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Single use Bioprocess components

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Extractable and Leachable studies, the physical and chemical characterization of materials, are important for patient safety and intended to identify and quantify harmful leachable impurities. These impurities could leach from single-use bioprocess components and poses a health risk.

Extractable and Leachable evaluations are an important part of product development, optimization and validation. EBPT-NL have extensive expertise to support this critical activity. We offer support during the entire Extractable and Leachable flow:

  • Setting up an extractable approach for your product and write your protocol
  • Perform an extractable study
  • Evaluate data through an toxicological assessment
  • Implement a suitable Leachable strategy

Extractable studies are performed through semi-quantitative methods. We set-up proposals based on the client’s needs and the specific scenario (extraction conditions, solvents, time, and temperature).

The extraction solutions will be analyzed by different analytical techniques through quali-quantitative screening methods wherever applicable:

  • HPLC-UV-MS for non-volatile organic compounds
  • GC/MS for Organic Semi-volatile compounds
  • Headspace GC/MS for volatile organic compounds
  • ICP/OES for specific target metals

Please contact us for more information.