American Sterilizer Company

Other

Dana Products, Inc.

Dana Prodicts, Inc.

Harry Bala

John C Mowli

Mark Bala

Anthony J Fiorello

Richard Koszyk

A sterilization challenge device for verifying the efficacy of a sterilization process includes a container, an insert member, a sterilization indicator, and a cap. The container includes an open end, a closed end, a chamber configured to contain the biological indicator and the insert member, and at least one hole arranged proximate the open end. The cap is configured to engage with the container to close the open end, and the at least one hole is configured to provide a flow path for the gaseous sterilant into the chamber.

Sterilization process challenge device

A sterilization challenge device for verifying the efficacy of a gas sterilization process includes an outer container, an inner container, a chemical indicator, and a cap. The outer container includes an open end, a closed end, a chamber configured to contain the inner container containing the chemical indicator, and at least one hole arranged proximate the open end. The cap is configured to engage with the outer container to close the open end, and the at least one hole is configured to provide a flow path for the gaseous sterilant into the chamber.

Gas sterilization process challenge device

A biological sterilization indicator for evaluating the effectiveness of a sterilization process includes a cap containing a culture medium, a container containing a concentration of microorganism, and a breakable barrier attached to the cap to encapsulate the culture medium therein. The breakable barrier is formed from a multilayer structure including an aluminum layer and a sealing layer. The biological indicator is configured such that the breakable barrier may be broken at a selected time by engaging the cap and the container at an activated position to introduce the culture medium into the container.

Biological sterilization indicator

A sterilization process challenge device configured to test the efficacy of a sterilization process includes a tubular body for containing at least one sterilization indicator and a filter assembly including at least one filter member. The only flow path into the interior of the tubular body containing at least one sterilization indicator is provided through the filter assembly to control and restrict flow of a gaseous sterilization medium from an external environment.

A sterilization process challenge pack including a base tray, a first cover, and a second cover is configured to provide a restrictive flow path for gaseous sterilization medium to test the efficacy of a sterilization process. The base tray includes at least one chamber containing a biological indicator and/or chemical indicator. The first cover including a notch is configured to cover the at least one chamber. The second cover is attached to peripheral surfaces of the base tray except at an unsealed portion. A flow path through the unsealed portion and the notch in the first cover provides the only fluid communication between an external environment and the at least one chamber.

Sterilization process challenge pack

A steam sterilization indicator for indicating acceptability of a sterilization cycle includes a temperature indicator for indicating the temperature used in the sterilization cycle.

Sterilization indicator with temperature indicator

A compact sterilization indicator includes a wicking element having at least two different wicking rates across the length of the wicking element.

Sterilization test strip

A sterilization test strip includes a temperature sensitive material, which liquefies and travels along a wicking element when exposed to steam at a predetermined temperature for a predetermined period time to reach a marker to indicate that an acceptable level of sterilization has not occurred.

An indicator for a sterilization process is configured to function for two different sterilization conditions. The indicator includes two pass zones to indicate whether an acceptable sterilization has occurred after a sterilization process at a first condition of after a sterilization process at a second condition.

Dual migrating indicator

An indicator for a sterilization process is configured to function for two different sterilization conditions. The indicator includes two pass zones to indicate whether an acceptable sterilization has occurred after a sterilization process at a first condition or after a sterilization process at a second condition.

An air removal test system for verifying adequate air removal during a sterilization cycle of a pre-vacuum type sterilizer includes specimen holder and a test strip. The test strip includes a solid indicator chemical, which liquefies and travels along a wicking element during the sterilization cycle. The test strip is configured to verify adequate removal of air during the sterilization cycle by displaying a color change through a window.

Air removal test strip

A counting device includes a shaft, a handle affixed to a first end of the shaft, and a locking unit mounted in the handle spaced from the shaft. A locking plate has an opening for accommodating the shaft. The locking plate has a plurality of recesses facing the locking unit for cooperating with the locking unit. A position indicating assembly is coupled to the shaft to move as the handle is rotated. The recesses are arranged in a circular pattern on the locking plate such that the locking unit engages each recess as the handle is rotated around the shaft. The recesses are configured to permit one-way rotation of the handle.

Sterilization challenge specimen holder counter

A sterilization challenge specimen holder is used with a test indicator to challenge sterilization on a consistent basis. The holder includes a body having an internal chamber region. A cap is sealable on the holder. An opening is defined in the body or cap that forms a single tortuous ingress and egress path communicating the interior chamber with the environs. An insulating layer is disposed over the body and cap to fully insulate the body and cap other than over the opening so as to not interfere with the ingress and egress path. The insulating layer reduces the heat transference from the environs to the interior chamber region.

Sterilization challenge specimen holder

A sterilization challenge specimen holder is used with a test indicator to challenge sterilization on a consistent basis. The holder includes a body having an internal chamber region and a sleeve positionable within the internal chamber. A cap is sealable on the holder and a plug is positioned in the body. The plug has a wall having a spiral formed groove therein in communication with the internal chamber region. An opening in the holder provides for a flow path for communication between the environs and the internal chamber, and another opening(s) provides for a second flow path for communication between the internal chamber and the inner chamber of the sleeve. An indicator tube carries a biological indicator and has openings therein.

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South Barrington, IL, United States of America

Harry Bala