Solvent Drying & Recovery
Pharmaceutical manufacturers are well aware of the industry statistics that at least 25% of time and energy can be saved by terminating the active pharmaceutical ingredient drying process at its true endpoint. However, actually determining the true endpoint has always been an obstacle. To avoid interrupting the process (traditional methods to determine the drying process involved sampling and analyzing the product in a lab) and possible contamination of an entire batch, many producers choose to overextend the drying process. In order to reduce costs and improve product quality, a recent trend in pharmaceutical drying applications is to accurately identify the end point of the drying process.
Our Quadrupole Mass Spectrometer MAX300-LG™ Laboratory Gas Analyzer monitors the atmosphere composition above the drying material. Because the headspace is in close relationship with the concentration of solvents in the material, the true drying process end point can be determined by analyzing the headspace vapors.
In a solvent drying process, the MAX300-LG high performance quadrupole process mass spectrometer monitors the atmospheric composition of the headspace above the drying material. This composition is in close relationship with the concentration of solvents in the material. By analyzing the concentration profiles of solvents in the vapor phase, the true drying process end point can be determined. With high precision of the MAX300-LG, each batch can be dried to the same specification, thus improving the rejection rate when the final product is tested. The detection capabilities are beneficial for dynamic processes such as solvent drying, in which it is desirable to analyze a component over a large concentration range.
Optimize sampling for ambient pressures, vacuum drying, and lyophilizers using our CRDS trace-level, low-pressure moisture analyzer for Lyophilization, HALO RP or HALO QRP. Both allow for quick trace moisture analysis and multi-species analysis of solvents such as IPA, MEK, DCM, ethyl acetate, styrene, acetonitrile, etc. Monitoring for contaminants close to the substrate or in the process chamber exhaust, significantly reduces the risk of process issues that cause product yield losses.
Due to the large number of chemical solvents used in the drying process, Quadrupole Mass Spectrometry is the only viable and economical analytical technology for Solvent Recovery applications. To achieve the flexibility of analysis and parts per billion detection (ppb) limits, the Extrel MAX300-IG™ Industrial Gas Analyzer is the system of choice.
Our online Quadrupole Mass Spectrometer System is capable of fast and flexible analysis of an unlimited number of compounds in a single analytical method. The selection and tuning of analysis masses is achieved through software, not hardware. Therefore, a pharmaceutical plant’s solvent recovery process can be streamlined with no idle time between batches. Additionally, this same system is capable of analyzing the final gas exhausted to the atmosphere to monitor plant compliance with environmental regulations.
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