HomeWebinarsRegulatory Considerations Including Extractables & Leachables for Single-Use Manufacturing

Regulatory Considerations Including Extractables & Leachables for Single-Use Manufacturing


Successful adoption of single-use technology in a biopharmaceutical process largely relies on confidence in the selection of materials. Understanding the regulatory and industry expectations are important to streamline the implementation and approval process.

This presentation will address the regulatory expectation for single-use manufacturing and demonstrate the key benefits of the Emprove® Program, including extractables data generated following the guidelines recommended by BioPhorum (BPOG) and adopting the USP <665> guidance. With a case study, a risk assessment process will be used to evaluate extractables and leachables requirements in a typical drug manufacturing process.

In this webinar, you will learn about:

  • Regulatory guidance for single-use manufacturing
  • Risk evaluation for single-use implementation


Jessica Shea

Jessica Shea


Emprove® Program Manager

Jessica Shea is the Emprove® program manager responsible for filters, single-Use, and chromatography resin portfolios within Merck. Previously, she was responsible for extractables and leachables global support for the BioReliance® validation services. She has more than 14 years of E&L experience, including method validation, designing of custom testing, and interpreting industry and regulatory guidance. Jessica has a B.S. in biochemistry and an MBA.