Weston Medical Group PLC (Cambridge, U.K.), a manufacturer of medical products, recently introduced a prefilled, disposable, needle- free drug injector. Called Intraject, the device uses a pressure of 160 bar to inject drugs directly through the skin. It can replace conventional syringes in many applications. And because the injections are subcutaneous, the risk of infection is also lessened.

Intraject is preloaded with the required medication, offering patients the convenience of self-medication at home without having to learn special injection techniques. The device can be used with many drugs, including proteins and pep- tides, monoclonal antibodies, small molecule-based drugs and vaccines.

For assembling the Intraject, Weston selected a Jetwing hybrid assembly system from Sortimat Technology GmbH & Co. (Winnenden, Germany). The Jetwing can be customized in a short amount of time. This not only reduces cost, it also enables the user to reduce time-to-market—a benefit that was important to Weston. The Jetwing is also suitable for combining automated tasks with manual operations, scalable for increasing production volume and adaptable to changing product designs.

Weston made a number of changes to the product design, while the assembly system was being developed. The Jetwing is modular so changes can be implemented quickly. It features assembly and test units that are easily customized to accommodate minor and major changes. This flexibility allowed Sortimat to respond quickly to Weston's new requirements, without impacting the budget and affecting the original time schedule.

Weston had the Jetwing installed in a Class 10,000 clean room. There, it assembles two components: the actuator and the capsule. The first step is performed manually. An operator places the actuator in a nest, and a second operator places the capsule on top of the actuator. All remaining assembly tasks are performed automatically.

Initially, there is a check to confirm both components are present and in the correct positions. The system verifies that the actuator has been placed in the nest, the capsule has been added, and the opening where a pin enters a latch is facing forward. If everything is correct, then the capsule and the actuator are threaded. The capsule must be screwed onto the actuator precisely. A servomotor provides the torque and ensures that the correct torque is applied.

At the next station, the trigger mechanism is activated. The trigger mechanism releases the charge of gas that dispenses the medicine. An integral part of this station is a latch measurement. The latch measurement ensures that the actuator is charged with gas and under pressure. The results are documented and shown on a screen. The measurement is compared with reference values to identify faulty units.

At the next station, rejected actuators are perforated in two different locations to allow the gas to escape, thereby disabling the injection system. A laser verifies that the perforations have been made and that the gas has been released. At the end of the assembly line, accepted Intraject units are returned to the manual stations, where the operators place them in blister packaging.

The Jetwing can execute up to 80 cycles per minute. However, the system presently assembles between 10 and 16 Intraject units per minute, or 600 to 960 per hour. The speed can be varied according to production requirements and the number of operators. The system could support a much higher output by replacing the manual stations with automatic units. It is also expected that some or all of the individual system modules can, at the end of the product lifecycle, be reused in a new assembly system.

For more information on automated assembly systems, call 847-925-1234, visit www.sortimat.com or Reply 1.