OBJECTIVES: To evaluate microbial contamination rates of low- and medium-risk level media fill tests performed by pharmacy students near the beginning and end of a parenterals laboratory course in the second- professional year of a doctor of pharmacy (PharmD) program. METHODS: Students enrolled in a required parenterals laboratory class (N = 84) participated in this study. The aseptic technique procedures performed at the beginning of the course were identical to the procedures performed at the end of the course and included 3 low-risk level media-fill tests and a medium-risk level media-fill test. Single-strength trypticase-soy broth (TSB) was substituted for the drug and was used to detect microbial contamination for all manipulations. RESULTS: The baseline and end-of-course contamination rate was 21 of 504 syringes and 0 of 498 syringes, respectively (p < 0.001). Eighteen of 84 students at baseline and 0 of 83 students near the end of the course produced one or more contaminated syringes (p < 0.001). Of the 21 contaminated syringes at baseline, low-risk manipulations accounted for 14 and medium-risk manipulations accounted for 7. Of the low-risk procedures, the ampule produced the highest contamination rate (11 syringes), followed by the vial (2 syringes) and the reconstitution (1 syringe). CONCLUSIONS: This study demonstrated a decreased rate of microbial contamination during the manipulation of parenteral products and a corresponding improvement in aseptic technique skills among pharmacy students enrolled in a parenterals laboratory course. The most sensitive tests for poor aseptic technique and bacterial contamination were medium-risk manipulations and low-risk manipulations involving an ampule.
OBJECTIVES: To evaluate microbial contamination rates of low- and medium-risk level media fill tests performed by pharmacy students near the beginning and end of a parenterals laboratory course in the second- professional year of a doctor of pharmacy (PharmD) program. METHODS: Students enrolled in a required parenterals laboratory class (N = 84) participated in this study. The aseptic technique procedures performed at the beginning of the course were identical to the procedures performed at the end of the course and included 3 low-risk level media-fill tests and a medium-risk level media-fill test. Single-strength trypticase-soy broth (TSB) was substituted for the drug and was used to detect microbial contamination for all manipulations. RESULTS: The baseline and end-of-course contamination rate was 21 of 504 syringes and 0 of 498 syringes, respectively (p < 0.001). Eighteen of 84 students at baseline and 0 of 83 students near the end of the course produced one or more contaminated syringes (p < 0.001). Of the 21 contaminated syringes at baseline, low-risk manipulations accounted for 14 and medium-risk manipulations accounted for 7. Of the low-risk procedures, the ampule produced the highest contamination rate (11 syringes), followed by the vial (2 syringes) and the reconstitution (1 syringe). CONCLUSIONS: This study demonstrated a decreased rate of microbial contamination during the manipulation of parenteral products and a corresponding improvement in aseptic technique skills among pharmacy students enrolled in a parenterals laboratory course. The most sensitive tests for poor aseptic technique and bacterial contamination were medium-risk manipulations and low-risk manipulations involving an ampule.
Keywords:
USP Chapter 797; aseptic technique; media fill tests; microbial contamination; parenteral products; sterile products
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