Silicone Tubing for Biopharmaceutical Applications: Particulates, Endotoxins, and Bioburden Characterization

Adoption of single-use systems (SUS) has increased steadily over the past few years driven by an increased focus on manufacturing biologics that require smaller scales than blockbuster drugs. Although SUS provide many benefits, some factors need to be considered when implementing them in biopharmaceutical production. With the regulatory landscape intensifying worldwide, drug manufacturers are expecting more data from suppliers to support the purity claims of supplied products, especially related to the purity of their product-contact surfaces.

In this article, we discuss how DuPont Liveo Pharma Tubing products meet the very high level of purity required in the biopharmaceutical industry:

  • A comprehensive data package demonstrates substantially low levels of particulates, endotoxins and bioburden
  • In-house compounding of biomedical grade elastomers backed by DuPont Material Science enable high purity by design
  • These data can help biopharmaceutical users and Single Use assemblies integrators accelerate the validation of the tubing products in their systems and processes.

Learn more on how DuPont’s silicone tubing products can meet the highest reliability, purity, and safety in critical biopharmaceutical processes.

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Lise Tan-Sien-Hee, PhD, is a technical service and development specialist for healthcare, DuPont Transportation and Industrial; lise.tansienhee@dupont.com. For more details about the properties and advantages of DuPont’s silicone tubing, visit https://www.dupont.com/brands/Liveo.html.

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