This paper descrribes 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.
- Received August 29, 1995.
- Accepted December 4, 1995.
- Copyright © Parenteral Drug Association. All rights reserved.
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