Course Details
Scheduled Events: June 2026
Learning Mode: Online
Language: English
(see more details below)
Learning Objectives
The objective of Module 1 of this course is to provide basic knowledge relating to the contamination control of medical devices.
The basic principles of microbiology will be illustrated, including growth and lethality curves of microorganisms that allow for the control of sterilization processes. Methods for determining bioburden, sterility testing, and possible approaches to their validation will be discussed in accordance with harmonised standards (ISO 11737-1 and ISO 11737-2, respectively) to ensure the reliability of results.
Emphasis will also be placed on bacterial characterization methods. Finally, methods for determining bacterial endotoxins in accordance with ISO 11737-3 will be covered. The meeting aims to provide the basic information needed to obtain appropriate contamination data for medical devices, suitable for their subsequent use, and to validate the sterilization process to which they will be subjected.
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 microbiological testing of medical devices. 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 Microbiology
- Types of microorganisms (bacteria, viruses, fungi, spores)
- Bacterial growth curves
- Source of bacterial contamination
- Lethality curves and related parameters (Dvalue, z value, F0)
- Bioburden testing according to ISO 11737-1
- Sample selection
- Procedure (removal of microrganisms from the device, seeding, microbial count)
- Characterization of detected bacteria
- Method validation (verification of growth inhibitory factors, recovery factor)
- Sterility testing according to ISO 11737-2
- Sample selection
- Procedure
- Method suitability (verification of growth inhibitory factors, bacteriostasis and fungistasis)
- Bacterial endotoxin testing (BET) according to ISO 11737-3
- Gel-clot (procedure and interpretation of results)
- Chromogenic and turbidimetric methods (procedure and interpretation of results)
- Calculation of the endotoxin limit on devices
- Method suitability, reagent qualification and operator qualification
- 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
- 16 June 2026, 09:00 am - 02:00 pm (CEST).
Price
510,00 € (per participant, taxation excl.).
Learning Mode
Online, Instructor-Led
Language
Training in English Language
