Gas Contamination of Vancomycin Hydrochloride Injections After Ethylene Oxide Gas Sterilization of Vials

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  • エチレンオキサイドガス滅菌した塩酸バンコマイシン注射剤へのガス混入
  • エチレンオキサイドガス メッキン シタ エンサン バンコマイシン チュウシャザイ エ ノ ガス コンニュウ

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Abstract

  Vancomycin hydrochloride (VCM) is mixed with bone cement during procedures such as joint prosthesis fixation for the prevention and treatment of infection. Such mixing of VCM with bone cement in the operating room requires aseptic manipulation. Therefore, VCM injection vials are sterilized with ethylene oxide gas (EOG) before transportation into the operating room. Since EOG is a group 1 carcinogen, any residue may have adverse effects on the human body. The present study examined the presence or absence of EOG contamination in VCM injection vials sterilized with EOG, the appropriate degassing period for safe use, and the possible decrease in the VCM titer caused by contact with EOG. The mean EOG contamination in the VCM injection vials after sterilization was 66.7 ppm immediately after aeration for 17 hours (n=3) following the sterilization and 8.3 ppm immediately after aeration for 41 hours (n=3). Subsequently, the vials were left to stand in the room. EOG in the vials disappeared after 14 days in the vials aerated for 17 hours and after 1 day in those aerated for 41 hours. The VCM titer did not decrease after EOG sterilization (n=5). Therefore, for the safe use of EOG-sterilized VCM for operations such as joint prosthesis fixation, we recommend that the sterilized vials should be aerated for 17 hours and left in a room for 14 days or more for degassing. If the VCM is to be used sooner, we recommend that the sterilized vials should be aerated for 41 hours and left in a room for 1 day or more for degassing.<br>

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