Rupp C A, Kikugawa C A, Kotabe S E, Barriere S L, Bowman W D
Am J Hosp Pharm. 1977 Jan;34(1):47-9.
A method for bacterial surveillance of small-volume sterile products in hospitals was developed and tested. The criteria for the method of quality control were to: (1) assure detection of contamination associated with touch, which could occur during the filling process; (2) be economically feasible; (3) be simple and easy to implement; and (4) be versatile in adapting to small-volume sterile packages with and without needles. Ten percent of each lot of prepackaged unit dose syringes is tested by filtration through a sterile micropore filter. The filter unit is incubated after fluid thioglycollate medium has been added. If turbidity or color change is found, further testing with blood agar and gram staining is performed to identify the organism. The effectiveness of the method was tested by adding E. coli to one lot within each of several lots tested of six products. The inoculated samples were stored under refrigeration for three days before testing. With one exception, the E. coli was detected in the samples. Growth did not occur in any of the noninoculated units. The apparent false negative result was believed to be caused by the bacteriostatic agent killing the organism during the three-day storage period.
开发并测试了一种用于医院小容量无菌产品细菌监测的方法。质量控制方法的标准为：(1) 确保检测到灌装过程中可能发生的与接触相关的污染；(2) 在经济上可行；(3) 简单且易于实施；(4) 能够灵活适用于带针和不带针的小容量无菌包装。每批预包装单剂量注射器的10%通过无菌微孔滤膜过滤进行检测。加入液体硫乙醇酸盐培养基后，对滤膜组件进行培养。如果发现浑浊或颜色变化，则用血琼脂进一步检测并进行革兰氏染色以鉴定微生物。通过向六种产品测试的几个批次中的每一批中的一批添加大肠杆菌来测试该方法的有效性。接种的样品在测试前冷藏保存三天。除一个例外，样品中检测到了大肠杆菌。未接种的单元中均未出现生长情况。明显的假阴性结果被认为是由抑菌剂在三天储存期内杀死微生物所致。
