PT  - JOURNAL ARTICLE
AU  - Berman, David
AU  - Myers, Ted
AU  - Chrai, Suggy
TI  - Factors Involved in Cycle Development of a Steam-In-Place System
DP  - 1986 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 119--121
VI  - 40
IP  - 4
4099  - http://journal.pda.org/content/40/4/119.short
4100  - http://journal.pda.org/content/40/4/119.full
SO  - PDA J Pharm Sci Technol1986 Jul 01; 40
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.