This application is used for evaluation of particulate contamination on medical devices originating from the production process and environmental conditions.

The degree of surface contamination with residual dirt particles might affect the tissue compatibility in terms of transplantation and the function of medical devices. Testing of cleanliness of medical devices can help reducing tissue intolerance or rejection and optimizing product quality.

The inspection is an indirect test method that requires a sampling step in which a test lot of the pre-cleaned medical device is taken and cleaned under defined conditions once more. The resulting extraction fluid is filtered by a laboratory process and the residual dirt particles are collected on a filter membrane.

The particle distribution is analyzed in terms of size and type, and are expressed in cleanliness classes (level).

By default, testing of medical products should be combined with the GxP module.