Osteoporosis patients can use a small transdermal patch to inject a bone-building biological substance directly under their skin. A six-axis Stäubli TX2-40 Stericlean robot plays a central role in coating the microneedles with the active ingredient – all under aseptic conditions.
A medical device manufacturer was looking to partner with a systems integrator to implement an ambitious project: a fully automated system for dip coating microneedle-based transdermal devices under aseptic conditions. A Stäubli Stericlean robot played a central role in the resulting system.
Kindeva Drug Delivery is a world-leading product development and manufacturing firm based in Minnesota that specializes in drug delivery systems. One of the devices it has developed is a microneedle-based transdermal injection system used for, among other things, self-administering abaloparatide, a biologic API (active pharmaceutical ingredient) that stimulates bone formation in osteoporosis patients.
Because abaloparatide cannot be sterilized, the devices must be coated and packaged entirely under cleanroom conditions (ISO Class 5). The goal was to develop a fully automated system that can be housed in an aseptic isolator.
With this objective in mind, Kindeva turned to Keller Technology, a systems integrator with experience in robotic applications in the biotech and pharmaceutical sectors.
For the engineers at Keller, there was never any doubt that Stäubli Stericlean robots, designed from the ground up for use in cleanroom environments, were the right choice for this project. They developed a robot cell with a six-axis TX2-40 robot, which handles both the dip coating and primary packaging – both inside of an aseptic isolator.
The robot’s high degree of precision is critically important in the dip-coating stage. The gripper picks up the individual devices and dips them into the coating bath, ensuring that the microneedles are completely covered with the biological API. This process is painstakingly calibrated to achieve an even coating on each unit. The robot then lifts the coated device out of the bath, sets it back down on the tray, and repeats the procedure with the next device. Full trays are transferred to a sealing station that Keller developed especially for this project, thus completing the sterile primary packaging process.
The isolator is equipped with a monitoring system that instantly detects septic antigens and triggers an alarm. It also provides laminar airflow, maintaining constant air speed and direction. All system components are designed to minimize any disruptions to this airflow – including the sleek, completely enclosed housing of the Stericlean robot. Its contours prevent the formation of eddies, dead spots and shadows where antigens could accumulate.
The most essential feature of this robot cell is that the risks associated with exposure of a biologic API like abaloparatide during the dip-coating stage are reliably eliminated. Keller developed and integrated the custom-tailored coating and packaging system into an aseptic isolator to maintain sterile conditions and ensure that the product is fully protected from contamination. The Stericlean robot’s design, which has proven its worth in numerous sensitive pharmaceutical applications, provides additional safety – protecting operators, products, and ultimately patients as well.
In addition to extensive safety precautions at each step of the production process, the robot-based automation system also provides the high speed and efficiency that Kindeva needed to reduce the time to market for its transdermal abaloparatide delivery system. The automated solution also ensures reliable traceability. Kindeva will enjoy these benefits throughout the system’s lifespan.