Type test according to EN 1422
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 indicator strip 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.
Therefore, the monitoring system should be validated with biological indicators (B. atrophaeus 106) before chemical indicators are used. For routine monitoring chemical indicators can be used with the advantage that they can be checked immediately after the sterilization has finished.