AMETEK Process Instruments demonstrates cost and time saving advance for pharma manufacturers
AMETEK Process Instruments, a US-based supplier of online process analysers, has 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.
Pharmaceutical quality control requires that the drying process be stopped periodically and samples removed for Loss on Drying (LOD) analysis. If the product is not dry, the process is restarted and allowed to run for an indeterminate period. This process is repeated until the LOD achieves a predetermined value.
AMETEK says pharmaceutical manufacturers who have moved to aqueous-based processing can now use TDLAS technology as a lower-cost, time-saving procedure to determine dryer end-point. The continuous real-time monitoring can pinpoint the exact moment when a product has dried as much as possible. This determination is then confirmed by LOD analysis, eliminating numerous stops and re-starts of the drying process.
Working with a pharmaceutical manufacturer, AMETEK set up a production trial using its 5100 HD analyser 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
The firm says 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 5100 analyser uses 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 over a wide range of 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.