Course Details
Scheduled Events: June 2026
Learning Mode: Online
Language: English
(see more details below)
Learning Objectives
The objective of Module 2 of this course is to provide basic knowledge relating to the validation and the routine control of the terminal sterilization process of medical devices by ethylene oxide.
The main validation approaches defined in the reference standard ISO 11135:2014 (harmonized with European Regulation 2017/745) will be illustrated, with particular emphasis on PCDs and the use of appropriate biological indicators. The interpretation of sterilization charts and the control of critical parameters for monitoring routine cycles will be addressed. Special emphasis will be placed on practical examples.
Finally, methods for demonstrating the equivalence of sterilization equipment will be discussed. The meeting aims to provide basic information for validating and monitoring the ethylene oxide sterilization process, whether conducted at the manufacturer's premises or by qualified third parties.
For a general overview of this training path and for details on all other modules, visit this page: Sterility Assurance for Medical Devices - Training Path
Who should attend?
The course is intended for managers and members of the Quality Assurance, Regulatory Affairs, Production, and Quality Control teams involved in ethylene oxide sterilization at any stage of the process (from validation to routine release). Basic knowledge will also be provided for new hires and those who, despite having worked in sterilization field for a long time, have identified the need to consolidate their training in these topics by reviewing the basics.
Course Agenda
- Basic information on terminal sterilization
- Types of sterilization and relevant labelling
- Definition for understanding of the process
- Ethylene oxide sterilization:
- Mechanism of action of ethylene oxide
- Sterilization equipment
- Critical process parameters
- Validation and revalidation of the ethylene oxide sterilization process according to ISO 11135:2014
- PPQ
- MPQ, Process challenge devices (PCD) and Biological Indicators (BI)
- Determination of ethylene oxide residues and dissipation curves
- Release of sterilized bathes
- Routine controls
- Parametric release
- Control of outsourced sterilized batches
- Demonstration of equivalence between equipment
- Practical aspects and examples:
- Management of documentation
- Data reading and interpretation
Prerequisites
None.
Course Materials
- Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
- Notebook for didactic use (where applicable), containing a copy of the standards necessary for the training course, to be returned at the end of the course. In order to respect copyright, all the standards of online courses can be provided for consultation only through access to a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is advisable that participants purchase the reference standard directly from the official ISO store https://www.iso.org/home.html or request a copy within their own organisation.
Learning Assessments
- Certificate of competence, in case of successful completion of final exam
- Certificate of attendance, in case of non-successful completion of the final exam or no exam.
Duration
5 hours. The training can be attended in modules or as a complete path. For details, check the individual module pages above.
Scheduled Events
- 17 June 2026, 09:00 am - 02:00 pm (CEST).
Price
490,00 € (per participant, taxation excl.).
Learning Mode
Online, Instructor-Led
Language
Training in English Language
