The gke Steri-Record® Mini-Bio-Plus self-contained biological indicators (SCBI) are used for validation and monitoring of ethylene oxide sterilization processes. After sterilization the SCBI can be incubated by the user without a microbiological laboratory. The SCBI can be used for routine monitoring inside packs or containers. They have also been designed to be used inside Bio-Compact process challenge devices (Bio-C-PCD). The SCBI consists of a plastic vial with a minimized internal volume containing a biological indicator spore disc and a glass ampoule with growth medium and pH-indicator inside. The outside label of the SCBI contains a type 1 indicator according to EN ISO 11140-1 to check if the SCBI has been in a sterilization process
