What is Process Analytical Technology?
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.
Featured PAT categories and resources
Fermentation process control in real time with fast, precise gas analysis
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 BT is a highly reliable, precise and flexible gas analyzer specifically designed for process development laboratories. Features include:
- Scanning magnetic sector technology for fast, flexible, precise multi-component analysis. Concentrations of respiratory gases, inerts and volatiles can be measured in seconds with high levels of precision.
- 16-port Rapid Multistream Sampler (RMS) for fast, reliable monitoring of multiple fermenters and bioreactors.
- 21 CFR Part 11 compliant GasWorks software.
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:
- Scanning magnetic sector technology for fast, flexible, precise multi-component analysis. Concentrations of respiratory gases, inerts and volatiles can be measured in seconds with high levels of precision.
- 32- or 64-port Rapid Multistream Sampler (RMS) for fast, reliable monitoring of multiple fermenters and bioreactors.
- 21 CFR Part 11 compliant GasWorks software.
- Built-in air conditioner means Prima PRO can operate reliably over a wide ambient temperature range.
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.
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Thermo Scientific Prima PRO VP can monitor up to 10 dryers, with a unique inlet that can switch between dryers at widely differing pressures and concentrations, and still provide reliable, stable solvent concentration data. Features include:
- Magnetic sector MS, providing stable fragmentation patterns and resistance to contamination.
- 10-port Variable Pressure sampling inlet, able to handle process pressures between 1000 mBar and 0.3 mBar.
- Samples from headspace above the product, measuring the bulk API in the dryer and avoiding problems with grab samples caused by lack of homogeneity.
- Easy, simple calibration with either gases or liquids ensures accurate quantitative data.
- 21 CFR Part 11 compliant GasWorks software.
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.
Off-Gas Analysis:
In mammalian cell fermentations, the feed gas composition is a frequently changing mixture of several compounds. The feed gas concentration also ranges vary dramatically. The implementation of real-time, off-gas analysis using Process Mass Spectrometry in mammalian cell culture can help identify process deviations during bioreactor runs and evaluate batch to batch variation, within predefined specifications, for robust manufacturing.
Metabolite Monitoring:
In biopharmaceutical production, cells require a feeding cycle of glucose to enable cell reproduction. The Thermo Scientific Ramina Process Analyzer leverages compact and simplified hardware along with data science tools to model the glucose content of a bioprocess and tell you exactly when to add more glucose to ensure cell production at a precise rate.
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Conduct real-time, nondestructive analysis without the need for sample preparation to make optimization decisions faster. Save on time and costs with inline process monitoring while ensuring quality assurance.
- A comprehensive range of probes are available for seamless integration in almost any application
- Portable, small footprint
- Factory calibration for hardware stability and portability
Prima BT is a highly reliable, precise and flexible gas analyzer specifically designed for process development laboratories. Features include:
- Scanning magnetic sector technology for fast, flexible, precise multi-component analysis. Concentrations of respiratory gases, inerts and volatiles can be measured in seconds with high levels of precision.
- Configured with 15 sample and 6 calibration ports for fast, reliable monitoring of multiple fermenters and bioreactors using 16-port Rapid Multistream Sampler (RMS).
- 21 CFR Part 11 compliant GasWorks Process MS Software.
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:
- Scanning magnetic sector technology for fast, flexible, precise multi-component analysis. Concentrations of respiratory gases, inerts and volatiles can be measured in seconds with high levels of precision.
- 32- or 64-port Rapid Multistream Sampler (RMS) for fast, reliable monitoring of multiple fermenters and bioreactors.
- Avoid compromising sterility with non-invasive sampling.
- 21 CFR Part 11 compliant GasWorks Process MS Software.
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In general, key advantages of utilizing magnetic sector analyzers in fermentation and cell culture process include improved precision, accuracy, long intervals between calibrations, and resistance to contamination. Benchtop magnetic sector mass spectrometers can also offer rapid multistream sampling when one has to monitor multiple bioreactors, measurement of oxygen, carbon dioxide, nitrogen and argon in both inlet and outlet to calculate the respiratory quotient for fermentation off-gas analysis, and analysis of volatiles that can yield vital information on the well-being of the fermentation.
The high signal stability and infrequent calibration requirements of the magnetic sector MS translate into an attractive process monitoring solution particularly as biopharmaceutical manufacturing operations shift from traditional fed-batch to continuous modes.
Published by: Royal Society of Chemistry
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.
Thermo Scientific GasWorks Process MS software provides the unique and powerful interface for the Prima PRO, Prima BT, Sentinel PRO and APIX δQ Mass Spectrometers. The software has been designed to ensure that the process analyzer is simple to configure, operate, and maintain without any prior mass spectrometer experience for better process analytics.
The suite includes a wide range of functions and features. Whether the requirement is for a simple alarm indication in the event of a manufacturing process failure, or for complex data presentation for process understanding and control, Gasworks Software is well equipped to offer an effective solution.
- Supports stand-alone analyzer operation.
- Sets no limits to the number of sample streams or analytical methods.
- Includes rigorous mathematical equations to deconvolute complex mixtures.
- Multi-layered security with expiring passwords and audit trail.
- Supports the integration of third-party analytical data.
Discover key functions and features of the GasWorks Process Analysis Software to easily configure, operate and maintain process mass spectrometers.
From raw material identification through manufacturing operations, to finished and packaged pharmaceutical product inspection, we offer a complete range of technologies and business solutions that can help improve each stage of the production process, gain efficiencies, and deliver a higher quality product to the end-consumer.
Featured products
Conduct real-time, nondestructive analysis without the need for sample preparation to make optimization decisions faster. Save on time and costs with inline process monitoring while ensuring quality assurance.
- A comprehensive range of probes are available for seamless integration in almost any application
- Portable, small footprint
- Factory calibration for hardware stability and portability
TruScan G3 Handheld Raman Analyzer
Rapid raw material identification to ensure process quality and audit readiness for the pharmaceutical industry.
Thermo Fisher Scientific plays a critical role in improving productivity and increasing the accuracy of pharma manufacturing through its Process Mass Spectrometers and IonicX XRF Analyzer.
Published by Pharma Manufacturing
Improve pharma and biotech manufacturing processes and help ensure patient safety
Save time, improve processes, protect brand integrity, and ensure patient safety, from raw material identification through the pharmaceutical manufacturing process, to finished and packaged product inspection.
Your guide to biopharmaceutical process monitoring with Raman spectroscopy
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Thermo Fisher Scientific Service Solutions are a vital component of your product’s lifecycle. These comprehensive solutions are exclusively created to drive optimal performance of your time-critical instruments.
When you partner with Thermo Fisher Scientific, you gain access to engineers trained within the same factory your instruments were manufactured. We only ship spare parts that were designed specifically for your instrument. Our expert service team is truly an integrated part of your product’s life cycle.
Featured resources
Process monitoring in biopharmaceutical industry
Gain Process Understanding and Control
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