Driving Innovation With Extractables Simulator |Sartorius

Webinar | Driving Innovation With Extractables Simulator (ExSim)

Wednesday, October 15, 2025

Session 1: 10 a.m. CET | 1:30 p.m. IST | 4 p.m. HKT  

Session 2: 8 a.m. PST |  11 a.m. EST | 5 p.m. CET

Extractables testing is a critical element in ensuring patient safety and regulatory compliance for single-use systems. However, traditional approaches are often time-consuming, costly, and resource intensive. In this in-depth webinar, we introduce ExSim: a powerful, science-based simulator that digitizes and accelerates extractables risk assessments.

Developed to support compliance with USP <665>, BPOG, and SEA guidelines, ExSim allows users to build virtual assemblies, define extraction parameters, apply validated diffusion and equilibrium scaling models, and instantly generate automated reports—streamlining workflows and enabling better use of expert time.

What You Will Learn:

Understand how ExSim addresses the limitations of classical extractables studies.
Get hands-on insights into ExSim's reporting and safety evaluation capabilities.
Compare different scaling methods (diffusion vs. equilibrium) and data models.

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Johannes Lemke

Project Manager

Johannes Lemke has been working for Sartorius since 2018, currently holding the position of Project Manager Validation Services. He completed his Master of Science in Biotechnology at the University of Applied Sciences Berlin. Johannes began his career at Sartorius as a Scientist in Corporate Research, where he developed intensified & connected cell culture processes.

Throughout his professional journey, Johannes has consistently focused on enhancing biopharmaceutical processes. His expertise spans hands-on research in process intensification, customer consultation for cost modeling and process optimization, and leading technical development teams in advancing process analytical technologies to expand automation capabilities.

Since 2025, Johannes has been instrumental in supporting customers with sterile filter validation projects. Recognizing the critical importance of extractables and leachables in single-use processes, he has conducted numerous E&L assessments for customer-specific projects, utilizing the Sartorius ExSim software to deliver tailored solutions.

Alisia Theeuwes

Validation Services Technical Specialist

Alisia Theeuwes has been working for Sartorius since 2021, where she is a Technical Specialist for Confidence^® Validation Services in the E&L laboratory. She earned her chemistry degree at Avans University of Applied Sciences in the Netherlands.

Since 2024, she has been maintaining ExSim (software) and training end users as an expert in ExSim.

As an active member of the E&L laboratory, she performs extractables and leachables studies from sample entry to reporting, developing methods, writing SOPs, and mentoring students.