New documentation and integration capabilities support the implementation of Raman Process Analytical Technology (PAT) in regulated pharmaceutical and biopharmaceutical manufacturing.
Timegate Instruments has enhanced the GMP support framework for its PicoRaman M3 spectrometer, helping pharmaceutical and biopharmaceutical manufacturers integrate Raman Process Analytical Technology (PAT) into GMP-regulated manufacturing environments.
The development builds on PicoRaman M3's real-time process monitoring capabilities by introducing additional documentation, lifecycle controls and system integration support to facilitate customer qualification and validation activities.
Raman spectroscopy provides valuable real-time insight into chemical composition and process changes, helping manufacturers improve process understanding, monitoring and control.
However, implementing analytical technologies in GMP-regulated manufacturing requires more than reliable measurements. Manufacturers must also consider system integration, risk management, software lifecycle documentation, data integrity and validation requirements.
To address these needs, Timegate has established an enhanced GMP support framework for PicoRaman M3, providing customers with a more structured foundation for integrating Raman measurements into their manufacturing processes.
The framework focuses on four key areas:
With its Timegated® Raman technology, PicoRaman M3 enables real-time chemical measurements with fluorescence suppression, supporting process monitoring in complex pharmaceutical and biopharmaceutical applications.
The enhanced GMP support framework extends these capabilities by addressing important documentation and integration considerations involved in regulated manufacturing.
PicoRaman M3 is designed and documented to support GMP-regulated use as part of a wider customer system. Qualification and validation of the complete system remain the responsibility of the customer, supported by Timegate's relevant technical documentation.