Near Infrared (NIR) Spectroscopy has become a staple of process monitoring in food and beverage, chemical, petrochemical and petroleum refining for many years. NIR has also been applied to process monitoring of industrial bioprocesses such as fuel ethanol production and other chemicals of industrial significance.
Process monitoring via optical spectroscopy methods requires robust calibrations that deliver the same accuracy and repeatability across multiple batches, and even across multiple spectrometers and probes. Probes must be amenable to cleaning and sterilization methods used to prevent cross-contamination as well.
The use of NIR as a process monitoring method in a cGMP environment adds additional requirements for PAT system validation including data integrity, process documentation. Incorporation of cGMP compliance features with optical spectroscopy instruments like 21CFR11 and audit trails is an important part of PAT system validation.
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