RT Journal Article
SR Electronic
T1 Factors Involved in Cycle Development of a Steam-In-Place System
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 119
OP 121
VO 40
IS 4
A1 Berman, David
A1 Myers, Ted
A1 Chrai, Suggy
YR 1986
UL http://journal.pda.org/content/40/4/119.abstract
AB A cycle was developed for an automated in-place steam sterilization process of a large volume batch (LVB) sterile holding tank assembled with product and tank vent filters and associated product transfer lines. An LVB system is defined as having a batch size of at least 1000 liters. The process is referred to as steam-in-place (SIP). The advantage of SIP lies in the fact that the system is sterilized as a complete unit eliminating aseptic assemblies whereby points of contamination may result. The scope of this article is to discuss the objectives and concerns involved in the development of an SIP process, and in particular describe considerations in developing the SIP cycle for E. R. Squibb & Sons' new parenteral facility.