Contract Manufacturing Of Devices

In addition, we work on specialty devices in drug delivery that require expertise in areas such as Molding, Tooling, Assembly and more.

Competences for Drug Delivery Systems

Design & Development

• 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

Intellectual property

• In cases of contract manufacturing, 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

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

• 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

Quality, Regulatory & Operational Excellence

• ISO 9001, ISO 15378, ISO 13485 certified quality management system compliant with 21 CFR Part 820 and FDA audited.
• Six-Sigma approach throughout the entire industrial product life cycle.
• Risk-based qualification and validation (DQ, IQ, OQ, PQ).
• State-of-the-art testing technologies, including computer tomography, and tactile and optical testing.
• In-house analytical services provided by accredited Technology Excellence Centers.
• Product registration support.

Modular, flexible and scalable assembly

• Manual, semi-automatic & fully automated assembly capabilities and ancillary processes
• Manufacturing of pilot lines
• 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 purchasing network
• Global logistics expertise