Extractables and leachables training courses to keep up-to-date with the changing regulations.

The guidelines for pharmaceutical packaging, manufacturing equipment and medical devices are continually progressing. Knowledge of the composition of these components is essential to determine their leachable risk. A thorough understanding of the supply chain for these materials enables you to evaluate any potential risk to your products when dealing with vendor imposed material changes.

Exova offers an extended range of training services covering extractables and leachables and the use of materials in packaging and medical applications. Examples of training topics are:

  • Overview of extractables and leachables
  • Review of the materials typically used in packaging and manufacturing equipment
  • Key factors that impact the leaching of chemicals from polymer substrates
  • Regulatory expectations for extractables and leachables testing
    • Container Closure Systems (CCS)
    • Single-Use Processing Equipment
    • Medical Devices – ISO 10993
  • The new suite of USP <661> testing along with <1663> and <1664>
  • Industry recognized “best practices” for performing extractables and leachables testing
  • Efficiently dealing with unexpected material changes
  • Implementing quality control measures to evaluate new batches of CCS components and single-use processing equipment
  • Partnering with vendors to manage the supply chain

In addition to these topics, Exova’s consultants can design customized training programs to meet your specific needs. The workshops include a combination of lectures and real time on-site consulting to better address your specific training needs.

The goal of our training programs is to create a company-wide understanding of the regulatory expectations for extractables and leachables testing, as well as to develop a strategy for the control and management of leachables from the materials used in packaging, medical devices, and single-use processing systems.