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Facilities
Purpose-Built Facilities for Every Stage of LFA Development
Purpose-Built for
Your Success
Our 34,000 sq. ft. facility in Carlsbad, CA, is designed to support IVD development and manufacturing at every stage. The space includes fully equipped laboratories for development and engineering as well as specialized environments, such as a cold room, dry rooms and aseptic facilities. Additional areas like manufacturing spaces, offices, and training rooms provide the flexibility needed for both custom and large-scale projects.
Facilities Highlights
Dedicated Wet Lab
Over 14,000 square feet of state-of-the-art wet laboratory space, including an aseptic room, isolation laboratories, and a microbiology laboratory for optimal control over environmental variables
Aseptic room
isolation laboratories
microbiology laboratory
Deposition Laboratory
A 700+ square foot laboratory equipped for manufacturing deposition, ensuring precision in high-quality production
Dry Room
A 2,300+ square foot, humidity-controlled room for critical handling and assembly of sensitive materials
Certifications
ISO 9001:2015
ISO 13485:2016
ISO 9001:2008
ISO 13485 since 2011
Advanced Equipment for
Every Stage of Development
Our laboratories are designed to support every phase of IVD development and
manufacturing with industry-leading equipment and specialized spaces.
Development Labs
01
Fully equipped to accommodate over 50 scientists, featuring workstations, pipettes, mixers, rockers, vortexes, and other essential laboratory tools.
BSL-2 Certified Spaces
02
Two biosafety cabinets and a calibrated fume hood support work requiring Biosafety Level 2 compliance, ensuring safe handling of potentially hazardous materials.
Temperature-Controlled Storage
03
Raw materials, reagents, and samples are stored and continuously monitored 24/7 with the Isensix system, ensuring quality in refrigerators, freezers, and ultra-low freezers.
Critical Manufacturing Tools
04
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.01
BioDot and Imagene fluid-dispense systems for precision reagent application.
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.02
Reel-to-reel dispensing and drying units for high-throughput production.
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.03
Custom-built reel-to-reel auto-laminator (Kinematic) for the seamless assembly of lateral flow strips.
Specialized Spaces
05
2,300 sq. ft. Dry Room: Maintains <15% relative humidity for handling and assembly of moisture-sensitive materials.
Engineering Lab: Equipped with 3D printers, heat sealers, and machine shop equipment for prototyping.
Spaces dedicated to aseptic filling, reagent lyophilization, and warehousing/inventory management to ensure streamlined operations.
Validated and Maintained Equipment
06
All equipment undergoes regular validation, calibration, and preventive maintenance to guarantee optimal performance and compliance with regulatory standards.
