Cleaning Chromatography Resin Residues from Surfaces: Evaluation of Cleaning Process Design for Non-dedicated Chromatography Columns

Cleaning Chromatography Resin Residues from Surfaces: Evaluation of Cleaning Process Design for Non-dedicated Chromatography Columns

04/03/2019, 4:15 PM - 5:00 PM

Javits Conventions Center - Innovation Stage - Booth 1281
Language:
English
Most cleaning validation approaches are centered around removing either protein or process impurities from surfaces, and not on the resin residue itself. Residues from a chromatography resin are different from a protein in multiple ways. For removing resin residues, the most commonly used solutions are NaOH and NaCl, or even hot Water for Injection (WFI). Nonetheless, the physical and chemical properties of resins. Cleanability studies should be conducted to demonstrate the suitability of these commodities for cleaning non-dedicated chromatography columns and to ensure that there is no cross contamination between resins used for previously manufactured product into the next product. Cross-contamination concerns may also include microbial or allergen risks. This talk provides a case study that evaluates the cleaning efficacy of NaOH and formulated cleaning agents against resin residues. A general recommendation for cleaning resin residues is provided.

Contributors

  • Elizabeth Rivera

    Speaker

    Technical Services Manager

    STERIS

    Elizabeth Rivera is a technical service manager for the Scientific Division of STERIS Corporation (Mentor, Ohio). Currently, she provides technical...

Type of Session

  1. Type of Session
    Session

Categories

  1. Track
    Optimizing Facilities through Innovation & Technologies

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