AMETEK Process Instruments has successfully demonstrated that tunable diode laser absorption spectroscopy (TDLAS) can provide the advantages of continuous process control of pharmaceutical drying to manufacturers using water as their primary solvent. This new capability offers water solvent users the cost savings that have long been available to processors using non-water solvents through process mass spectrometry.
Model 5100 HD TDLAS Analyzer
Up to now, water solvent users have had to stop the drying process and manually remove a sample for Loss of Drying (LOD) analysis. If the product is not dry, the process is restarted and allowed to run for an indeterminate period. This time-consuming process is repeated until the LOD achieves a predetermined value.
Manufacturers have long known that process mass spectrometry can be used for continuous real-time monitoring and control of non-water solvent drying processes. Pharmaceutical makers who rely on water as their principal solvent can now use TDLAS technology as a lower-cost, time-saving procedure to determine dryer end-point.
Trial Demonstrates Effectiveness of TDLAS in Water Solvent Drying
Working with a pharmaceutical manufacturer, AMETEK Process Instruments set up a production trial using its Model 5100 HD analyzer to monitor the batch production of a widely prescribed medication whose synthesis involves the use of water as the final rinse agent.
The trial demonstrated that TDLAS techniques could be used to continuously monitor and control the solvent drying process online, in real time, without operator intervention or process interruption. The results further indicated that TDLAS has the potential to significantly reduce drying times, while improving both production and product quality for pharmaceutical manufacturers and other bulk powder producers who rely on water as the principal solvent in their processes. Because TDLAS is a non-contact technique, it offers fast response speeds, which can mean substantial savings in both time and cost.
The Model 5100 analyzer is a highly versatile instrument that utilizes TDLAS technology in a variety of configurations, including single- and dual-laser platforms with one or two sample cells for measuring different process components simultaneously. It can provide on-line, real-time process control of moisture levels down to 4 parts per million, or 2%, of the reading, whichever is greater, based on the moisture level requirements of a drying chamber.