Sterilization processes for medical device manufacturers
The seminar covers the essential requirements for the sterilization of medical devices and hygiene monitoring as the basis for the manufacture of sterile medical devices. You will gain a good overview of the validation and documentation of sterilization processes in the medical device industry in order to ensure a valid manufacturing process in practice. Building on this, you will learn about the special aspects of the various sterilization processes. Specifically, the following standards harmonized under the Medical Devices Directive 93/42/EEC and/or Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices or adopted as the state of the art will be discussed:
- (EN) ISO 17665-ff
- EN ISO 11135
- EN ISO 11137-ff
- EN ISO 14937
- Basics of microbiology
- Where do germs occur and how are they transmitted?
- Procedures for germ reduction
- Cleanrooms and their operation in accordance with the EN ISO 14644 series.
- Production hygiene monitoring program
- Method validation
- Principles of sterilization validation according to EN ISO 14937
- Specific aspects of the various sterilization methods
- Overview of (EN) ISO 17665 series, EN ISO 11135, EN ISO 11137 series, EN ISO 14937
- Special features of sterilization with moist heat
- Special features of sterilization with ethylene oxide gas
- Special features of radiation sterilization
- They understand microbiological data and can interpret it.
- You will acquire in-depth knowledge of sterilization in the manufacturing process of medical devices.
- You will learn about the requirements for the validation of sterilization processes.
- You will be familiar with the documentation requirements for validation reports for the sterilization of medical devices.
- You will be familiar with the hygiene requirements for the manufacture of medical devices.
- Manufacturers of medical devices
- Employees from controlled and clean areas
- Persons responsible for the validation of sterilization
- Persons responsible for the preparation of technical documentation
- Employees from the development and quality assurance departments
- Product managers
This seminar is part of a modular training program. After successfully completing all modules, you can obtain this recognized qualification:
- Safety Expert Non-active Medical Devices - TÜV The seminar deals with internationally valid standards and is also suitable for implementation abroad. The contents of the seminar correspond to the current state of revision/harmonization.
English
Certificate of attendance from TÜV SÜD Academy.
This training is being operated by TÜV SÜD Akademie GmbH in Germany. The General Terms and Conditions as well as the Privacy Notice of TÜV SÜD Akademie GmbH apply. In case of any questions, do not hesitate to contact us.