Clean by Design: Navigating Medical Device Cleanliness Through Validation, Regulatory Alignment, and Failure Response

Description

In medical device manufacturing, “clean” is not a one-time achievement; it’s an ongoing process that must remain controlled, defensible, and aligned with patient safety. Yet even well-designed cleaning strategies can be challenged by real-world conditions, evolving regulatory expectations, and unexpected results. 

This webinar explores three common scenarios manufacturers face and provides a practical framework for cleaning validation interpreting outcomes and determining next steps: 

• Initial Cleaning Validation (and Revalidation Triggers) Defining “clean,” selecting appropriate methods, and building a robust validation approach are critical, not only for initial success, but for managing future changes with confidence. 
• Regulatory Scrutiny and Notified Body Challenges Increasing expectations from notified bodies and regulators can expose gaps in cleaning rationale, acceptance criteria, or validation strategy, often late in the process.
• Excursions in Established Processes When validated cleaning processes drift, due to variability, contamination events, or manufacturing changes, teams must determine impact, root cause, and whether revalidation is required. 

Through real-world examples, we’ll walk through how to evaluate each scenario, connect cleaning data to risk, and take appropriate, defensible action. 

Attendees will learn how to: 

• Define and justify “clean” using risk-based approaches 
• Interpret cleaning results in context, not in isolation 
• Strengthen validation strategies to withstand regulatory scrutiny 
• Assess the impact of excursions and process changes
• Make informed decisions that support both compliance and patient safety 

Speakers

Stephen Spiegelberg, Chief Scientific Officer, Cambridge Polymer Group 

Dr. Stephen Spiegelberg is Chief Scientific Officer and co-founder of Cambridge Polymer Group, with more than 30 years of experience in polymer science and over 25 years in biomedical consulting. He leads multidisciplinary teams developing materials, analytical methods, and test protocols for medical devices, with particular expertise in material characterization and device cleanliness. His work focuses on polymers for biomedical applications, including polyethylene and hydrogel systems, as well as cleaning validation, failure analysis, and test method development. He chairs multiple ASTM task groups and is widely recognized for his leadership in advancing standards for medical device cleanliness. 

Jeffrey Rufner, Principal Consultant, JAR Consulting 

Jeffrey Rufner is a medical device cleaning subject matter expert and Principal Consultant at JAR Consulting LLC, providing guidance on cleaning validation, test methods, and process development for regulated products. He previously served as a Staff Engineer at Zimmer Biomet, where he supported global operations in device cleanliness, water systems, and end-of-line processing, and developed corporate standards and validation methodologies. Jeff brings deep expertise in cleaning chemistry, equipment selection, and analytical method development. He is an active contributor to ASTM and ISO initiatives, helping advance industry approaches to cleaning validation and scientifically justified residue limits.

Click here to register.