Workshop and materials will be in English language.
Sterilization is one of the key processes in the production of sterile medical devices. Among the different sterilization types, each has its advantages and disadvantages. Evidence of successful sterilization is important and expected when demonstrating conformity with regulatory requirements.
The workshop will address the following topics related to medical device sterilization: microorganisms and their characteristics, bioburden determination for medical devices, controlled environments, clean rooms in the production of medical devices, cleaning and sterility assurance for reprocessed medical devices, and sterile barrier systems. Through the presentation of practical examples, the attendees will learn the details of compliance assurance and get the knowledge for competent performance of medical device sterilization.
- Basic sterility – microorganisms and their characteristics, medical devices’ bioburden, controlled environments and cleanrooms, cleaning and sterility assurance processes with a sterile barrier system.
- Requirements for the sterility of medical devices according to medical device directives and regulations, ISO 17665-1, and other harmonized standards regarding the sterilization of medical devices.
- Presentation of the different sterilization types (steam, dry, gas, radiation)
- The importance of contamination control of work environments and sterilization processes in relation to ISO 13485
- Procedures for the confirmation of successful sterilization of medical devices (control, validation, sterility)
- Packaging and release of sterile medical devices
- Review of the most important sterilization methods used in the medical device industry – practical cases
The workshop will cover the theoretical basics and requirements through practical examples and exchange of experience.
Marjetka Kralj Kunčič PhD is a doctor of science in the field of microbiology with more than 12 years of experience in the manufacturer of medical devices. Her work was extensive, as in addition to managing laboratories, as the head of quality control, she also actively participated in the field of development, production and ensuring legislative compliance, as well as the compliance of the quality system of medical devices. She currently works as an auditor at SIQ and a consultant in the field of medical devices and is a member of the technical group for the preparation of the standard.
The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between. Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.
- Medical device manufacturers
- Design and development/quality control specialists and those responsible for the production of medical devices
- Persons responsible for sterilization in hospitals and clinics
- All who would like to upgrade and refresh their knowledge on sterilization of medical devices