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Evaluation of the Efficacy and Superiority of Different Vial Rubber Closure Disinfection Techniques

Author(s):  Bjornstad Matthew, Kosinski Tracy, Burlage Robert

Issue:  Sep/Oct 2020 - Volume 24, Number 5
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Abstract:  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. 

Related Keywords: Matthew Bjornstad, BS, PharmD, Tracy Kosinski, PharmD, CPPS, BCSCP, Robert Burlage, PhD, compounded sterile preparation, rubber vial stopper surfaces, disinfection techniques, microbial contamination, multi-dose vials, sterile isopropyl alcohol wipes, parenteral preparations

Related Categories: PACKAGING, PEER-REVIEWED, STERILE PREPARATIONS, QUALITY CONTROL

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