TY - JOUR T1 - Effect of Sublethal Ethylene Oxide Exposure on Bacillus subtilis Spores and Biological Indicator Performance JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 200 LP - 211 VL - 34 IS - 3 AU - Robert R. Reich Y1 - 1980/05/01 UR - http://journal.pda.org/content/34/3/200.abstract N2 - Ethylene oxide gas (EO) is shown to affect Bacillus subtilis spore outgrowth kinetics without detectably affecting germination kinetics. Outgrowth of EOtreated spores is delayed up to 18 hr. The delay is not the result of an alteration in the exponential growth rate of the resulting vegetative cell population. Post-process B. subtilis biological indicators (BI’s) utilizing paper carriers, retain detectable residual EO levels for at least 48 hr. The data indicate that these levels are absorbed to the spores. Consequently. small EO residual levels potentially have significant biological consequences. As a result of the evidence of EO spore injury and retained EO residual levels, it is important that EO, BI recovery systems must be designed with meticulous care. Specific considerations for the design of a BI recovery system are outlined. ER -