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Facilities & Equipment

Purpose-built medical device manufacturing, assembly, packaging, and sterilization space. Under one roof.

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)

Our Shipping and Storage Capabilities

  • 30,000 square foot warehouse and shipping site
  • Shipping docks with dock level doors
  • Truck-friendly access up to 53-foot trailers
  • Climate-controlled storage
  • Secure GMP Warehouse Facility
  • Bar-code capabilities

In-house tooling center reduces costs and timelines

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 streamline engineering, prototyping, testing and quality control

Product engineering and on-site quick-turn prototyping are available with in-house laboratory spaces where our team develops the validated processes you require to launch your product on the market.

In our quality control lab, trained inspectors monitor incoming components, in-process assemblies and final product releases.

Quick-turn Steam and EtO sterilization under one roof

Our facilities offer comprehensive in-house EtO and steam sterilization capabilities to ensure faster time to market and reduced costs. With quick-turn single LOT release EtO sterilization in our 3M chambers (8 ft^3, 0.22 m^3), we minimize the turnaround times for lot release. Our in-house testing of biological indicator sterility further streamlines 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. Leverage our advanced in-house sterilization services for efficient and cost-effective medical device production.

Medical Device Incubator Service

Our Medical Device Incubator Service offers 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.

Our Equipment

We continuously invest in industry-leading equipment to support organizations of all sizes and accelerate the commercialization process.

 

Let’s work together

Life Science Outsourcing prides itself on our role as partners in bringing medical innovations to life. That partnership forms the foundation of what sets us apart.

Join Us at OMTEC 2024!

Booth #156

Let's meet at the show!