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Multipoint Analysis in Biological Production by Process Mass Spectrometry


Multipoint Analysis in Biological Production by Process Mass Spectrometry
In recent years, the utilization of online process analytical technology (PAT) has become a high-profile endeavor in the biotechnology industry.
Since the early 1980s, a number of fermentation scientists have employed Thermo Scientific™ Process Mass Spectrometers to reliably monitor the composition of gas streams into and out of bioreactors and fermenters.
When making the first steps towards process control, it is not uncommon for some to think that the measurement of carbon dioxide and oxygen in the effluent is all that is needed and that sufficient accuracy can be acquired by discrete measurement technology. Both of these assumptions are incorrect. ....

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Monitoring Pharmaceutical Solvent Drying Processes


Monitoring Pharmaceutical Solvent Drying Processes
Image Credit: Thermo Fisher Scientific – Environmental and Process Monitoring Instruments
In a number of pharmaceutical processes, one of the key stages is the partial or complete removal of a solvent, or solvents, from an intermediate or product. The drying process needed can happen in a number of process vessels, including tray dryers, vacuum dryers, and rotary dryers.
The success of the drying process was measured upon conclusion by simply taking a sample for laboratory analysis until now.
Organic solvent concentrations in the active pharmaceutical ingredient (API), or intermediate, were measured by gas chromatography; residual water levels were usually investigated by carrying out a Karl Fischer titration. ....

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Technologies Accelerating the Verification of Raw Materials


Technologies Accelerating the Verification of Raw Materials
Image Credit: Thermo Fisher Scientific – Environmental and Process Monitoring Instruments
Pharmaceutical manufacturing is a strictly regulated, process-driven industry. A mistake in manufacturing can be costly in the best-case scenario and at worst, it can be life-threatening, particularly if a product has reached consumers.
The industry must adhere to numerous guidelines that are laid out by the Food & Drug Administration (FDA), for example, the Current Good Manufacturing Practices (cGMP). Product quality is at the center of cGMP, which assures the correct monitoring, design, and control of manufacturing facilities and processes.
cGMP also supplies guidance for how to attain quality raw materials, in addition to the preferred management processes and systems for maintaining optimum laboratory testing procedures. All factors play a key part in the effectiveness and safety of pharmaceutic ....

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Maintain Compliance to Petrochemical and Organic Chemical Sector Flare Gas Rules


Maintain Compliance for Petrochemical and Organic Chemical Sector Flare Gas Rules
Image Credit: Thermo Fisher Scientific – Environmental and Process Monitoring Instruments
Local and national government bodies are telling processing companies to monitor the various emissions from their flares and plant stacks to decrease the amount of pollution entering the atmosphere at a growing rate.
The focus was initially on oil refinery flares and more recently the focus was on petrochemical and chemical plant flares receiving attention as possible sources of hazardous air pollutants.
Petrochemical Plants
In March 2020, EPA signed numerous Risk and Technology Review (RTR) rules, including National Emission Standards for Hazardous Air Pollutants (NESHAP): Generic Maximum Achievable Control Technology Standards for Ethylene Production (EMACT). ....

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