RT Journal Article
SR Electronic
T1 Approaches to Cycle Development for Clean-in-PIace Processes
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 9
OP 15
VO 41
IS 1
A1 Myers, Ted
A1 Kasica, Ted
A1 Chrai, Suggy
YR 1987
UL http://journal.pda.org/content/41/1/9.abstract
AB A process is described for the in-place automated cleaning of manufacturing and hold tanks. The process evaluations conducted during cycle development are described. A qualified cycle is recommended. This cycle is comprised of a 5-min chlorinated water rinse, a 3-min air purge, a 15-min detergent wash (recirculated) followed by a 12-min detergent wash, a 3-min air purge, a 15-min WFI rinse, a 3-min air purge, a 15-min WFI rinse, and a 3-min air purge. The article describes the various factors that play a role in developing a clean-in-place process.