Ocean Insight applies Spectral Knowledge to Medical and Pharma GMP challenges

news-releasesOcean Insight
April 8th 2021

Orlando, FL: – 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, while ensuring all regulatory requirements are met.

Hardware: Manufacturing and Supply Chain

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.

A well-established medical device manufacturer recently named Ocean Insight as its “Supplier of the Year” for consistent adherence to process controls and continuing support in developing next-generation products.

cGMP Manufacturing and Hardware

Ocean Insight 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.

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.

Software: Communication Protocols & Machine Learning

Ocean Insight’s machine learning platform, Ocean Intelligence, can be applied large datasets to give customers application-specific, actionable answers rather than the often-complex spectral data that requires further interpretation by trained personnel.

Recent partnerships with software companies have enabled FDA-regulated Ocean Insight customers to take full advantage of Ocean Intelligence capabilities while assuring compliance with 21 CFR Part 11.

For those clients interested in OPC (Open Platform Communications), the Ocean Insight Custom Solutions Team can equip its OEM spectrometers with such technology features. This allows Ocean Insight devices to integrate seamlessly with standard equipment for industrial control systems utilizing OPC Unified Architecture. It provides the customer with the ability to control any supported spectrometers and to fully integrate existing systems with Ocean Intelligence.

About Ocean Insight

Based in Orlando, Florida, Ocean Insight is a manufacturer specializing in applied spectral knowledge, offering a range of advanced products and solutions that benefit a wide range of industries, including pharmaceuticals, healthcare and life sciences.

Ocean Insight combines innovative spectroscopy hardware, software and on-demand data delivery with deep category expertise to create innovative and customized solutions that help clients ‘Unlock the Unknown’.

Main Ocean Insight product areas include spectrometers, light sources, multispectral imaging devices, spectral systems, oxygen sensors, laboratory facilities, machine learning, and software development including Artificial Intelligence (AI).

Ocean Insight is the trading name of Ocean Optics, Inc., which was founded in 1989 by university researchers in Florida to develop a pioneering miniature spectrometer, which was commercially released in 1992. In 2004, Ocean Optics became part of Halma plc, a global group of life-saving technology companies.  In 2019, the company was rebranded as Ocean Insight, an applied spectral knowledge company.  

Further information at: www.oceaninsight.com


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Ocean Insight applies Spectral Knowledge to Medical and Pharma GMP challenges

Ocean Insight has adapted manufacturing, devices and processes to work in highly regulated GxP environments