Plasma Sterilization: What are the Conditions to Meet this Claim?

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