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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
Author(s) -
Maucher Tanja,
Schnabel Uta,
Volkwein Wolfram,
Köhnlein Johanna,
Winter Jörn,
Weltmann KlausDieter,
Trick Iris,
Oehr Christian
Publication year - 2011
Publication title -
plasma processes and polymers
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.644
H-Index - 74
eISSN - 1612-8869
pISSN - 1612-8850
DOI - 10.1002/ppap.201000141
Subject(s) - sterilization (economics) , contamination , human decontamination , materials science , biomedical engineering , medical device , process engineering , pulp and paper industry , waste management , engineering , biology , ecology , monetary economics , economics , foreign exchange market , foreign exchange
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.