Process Analytical Technology (PAT) is a regulatory framework initiated by the United States Food and Drug Administration (FDA) that encourages pharmaceutical manufacturers to improve the process of pharmaceutical development, manufacturing, and quality control. PAT aims to improve process efficiency and process control by defining Critical Process Parameters (CPP) and monitoring these CPPs to stay within a defined limit, either in-line or on-line to maintain a product’s Critical Quality Attributes (CQA). Monitoring CPPs with process mass spectrometry gas analysis reduces over-processing, pinpoints contaminants and increase product consistency. Check out our Process Mass Spectrometer Comparison Guide.
Analysis of respiratory gases is an ideal way of fermentation monitoring. It’s non-invasive and provides invaluable information on the physiological state of the culture, including growth kinetics and substrate consumption. It also helps determine the optimum point to halt the process for maximum yield. Many fermentations are characterized by small changes in oxygen and carbon dioxide concentrations. The speed of MS makes it ideal for fermentation process control, but speed must not be at the expense of precision. It is equally important that precise data is acquired; otherwise, small changes in concentration will be lost.
Over 30 years of industrial experience have shown that magnetic sector analyzers offer the best performance for fermentation off-gas analysis. Key advantages include improved precision, accuracy, long intervals between calibration, and resistance to contamination. Typically, analytical precision is between 2 and 10 times better than a quadrupole mass spectrometer.
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Thermo Scientific Prima PRO is currently the world’s leading process mass spectrometer, designed to operate reliably in harsh production environments and backed up with an industry-best three year warranty. Features include:
The Thermo Scientific HyPerforma Single-Use Fermentor (S.U.F.) is pioneering the single-use technology market by delivering a unique and rigorous solution for microbial fermentation applications while offering the flexibility, ease of use, and efficiency found in single-use systems. Available in 30 L and 300 L sizes, the S.U.F. consists of a fermentor tank and a standard Thermo Scientific HyPerforma S.U.F. BioProcess Container (BPC).
Want to reduce over-processing? Need to increase product consistency? Discover how to gain productivity by monitoring critical process parameters with process mas spectrometry gas analysis.
Use magnetic sector mass spectrometry to control the solvent drying process with fast, precise, quantitative data
A key stage in many pharmaceutical processes is the complete or partial removal of a solvent or solvents from a product or intermediate. This solvent recovery process can occur in a variety of process vessels, including vacuum dryers, tray dryers and rotary dryers.
In the past, the success of the solvent drying process was simply measured at the end by taking a sample for laboratory analysis and the amount of residual solvent was defined by the Loss on Drying (LOD). If the sample failed the LOD test for one or more of the solvents, then the drying process had to be restarted. If the drying took place under vacuum, this provided additional complications in terms of both sampling the active pharmaceutical ingredient (API) and re-starting the dryer.
Mass spectrometers have been used to monitor solvent levels in the headspace above the API during drying processes but they have typically only produced qualitative or semi-quantitative data. If the MS is to be used as part of a PAT solvent drying process control project, it must produce accurate, reliable quantitative data, even for multi-dryer, multi-solvent systems.
