采用荧光素培养基灌装组合试验评估静配中心危害药品溢出污染与无菌操作规范性的研究

Research on Media-fill Test Combined with Fluorescein for Evaluating Hazardous Drugs Spill Contamination and Sterile Operation Standardization in PIVAS

关键词:  荧光素  培养基灌装试验  静配中心  危害药品  溢出污染  无菌操作

Key words:  fluoresceinmedia-fill test  PIVAS  hazardous drugs  spill contamination  aseptic manipulation

摘要:

摘要：目的 针对静脉用药调配中心（PIVAS）危害药品配制过程中溢出污染和无菌操作评估的需求，探索一种结合荧光素钠注射液的培养基灌装试验（MFT-F）方法，用于危害药品负压调配技术的培训考核。方法 选取60名配制人员参与测试，其中20名未培训的实习生、进修生为对照组，20名进行培训过一次的人员为观察组A，20名经验丰富的药师为观察组B，在ISO 5级环境中进行MFT-F模拟危害药品调配，配制含0.01%荧光素胰酪大豆胨培养基（TSB-F）溶液，制备C样本与T样本，并通过紫外光（365nm）检测荧光素溢出污染和培养微生物样本（30℃恒温箱，14天）验证无菌操作。结果 对照组的无菌操作通过率为20%，观察组A的无菌操作通过率为65%，观察组B的无菌操作全部合格（P<0.05）；对照组荧光污染全部不合格（22.45±2.39），观察组A荧光污染评分有10人合格（26.50±1.28），观察组B荧光污染评分全部合格（28.40±1.05）（P<0.05），荧光素污染主要集中于手套、治疗垫巾和无菌瓶；对照组质控有2人合格（25.60±1.14），观察组A质控有17人合格（27.60±1.14），观察组B质控评分全部合格（29.55±0.76）（P<0.05）；对照组的MTF-F结果全部不合格，观察组A结果9人合格，观察组B结果全部合格（P<0.05）。结论 MFT-F可用于危害药品溢出污染和无菌操作评估，验证配制人员的危害药品负压调配技术，为PIVAS危害药品配制的人员培训及质控提供科学依据。

Abstract:

OBJECTIVE To address the need for evaluating spill contamination and aseptic operations during hazardous drug dispensing in Pharmacy Intravenous Admixture Services (PIVAS), this study explores a media-fill test combined with fluorescein (MFT-F) for training and assessment of negative pressure dispensing technology for hazardous drugs.METHODS 60 preparation personnel were selected to participate in the test, including 20 untrained interns and trainees as the control group, 20 trained personnel as the observation group A, and 20 experienced pharmacists as the observation group B. In an ISO Class 5 environment with dynamic airflow, conduct MFT-F to simulate the dispensing of hazardous drugs，and dispense a tryptone soy broth with 0.01% fluorescein (TSB-F). Prepare C and T samples, and verify sterile operation by detecting fluorescein spill contamination under ultraviolet light (365 nm) and microbial samples cultured (30℃ incubator, 14 days) . RESULTS The sterile operation pass rate of the control group was 20%, the sterile operation pass rate of observation group A was 65%, and all sterile operations of observation group B were qualified (P<0.05); All fluorescence pollution in the control group was unqualified (22.45 ± 2.35), while 10 people in observation group A passed the fluorescence pollution score (26.50 ± 1.248), and all fluorescence pollution scores in observation group B passed (28.40 ± 1.05) (P<0.05). Fluorescence pollution was mainly concentrated in gloves, treatment pads, and sterile bottles; Two individuals in the control group passed the quality control test (25.60 ± 1.14), 17 individuals in the observation group A passed the quality control test (27.60 ± 1.14), and all individuals in the observation group B passed the quality control score (29.55 ± 0.76) (P<0.05); The MTF-F results of the control group were all unqualified, while the results of observation group A were qualified by 9 people, and the results of observation group B were all qualified (P<0.05). CONCLUSION MFT-F can be used for the assessment of hazardous drug spill contamination and aseptic operation, to verify the negative pressure dispensing technology of hazardous drugs by the preparation personnel, and to provide scientific basis for the training and quality control of PIVAS hazardous drug preparation personnel.