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The toxicogenic potential of medical plastics sterilized with ethylene oxide vapors

✍ Scribed by O'Leary, Robert K. ;Guess, Wallace L.


Publisher
John Wiley and Sons
Year
1968
Tongue
English
Weight
660 KB
Volume
2
Category
Article
ISSN
0021-9304

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✦ Synopsis


Ethylene oxide appears to be an ideal sterilant for many heat-sensitive items, but there are a number of disadvantages which require caution in it.s usage. Ethylene oxide has some deleterious effects on certain plastics and rubber. I n particular, it acts as a solvent on such acrylic plastics as Lucite and I'lexiglas, and it will attack the plasticizers found in many flexible medical-grade tubing formulations. Perhaps more significant is the fact that this sterilant can produce some serious toxic manifestations when medical plastics are not properly degassed. This paper reviews some of the toxicities already reported in the medical literature and also presents new data on the hemolysis liability of many gas- sterilized pharmaceutical plastics. Both human blood hemolysis studies and cell culture data on 18 different polymers suggest that plasticized vinyl plastics have the highest toxicogenic potential. Experimental data presented on the solubility and partial pressure of ethylene oxide in a homologous series of phthalic acid esters indicate that the structure and concentration of plasticizers play a major role in the selection of the most effective degassing procedures to be used following ethylene oxide sterilization.


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