ISO 11137 in Action: A Guide to Dose Mapping & VDmax25 for Mobius^® Single-Use Assemblies

WEBINAR

In this insider session, you will learn:

• Steps for equipment qualification (IQ/OQ), irradiator verification, and site PQ through detailed dose-mapping studies
• Packaging-qualification strategies (box codes, carrier configurations) to achieve consistent 25–40 kGy delivery
• Sterility-assurance methods using VDmax sampling, design philosophy for Mobius^® simulated assembly (dose audit assembly) concept.
• How to execute periodic dose audits, interpret audit-report data, and manage supplier/end-user responsibilities.

Master sterilization validation for Mobius^® single-use assemblies! Explore ISO 11137 compliance—from 25–40 kGy dose setting and irradiator qualification to VDmax, dose mapping, and audit analysis. Gain practical strategies for supplier collaboration and audit-readiness. We’ll walk through every step—from materials selection and establishing your 25–40 kGy target dose (including VDmax methodology) to qualifying irradiation equipment (IQ/OQ), performing site performance qualification via dose mapping, and assuring uniform dose distribution. You’ll see how to interpret dose-map and audit reports, design simulated “master” assemblies for sterility verification, and implement a robust Dose Audit program. Finally, we’ll clarify shared supplier and end-user responsibilities, revalidation triggers, and best practices for ongoing audit readiness.