Close to the Body, Good for the Patient: ZwickRoell Offers Complete System for Standard-Compliant Testing of Wearable Autoinjectors
They are called on-body delivery systems (OBDS), wearable autoinjectors, or simply wearables. While their names may vary, they ultimately refer to the same thing: devices that automatically administer highly viscous biologic drugs, while attached to the patient’s body. In the fast-growing market for biotechnological applications, machine manufacturer ZwickRoell now offers a customized, comprehensive solution for all tests performed in accordance with the ISO 11608-6 standard.
OBDS have clear benefits
“Persons suffering from an illness are likely to recover faster in a familiar environment— in other words, at home. For chronically ill patients, shortening the healing process is of particular significance and autoinjectors worn on the body can help. They not only reduce the cost of long-term therapies; they also have the ability to promote patient comfort by allowing them to set up and undergo treatment in their own surroundings. These systems reduce frequent visits to a clinic or doctor’s office for required injections that would otherwise have to be administered by qualified personnel,” explains Heiko Haller, Business Development Manager - Medical Industry at ZwickRoell.
The benefits provided by injection systems securely attached to the patient’s body (on-body delivery systems) are clear: they reduce possible risks that result from administration of medicines through more commonly used needle-based injection systems. In addition, they are capable of optimally dispensing drug volumes ranging from 2 ml to 20 ml, in different time intervals from as little as a few seconds up to several hours. This form of therapy is ideal for daily self-treatment and can be implemented without having to spend time in a medical facility. The adhesive side of the injection system is attached directly to the patient’s skin, and the injection is administered through needle or cannula integrated in the device.
On-body delivery systems: ZwickRoell develops sequential testing solution
All the while, in today’s OBDS market—which is growing over 20% annually—manufacturers face a number of challenges when it comes to developing large-volume injectors. More specifically, ISO 11608-6 requires them to test the forces that result during the injection process due to the viscosity of the drug, the high volume, the injection time, the internal diameter of the syringe and needle, the needle length, and the occurring frictional forces (including static friction).
ZwickRoell has responded to this requirement by applying their many years of experience in materials testing and collaborating with customers in the pharmaceutical industry and autoinjector device manufacturers to develop a sequential testing solution for on-body delivery systems. The solution is based on the zwickiLine 2.5 kN static testing machine. With a number of newly designed adaptations, the machine now measures the force required to trigger the actuation button, as well as the injection depth, injection time, and the amount of liquid delivered using a high-resolution, camera-based measuring system. An integrated camera records the process to verify how the sequences of the display elements react and documents the audible signals (clicking sounds) of the injection system via a microphone.
In a second test area, the testing machine optionally supports additional tests, such as determining the adhesion force of the bonding surface.
Traceability of the test results is important for quality control
Another advantage of ZwickRoell’s comprehensive solution is the corresponding test sequence for their testXpert testing software. It not only documents the obtained results, but also quickly displays them in a clearly presented format. For maximum transparency, secure traceability for validation, and quality control, the machine performs the tests reliably and according to the required standards. Why this is important: in the biotechnology sector and the pharmaceutical industry, it is imperative to know who did what, when and why, and who is responsible. Every action must be documented in a tamper-proof and traceable manner according to FDA CFR Part 11.
Haller has no doubt about the success of this new testing solution: “Throughout the machine development process, we accounted for every requirement specification included in the standard, and are therefore able to provide a very good and complete solution for the development of autoinjectors for cancer treatment therapies, autoimmune diseases and neurological disorders.” And he adds: “This is very close to meeting every customer requirement and is ultimately intended to benefit the patient.”
