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Pharmaceutical and Medical Industry Increasingly Demands Automated Testing Solutions

ZwickRoell


After the manufacturing processes in pharmaceutical and medical industries reached a high level of automation in recent years, manufacturers are more committed to automating their testing processes as well. Production-related tests as well as tests for product release are to be largely automated. In addition to higher specimen throughput, an increase in reproducibility through the elimination of operator influence is a main objective for manufacturers. Zwick Roell offers various levels of automation for testing syringes, insulin pens, and auto injectors.

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.

Zwick Roell 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.

The test is controlled and evaluated via the testXpert III software, enabling all requirements of the expanded Traceability to be met according to FDA 21Part 11. The testing system can also be equipped with a precision scale that can be used to determine the escaping drug amounts in addition to the breakaway/glide force. To support the validation of the testing machine, Zwick can perform a complete qualification (DQ/IQ/OQ).
phone +49 7305 100
email info@zwick.com
web www.zwick.com/medical
email August-Nagel-Strasse 11, 89079, ULM, Germany
 
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