As a type of production equipment used in biopharmaceutical manufacturing processes, single-use systems need to conduct process-specific validation, including chemical compatibility, adsorption, and Extractable & Leachables. Among the aforementioned testing, Extractable & Leachables testing is a key element of single-use systems. For single-use systems used in the whole manufacturing processes, the testing of components is driven by the risk that the component could be unsuited for its intended use. Once the extactables and leachables data set is available, a DP-specific safety evaluation based on production batch size and dosing regimen should be conducted to evaluate the patient safety aspects of extracted compounds.

Product Features

  • ✔ Localization of Experimental Samples: From design, production, radiation, to validation, all can be localized to achieve rapid delivery.
  • ✔ Advanced and Comprehensive Analytical Instruments: To achieve comprehensive characterization of extractables/leachables.
  • ✔ Professional Technical Team: Providing regulatory interpretation, technical support, and validation experiments.
  • ✔ Robust Quality System: Ensuring data authenticity, integrity, and traceability.

Product Advantage

  • ● Quick delivery from scale-down testing system design, production, irradiation and testing
  • ● Comprehensive E&L profile through advanced analytical instruments
  • ● Professional technical team to provide regulatory interpretation, technical support and validation experiment
  • ● Good quality assurance to make sure data authenticity, integrity and traceability