Information about steam sterilization
Besides validation of sterilization processes, chemical indicators are used for routine monitoring. Chemical indicators have the advantage, that the information about the result is immediately available after sterilization. There are various chemical indicators on the market. It is important that these indicators provide information about the quality of a sterilization process.
Chemical indicators have been tested according to their operational reliability and are constantly monitored. Manufacturing processes of the pharmaceutical and medical industry are based on GMP (Good Manufacturing Practice) and quality management standards EN ISO 9001 and EN ISO 13485. For hospitals the same guidelines apply according to the Medical Device Directive (MDD) and the recommendation of the commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch-Institute (RKI) and the German Institute for Pharmaceuticals and Medical Devices (BfArM).