The team at Calibrex has many years of experience in advanced liquid handling solutions, lab automation on a variety of platforms, systems integration, automation software and instrument development in our core markets. We combine conceptual creativity with state of the art technological knowledge and expertise. Together with our partners and customers, we convert needs into the most logical solutions.
Calibrex offers something outside the usual box for a standard instrument/component OEM partner: engineering design, CFR software development, ISO 13485:2016 QMS & design manufacturing, application development, installation, and in some cases, field service support. This gives our chemistry-based customers the opportunity to concentrate on their core technology without the requirement of setting up an entire instrument support operation.
Using advanced material science, Calibrex exclusively markets a line of custom-designed and stock labware, offering improved performance and consistency to life sciences, biotech, clinical diagnostics, biobanking, and clinical trial markets. All products are precision-molded from medical-grade polymers, with select surfaces that have a thin, transparent, silicon-based coating system, composed of organosiloxane and silica nano-layers. Our labware is engineered to combine the durability and dimensional precision of plastic with the barrier properties of glass, while also providing the distinct benefits associated with the applied technology. X-Factor LabWare™ is manufactured in a state-of-the-art, 160,000 sq. ft. state-of-the-art plant located in Auburn, Alabama. It is ISO 13485 and ISO 9001 certified, and, delivers best-in-class particle control through manufacturing excellence and vertical integration of packaging manufacturing. Manufacturing excellence is achieved through clean room controls, proper material flow, and contamination isolation. An established Quality Management System assures that all aspects of the design, development, manufacture, and distribution of our products are conducted in conformance with 21 CFR 820.
By directly collaborating with our customers, our cross functional design team brings a conceptual development and design process from prototype design through system validation and manufacturing. Following the FDA’s Quality Systems Regulations and ISO 13485:2016 standards for medical device design and manufacturing we offer our customers the ability to move from proof-of-concept, to validation and to market quickly and efficiently.
Supporting specific custom research applications to clinical assay support applications, is at the heart of Calibrex. With decades of experience, we are able to transfer a methodology into an automated procedure using optimized hardware and software configurations. All under the QC requirements of ISO 13485:2016.