Course Details
Scheduled Events: June 2026
Learning Mode: Online
Language: English
(see more details below)
Learning Objectives
Dry heat, used under appropriate conditions, is the only sterilizing agent that also produces depyrogenated products.
The objective of Module 5 of this course is to provide basic knowledge regarding the validation and routine control of both the dry heat terminal sterilization process and the depyrogenation process of medical devices.
The main sterilization and depyrogenation equipment will be illustrated and the differences between the two processes will be evaluated in accordance with the reference standard EN ISO 20857:2013, considered the most up-to-date state of the art on dry heat sterilization. Particular emphasis will be placed on validating the two processes using appropriate sterilization and depyrogenation indicators.
Finally, methods for monitoring the two processes during routine cycles will be examined. The purpose of this meeting is to provide basic information for validating and monitoring dry heat sterilization processes and dry heat depyrogenation processes, 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 dry heat sterilization or/and depyrogenation of medical devices 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 dry heat sterilization
- Mechanism of action of heat
- Sterilization equipment
- Critical process parameters
- The depyrogenation process by dry heat
- Depyrogenating tunnels
- Critical process parameters
- Validation and revalidation of the sterilization/depyrogenation process according to EN ISO 20857:2013
- PPQ, heat penetration curves
- MPQ
- Release of sterilized/depyrogenated 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
- 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
4 hours. The training can be attended in modules or as a complete path. For details, check the individual module pages above.
Scheduled Events
- 24 June 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
