Fundamentals, Common Practices, and Pitfalls in Practice
The sterilization of medical devices to protect human health is a central element in the development, manufacture, use, and reprocessing of medical devices. When applied correctly, it can ensure the safety of medical devices and improve product quality.
It is important to distinguish between products that are manufactured and sterilized under aseptic conditions and medical devices that are sterilized on-site by the user.
Gain an understanding of the validation process for sterilization procedures and learn the normative fundamentals according to DIN EN ISO 11135, DIN EN ISO 11137 and DIN EN ISO 17665.
Learn how to select appropriate methods, process parameters, and service providers; understand the tasks and responsibilities you have as a manufacturer, service provider, or testing laboratory; and discover how to maintain sterility over the long term.
- Content
- Regulatory and legal requirements for the sterilization of medical devices
- Fundamentals of medical device sterilization
- Requirements for sterilization packaging materials
- Sterilization methods
- Sterilization with ethylene oxide
- Sterilization with radiation (gamma and e-beam)
- Steam sterilization
- Verification of sterilization
- Labeling of sterile products
- Your Benefits
- You will learn about the various requirements for the sterilization of medical devices.
- You will become familiar with the different sterilization methods.
- You will learn how to implement the requirements for the validation and qualification of sterilization processes.
- You will receive practical tips for your company.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Medical device manufacturers
- Manufacturers of sterile products
- Product management professionals
- Quality assurance and quality management professionals
- Research and development
- Regulatory affairs managers
