Particle Shedding from Peristaltic Pump Tubing in Biopharmaceutical Drug Product Manufacturing

In a typical manufacturing setup for biopharmaceutical drug products, the fill and dosing pump is placed after the final sterile filtration unit in order to ensure adequate dispensing accuracy and avoid backpressure peaks. Given the sensitivity of protein molecules, peristaltic pumps are often prefe...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2015-04, Vol.104 (4), p.1440-1450
Main Authors: Saller, Verena, Matilainen, Julia, Grauschopf, Ulla, Bechtold-Peters, Karoline, Mahler, Hanns-Christian, Friess, Wolfgang
Format: Article
Language:English
Subjects:
Biopharmaceutics - instrumentation
Buffers
Drug Contamination
Equipment Design
filling
Infusion Pumps
light scattering (dynamic)
microscopy
Microscopy, Confocal
morphology
nephelometry
Nephelometry and Turbidimetry
particle size
polymers
processing
Risk Assessment
Silicones - chemistry
Solubility
Surface Properties
Technology, Pharmaceutical - instrumentation
unit operations
Water - chemistry
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Summary:In a typical manufacturing setup for biopharmaceutical drug products, the fill and dosing pump is placed after the final sterile filtration unit in order to ensure adequate dispensing accuracy and avoid backpressure peaks. Given the sensitivity of protein molecules, peristaltic pumps are often preferred over piston pumps. However, particles may be shed from the silicone tubing employed. In this study, particle shedding and a potential turbidity increase during peristaltic pumping of water and buffer were investigated using three types of commercially available silicone tubing. In the recirculates, mainly particles of around 200 nm next to a very small fraction of particles in the lower micrometer range were found. Using 3D laser scanning microscopy, surface roughness of the inner tubing surface was found to be a determining factor for particle shedding from silicone tubing. As the propensity toward particle shedding varied between tubing types and also cannot be concluded from manufacturer's specifications, individual testing with the presented methods is recommended during tubing qualification. Choosing low abrasive tubing can help to further minimize the very low particle counts to be expected in pharmaceutical drug products.
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.24357