Course Details
Scheduled Events: June 2026
Learning Mode: Online
Language: English
(see more details below)
Learning Objectives
The objective of Module 6 of this course is to provide basic knowledge relating to the validation and the particulate and microbiological monitoring of controlled contamination environments, known as "cleanrooms," for the production of medical devices requiring terminal sterilization.
The characteristics of these environments (design, filters, personnel and material flows) and their classification in accordance with the reference standard ISO 14644-1:2015, considered the most up-to-date standard for the classification of cleanrooms based on airborne particle concentrations, will be illustrated. Particular emphasis will be placed on particulate monitoring plans in accordance with ISO 14644-2:2015 and on microbiological monitoring methods for cleanrooms in accordance with EN 17141:2020, to ensure the continuous efficiency of these environments.
The meeting aims to provide basic information for validating and monitoring controlled contamination environments where devices intended for sterilization are produced.
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 and Production teams involved in sterile medical devices manufacturing. Basic knowledge will also be provided for new hires and those who, despite having worked in the production of sterile medical devices for a long time, have identified the need to consolidate their training in these topics by reviewing the basics.
Course Agenda
- Definition of controlled contamination environments
- Difference between cleanrooms and clean zones
- Types of flow (unidirectional, turbulent)
- Characteristics of controlled contamination environments
- Surfaces, airflows, personnel and material access, differential pressures, filters
- Particle classification of controlled contamination environments according to ISO 14644-1:2015 (“as bulk,” “at rest,” and “operational”)
- Validation of cleanrooms: main performance tests (differential pressure, flow direction, temperature, humidity)
- Environmental microbiological monitoring plans according to EN 17141:2020
- Air sampling
- Surface sampling (deposition plates, contact plates)
- Dressing for accessing to cleanrooms
- Cleaning aspects of controlled contamination environments
- 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
- 30 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
