Gas sterilization process challenge device

Abstract

Abstract The present invention provides a sterilization challenge device for verifying an efficacy of a gas sterilization process. The device comprises an outer container including an outer container wall, an outer container open end, an outer container closed end, an outer container chamber defined therein, and at least one outer container through-wall opening defined through a thickness of the outer container wall proximate the outer container open end, the outer container having an external thread proximate the open end. The device further comprises an inner container including an inner container wall, an inner container open end, an inner container closed end, and an inner container chamber defined therein, and a cap configured to engage with the outer container to close the outer container open end, the cap including an internal thread arranged along an inner surface of the outer wall and configured to engage the outer container external thread. The outer chamber is configured to contain the inner container wherein the at least one outer container through-wall opening is configured to provide a flow path for a gaseous sterilant into the outer container chamber. The at least one outer container through-wall opening is disposed proximate the open end. The inner container includes an inner container hole defined through a thickness of the inner container wall, and the cap includes a sealing member, wherein the sterilization challenge device is configured such that the inner container open end is covered by the sealing member and pressed against the sealing member when the outer container is engaged with the cap. Abstract 20 26 21 39 77 04 A ug 2 02 6 A b s t r a c t 2 0 2 6 2 1 3 9 7 7 0 4 2 0 2 6 A u g

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