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What does pure mean? How can I achieve pure medical devices? And how do I ensure reproducible purity in the long term? In this practice-oriented seminar, the participants have the opportunity to discuss things together, but also to ask many questions, including the requirements for product bacterial contamination that must be met prior to sterilization and which other parameters (e.g. endotoxin/pyrogen contamination, particle contamination , cytotoxicity, chemical analysis) must also be considered. Which cleaning process is suitable for removing production-related contamination and how cleaning processes are to be qualified at all. It is not only important for SMEs to recognize requirements, sensible solutions and no-gos before purchasing and qualifying a cleaning system.
Also an important part of the seminar will be the already set standards of DIN TS 5343 and the new ISO 10993-18 as well as what the standardization for cleanliness will bring (ISO 8250).
The speaker is an expert in biological safety, has been supporting medical device manufacturers in Germany and abroad for almost 30 years and is, among other things, chairman of the standards committee for the cleanliness of medical devices in the manufacturing process.
topic overview
- Requirements for sterile medical devices with regard to contamination with germs, endotoxins, particles and chemical substances
- Basic concepts for ensuring a reproducible product status (in the clean room, with final cleaning, ...)
- Production in the clean room (including qualification)
- Product purity / purification (including qualification) from the point of view of the philosophy introduced with ISO 19227: 2018 and continued with DIN TS 5343: 2022, which already also takes ISO 10993-18: 2020 into account
- Product quality monitoring (including strategies, parameters, limits, corrective actions, laboratory testing and documentation)
- Summary / Discussion
target group
Newcomers to medical technology as well as employees in the areas of development, production, quality assurance and approval and assessment of medical devices.
previous knowledge
Attending the seminar “Important aspects of medical devices delivered sterile” is recommended.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen
