PT  - JOURNAL ARTICLE
AU  - Yeung, A. C.
AU  - Alguire, D. E.
TI  - A Conceptual Framework for the Qualification/Validation of Ethylene Oxide Sterilization Cycles
DP  - 1980 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 248--253
VI  - 34
IP  - 4
4099  - http://journal.pda.org/content/34/4/248.short
4100  - http://journal.pda.org/content/34/4/248.full
SO  - PDA J Pharm Sci Technol1980 Jul 01; 34
AB  - Recent FDA inspections of ethylene oxide sterilization facilities have revealed that many medical products labeled as sterile are processed without a properly validated sterilization cycle. Since there is no clear definition as to what ethylene oxide sterilization qualification/validation entails, this study is an attempt to clarify the meanings of these terms. The difficulty in arriving at the “maximum/minimum” conditions in an ethylene oxide sterilizer is examined. A comparison is made to the use of the Stumbo equation as a measurement of the sterilization effectiveness delivered to the product. The 3-dimensional Cartesian co-ordinate is introduced as a means of defining the loading pattern and the location with the “minimum” conditions for the placement of innoculated products and/or biological indicators. Graphical presentation of the trajectories of the key process parameters is used to illustrate the importance of validation studies prior to making production runs.