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Several recent projects have highlighted Ocean Insight’s capabilities to work effectively in Good Manufacturing Practice (GMP) environments.
These capabilities have grown through several recent projects and partnerships with external design, manufacturing, and software companies, which ensure that all regulatory requirements are met.
Ocean Insight manufacturing facilities, headquartered in Winter Park, Florida, and with locations in Germany and China, are set up to support GMP environments. Controlled manufacturing processes allow for full end-to-end traceability of serialized devices.
Ocean Insight has over a decade of copy exact experience in FDA-approved medical devices and has worked closely with process analytical technology engineers in pharmaceutical manufacturing. The supply chain is compliant with the needs of medical device and biopharmaceutical companies, and recently, Ocean Insight was awarded “Supplier of the Year” from a longstanding medical device customer, for consistent adherence to process controls and continuing support in developing next-generation products.
Further, Ocean Insight hardware is designed for integration into industrial environments and process lines. New Ocean products such as the Liquid Transmission Measurement System (LTMS) are ruggedized and sealed to meet IP67 protocols and designed for self-calibration during continuous, 24/7 operation.
Ocean Insight is on track to meet all requirements and achieve ISO 13485 by 2023, and Ocean Insight protocols comply with Decree No 591 of the State Council of China and the forthcoming Law on Safe Management of Hazardous Chemicals.
Ocean Intelligence, Ocean Insight’s machine learning platform, can be applied to give customers application-specific, actionable answers rather than spectral data that requires further interpretation by trained personnel.
Recent partnerships with software companies enable FDA-regulated Ocean Insight customers to take full advantage of Ocean Intelligence capabilities while assuring compliance with 21 CFR Part 11.
Ocean Insight spectrometers use OPC (Open Platform Communications) protocols, with others available on request. This allows Ocean Insight devices to easily integrate with standard equipment for industrial control systems utilizing OPC Unified Architecture. This gives the customer the ability to control any supported spectrometers and to seamlessly integrate existing systems with Ocean Intelligence.