Jessica Shea is responsible for Extractables and Leachables Global Support at Merck.
Previously, she was the manager of the Extractables and Leachables (E&L) Laboratory for the BioReliance® Validation Services. She has more than 12 years of E&L experience, including method validation, designing of custom testing, and interpreting industry and regulatory guidance.
A successful adoption of single use technology in a Biopharmaceutical process largely relies on the confidence in selection of such materials for the process. Changes to an existing process can be difficult even when there are potential benefits to the change. Considerations include compatibility, functionality and E&L evaluation.
This presentation will evaluate the change control process using an example of the implementation of Millipak® final fill into existing processes. Evaluation of the functional testing and extractables data will be presented. The case study will continue with the risk assessment and patient safety evaluation.