Contract Manufacturing Services

Contract Manufacturing Capabilities for Drug Delivery and Diagnostic Devices

With decades of industrial experience and a global manufacturing infrastructure, Stevanato Group provides robust contract manufacturing (CMO) services for complex regulated products, including drug delivery systems (DDS) and single-use, disposable diagnostic (Dx) components and assemblies.

Our manufacturing capabilities support products from pilot and clinical phases through to high-volume commercial production, ensuring consistency, repeatability, and long-term supply continuity.

Production_injection_molding_drug_delivery_systems

Industrialized manufacturing, from pilot to high volume

Our manufacturing model adapts to evolving production demands while maintaining strict control over performance and process stability. This approach allows customers to progress seamlessly across development stages without redesigning manufacturing strategies.

Manufacturing capabilities include:

Pilot and clinical manufacturing
Medium- and high-volume commercial production
Manual, semi-automatic, and fully automated assembly
Flexible manufacturing layouts to support multiple product variants

Precision molding and component manufacturing

Stevanato Group supports molding operations through established partnerships with leading toolmakers, combined with in-house expertise in tool design and maintenance. This ensures that the most appropriate tooling solution is selected for each project while maximizing tooling lifetime.

Dedicated tool maintenance programs and the availability of critical spare parts help minimize production downtime and support long-term manufacturing continuity.

Molding infrastructure highlights include:

200+ high-precision injection molding machines
Tooling solutions from low- to high-cavitation (up to 128 cavities)
Clamping forces ranging from 20t to 500t
Integrated metrology, computer-aided tomography, and Statistical Process Control (SPC)

Established global network of qualified suppliers for raw materials and bought-in components
Capabilities for sourcing and managing critical raw materials
Development of risk mitigation strategies and multi-source approaches
Centralized coordination supporting multi-site manufacturing
Strategic use of internal and external warehousing solutions, including temperature- and humidity-controlled storage, tailored to specific project requirement

Flexible sub-assembly and final assembly

We provide flexible sub-assembly and final assembly solutions tailored to different product architectures, volumes, and lifecycle stages, and supported by process Failure Mode and Effect Analysis (pFMEA).

Assembly capabilities include:

100+ assembly installations, ranging from manual workstations to fully automated lines
Modular equipment concepts designed and manufactured in-house
Inline process controls and in-process inspection
Compatibility with customer-specific components and suppliers
Heat staking, ultrasonic welding, epoxy UV curing, and silicone oil application
Leak testing (pressure decay and flow rate), tensile, compression, and torque testing
Part pouching, tray sealing, and preparation of finished devices

Global manufacturing footprint

Stevanato Group’s contract manufacturing activities for medical devices are supported by dedicated production sites in Germany (Bad Oeynhausen) and the United States (Ontario, California, and Fishers, Indiana). All the facilities offer controlled and cleanroom manufacturing environments, compliant with GMP requirements, including ISO 7 (Class 10,000) and ISO 8 (Class 1,000,000).

Facilities are set up for continuous 24/7 production, supporting high-volume mass production output, within regulated and routinely inspected environments. Harmonized manufacturing and quality processes ensure consistency across sites, supporting global distribution and regional proximity.