Plasma sterilization: What are the conditions to meet this claim?

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.