Advancing Cleaning Validation with TOC and Process Analytical Technology

Implementing TOC as a PAT Technology

Total Organic Carbon (TOC) has long been used as a tool in cleaning validation, but its implementation as a Process Analytical Technology (PAT) continues to expand as companies look for faster, more efficient ways to monitor cleaning processes and support real-time quality decisions.

This webinar will explore how TOC can be implemented as a PAT solution for cleaning validation and regulatory compliance. The session will begin with an overview of TOC fundamentals, how the technology works, and why its speed, sensitivity, and non-specific detection capabilities make it well suited for cleaning applications. The presenters will then discuss how TOC is used for rinse analysis, swab sample testing, and real-time monitoring, as well as how it compares to more traditional analytical approaches.

A key focus of the session will be regulatory acceptance and inspection readiness. The discussion will address common concerns around TOC implementation, including method validation, system suitability, documentation expectations, and how to align TOC strategies with FDA, EMA, and PIC/S expectations. The presenters will also provide practical guidance on implementation planning, risk assessment, equipment qualification, acceptance criteria, training, maintenance, and common pitfalls to avoid.

Attendees will hear perspectives from both the TOC manufacturer and cleaning validation consulting sides, with Veolia/Sievers providing technology insight and Hyde Engineering + Consulting sharing practical experience from cleaning validation and PAT implementation projects. The session will also include a success story highlighting lessons learned, key success factors, and the potential value of implementing TOC as part of a modern cleaning validation program.

The webinar will conclude with key takeaways and a live Q&A session based on attendee-submitted questions.

Presenters