Instant Biological Indicator & Batch Monitoring System Bio (BMS) Green 235-324-550-1Tr_AnlıkBioIndikator.pdf

Application
The gke Steri-Record® Instant-Mini-Bio-Plus self-contained biological indicators (SCBI) are used for validation and routine monitoring and allow an im-mediate release of the load in steam sterilization processes without having to wait for the result after incubation.
The Instant-Mini-Bio-Plus SCBIs can be used for routine monitoring inside packs or containers. They have also been designed to be used inside a gke Steri-Record® Bio-Compact Process Challenge Device (Bio-C-PCD®). Special adaptations have been made to the SCBI so it can be used together with a PCD as a type 2 indicator according to EN ISO 11140-1 which reaches the required sensi-tivity to check the internal lumens of a minimal inva-sive surgical (MIS) instrument.
Seven Bio-C-PCD®s with different air removal char-acteristics are available. The sensitivity of these Bio-C-PCD®s can be selected to meet the require-ment of the load. The validation of the Bio-C-PCD® according to the load can be achieved by using the test method described in DIN 58921. Depending on the process used and on the load configuration an appropriate Bio-C-PCD® should be selected.
Product Description
The gke Steri-Record® Instant-Mini-Bio-Plus SCBI uses a plastic vial with a minimized internal volume containing a biological indicator spore plate and a glass ampoule with a growth medium and pH-indicator inside.
The outside label of the SCBI contains a type 1 chemical indicator according to EN ISO 11140-1 to check, if the SCBI has been in a sterilization pro-cess.
The Instant-Mini-Bio-Plus SCBI also contains a type 5 chemical indicator inside the SCBI allowing the result to be instantly evaluated at the end of the sterilization process. Therefore, it is not necessary to wait for the outcome of the SCBI incubation since the type 5 indicator provides equivalent or better information about the result of the sterilization pro-cess according to the above chemical indicator standard.
The specially designed and patented gke Steri-Record® Bio-C-PCD® construction consists of a large initial internal volume with a stainless steel tube inside and a minimal capsule volume at the closed end. It can be used only with the specially designed Mini-Bio-Plus SCBIs as described before, to create a high sensitive Hollow Load PCD. Con-ventional SCBIs cannot be used because of the lower sensitivity for air removal and steam penetra-tion inside the PCD.

For detailed technical data, please see the brochure in the "Files" tab above and the product in the "Videos" tab, if available.