RT Journal Article
SR Electronic
T1 Validation of the Steam-ln-Place Sterilization of Disc Filter Housings and Membranes
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 55
OP 64
VO 37
IS 2
A1 Kovary, Stephen J.
A1 Agalloco, James P.
A1 Gordon, Barbara M.
YR 1983
UL http://journal.pda.org/content/37/2/55.abstract
AB Steam-in-place (SIP) sterilization of manufacturing equipment has emerged as an improvement over systems requiring aseptic connections. Validation of a SIP sterilization process requires proper consideration of all particulars of the system This is true, especially when a disc filter membrane and housing are present, such as vent filtration equipment on a tank system. This paper presents important criteria to be addressed in the validation effort and specifically focuses upon the sterilization conditions required in the disc filter housing. The study examined essential criteria such as sterilization time, filler housing design. membrane type, and the microbioligical test method The work was primarily conducted with 142-mm disc filter housings but the applications lend themseh es to other size disc filter housings which are steam sterilized in-place