Risk assessment of extractables and leachables

The numerous assessments of extractables and leachables (E&L) associated with medical devices or pharmaceutical products that through the years have been submitted by TKT to clients and regulatory authorities provides proof of competence, resulting in a favorable outcome for our clients. We offer e.g., the following services:

  • Risk assessment of E&L in pharmaceutical products (from manufacturing system, container-closure systems, drug delivery device components, and packaging).
  • Risk assessment of E&L from medical devices (according to ISO 10993-17).
  • In silico predictions for E&L with limited experimental data.
  • Literature and database searches according to clients’ specific requirements.

For further information and requests for quotations, please use our contact form, or contact any of our consultants.

Drug manufacturing support