Thinking outside the box: New approaches to conduct cleanliness validation

The cleanliness of medical devices, like reusable surgical instruments, moves more and more into the public focus. Issues, such as the increasing number of nosocomial infections and recall campaigns initiated by the FDA, led to this public awareness. Although the knowledge that cleanliness is important for medical devices is available since many decades and written down in numerous national and international guidelines, there are always problems caused by poor hygiene or cleanliness. But also the cleanliness validation, i.e. inspecting the cleanliness state of products, instruments or other surfaces in the medical environment lags behind. At this point it is worth thinking outside the box. In particular, new measuring techniques, new approaches for conducting cleanliness validations and considering industries where cleanliness plays an important role is opening new and promising horizons. Using practical project examples, new approaches for detecting particles, thin-film contamination, and biotic contaminants are introduced and discussed.