Ethylene oxide sterilization: III--Influence of carrier nature in a biological monitor performance.
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.
Pinto
T J
TJ
Faculdade de Ciencias Farmaceuticas-USP, Sao Paulo, Brazil.
Saito
T
T
Iossif
M
M
D001412:Bacillus subtilis / Q000254:growth & development; D015169:Colony Count, Microbial; D004784:Environmental Monitoring / Q000379:methods; D005027:Ethylene Oxide; D016014:Linear Models; D008422:Materials Testing; D010209:Paper; D010969:Plastics; D013170:Spores; D013242:Sterilization / Q000379:methods* / Q000592:standards*
D010969:Plastics; D005027:Ethylene Oxide