OBJECTIVE: To investigate the feasibility of easy oxide detection method in equipment cleaning validation of Glucose injection. METHODS: The cleaning procedure of equipment for Glucose injection by rinse water method was established; potassium permanganate titration solution (0.02 mol/L) was used to detect easy oxide, and the results were compared with those of total organic carbon. RESULTS: The limits of residual glucose were 10 mg/L; the detection limit of easy oxide was 3 mg/L. The linear range were 5-30 mg/L (r=0.999 5). The consumption amount of potassium permanganate titration solution (0.02 mol/L) would not be greater than 0.35 ml, and the limits of residual total organic carbon were 4 mg/L. The results of 4 times of validation tests showed that the amount of potassium permanganate in rinse water of sample sites were in line with the requirements, and the determination result of total organic carbon was concordant with the standard. CONCLUSIONS: The method of easy oxides determination is easy in operation, low in cost, and can be used for equipment cleaning validation of Glucose injection and provide reference for equipment cleaning validation of other organic compounds containing carbon.
关键词
易氧化物清洁验证葡萄糖注射液淋洗水法
Keywords
Easy oxideCleaning validationGlucose injectionRinse water method