Unmatched Expertise in
Auto-injector assembly
At Mikron Automation, we specialize in auto-injector assembly lines, leveraging over 50 years of expertise in complex assembly processes. Our customers benefit from our extensive experience, ensuring high efficiency and reliable results throughout the entire life cycle of their products.
Whether you need a pre-assembly line or final assembly solutions for your device, Mikron Automation guarantees top-notch performance at the highest quality. As a trusted leader in medical device assembly, we develop modular and scalable solutions tailored to your specific project requirements, with the flexibility to adapt to future needs.
From low-volume, lab-scale equipment to high-volume production lines, Mikron ensures consistent processes and parameters on our auto-injector assembly machines. Our key processes include spring handling, feeding and inserting, pre-filled syringe (PFS) handling and placement, controlled force press, vision control, and labeling—part of over 450 processes we expertly manage.
For regulatory submission samples, our Mikron MAIA and Mikron MiniCell platforms offer efficient and repeatable assembly, ideal for agencies like the FDA or EMA. If your auto-injector device is in development, our Pre-Production services can help you achieve a successful product launch with minimal risk, thanks to our comprehensive engineering services.
Our Pre-Production services provide end-to-end support, including design for manufacturing/assembly (DFM/DFA), process development, and Proof of Principle, all compliant with FDA, GMP, and GAMP 5 standards. Additionally, our Denver facility supports small-batch assembly production of non-commercial products in a cleanroom environment. For regulatory submission samples, our Mikron MAIA and Mikron MiniCell platforms offers efficient and repeatable assembly. If your auto-injection pen device is in development, our Pre-Production services can help you achieve a successful product launch with minimal risk, thanks to our comprehensive engineering services.
With a global presence, Mikron Automation provides comprehensive support from initial engineering consultations to high-volume assembly production and ongoing manufacturing asset support. Join us and be part of a team that drives innovation and excellence in medical device assembly.
Complex process expertise
From low to high volume
Sub-assembly
- Springs handling directly from coiling machine
- Long spring insertion
- Loading and locking powerpack
- 100% process check
- Quality inspection by vision
Final assembly
- US welding
- Pre-filled syringe insertion
- Syringe glass quality inspection by vision
- Mechanism insertion and force monitoring
- Labelling
- Quality inspection by vision
Scalable Assembly Solutions
Complex process expertise from low to high volume production
Mikron’s scalable solutions are the result of decades of experience in the design and manufacture of high-performance assembly systems.
Pre-Production Services
Cutting edge services for accelerated market launch
We offer a full suite of services, developed to help medical device manufacturers de-risk their programs and accelerate through the manufacturing design phase.
Advise
Supporting the development of robust design that can reliably be assembled.
Helping you design a product that is ready for successful design transfer.
Characterize
Developing process characterization to ensure your product is ready for manufacturing.
Identifying critical processes at an early stage and optimizing your manufacturing processes step by step.
Assemble
Offering clean room access to assemble medical devices for design validation activities.
Expediting the regulatory submission process.
Validate
Executing the qualification protocols and delivering all documents for validation requirements.
Helping generate your equipment’s validation package.
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