ABSTRACT
Steam SIP is in daily use in the parenteral industry as a
result of the desire for enhanced sterility assurance for
aseptically producedmaterials. Along with this increased
usage, there has been concomitant interest in the vali-
dation of SIP procedures. It is essential that the readers
have a fuller understanding of SIP concepts in order to
properly apply the technology and subsequently validate
SIP. The available literature on the subject of SIP has been
extremely limited when compared with other steriliza-
tion processes. Articles which have been published on
this subject have focused on issues such as process
fundamentals, heat penetration, and filter sterilization
(1-10). Each of these articles has proven valuable in
helping SIP become better understood and in advancing
the industry’s awareness of the subject. Only limited
assistance has been provided to the individual who is
responsible for the detailed design of the SIP system. The
criticality of system design to achieving sterility with SIP
systems is such that it must be considered more closely
than any other aspect of the SIP validation effort.
