Drug delivery devices contract manufacturing - Stevanato Group
Stevanato Group supports drug delivery device projects through proprietary offer and contract manufacturing capabilities. Drug delivery devices contract manufacturing.
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Your contract manufacturing partner of drug delivery devices
We offer a broad range of manufacturing services and capabilities to produce high-quality devices including pen injectors, auto-injectors, and on-body delivery systems.
In addition, we work on specialty devices in drug delivery that require expertise in areas such as Molding, Tooling, Assembly, and more.
Contract Manufacturing of Drug Delivery Devices Brochure
We have extensive experience in Design for Manufacturing (DfM) and Design for Assembly (DfA) for production at different volumes
Our R&D staff work closely with our clients backed by a sound network of development and testing partners, as well as consulting experts where needed
We offer mechanical and functional testing, complex math modeling, risk management, usability studies, and verification support
Plastic Solutions Pharmaceutical Industry
Intellectual property
In cases of contract manufacturing of drug delivery devices, IP belongs to our clients and we support efforts to enhance or optimize device design for clinical and commercial production
We protect the IP of our clients and their confidentiality surrounding their device program
We offer additional IP support from our existing portfolio if needed to support your device program
Product machine
Tooling
Established partnerships with leading tool producers and in-house expertise in tool design & maintenance to prolong the life of your tooling and to ensure that the right tooling solution is provided
Experience with a range of tooling, from low to high cavitation solutions that suit our client needs
Tool maintenance programs and availability of spare parts are available to minimize production downtime
Injection molding
Injection molding
16,900sqm of controlled & cleanroom areas (GMP, class ISO 8 and ISO 7) in Germany and the US
200+ High-precision injection molding in Germany and the US
Up to 128 cavities, with a broad range of clamping forces from 20t-500t
Available 24/7 production from small scale to mass production
Product Development
Quality, Regulatory & Operational Excellence
Quality Management System according to ISO 15378, ISO 13485 and 21CFR820 (for our US operations)
FDA inspected site (Germany)
State-of-the-art measuring technologies with computer tomography, tactile and optical measurements
Risk-based qualification and validation (DQ, IQ, OQ, PQ)
Offering bio-compatibility study support, shipping validation and stability testing
Worldwide product registration experience
Six-Sigma approach throughout the entire industrial product life cycle
Modular, flexible and scalable assembly
Modular, flexible and scalable assembly
Manual, semi-automatic & fully automated assembly capabilities and ancillary processes
Manufacturing of pilot lines
100+ Assembly installations from manual to full automation
Equipment designed & manufactured in-house to be modular & easy to upgrade
Inline process controls
Cleanroom assembly in both ISO7 and ISO8 environments
Process Failure Mode and Effect Analysis (FMEA)
Epoxy UV curing assembly, mechanical assembly, part pouching and sealing, and tray sealing from sub assembly to delivered, finished, sterile devices
Verification and validation testing; tensile, compression, and torque testing; leak testing by pressure decay and flow rate
Heat staking and ultrasonic welding
Silicon oil application, e.g. for damping
Global supply chain
Global supply chain
Global purchasing network
Global logistics expertise
More information on our proprietary and licensed products
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