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Applying Spectral Knowledge in Medical and Pharma
- Medical & Life Sciences
Several recent projects have highlighted Ocean Optics' capabilities to work effectively in Good Manufacturing Practice (GMP) environments.
Ocean Optics in 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.
Hardware: Manufacturing and Supply Chain
Ocean Optics manufacturing facilities, headquartered in Orlando, 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 Optics 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 Optics 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.
Ocean Optics hardware is designed for integration into industrial environments and process lines. Also, Ocean Applied-branded 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 Optics is on track to meet all requirements and achieve ISO 13485, and Ocean Optics protocols comply with Decree No 591 of the State Council of China and the forthcoming Law on Safe Management of Hazardous Chemicals.
