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Plasma Sterilization: What are the Conditions to Meet this Claim?
Author(s) -
von Woedtke Thomas,
Kramer Axel,
Weltmann KlausDieter
Publication year - 2008
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.200800013
Subject(s) - sterilization (economics) , extrapolation , plasma , process engineering , biochemical engineering , antimicrobial , materials science , computer science , biomedical engineering , nuclear engineering , pulp and paper industry , chemistry , mathematics , engineering , statistics , physics , business , organic chemistry , finance , exchange rate , foreign exchange market , quantum mechanics
Plasma‐based processes to inactivate micro‐organisms are usually called ‘plasma sterilization’. Based on the debatable assumption of exponential first‐order micro‐organism inactivation kinetics, sterilization process validation is realizable by a combination of experimental tests and data extrapolation. In this article, an alternative concept for a solid and reproducible process qualification is proposed to guarantee reliable microbiological safety on a sufficient level for products that must be sterilized by alternative procedures like plasma processes. A proof of antimicrobial efficacy on the highest experimentally accessible level under experimentally realizable, reproducible, and statistically evaluable conditions is demanded.