Validation of Sterilization Process for Medical Devices (ISO 11135)

Ethylene Oxide (ETO) sterilization remains one of the most widely used methods for medical devices but ensuring a compliant and effective sterilization process requires a strong understanding of both microbiological principles and regulatory expectations. ISO 11135 defines the requirements for the development, validation, and routine control of ETO sterilization processes, making it essential knowledge for medical device manufacturers.

In this expert-led webinar, we explore the validation of sterilization processes in accordance with ISO 11135, focusing on the microbiological foundations and critical process parameters that underpin successful ETO sterilization. The session combines regulatory insight from a Notified Body assessor with practical, real-world experience from an industry expert bridging scientific theory with operational practice.

Please join us for a free webinar recording featuring Klaus Lindenberg from DQS and Anil Chaudhury from Operon Strategist, as they share their perspectives on regulatory compliance, validation strategy, and common challenges faced during conformity assessments.

The webinar at a glance:

• Key microbiological considerations for ETO sterilization process validation
• Gas-volume determination and ETO hold-time strategies
• Regulatory requirements under ISO 11135
• Common challenges and how to prepare for conformity assessments
• Live Q&A with regulatory and industry experts

This webinar is ideal for professionals working in Quality Assurance, Regulatory Affairs, sterilization, validation, and production within the medical device industry.

Speakers:

• Klaus Lindenberg, Technical Assessor, DQS
• Anil Chaudhury, CEO, Operon Strategist

Duration: 01:00 hr