Integrated cleaning/sterilization process with lumen devices

Abstract

A method for cleaning and sterilizing a medical device having a lumen with at least two open ends comprises the steps of: a) providing a container having at least one enclosure separated from the container by an interface, b) placing the device into the container and enclosure across the interface in such a way that one end of the lumen of the device is located in the container and the other end in the enclosure, c) generating a flow of a cleaning solution through the lumen to clean the inner surface of the lumen, d) generating a flow of rinse solution through the lumen to rinse the inner surface of the lumen, e) treating the device with a liquid sterilant, f) vaporizing the liquid sterilant in the container or enclosure thereby simultaneously sterilizing and drying the device, and providing a sterile, dry product without further rinsing. In the method, step f) can be conducted under a diffusion restricted environment, or by reducing pressure to a first predetermined pressure followed by further reducing the first pressure to a predetermined second pressure, or at controlled pump down rate. The method further comprises retaining a predetermined amount of the liquid sterilant in the container and enclosure prior to step f).

Dependencies are inferred from the claim text.