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.