Process Monitoring System

The gke Steri-Record® process monitoring system (PMS) is a hollow load test according to EN 867-5 that is described as a type test for formaldehyde sterilzation processes in EN 14180 and is used as a PMS. The PCD is either available as Helix-PCD or Compact-PCD®, see image.

There are various sterilization programs on the market. Before using a process challenge device (PCD) as a PMS or batch monitoring system (BMS) with different sterilization programs, the most difficult instrument to be sterilized should be inoculated with biological indicators and a validation shall be carried out. 

For sterilization cycles with vacuum a PCD is not recommended. In this case one or more indicators should be placed into the packages - without using a PCD.

Hollow Load Tests according to EN 867-5