Isanhart Christine M, McCall Kenneth L, Kretschmer Diane, Grimes Barbie A
School of Pharmacy, Texas Tech University Health Sciences Center, Amarillo, TX 79106, USA.
Am J Pharm Educ. 2008 Apr 15;72(2):27. doi: 10.5688/aj720227.
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.
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.
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).
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.
评估药学博士(PharmD)项目第二专业年注射剂实验室课程接近开始和结束时,药学专业学生进行的低风险和中风险水平培养基灌装试验的微生物污染率。
参加必修注射剂实验室课程的学生(N = 84)参与了本研究。课程开始时进行的无菌技术程序与课程结束时进行的程序相同,包括3次低风险水平培养基灌装试验和1次中风险水平培养基灌装试验。用单强度胰蛋白胨大豆肉汤(TSB)替代药物,用于检测所有操作中的微生物污染。
基线和课程结束时的污染率分别为504支注射器中有21支和498支注射器中有0支(p < 0.001)。基线时84名学生中有18名,课程接近结束时83名学生中有0名产生了一个或多个受污染的注射器(p < 0.001)。在基线时的21支受污染注射器中,低风险操作占14支,中风险操作占7支。在低风险程序中,安瓿产生的污染率最高(11支注射器),其次是小瓶(2支注射器)和复溶(1支注射器)。
本研究表明,在注射剂产品操作过程中微生物污染率降低,参加注射剂实验室课程的药学专业学生的无菌技术技能相应提高。无菌技术差和细菌污染最敏感的测试是中风险操作和涉及安瓿的低风险操作。