Contract Manufacturing of Drug Delivery Devices

Design and Development for Drug Delivery Devices

• 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 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

Tooling for Manufacturing Drug Delivery Systems

• 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

Efficient Injection Molding for Drug Delivery Device Manufacturing

• 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

• 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

Drug Delivery Device Flexible and Scalable Assembly

• Manual, semi-automatic & fully automated assembly capabilities and ancillary processes
• 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

Optimized Global Supply Chain for Contract Manufacturing

With several sites worldwide, our global capabilities and service offerings allow us to minimize supply chain risk.