Course Name
Ethylene Oxide Sterilization of Medical Devices – ISO 11135:2014 Requirements
Course Overview
Welcome to the Ethylene Oxide Sterilization of Medical Devices – ISO 11135:2014 Requirements training course by ARG Academy. This comprehensive program is designed to provide a foundational understanding of EtO sterilization methods, EtO characteristics, and strict regulatory requirements. The curriculum walks participants through the complete structure of ISO 11135:2014, covering everything from initial risk management and process overviews to detailed validation protocols and routine operational control.
Course Objective
By the end of this training, participants will be able to:
● Understand the clause-by-clause structure and key focus areas of the ISO 11135:2014 standard.
● Identify the legal obligations, documentation needs, and distinct roles of manufacturers versus contract sterilizers.
● Integrate EtO sterilization documentation, traceability, change control, and internal audits into an ISO 13485 Quality Management System.
● Apply risk management principles linked to ISO 14971, including hazard identification and risk control measures for EO toxicity, residuals, and process risks.
● Understand the complete EtO process flow including preconditioning, sterilization, aeration and manage critical process parameters.
● Execute detailed validation protocols encompassing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Course Benefits
Participating in this course provides valuable operational, safety, and compliance advantages:
● Gain hands-on experience through interactive group case studies, such as preparing a sterilization validation plan for a new product.
● Learn how to effectively manage microbiological requirements, including bioburden testing, Biological Indicators (BI) placement and analysis, and Sterility Assurance Levels (SAL).
● Ensure strict compliance with ISO 10993-7 requirements for EO, ECH, and EG exposure limits, testing, and acceptance criteria.
● Develop the ability to confidently handle deviations, investigate out-of-spec results, and manage the CAPA process for regulators.
● Achieve audit readiness for MDA, FDA, and Notified Body (NB) inspections through proper validation files, recordkeeping, and audit trails.
● Receive comprehensive deliverables, including a Participant Manual, group case study worksheets, and a Certificate Template.
Who Must Attend
This training is highly relevant for professionals involved in medical device sterilization operations and compliance, including:
● Personnel from medical device manufacturers and contract sterilizer facilities.
● Quality Management System professionals responsible for ISO 13485 integration and documentation control.
● Risk management personnel applying ISO 14971 to sterilization processes.
● Validation, engineering, and process control personnel responsible for IQ, OQ, PQ, equipment requirements, and routine monitoring.
Methodology
The course utilizes an interactive and practical learning approach to ensure maximum retention:
● Instructor-Led Modules: Detailed breakdowns of standards, microbiological tools, process charts, and validation requirements.
● Interactive Group Case Studies: Scenario-based workshops requiring group discussion and presentation, such as drafting a validation plan.
● Risk-Based Workshops: Collaborative group activities focused on evaluating change control and requalification needs.
● Knowledge Assessments: A 10-question multiple-choice pre-test and post-test, followed by a review of answers and a participant feedback session.
Course Duration
● The total training duration is 2 Days (14 Hours Total).
● Day 1 focuses on Foundational Understanding and Regulatory Requirements, while Day 2 focuses heavily on Validation, Monitoring, and Operational Control.
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