Shaw hemostatic scalpel.
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Clinical Trials as Topic↗
Biomedical subjects
S Cates
Publications and source records attributed to S Cates.
Studies on the scale-up of microfiltration membrane devices.
This paper addresses the prediction and modeling of fouling in microfiltration (MF) membrane devices during the filtration of biological solutions. The membrane-fouling model described can be used by bioengineers to characterize a solution's filterability when using a specific microfiltration product line. This allows bioengineers to predict the scale up of filtration from laboratory through clinical production to full marketing production. The model used to correlate filtration results contains two parameters (initial flux and membrane plugging constant) that must be determined experimentally. Once these parameters are known, it is possible to predict the performance (fouling and throughput) of larger membrane devices as a function of operating pressure, processing time, and membrane area. This allows users of MF devices to perform laboratory tests of their solution at relatively small scale, and based on these tests determine the performance of larger-scale MF devices for filtration of the same solution.
Animals↗
Studies on the scale-up of crossflow filtration devices.
This paper describes a new method that makes it possible to predict the performance of crossflow ultrafiltration and microfiltration when scaling up from small laboratory scale to process-scale systems. Using this method, one characterizes a solution's filtration properties with a specific ultrafiltration or microfiltration membrane in a laboratory-scale crossflow device. Based on experimental results at this scale, one can accurately predict scale-up performance from laboratory through clinical production to full marketing production. Given the need for biopharmaceutical engineers to rapidly predict the size and cost of full-scale filtration processes once products receive regulatory approval, this method will find wide use in the pharmaceutical industry.
Drug Industry↗