Morris B G, Avis K E, Bowles G C
Am J Hosp Pharm. 1980 May;37(5):668-72.
A plan for the validation of aseptic-operator technique in i.v. admixture programs and two test methods for evaluating the plan are proposed. After a new operator has been trained, the plan involves qualification of the operator through the preparation of statistically valid samples, to be followed by the random selection of samples for in-process monitoring. To test the plan, trypticase soy broth transfers were used in one hospital and Addi-Chek (Millipore Corp.) filtrations were used in another. The participants, all trained operators, initially prepared 40 test samples as a validation step. The finding of no microbial growth in these test samples permitted continuation into the monitoring phase, during which test samples were prepared randomly, one test sample out of every 25 i.v. admixtures prepared for patient use. All samples were negative for microbial growth, indicating that the operators maintained aseptic technique. These findings give evidence that the proposed testing plan is valid. The authors propose the plan as a phase of a quality control program, based on valid statistical principles, to give assurance that i.v. room operators are qualified to prepare sterile parenteral medications.
提出了一个在静脉药物配置程序中验证无菌操作技术的计划以及两种评估该计划的测试方法。在对新操作人员进行培训后，该计划包括通过制备具有统计学有效性的样本来对操作人员进行资格鉴定，随后随机选择样本进行过程监测。为了测试该计划，一家医院采用胰蛋白酶大豆肉汤转移法，另一家医院采用Addi-Chek（密理博公司）过滤法。所有参与者均为经过培训的操作人员，最初制备40个测试样本作为验证步骤。这些测试样本中未发现微生物生长，这使得可以进入监测阶段，在此阶段，随机制备测试样本，每为患者制备25份静脉药物配置制剂中抽取一个测试样本。所有样本的微生物生长检测均为阴性，表明操作人员保持了无菌技术。这些结果证明所提出的测试计划是有效的。作者将该计划作为质量控制程序的一个阶段提出，该计划基于有效的统计原则，以确保静脉配置室的操作人员有资格制备无菌的胃肠外药物。
