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A step closer to continuous buffer preparation from solids: Predicting powder compaction and how to prevent it
D Komuczki1, N Hesse2, J Schmidt2
1Institute of Bioprocess Engineering and Sciences (IBSE), University of Natural Resources and Life Sciences, Vienna, Austria.
New Biotechnology
|May 25, 2023
Summary
Predicting powder caking in biopharmaceutical buffer preparation is crucial. Force displacement measurements accurately forecast buffer component behavior in continuous feeding systems, ensuring stable and precise powder delivery.
Area of Science:
- Chemical Engineering
- Pharmaceutical Manufacturing
- Materials Science
Background:
- Biopharmaceutical buffer preparation traditionally relies on manual methods.
- Continuous buffer preparation using powder feeders offers efficiency but faces challenges with powder properties like hygroscopicity and caking.
- A predictive methodology for buffer powder behavior is lacking.
Purpose of the Study:
- To develop and validate a methodology for predicting the feeding behavior of buffer components.
- To identify buffer species requiring special handling during continuous powder feeding.
- To ensure stable and precise buffer preparation in the biopharmaceutical industry.
Main Methods:
- Force displacement measurements using a customized rheometer over 18 hours.
- Testing eight different buffering reagents.
- Validation using a 3D printed miniaturized screw conveyor.
- Implementing additional precautions and hopper design adjustments.
Main Results:
- Most buffer reagents showed uniform compaction; sodium acetate and dipotassium hydrogen phosphate exhibited increased yield stress after 2 hours.
- Rheometer data correlated with observed compaction and feeding failures in the screw conveyor.
- Adjusted setups enabled highly linear feeding profiles for all reagents over 12-24 hours.
Conclusions:
- Force displacement measurements are a reliable tool for predicting buffer component behavior in continuous feeding devices.
- This methodology aids in identifying buffers needing specialized handling for stable, precise continuous buffer preparation.
- Rapid identification of buffers requiring specific setups is vital for process optimization.
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