Jessica Shea

Jessica Shea, Merck MilliporeSigma - Qepler Summits And Conferences

Jessica Shea

Senior Validation Consultant, Global Support, BioReliance® Validation Services
Merck MilliporeSigma
Portland, Maine, USA
Merck offers chemicals for applications in laboratories and industry. Biosciences, biopharma, food, cosmetics, LCDs, pharmaceuticals, printing, plastics and coating

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.

Related Sessions:

Qepler - 2nd Annual Extractables & Leachables Summit thumbnail Details

2nd Annual Extractables &
Leachables Summit 2020

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 22 Oct 2020
  • Virtual,
  • Pharma
Day 1: Thursday, 22 October 2020
CASE STUDY: E&L Considerations for Adoption of new Single-Use components: A Case Study with Millipak® Final Fill

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.

  • Risk assessment of Single-Use Final Fill application
  • Material changes and change control
  • Extractables and Leachables Safety Evaluation Comparison
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