Sterilization Assusrance at higher level
PMSSteriTest Helix PCD Test (process challenge device) is used as a daliy test for pre-vacuum hospital sterilizers and for bench top steam sterilizers Class B for steam penetration and inert gases. The Helix PCD test is an excellent test to detect even the smallest amounts of inert gases and steam penetration capabilities.
The EN 867 Part 5 is describing a Helix PCD based steam penetration test as an alternative for the Bowie & Dick Test for bench top steam sterilziers Class B The EN 285 is specifying the Helix PCD test for hospital steam sterilizers when it is mainly used to sterilize hollow loads.
PMSSteriTest Helix PCD test is not replacing routine monitoring of sterilization cycles. This should be done by lot control sets and/or with inpack integrators.
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