Caister Academic Press

Concomitant Achievement of a Sterility Assurance Level of 10-6 with Material and Functional Compatibility by Gas Plasma Sterilization

Hideharu Shintani
from: Gas Plasma Sterilization in Microbiology: Theory, Applications, Pitfalls and New Perspectives (Edited by: Hideharu Shintani and Akikazu Sakudo). Caister Academic Press, U.K. (2016) Pages: 13-24.

Abstract

In this chapter, we discuss the importance of attaining a sterility assurance level (SAL) of 10-6 while maintaining material/functional compatibility. Simultaneous achievement of both these factors is required in ISO 14161 and for sterilization validation. Because the level of penetration achieved by gas plasma sterilization is quite shallow, at around 10-20 nm from the surface, the procedure kills only one layer of bioburden but readily maintains material and functional compatibility. In reality, there is an absence of bioburden that form multi-layer clumps in healthcare products. Thus, gas plasma treatment easily displays material/functional compatibility whilst achieving a SAL of 10-6 due to its low temperature of operation and shallow penetration read more ...
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