceed or fall below certain limits to ensure that a safe drug dose is administered. In addition to the friction in the syringe, the forces are influenced by the viscosity of the drug and the size of the cannula. To reducer operator influence (MSA 3/Gauge R&R Type 3) when simultaneously increasing the clock frequency, the test fixture can be combined with a semi-automatic feeding system. This rotation magazine holds up to 15 syringes and isversatile since the fixture can be used for various syringe diameters. By using a second rotation magazine on the the same machine, the cap removal force can also be determined before the glide force.