Course Details
Scheduled Events: July 2026
Learning Mode: Online
Language: English
(see more details below)
Learning Objectives
The objective of Module 7 of this course is to provide basic knowledge regarding the validation and monitoring of the packaging p rocess of sterile medicale devices.
The characteristics of packaging that must ensure device sterility in accordance with the reference standard EN ISO 11607-1:2020+A1:2023 (harmonized with European Regulation 2017/745 and subsequent amendments) will be illustrated, with particular emphasis on the new usability requirements and the use of sterile barrier symbols on labeling. Process validation in accordance with EN ISO 11607-2:2020+A1:2023 (IQ, OQ, PQ) will be examined, along with the main tests recommended by the standard for verifying packaging integrity.
Finally, the main protocols (ASTM D4169 and ISTA) for transport validation and accelerated packaging stability studies will be discussed. The meeting aims to provide basic information to validate and monitor the packaging process of medical devices requiring terminal sterilization to ensure that sterility is maintained until the moment of use.
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 who handle sterile medical devices. Basic knowledge will also be provided for new hires and those who, despite having handled sterile device packaging for a long time, have identified the need to consolidate their training in these topics.
Course Agenda
- Definition of the different types of packaging (packaging system, sterile barrier system, protective packaging, sterile fluid path)
- Reference standards (Table B.1 ISO 11607-1)
- General packaging requirements (examples)
- Labeling (sterile barrier symbol)
- Packaging process validation:
- - IQ
- - OQ
- - PQ
- - Packaging integrity testing
- Accelerated stability studies
- Transport simulation studies according to ASTM D4169 and ISTA protocols
- Practical aspects and examples.
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
- 01 July 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
