The number of people who live with diabetes is on the rise. By estimates of the World Health Organization (WHO), one in eleven people are affected by the disease. This makes the auto-injector market one of the fastest growing subsets of the pharmaceutical industry, with a predicted market volume of over $2.5 billion by 2020. Moreover, with the rise of biologic and sustained release drugs, the market will see an even greater demand for auto-injectors in the near future.
Strict regulations by the FDA for these Class II devices mean that testing to ISO 11608-5 is a critical step for manufacturers to ensure the quality and safety of their products. Whether testing is managed in-house or handled by a contract testing laboratory, for one or for many different product designs, these organizations are turning to testing platforms that are both versatile and comprehensive. Testing must support manufacturing protocols and industry regulations, while maintaining absolute accuracy and reducing time to market.
As a result, concepts used in modern manufacturing have shaped product development at ZwickRoell. Best practices from lean manufacturing and other supporting methods rooted in quality management systems are part of the ZwickRoell design process. Features based on poka-yoke principles help auto-injector producers manage high volumes while maintaining compliance with GMP standards and FDA regulations, and reduce the potential for costly errors.
Poka-yoke systems, first established in Japan by Toyota, prevent inadvertent errors made by workers performing a process. Companies have benefited from implementing such systems because they are able to eliminate set-up errors and decrease set-up times to boost production throughput, improve quality, increase safety, and lower costs. Implementing this type of “mistake proofing”, as it is sometimes called, has never been more crucial in the pharmaceutical and medical device industries, as companies strive to ensure compliance with regulatory requirements while providing next generation products on which patients can rely.
In a high throughput testing environment, such as the manufacture of auto-injectors, multiple operators use the testing system over the course of a production period. The gathered results are then evaluated to make decisions on product quality. Reducing the steps required to set up and run tests improves efficiency and substantially minimizes the potential for inadvertent human error.
One example of this is the barcode and Bluetooth integration feature ZwickRoell has introduced to ensure consistent selection of jaw faces and grips when running tests, because every auto-injector has a slightly different design and requires a unique test setup. First, the correct jaw face and grips are selected and their configuration is saved in the testXpert III software so it is impossible to start a test with the wrong jaw face. Then, a Bluetooth transmitter in the auto-injector testing system works together with a special barcode reader to help the operator simplify test setup. Before the operator starts the test, the testXpert III testing software specifies the exact tooling needed for that particular test and auto-injector. The operator pulls the corresponding grips and uses the barcode to scan the jaw face. testXpert III then validates the selection of the correct configuration, allowing the test to continue. If the operator chooses the wrong grip, the software does not allow the test to start and prompts the operator to choose the grip that corresponds to the type of auto-injector being tested. Grips and jaw faces are also color-coded to visually aid in selection of the right tooling.
A typical market solution is a semi-automated testing machine that requires an operator to load the test specimen, close the safety door, and start the test. From that point forward, all steps in the test sequence are carried out automatically by the machine within just a few minutes per injector. As a leader in the market, ZwickRoell also offers a robot-driven fully automated testing system.
The roboTest R specimen handling system removes the auto-injector from the cartridge and inserts it into the testing machine. This solution removes the risk of errors caused by operator influence."
ZwickRoell’s fully automated solution is an efficient system that measures the dosage setting, activation force, glide force, and specified dosage in one continuous process. roboTest R is controlled by ZwickRoell’s automation software, AutoEdition2. The software directs the robot to remove insulin pens one by one from the magazine, feed them into the testing machine, and start the test. Test results are accurate because operator influence is minimized and the test process is significantly more efficient because of increased specimen throughput.
The testing system can perform a variety of tests to check the pen's mechanical function with or without the drug. Along with force and torque, it measures the activation force with the utmost precision. When testing prefilled pens, an integrated high-resolution scale is used to measure the dosing accuracy to DIN EN ISO 11608-1. The testXpert III testing software, together with the Expanded Traceability option to FDA 21 CFR Part 11, makes it possible to create documentation for the testing process that is complete and tamper proof.
Growth in market demand for auto-injectors is placing greater emphasis on throughput. Yet accurate test results are critical when it comes to patients’ health. This challenge has motivated manufacturers to seek solutions that streamline and automate the testing process without sacrificing accuracy, repeatability, reproducibility and traceability. Implementation of mistake-proofing mechanisms ensures consistency in testing programs, further elevating accuracy in measurement and supporting excellence in manufacturing in alignment with GMP standards and FDA regulations.