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Merck
CN
  • Particle shedding from peristaltic pump tubing in biopharmaceutical drug product manufacturing.

Particle shedding from peristaltic pump tubing in biopharmaceutical drug product manufacturing.

Journal of pharmaceutical sciences (2015-01-22)
Verena Saller, Julia Matilainen, Ulla Grauschopf, Karoline Bechtold-Peters, Hanns-Christian Mahler, Wolfgang Friess
摘要

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.

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L-组氨酸 单盐酸盐 一水合物, from non-animal source, meets EP testing specifications, suitable for cell culture, 98.5-101.0%
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L-组氨酸 单盐酸盐 一水合物, ≥98% (HPLC)
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蔗糖, Grade I, ≥99% (GC), suitable for plant cell culture
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SAFC
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Supelco
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蔗糖, ACS reagent
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组氨酸 盐酸盐 一水合物, European Pharmacopoeia (EP) Reference Standard
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