American Sterilizer Company

Christopher J Justi

Michael M Tsentr

Susan G Quick

Kevin O Williams

A process challenge device (PCD) for determining the effectiveness of a microbial deactivation process that uses a vaporous deactivating agent (e.g., vaporized hydrogen peroxide) as a deactivating agent. The PCD includes first and second layers that are joined together to form (1) a chamber dimensioned to receive a biological and/or chemical indicator, and (2) first and second conduits fluidly connecting the chamber with a region outside the PCD. Each conduit has one end in communication with the region outside the PCD and another end in communication with the chamber. A removable seal member seals the biological and/or chemical indicator inside the chamber.

Process challenge device for assessing the effective performance of a biocontamination deactivation process

An apparatus for the sterilization of lumen devices. The apparatus for sterilizing lumen devices is comprised of a chamber defining a region for sterilization, an expansion tank assembly, and a mixing member. The chamber is adapted to receive the expansion tank. The expansion tank is adapted to fluidly connect to at least one lumen device. The mixing member is disposed within the expansion tank to mix gaseous sterilant within residual gas that may include contaminants.

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Morgantown, PA, United States of America

Christopher J Justi