Bjornstad Matthew, Kosinski Tracy, Burlage Robert
Concordia University Wisconsin School of Pharmacy, Mequon, Wisconsin.
Int J Pharm Compd. 2020 Sep-Oct;24(5):434-438.
Contamination of sterile products has caused significant adverse outcomes in patients, including death. Limited research has been conducted on the efficacy and/or superiority of sterile isopropyl alcohol disinfection techniques of rubber stopper surfaces in sterile compounding. The objective of this evaluation was to investigate the efficacy and/or superiority between the following three disinfecting techniques of vial rubber tops when utilizing sterile isopropyl alcohol wipes: Intervention 1) three swipes back and forth using the same surface; Intervention 2) three swipes in a unidirectional manner using the same surface; Intervention 3) three swipes in a unidirectional manner using a different side of wipe with each swipe. The rubber stopper surfaces of 90 vials were contaminated with bacteria. Thirty vials were disinfected with each assigned technique, swabbed after drying, and plated. After plates were incubated for 48 hours, colonies were quantified, and the different techniques compared. When comparing the varying disinfection techniques to the positive control, Intervention 1 and Intervention 3 techniques showed statistical significance (P=0.00). The Intervention 2 technique showed no difference in colony counts from the positive control (P=0.259). Comparing the different techniques side by side, both Intervention 1 and Intervention 3 techniques were statistically different from the Intervention 2 technique (P=0.027, P=0.00). There was no statistical significance noted between the Intervention 1 and Intervention 3 disinfecting techniques (P=0.141). Disinfecting vials with three swipes in one direction with a different surface of the sterile alcohol wipe or disinfecting vials with a back and forth motion three times is superior to either not disinfecting the vial or disinfecting the vial with three swipes in one direction using the same surface of the sterile alcohol wipe during sterile compounding.
无菌产品的污染已给患者带来严重不良后果，包括死亡。关于无菌配料中橡胶塞表面的无菌异丙醇消毒技术的有效性和/或优越性，所开展的研究有限。本评估的目的是研究在使用无菌异丙醇擦拭巾时，小瓶橡胶瓶盖的以下三种消毒技术之间的有效性和/或优越性：干预措施1）在同一表面来回擦拭三次；干预措施2）在同一表面单向擦拭三次；干预措施3）每次擦拭使用擦拭巾的不同面单向擦拭三次。90个小瓶的橡胶塞表面被细菌污染。每种指定技术对30个小瓶进行消毒，干燥后进行擦拭取样并接种培养。平板培养48小时后，对菌落进行计数，并比较不同技术。将不同的消毒技术与阳性对照进行比较时，干预措施1和干预措施3技术具有统计学意义（P = 0.00）。干预措施2技术与阳性对照在菌落计数上无差异（P = 0.259）。将不同技术相互比较时，干预措施1和干预措施3技术与干预措施2技术在统计学上均有差异（P = 0.027，P = 0.00）。干预措施1和干预措施3消毒技术之间未发现统计学意义（P = 0.141）。在无菌配料过程中，用无菌酒精擦拭巾的不同面单向擦拭小瓶三次或来回擦拭小瓶三次进行消毒，优于不进行消毒或使用无菌酒精擦拭巾的同一面单向擦拭小瓶三次进行消毒。
