Busting the No.1 Automation Myth: Automation = Robot
The most common misconception when it comes to automation is that it requires the use of a complex system with an integrated robot that is big and expensive. In reality, automation—which refers to “the application of technology, programs, robotics or processes to achieve outcomes with minimal human input” (IBM)—does not always equal robot.
For functional tests on medical injection devices, the differences between the possible means to achieve outcomes with minimal human interaction can be as extreme as the complexity gap between a bike and a car: the best solution depends on where you want to go and the most efficient way to get there. This means, for example, that automation can:
- Provide significant benefits starting with a single specimen, or
- Handle 24/7 testing with a throughput up to 500 specimens in a single test run (in this case, automation = robot),
- Present a system ROI of as little as 1-2 years
- Require minimal use of lab space
Consider an autoinjector test, for example, and the fact that all parts of the device must work together seamlessly to 1: meet strict pharma industry standards and 2: ensure proper delivery of the exact amount of necessary medication to the patient. Industry standard ISO 11608-5 requires testing of every device component and function, including:
- Safety cap removal (where testing in both upward and downward direction is a bonus)
- Injection activation force
- Effective needle length/injection depth
- Injection time
- Injection volume (including last drop measurement)
- Needle safety force
Every step can be tested on a single specimen in a semi-automatic single sequential multi-stage function test, a process that in the past was performed with a separate specimen for each required test result. Automation achieved with an easy-to-use machine test fixture, therefore, reduces the number of specimens needed for quality assurance, reduces overall testing costs, and increases the accuracy of results by eliminating operator interference.
Depending on your needs, automation solutions also offer the option to automatically test injection devices in parallel. You can, for example, test the plunger glide force over an extended period of time in drug delivery systems used in syringe drivers (e.g., syringe pumps used in hospitals). Assume one of these tests takes 2 hours. If you run 8 tests in parallel, a test sequence that would normally take 16 hours is now taking 2—without the need for operator intervention and the increased possibility of errors after each result.
Another favorable, non-complex option is automated serial testing of multiple syringes in a carousel magazine. Additionally, you can use two carousels—one in the upper test area of a materials testing machine for safety cap removal tests and the other in the lower test area for plunger glide force tests, for example. This gives you the option to decrease the overall testing time and increase test accuracy. Here, depending on the type and size of syringe, it makes sense to load anywhere from 2 to 15 syringes (more if needed) in a rotating magazine and press a button to run the test series. While easy to use, this solution reliably helps to minimize user influence. The number of specimens tested in a single serial run can be further increased using an X-Y table system that can house a magazine rack holding 64 specimens, a number that can also be further increased depending on your needs.
Serial and parallel approaches can be very helpful for automated tests on syringes, cartridges, and vials with fairly specific throughput requirements. They guarantee optimal efficiency and the highest level of accuracy and cost-effectiveness with reliable and tamperproof results. These systems also provide additional advantages:
- Specimens are evenly fed into the testing machine for result repeatability
- Standard deviations in test results are reduced by minimizing operator influence
- Measurement uncertainty is reduced, improving the reproducibility of test results
The next level of automation may then involve a robot, also referred to as automated handling system. As stated before, it’s important to keep in mind that robots vary in size, capability, and complexity and should therefore no longer be categorized as unattainable. Automated solutions are available in all sizes and can benefit your testing processes whether you have low or high specimen throughput requirements.
Automation at all levels reduces operator influences and human error and increases test result accuracy and repeatability. With the reduction of test errors, the freedom of moving highly qualified employees to less repetitive and time-consuming tasks, the significant reduction of drug delivery device waste, and the added benefit of getting the right results the first time increases overall efficiency of your testing processes—regardless of your level of automation!
ZwickRoell’s testXpert testing software brings it all home. As you embark on your automated testing journey, think of the software as your GPS—making sure that you get to your final destination along the most efficient and correct route possible. Wherever you’re going, ZwickRoell will get you there!
For information on materials testing and ongoing trends for drug delivery systems, we invite you to download our latest whitepaper Must Know Trends for Drug Delivery Systems – And the Crucial Role of Materials Testing.