Drug manufacturers currently use a combination of approaches involving heat, pressure and vacuum to remove the solvents used in the manufacture of their products. The most common method requires that the drying process be stopped and a sample manually removed for Loss of Drying (LOD) analysis. If the product is not dry, the process must be restarted and allowed to run for an additional indeterminate period. This time-consuming process is repeated until the LOD achieves a predetermined value.
The ProMaxion process mass spectrometer from Ametek Process Instruments provides pharmaceutical manufacturers with a system for the continuous real-time monitoring and control of their solvent drying processes. By allowing manufacturers to pinpoint, without operator intervention, the exact moment when a product has dried as much as possible, the ProMaxion places Ametek at the forefront of the U.S. Food and Drug Administration’s drive for Process Analytical Technologies (PAT) enhancements.
The ProMaxion works by monitoring solvent vapors in the headspace of the dryer, which are driven from the product during the pressure or vacuum drying process. The amount of solvent measured is directly proportional to the amount of solvent remaining in the product. Online detection avoids the need for pharmaceutical manufacturers to stop, analyze and then restart the drying process.
Large-scale drying involving thousands of pounds of product can take 20 hours or more to complete. Repeated interruption of the process to accommodate manual product analysis can add hours to that process. In addition, many of the solvents that are used are flammable or pose other potential hazards, so there are added risks to manual analysis as well.
The ProMaxion can be used to control all aspects of the drying cycle from product entry to its removal for further processing. The versatile analyzer can be used to signal the end point of the drying cycle, determine the optimum time to begin vacuum drying after filtration, or track other process variables, such as air entry into the drying chamber.
The ProMaxion is practical and affordable. With up to 32 sample inlets, a single ProMaxion mass spectrometer can monitor multiple reactors and sample points. Because of its real-time response and ability to detect different solvents, multiple dryers can be assigned their own individual configuration. The analyzer handles pressure ranges from 50 psi g to 10 Torr absolute. It comes packaged in an explosion-proof housing and is certified Class 1, Div. 1 for hazardous environments.
The ProMaxion is factory programmed for easy set up, operation and calibration. It’s advanced alarm, automation, and self-diagnostic features ensure confident operation by non-technical plant personnel. Its modular design turns trouble-shooting and repair into simple tasks that can be performed on site in minutes by plant personnel. A built-in modem allows for remote access should additional factory support be needed.