The injectable drug delivery market has been changing significantly. With a drastic surge in lifestyle-related diseases such as diabetes, as well as major advances in oncology and hormone therapy, self-administration of drugs is on the rise. Considerably easier than the standard syringe-and-vial option, technologically advanced auto-injectors help patients treat themselves more independently and autonomously than ever.
They are already standard for medical emergencies, such as the immediate treatment of an allergic reaction. But for all application, auto-injectors help avoid common risks associated with self-administration via syringes, such as incorrect dosages and misuse, serious injuries and discontinuation of treatment. Demand for self-administrable drugs—and auto-injectors—will only continue to rise in the coming years.
But pharmaceutical companies and service providers are facing a number of challenges when it comes to the assembly, labeling and packaging of the auto-injector devices. Drug manufacturers need to be highly flexible, adapting their approaches for new generations of medication. Contractors and service providers in particular need to be able to adapt to a range of injector sizes, materials, and shapes. To meet the growing demand for auto-injectors, they need production processes that are both time-efficient and customizable.
PCI Pharma Services—headquartered in Philadelphia with manufacturing sites across the globe—relies on highly flexible equipment to match individual requirements. With a desire to further expand its range of production capabilities, PCI turned to the flexible range rotary assembly (RRA) machine from Syntegon Technology (formerly Bosch Packaging Technology).
Flexibility is key
PCI needed a system that would not only let them customize solutions for their clients but also meet their own requirements for optimized efficiency. The machine supplied had to allow fast and easy changeovers for any known auto-injector type to ensure flexibility. “In our business, we need to meet diverse customer demands, so flexibility is critical to our success,” says Chris Blanton, vice president and general manager, Philadelphia, for PCI.
Syntegon and PCI teamed up early in the project to define all the necessary parameters of the final equipment and develop a comprehensive concept to expand PCI’s services. To define the project scope, the partners first had to specify which current auto-injector types the machine must be able to assemble and which future types would be implemented later.
Ultimately, they went with a machine design that would give PCI the most flexibility in the long run: a semi-automated RRA that will be used in the serialized line together with an automated cartoner. The RRA from Syntegon combines complex functionality with a simple interface and safe assembly. It includes systematic control processes and inspections to ensure consistent quality and to meet device assembly instructions provided by end customers, and gives operators a good process overview for easy monitoring. The machine’s fixture design ensures correct placement of all auto-injector components during assembly, regardless of their size, material, or design.
Syntegon TechnologyDesigned as a standardized, modular assembly platform, Syntegon’s RRA can be configured to meet customers’ needs in terms of flexibility and capacity. It includes a fully automated base machine with roundtable transport and 12–24 process modules. The primary feeding section enables up to three operators to feed auto-injector components from trays. The machine is further equipped with a fully automated syringe feeding section and a syringe inspection module, as well as a secondary feeding section similar to the primary one. The system also includes a labeling unit with laser-printing technology to print and verify variable data, and a tray loading unit for the assembled, labeled and approved auto-injectors.
The RRA’s key benefits are its ability to implement several auto-injector formats, and the rapid, tool-free changeover time of less than two hours. “We will be able to efficiently assemble auto-injector formats that cover 80% of today’s auto-injector market,” Blanton says. “What’s more, the RRA can easily and cost-effectively be retooled for future new auto-injector types. This allows us to react quickly and efficiently to technological changes and to continue providing our clients with excellent services, regardless of market volatility.”
With the Syntegon RRA, PCI is able to establish a flexible assembly process with a minimum of downtime between batches, which ultimately results in cost-effective and faster production and delivery. Thanks to its automated and flexible alignment, the machine’s utilization rate is very high, which offers PCI a high return on investment within a short timeframe.
The system’s modular design also allows future adaptations and retrofitting—including the possible integration of robotized production systems—with only minor adjustments. The RRA can also be complemented with further equipment for container handling, inspection, labeling, and packaging. “Thanks to the new machine, we can monitor all critical processes and are able to ensure that the devices are assembled correctly so that they perform as expected in the field to make patients’ self-administration as convenient and safe as possible,” Blanton says.