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Abstract 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. magnified image
Woedtke et al. (Thu,) studied this question.