Biological indicators for ethylene oxide sterilization: performance evaluation
Oxborrow, G.S.; Kallander, K.D.; Mendenhall, C.R.
Journal of Parenteral Science and Technology a Publication of the Parenteral Drug Association 37(1): 13-14
1983
ISSN/ISBN: 0279-7976 PMID: 6834211 Document Number: 201907
Biological indicators (BI) from 12 manufacturers were tested by the USP XIX window method and the USP XX D-value method. More samples were found acceptable by the USP XX method, and the number failing either test was similar to that of previous years. Little progress was indicated in increasing the reliability of BI used in manufacturing processes.