Facilities & Equipment
Life Science Outsourcing has multiple purpose-built facilities to meet global medical device manufacturing, assembly, packaging, and sterilization client needs.
FDA Registered & ISO 13485 Certified: Bicoastal Facilities and Nearshore Capabilities
With state-of-the-art facilities in California, New Hampshire and Costa Rica, Life Science Outsourcing supports over 125,000 total square feet of dedicated medical device manufacturing, assembly, packaging and sterilization space.
These sites include 12 total Class 5, 6, 7 and 8 cleanrooms, including a Class 7 dry room. Within these rooms are spaces dedicated to low-humidity manufacturing and solvent scouring for careful handling of bioabsorbable polymers.
Each site also features over 30,000 square feet of warehouse space with multiple shipping and receiving bays for flexible raw material and finished product staging.
Our Cleanrooms
All cleanrooms are CEPA-certified and allow clients to closely observe product assembly from outside and inside the rooms.
- Class 100 Room (ISO Class 5)
- Class 1,000 (ISO Class 6)
- Class 10,000 (ISO Class 7)
- Class 100,000 (ISO Class 8)
Shipping and Storage Capabilities
- 30,000-square-foot warehouse and shipping site
- Shipping docks with dock level doors
- Truck-friendly access fits up to 53-foot trailers
- Climate-controlled storage
- Secure GMP warehouse facility
- Bar-code capabilities
In-house Tooling Center
An extensive tool room in our Somersworth facility enables the rapid development of custom tooling for nearly every medical device and diagnostic application.
Our ownership of precision machinery supporting the fabrication of unique, custom tools means your custom requirement will be met with reduced time to market, increased program efficiency and the burden of equipment investment off your shoulders.
On-Site Labs
Product engineering and on-site quick-turn prototyping are available with in-house laboratory spaces where the Life Science Outsourcing team develops required validated processes to launch your product to market. Our labs effectively streamline engineering, prototyping, testing and quality control.
In our quality control lab, trained inspectors monitor incoming components, in-process assemblies and final product releases.
Quick-turn Steam and EtO Sterilization
Our facilities offer comprehensive in-house EtO and steam sterilization capabilities to ensure faster time to market and reduced costs. Turnaround times for lot release are minimized with quick-turn single LOT release EtO sterilization in our 3M chambers (8 ft^3, 0.22 m^3). Our in-house testing of biological indicator sterility further integrates the process.
Our sterilization capacities include:
- In-house steam sterilization: 17 ft3, 19 ft3, and 74 ft3 sterilizers
- In-house EtO sterilization: 8 ft3 sterilizers
- Biological indicator (BI) testing
Additionally, we offer contracted gamma, e-beam, and large chamber EtO capabilities to cater to your specific sterilization requirements.
Medical Device Incubator Service
Our medical device incubator services offer comprehensive support for medical device development, including facility utilization, quality management guidance, FDA registration assistance, clinical and R&D builds, full traceability, and product packaging and validation support.
