Course Details
Scheduled Events: October 2026
Learning Mode: Online
Language: English
(see more details below)
Learning Objectives
The objective of Module 3 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 gamma rays, beta rays or X rays.
The main validation approaches defined in the reference standard ISO 11137-1:2015 and its amendments (harmonized with European Regulation 2017/745) will be illustrated, with particular emphasis on dose mapping and the definition of the sterilization dose for interpreting treatment certificates provided by the sterilization site.
Finally, the various validation methods defined in ISO 11137-2:2013 + Amd 1:2022 (method 1, method 2, VDmax methods) and process monitoring through periodic dose audits will be discussed. Particular emphasis will be placed on practical examples. The meeting aims to provide basic information for validating and monitoring the irradiation sterilization process, which is generally conducted by qualified third-party contractors.
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 irradiation 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
- The irradiation sterilization
- Mechanism of action of the radiations
- Sterilization equipment
- Critical process parameters
- Validation and revalidation of the sterilization process according to ISO 11137:2015
- Dosimeters
- PPQ, dose mapping
- MPQ, method 1, method 2, methods VDMax
- ISO 13004:2022
- Release of sterilized batches
- 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
At the end of the course, a Certificate of Attendance will be issued.
Duration
4 hours. The training can be attended in modules or as a complete path. For details, check the individual module pages above.
Scheduled Events
- 22 October 2026, 09:00 am - 01:00 pm (CEST).
Price
490,00 € (per participant, taxation excl.).
Learning Mode
Online, Instructor-Led
Language
Training in English Language
