Assembly of Standardized Test Specimen for Microbial Quantification of Plasma Sterilization Processes of Fine PTFE Tubes as Used in Thermo Sensitive Medical Devices Like Flexible Endoscopes

Abstract Fine PTFE tubes are used in high‐end and high cost devices like flexible Endoscopes where no standard sterilization procedure like autoclaving applies due to material properties. The study of innovative decontamination processes like plasma sterilization request appropriate analysis methods in order to verify the process functionality. In a related research project the IGB‐cycle‐method for contamination and recovery of indicator organisms like Bacillus atrophaeus spores was developed. It was possible to proof the IGB‐cycle‐method to be reproducible and reliable using round robin tests between three laboratories that compared their results in reference to a relevant level of contamination and recovery. Of a relevant contamination more than 7 log 10 steps of cfu/specimen could be recovered from the tube surface. magnified image