The Unknowns in Contamination Control
In this joint webinar, Particle Measuring Systems and Tema Sinergie will explore the hidden challenges of contamination control in modern barrier systems.
A robust Contamination Control Strategy (CCS) depends not only on what can be measured, but also on understanding what may remain hidden. In isolator-based aseptic processing, factors such as airflow behavior, equipment design, operational interventions, and monitoring limitations can create risks that are not always apparent during routine assessments.
In this joint webinar, Particle Measuring SystemsĀ and Tema Sinergie will explore the hidden challenges of contamination control in modern barrier systems, focusing on the role of Computational Fluid Dynamics (CFD), Environmental Monitoring (EM), and risk-based decision making. Drawing on practical industry experience, the speakers will discuss how unseen contamination pathways, airflow uncertainties, and monitoring blind spots can impact process assurance and product protection.
The session will highlight the strengths and limitations of individual assessment tools and demonstrate how integrating engineering expertise, airflow analysis, environmental monitoring data, and contamination control principles can provide a more complete understanding of risk. Attendees will gain practical insights into identifying hidden vulnerabilities, strengthening their CCS, and improving confidence in contamination control performance.
Key Learning Objectives:
- Identify hidden contamination risks in modern barrier systems
- Understand strenghts and limitations of individual assessment tools, like CFD, EM data…
- Learn how to integrate engineering expertise and risk assessment tools for a robust CCS
Who should attend:
- Sterility Assurance Specialist,
- QC/QA,
- Environmental Monitoring Specialist,
- Production Manager,
- Compliance Officer,
- Validation Specialist,
- Facility Manager
Speakers
Luca Calisi
Advisory Specialist
Luca is an Advisory Specialist in the Global Sterility Assurance Team at Particle Measuring Systems, with extensive experience in pharmaceutical microbiology, contamination control, and environmental monitoring. He began his career in microbiological quality control and now focuses on contamination control strategies, risk-based solutions, and sterility assurance for GMP manufacturing. Luca supports global pharma companies with risk assessments and Quality by Design (QbD) process validations. He presents regularly for ISPE, PDA, AFI, and Sapienza University of Rome. Luca is a trusted expert for cleanroom professionals worldwide.
Giovanni Tronci
Product Manager, Pharma & Biotech, Tema Sinergie
Giovanni Tronci earned his degree in Chemical Engineering from the Politecnico di Torino, where he also successfully completed a PhD in Chemical Engineering. His doctoral research focused on simulating the bottle-filling process for carbonated soft drinks, developing custom code using open-source software.
Since 2021, he has been part of the Pharma & Biotech Business Unit at Tema Sinergie, working as a Sales Engineer. As of January 2025, he has taken on the role of Product Manager within the same Business Unit.
