RT Journal Article
SR Electronic
T1 Ethylene Oxide Sterilization: III—Influence of Carrier Nature in a Biological Monitor Performance
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 155
OP 158
VO 48
IS 3
A1 Pinto, Terezinha J. A.
A1 Saito, Takako
A1 Iossif, Mario
YR 1994
UL http://journal.pda.org/content/48/3/155.abstract
AB The ethylene oxide sterilization process control should take into account several parameters, so that only the biological monitor can integrate in all of them, presenting a biological challenge similar to the product under sterilization conditions. The authors evaluated spore resistance on several different carriers: paper, aluminum foil and plastic. The influence was studied through the challenge of sub-lethal cycles, followed by the lethality study and the D-value calculation. There was a significant statistical difference in spore resistance between paper and plastic carriers.