Company insight
A journey: The assembly of a medical auto-injector
Mikron Automation, with over 25 years of experience in assembling injectable devices, plays a pivotal role in the production of auto-injectors.
user-friendly auto-injectors has surged. These devices are essential for patients managing chronic conditions at home, particularly with the rise of treatments like GLP-1-based drugs for obesity and other high-viscosity formulations. Auto- injectors simplify the injection process, making it accessible even to individuals with physical limitations or needle phobia, thereby improving patient adherence and outcomes.
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Auto-injectors are compact medical devices designed to deliver a pre-measured dose of medication either subcutaneously or intramuscularly. While they may appear simple externally, their internal mechanisms are highly sophisticated. They incorporate energy storage systems – such as springs or compressed gas cylinders – to drive the syringe piston with precision. Key requirements include consistent drug flow, controlled injection time, ease of use and elimination of needle-stick injury risks. These demands necessitate advanced engineering and deep technical expertise.
s self-administered therapies become increasingly prevalent, the demand for reliable, safe and
For Mikron Automation, the assembly process is divided into two main stages: the dry side and the wet side.
Dry side assembly
The dry side involves assembling the mechanical components, particularly the spring mechanism. This phase is critical due to the high energy stored in the spring, which must be handled with extreme care. The spring must be fed, compressed and securely positioned to ensure safety and functionality. Since a final functional test cannot be performed – due to its destructive nature – inline testing between stations is essential. These tests verify mechanical integrity and compliance with customer specifications, ensuring the device will perform reliably once in use.
Wet side assembly
The wet side incorporates the pre-filled syringe (PFS) into the auto-injector body. This stage requires precise handling to avoid damaging sensitive components such as the syringe barrel, flanges, needle and rigid needle shield.
The dry mechanism is inserted using controlled force to maintain alignment and functionality. Comprehensive traceability is maintained throughout the process to ensure product quality and confirm the correct drug is present in the PFS. As with the dry side, functional testing is limited, reinforcing the need for robust, validated processes.
From lab to mass production The journey of a medical device extends beyond assembly to full-scale production. Regulatory validation by authorities such as the FDA and EMA is mandatory. This requires early validation of assembly and testing processes, with mechanical and software controls in place from the outset. Initial production involves a few thousand pre-clinical units to validate and optimise processes before scaling up.
High-volume production lines are costly and time-consuming to build. Therefore, laboratory-scale set-ups are crucial in early development. Mikron’s MAIA and MiniCell platforms offer flexible, low-speed assembly solutions that replicate final processes. These platforms support quick tooling changes and configurable software, enabling efficient format and variant switching. Once validated, these processes can be seamlessly transferred to high-volume lines, reducing regulatory hurdles. Mikron’s global expertise, backed by 50 years in automation and a team of over 1,000 professionals, ensures scalable, reliable solutions. Beyond equipment, Mikron provides value-added services such as design for assembly (DFA), design for manufacturing (DFM), proof of principle (PoP) and medical validation guidance aligned with GAMP5 standards. These services support clients throughout the product life cycle, reinforcing Mikron’s role as a long-term partner in medical device success. ●
Mikron Automation provides expertise in high-speed dry side assembly – particularly the spring mechanism.
www.medicaldevice-developments.com
www.mikronautomation.com 55
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