Company insight Automating D
rug development’s breakneck expansion in both scope and speed is nowhere more evident than in the combination product market, where pharma companies often need to adjust production scales and marketing strategies in an agile manner. Fully automated assembly has long been considered the holy grail for high-mix/ low-volume manufacturing. However, full automation, in contrast to machine-assisted manual or semi-automated assembly systems, involves longer timelines and higher initial costs, which limit its use to large-scale projects. However, as labour costs and demand rise, a fully automated assembly machine with the flexibility to produce smaller batches – or one that can help scale up from low to mid-volume production – has quickly gone from a want to a need. SHL Medical’s Semi-Modular Automatic Robot Track (SMART) is a pioneering solution addressing this need for the self-injection device industry. It is a fully automated, modular assembly machine combining the flexibility of manual assembly processes with the speed and reliability of fully automated processes. The SMART can reach an annual capacity of 7.5–10 million
autoinjector assembly
The combination product market is booming, yet it has been unable to meet the surging demand for high-mix/low-volume production. Now, fully automated assembly machines like SHL Medical’s SMART, which can easily scale for low to mid-volume production, are breaking down barriers to deliver a wider range of self-injection treatments to patients.
devices using two to three times less labour compared to manual assembly set-ups, and can be adapted to assemble various devices, such as SHL’s Molly 1.0ml and 2.25ml autoinjectors, on the same equipment.
Smarter, modular assembly Much of the SMART’s innovation lies in its modular design, which integrates physical components with digital controls for versatile assembly and efficient project changeovers. Its movable base frames and extendable linear tracks house robots to create modular stations, which are compatible with various standardised material feeding modules. This design allows for faster development and technical support. Additionally, the patent- pending Quick Tool Change interface enables rapid fixture exchanges, reducing downtime when changing between device assembly projects. One way the SMART maximises modularity is with its six-axis robots. Utilised for both feeding and assembly, these flexible robots replace traditional pick-and-place units, offering superior precision, flexibility and adaptability. Eliminating physical enclosures in favour of safety LiDAR (laser- based object detection) gives the robots increased workspace to perform additional
tasks like removing rejected parts, while also providing easier access for troubleshooting. The SMART’s modularity extends to its software and data control system, which benefits from SHL’s experience developing more than 1,400 assembly machines. Central to this system is the SHL Control Library, a modular, standardised software framework that ensures consistent and transferable machine data across different assembly projects. The library is categorised into modules that control physical components like robot arms and tools for non-physical tasks such as data processing. Particularly, the human-machine interface (HMI) modules enable the faster development of a user-friendly interface. For a new autoinjector project, this modular approach allows engineers to quickly assess relevant processes, integrate pre-developed functionalities, and deploy them efficiently, leading to faster project timelines and smoother transitions across different assembly systems.
Integrated in-line quality measures, including vision systems, further help the SMART ensure the quality and repeatability of products through real-time, high-precision inspections. Extensive data is also gathered for AI-driven process control and adaptability. The SMART’s early success, including its role in assembling a newly launched combination product for atopic disorders, offers a glimpse of a future where flexible, fully automated assembly makes high-mix/low-volume manufacturing not just possible but practical. This can empower pharma and medtech companies to pursue drug development and product launches less encumbered by manufacturing mix and volume restrictions, democratising the drug landscape and ensuring patients can access the treatments they need. ●
The SMART robot arm with the front sub-assembly of SHL Medical’s Molly modular platform autoinjector.
www.worldpharmaceuticals.net
www.shl-medical.com 19
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