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.