ABSTRACT

The recent history of EO sterilization has been dominated

by advances in engineering technology. These advances

include not only the computerized controls for the

operation of sterilizers, but also the physical environ-

mental controls that permit safe use of 100% EO gas.

Most of these improvements have been driven by econ-

omics. Faster, cheaper processes are indeed worthy

objectives. However, sometimes it seems we have lost

the focus on what we are really attempting to accomplish

in the sterilization processes. Any sterilization process

must deliver a lethality that kills the naturally occurring

bioburden microbes that contaminate the products and

materials. If the process does not render the products or

materials free from living microorganisms, then steriliza-

tion has not been achieved.