目的  建立和验证分装车间灌装器具清洁确认中铝残留量的电感耦合等离子体质谱仪（inductive coupled plasma emission spectrometer，ICP）检测法。 方法 对分装车间玻璃、不锈钢、陶瓷材质器具清洁后，采用擦拭法取样，ICP检测法仪器的参数确定为分析波谱396.152 nm，等离子体射频功率1 150 W，载气流速0.5 L/min，蠕动泵转速50 r/min，观察模式Axial，数据采集3次。检测该方法的系统适应性，并验证方法的线性、定量限、特异性、拭子回收率、准确度、重复性、中间精密度及耐用性。结果 该方法铝元素标准品标准曲线的线性良好，线性决定系数为0.999 8。对该方法检测的定量限（5%目标浓度，铝元素标准品1.40 μg/ml）进行6次检测，相对标准偏差（relative standard deviation，RSD）为0.3%。该方法的特异性空白材质擦拭溶液响应值为玻璃-125、不锈钢-138、陶瓷-138，均小于5%目标浓度响应值27 852。该方法的6个拭子回收率分别为101.26%、100.34%、100.57%、100.70%、100.56%、100.32%，RSD为0.3%。50%目标浓度（14.05 μg/ml）、100% 目标浓度（28.10 μg/ml）、150%目标浓度（42.10 μg/ml）回收率分别为 76.43%〜77.12%、78.54%〜80.06%、78.67%〜79.44%，均符合规定的要求；6次检测100%目标浓度玻璃、不锈钢、陶瓷的RSD分别为0.4%、0.3%、0.3%。2名分析员在不同时间对100%目标浓度3种材质各做6个平行试验，RSD分别为1.3%、0.8%、0.9%。在ICP载气流量为0.5、0.6 L/min的条件下，将100%目标浓度3种材质擦拭溶液分别进样3次，3种材质的RSD分别为1.2%、0.2%、0.8%。 结论  建立的ICP检测法可用于分装车间清洁验证时铝残留物分析研究。

Objective To establish and verify the inductive coupled plasma emission spectrometer (ICP) method for residual aluminum detection after cleaning the filling apparatuses in the filling & packaging workshop. Methods Filling apparatuses made of glass, stainless steel or ceramic materials were sampled by wiping after cleaning. The parameters of the ICP method were determined as analytical spectrum 396.152 nm, inductive coupled plasma radio frequency power 1 150 W, carrier gas flow rate 0.5 L/min, peristaltic pump speed 50 r/min, observation mode Axial, data collected 3 times. The system suitability, linearity, limit of quantification, specificity, swab recovery, accuracy, repeatability, intermediate precision and durability of the method were validated. Results The linearity of the standard curve of aluminum standard reference was good, and the linear coefficient of determination was 0.999 8. The limit of quantification (5% target concentration, aluminum standard reference 1.40 μg/ml) was tested 6 times, and the relative standard deviation (RSD) was 0.3%. The response values of specific blank wiping solution were -125 for glass, -138 for stainless steel and -138 for ceramic, all less than the response value of 5% target concentration (27 852). The swab recoveries were 101.26% , 100.34%, 100.57%, 100.70%, 100.56%, 100.32%, and RSD of 6 swabs was 0.3%. The recoveries with 50% target concentration (14.05 μg/ml), 100% target concentration (28.10 μg/ml) and 150% target concentration (42.10 μg/ml) were 76.43%-77.12%, 78.54%-80.06%, 78.67%-79.44%, respectively, meeting the requirements, and RSDs of 6 tests on glass, stainless steel and ceramic with 100% target concentration were 0.4%, 0.3%, and 0.3%, respectively. Two analysts made 6 parallel tests for 3 materials with 100% target concentration in different days, and RSDs were 1.3%, 0.8%, and 0.9%, respectively. Wiping solutions of 3 materials with 100% target concentration were tested 3 times under the carrier gas flow rate of 0.5 and 0.6 L/min, and RSDs were 1.2%, 0.2% and 0.8%, respectively. Conclusion The established ICP method can be used to provide data and reference for residue analysis in cleaning validation of filling & packaging workshop.