Wolfgang Moersch, international marketing manager for manufacturer ZwickRoell, explains how manufacturers could reduce the testing steps required for autoinjectors whilst maintaining accuracy.
Across all pharma applications, the auto-injector market is one of the fastest growing sectors. By 2020, global market volume of approximately US $2.5 billion (£1.9 billion) is expected, and auto-injectors represent the largest segment of this.
Strict regulations of these class II devices means that testing is a critical step for manufacturers to ensure both product quality and safety. Testing can be managed in-house or by a contract testing laboratory, for one or for many different product designs. Additionally, testing must support manufacturing protocols and industry regulations, whilst also focusing on accuracy and reducing time to market.
“Manufacturers need solutions that help them test complete device functionality on a single platform in an all-in-one test,” explains Erik Berndt, medical industry manager at ZwickRoell. “Market demand and growing expectations when it comes to time to market, mean our customers are operating in high-throughput environments where there is no margin for error. After all, patients everywhere are depending on reliable test results.”
The patients‘ dependency on these tests being both reliable and thorough is why pharma companies strive to achieve a high level of automation with auto-injector technology. The injection process is completely automated as the patient is able to simply remove the safety cap, position the injector, and inject the drug by the press of a button. Therefore, this means that all of the injector’s relevant functions must be checked before the production batch is released on to the market. “During our discussions with pharma companies, we identified a need for one testing system that could perform all standard tests,” says Berndt.
The standard tests typically consist of:
1. Removal force of the safety cap
2. Activation force and displacement
3. Injection time
4. Determination of the administered drug volume, including the last drops
5. Effective needle length
6. Safety function of the needle guard
Other optional testing steps may also be conducted.
Zwick Roell created a solution which combines these six testing steps in to a two-column universal testing system with a safety device which incorporates non-contact sensors that are able to measure the injection time and the effective needle length by means of light barriers. Additionally, an integrated scale is able to measure the quantity of the administered drug. This ZwickRoell solution is able to perform all of these test steps on just one specimen. As a result, this reduces the number of specimens required and increases throughput.
A typical market solution is a semi-automated testing machine that requires an operator to load the specimen, close the safety door, and start the test. From that point forward, all steps in the test sequence are able to be carried out automatically by the machine within just a few minutes per injector. ZwickRoell also offers a robot-driven fully automated testing system. “The roboTest specimen handling system removes the auto-injector from the storage magazine and inserts it into the testing machine. This solution removes the risk of operator error,” explains Berndt.
ZwickRoell’s fully automated solution is an efficient system that can measure up to 10 different parameters in one continuous process. ZwickRoell’s roboTest is controlled by automation software, AutoEdition 3, which directs the robot to remove the injectors one by one from the magazine, feed them into the machine, and start the test.
As the operator influence is minimised the results are thought to be accurate. Additionally, the process is significantly more efficient because of increased specimen throughput. The ZwickRoell testXpert III testing software, together with the expanded traceability option makes it possible to create documentation for the testing process that is complete and tamperproof.
Growth in market demand for auto-injectors is placing greater emphasis on throughput. Yet accurate test results are critical when it comes to patient health. This challenge has motivated manufacturers to seek solutions that streamline and automate the testing process without sacrificing accuracy, repeatability, reproducibility and traceability. The implementation of error-proofing mechanisms ensures consistency in testing programs, further elevates accuracy in measurement and supports excellence in manufacturing in alignment with stringent international standards and regulations.