Caister Academic Press

Future Perspectives and Trends in 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: 147-150.

Abstract

Gas plasma sterilization has a shallow penetration depth of approximately 10-20 nm. Thus, material and functional compatibility can be easily attained. Sterility assurance of a 12 log reduction is not always required of BI users (ISO 14161). Indeed, a 12 log reduction is quite difficult to achieve with the current gas plasma process, because a tailing phenomenon in the survivor curve can occur due to clumping of the biological indicator. Similarly, a 6 log reduction from 106 CFU/carrier to a SAL of 100 is also difficult to attain as is often seen in the engineering research. Nonetheless, a 12 log reduction is required in sterilization validation studies for BI manufacturers according to ISO 11138-1. However, simultaneous attainment of material/functional compatibility is not required of BI manufacturers in ISO 11138-1 because there are no materials being tested. When using the overkill method, a 12 log reduction is required together with material/functional compatibility for BI users according to ISO 14161. To achieve this requirement, deeper penetration of gas plasma sterilization will be needed in the future, but the penetration depth must be limited in order to maintain material/functional compatibility read more ...
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