A globally operating pharmaceutical company partners with innovators in the fields of pharmacy, biotechnology and consumer health, for the development, manufacture and delivery of high-quality products. One of the company’s sites specializes in manufacturing of sterile, injectable drugs. For testing of these products, the company relies on ZwickRoell and thereby, on reliable test results.
For many years, certain medications have been made available in autoinjector systems so they can be injected easily and safely in case of an emergency. It goes without saying that quality control of these autoinjectors is paramount. Part of the quality control process is to determine proper function of the autoinjector itself. The force to remove the cap, the actuation force, measurement of injection time, injection depth and the dispensed volume, as well as the determination of blocking force of the needle shield are all parameters that must be tested. This ensures that the autoinjector can be easily and efficiently used in case of an emergency. To obtain reliable test results of these function tests, the globally operating pharmaceutical company relies on ZwickRoell.
ZwickRoell worked very closely with the customer to understand their needs and used this information to prepare a customized offer based on the specified requirements. According to these requirements, the autoinjector testing machine, which performs components testing sequentially and automatically on the same specimen was the perfect solution. These tests can also be performed individually, but this requires a lot of resources and is time consuming and prone to errors. With this system ̶ since the tests are performed in sequence ̶ operator influence is reduced to loading the specimen into the testing machine, and optimal repeatability is guaranteed.
The testing machine is equipped with a highly accurate Xforce load cell, a precise scale and an HD camera that can record the entire injection process. The complete system is controlled with testXpert III, ZwickRoell’s intelligent testing software, according to pharmaceutical industry requirements (FDA 21 CFR Part 11).
During a factory acceptance test at ZwickRoell in Ulm, Germany, a live final inspection of the machine’s operation was carried out and the different instrument settings were completed. The autoinjector testing machine was delivered on time and in accordance with all customer deadlines. Finally, installation and qualification of the machine were carried out at the customer site according to the strict requirements of the pharmaceutical industry. Since then, the customer has been successfully testing their autoinjectors with the leading autoinjector testing system from ZwickRoell.