Medical device manufacturers have always been under scrutiny to ensure that their product does no harm to the patient. Regulatory agencies have become increasingly aware of the potential dangers of residual manufacturing materials on medical devices. Therefore, cleanliness has become a hot topic in the medical device community. A thorough validation of the cleaning processes used to remove residual materials from newly manufactured medical devices is necessary to ensure patient safety. One of the most common methods is using extraction techniques to validate the cleanliness of a device.
This 60 minutes webinar will provide in-depth and valuable guidance on how to achieve a thorough validation of a cleaning process.
- Cleaning Validation Overview
- Defining the Scope
- Identifying the Contaminants
- Choosing the Test Method
- Choosing the Solvents
- Setting Extraction Parameters
- Validating the Extraction
- Setting Limits
- QA/QC managers and personnel
- Validation managers and personnel
- Manufacturers of Implantable Medical Devices
- Manufacturers of Single-Use Medical Devices
- Manufacturers of Reprocessed/Reusable Medical Devices