A shot in the arm2 June 2020
Packaging Today presents edited extracts from ‘Auto-injector assembly: flexible and scalable production is key’, a case study showcasing Syntegon Technology’s rotating rectifier assemble (RRA) machines, and what characteristics explain why PCI Pharma Services, a pharmaceutical development services company, relies on them so heavily
The self-administration of drugs is on the rise due to a drastic surge in lifestyle-related diseases, as well as major advances in oncology and hormone therapy. Thanks to the use of auto- injectors, patients today can be treated, or rather treat themselves, more independently and autonomously than ever before. In contrast, pharmaceutical companies and service providers are facing a number of challenges when it comes to the assembly, labelling and packaging of these devices
The injectable drug delivery market has experienced a paradigm shift in recent years. Due to drastic changes in lifestyle, and the accompanying increase in chronic diseases such as diabetes, the demand for injectable drugs has been growing. This transformation relates not only to the quantity, but also to the way in which injectable drugs are delivered today.
In order to meet the growing demand for auto- injectors, they need production processes that are both time-efficient and customisable. Partners such as Syntegon Technology, formerly Bosch Packaging Technology, provide extremely flexible production equipment that can be used for the assembly and labelling of various auto-injector formats, allowing for a faster time to market. Traditional self-injection devices, such as standard syringes, are frequently being replaced by technologically advanced auto-injectors. This development also stems from the fact that self- injectable medicines are no longer used only for diabetes treatments or growth hormone therapies, but also for the increasing number of available parenteral biotherapeutics in oncology.
The new normal
Auto-injectors are already standard equipment when it comes to medical emergencies, such as the immediate treatment of an allergic shock. All application areas have one thing in common: auto-injectors help avoid the common risks associated with self-administration via syringes, such as incorrect dosages or misuse. As a result of these developments, the demand for self- administrable drugs and the corresponding devices will rise even further over the coming years – and so will the demand for corresponding manufacturing solutions.
The rapidly changing market demands that drug manufacturers be highly flexible and adapt their approach for this new generation of medication. Although many injector types have similar components, their design varies in terms of size, material and shape. This is a major challenge, especially for contractors and service providers that produce auto-injectors for pharmaceutical companies worldwide, and therefore have to assemble a wide variety of differently shaped auto-injectors. Biopharmaceutical service providers like PCI Pharma Services, with sites across the globe, in Australia, the US, Ireland and the UK, rely on partners that are able to provide it with highly flexible machines to match individual patient requirements. Looking for an opportunity to further expand their wide range of production capabilities, PCI opted for the flexible rotating rectifier assemble (RRA) machine from Syntegon. PCI needed a solution that enabled it to continue providing excellent service and customised solutions to its clients, while also meeting its own requirement for optimised equipment efficiency.
PCI frequently need to meet diverse customer demands, so flexibility is critical. For Syntegon, this meant that the machine supplied had to allow fast and easy changeovers for any known auto-injector type, ensuring the necessary flexibility. At the same time, PCI needed to keep production downtime during format changeovers as short as possible. Syntegon and PCI teamed up at an early project stage to define all the necessary parameters of the final equipment, and develop a comprehensive concept to expand PCI’s services to meet its customers’ needs. To define the project scope, the partners first had to clarify which current auto-injector types the machine must be able to assemble, and which future types will be implemented at a later stage. In the end, PCI and Syntegon decided to go with the design that provides PCI with the most flexibility: a semi-automated RRA that will be used in the serialised line, together with an automated cartoner. Syntegon’s RRA combines complex functionality with a simple interface and safe assembly, including systematic control processes and inspections to ensure consistent quality, as well as meeting the device assembly instructions provided by end-customers. This provides operators with a good process overview for easy monitoring. The machine’s fixture design ensures correct placement of all auto-injector components during the assembly, regardless of their size, material or design.
The RRA is designed as a standardised, modular assembly platform, specifically configured to meet customers’ needs in terms of flexibility and capacity. It includes a fully automated base machine with roundtable transport, and 12 to 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. A labelling unit with laser- printing technology to print and verify variable data, and a tray loading unit for the finally assembled, labelled and approved auto-injectors, rounds the item off.
Speed of tool
The RRA’s key benefits is 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,” said Chris Blanton, vice-president and general manager at PCI, about its Syntegon-RRA decision. “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.”
The RRA also enables PCI to establish a flexible assembly process with a minimum of downtime between batches, resulting in faster, cost-effective production and delivery. Thanks to its automated and flexible alignment, the machine’s utilisation rate is very high, offering PCI a high return on investment within a short time frame. The RRA’s modular design allows for future adaptations and retrofitting, like the possible integration of robotised production systems, with only minor adjustments. In line with Syntegon’s pharmaceutical line competence, the RRA can be complemented with further equipment for container handling, inspection, labelling and packaging. “Thanks to the new machine,” Blanton concluded, “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.”