Type test according to EN 1422 with SCBI
The gke Steri-Record® Process Challenge Device (PCD) for ethylene oxide sterilization processes has been developed according to the standard EN 1422. It consists of a 4.55 m long stainless steel tube of 3 mm diameter connected with a capsule holding the self-contained biological indicator (SCBI) sealing one end.
The PCD complies with the type test described in the European standard EN 1422, annex F, for air removal and ethylene oxide penetration. Ethylene oxide sterilization processes differ in temperature, pressure, EO concentration and intergas mixtures, e.g. CO2.