Content
What does pure mean? How can I access pure medical products? And how do I ensure reproducible purity in the long term? In this practice-oriented seminar, participants have the opportunity to discuss together, but also to ask many questions, including about requirements for product germ contamination that must be met before sterilization and what other parameters (e.g. endotoxin/pyrogen contamination, Particle pollution, cytotoxicity, chemical analysis) must also be taken into account. Which cleaning process is suitable for removing production-related contamination and how cleaning processes are to be qualified. It is not only important for SMEs to identify requirements, sensible solutions and no-gos before purchasing and qualifying a cleaning system.
Also an important part of the seminar will be the standards already set by ISO 19227, DIN TS 5343 and the updated ISO 10993-18, as well as what standardization will bring about purity (future ISO 8250).
Topic overview
- Requirements for sterile medical devices with regard to exposure to 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/cleaning (including qualification) from the perspective of the philosophy introduced with ISO 19227: 2018 and continued with DIN TS 5343: 2022 and future ISO 8250
- Product quality monitoring (including strategies, parameters, limits, corrective actions, laboratory tests and documentation)
target group
Newcomers to medical technology as well as employees in the areas of development, production, quality assurance as well as approval and assessment of medical devices.
Prior knowledge
Attending the seminar “Important aspects of medical devices delivered sterile” is recommended.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
KONTAKT:
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