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Keywords:

  • Extractables;
  • Leachables;
  • Model solvent approach;
  • Regulations;
  • Risk assessment;
  • Safety threshold;
  • Single-use systems

Abstract

Single-use systems have been increasingly used in biopharmaceutical manufacturing processes. Despite their multitude of advantages, these plastic and elastomeric assemblies also draw concerns about chemical compounds that may migrate to finished products and impact product quality or safety. Evaluation of such extractables/leachables and their potential impact remains a challenge to many suppliers and end users. Based on extensive experience on filter extractables study, a practical and science-based approach for determination of extractables/leachables from single-use systems used in biomanufacturing has been developed. The general procedure is presented through a case study.