疫苗生产洁净室中悬浮粒子检测的不确定度评估(1)
[摘要] 目的 评估疫苗生产洁净室中悬浮粒子检测结果的不确定度。 方法 分析影响悬浮粒子检测结果不确定度的因素，建立数学模型，逐项评价并量化各项的相对标准不确定度，计算合成标准不确定度，最终得出测量结果的扩展不确定度并给出测量结果不确定度报告。 结果 取k=2(置信概率95%)时，粒径≥0.5 μm悬浮粒子测量结果的扩展不确定度为672粒/m3，悬浮粒子数为(1781±672)粒/m3；粒径≥5 μm悬浮粒子测量结果的扩展不确定度为138粒/m3，悬浮粒子数为(270±138)粒/m3。 结论 此评价方法适用于洁净室中悬浮粒子测量结果的不确定度评估。
[关键词] 洁净室；悬浮粒子；不确定度
[中图分类号] R134+.2 [文献标识码] A [文章编号] 1674-4721(2016)04(c)-0145-04
Uncertainty degree evaluation of suspended particle test in vaccine production clean room
FANG Chao-dong SHI Chang-jun WANG Yong-zhi QIU Wen-na WU Hong-bin LI Jian-feng
Vaccine Engineering Center，Taizhou Medicine High-Tech Industrial Park of Jiangsu Province，Taizhou 225300，China
[Abstract] Objective To evaluate the uncertainty degree of suspended particle test in vaccine production clean room. Methods Uncertainty factors that impacted the suspended particle test results were analyzed，mathematical model was established to evaluate and quantificat the related standard uncertainty of each term by term.Synthetic criterion uncertainty was counted and then expanded uncertainty of determination results was got and the report of determination results uncertainty was provided. Results When k was equal to 2 (the confidence probability was 95%)，the expanded uncertainty of particle size greater than or equal to 0.5 μm suspended particle test results was 672/m3 and the number of suspended particle was (1781±672)/m3.The expanded uncertainty of particle size greater than or equal to 5 μm suspended particle test results was 672/m3 and the number of suspended particle was (270±138)/m3. Conclusion This evaluation method is suitable for uncertainty evaluate of suspended particle test results in clean room.
[Key words] Clean room；Suspended particle；Uncertainty degree
悬浮粒子是医药工业(如疫苗无菌生产)洁净环境中最重要的监测指标之一[1]，空气中的微生物大都以其为载体在空气中传播，因此定期对悬浮粒子进行检测显得尤为重要[2-3]，常通过检测洁净室环境单位体积空气中某特定粒径的悬浮粒子数，评定洁净室中的悬浮粒子洁净度级别[4]。非单向流洁净室气流紊乱，影响悬浮粒子浓度的因素较多，导致各局部环境中的悬浮粒子分布不均，在进行测试时，各采样点的检测值可能会出现较大偏差。本实验参考《测量不确定度的要求》[5]和《测量不确定度评定与表示》[6]中的有关要求，测试方法参照《医药工业洁净室(区)悬浮粒子的测试方法》[7]和ISO14644-1[8]，对非单向流洁净室中悬浮粒子的测量不确定度进行评定，分析影响其测量不确定度的主要因素，旨在提高检测结果的准确性。
1 仪器与测试对象
1.1 测试仪器
激光粒子计数器品牌(美国CLIMET，规格型号：CI-750t)。
1.2 仪器主要性能参数
取样流量：75 L/min；粒径：4通道，0.3、0.5、1.0、5.0 μm。
1.3 测试对象
选择疫苗原液中试生产车间接种室，洁净级别为C级，面积约15 m2，气流为非单向流。
2 方法与结果
2.1 测试方法
依据GB/T16292-2010《医药工业洁净室(区)悬浮粒子的测试方法》[7]中的相关要求，静态测试。具体步骤：①开启净化空调系统，正常运行至少30 min，使环境达稳定状态，温度为(23±2)℃，湿度为55%±2%，静压差为(15±0.5) Pa；②尘埃粒子计数器开机预热、自净至少5 min，使之达到自净要求；③尘埃粒子计数器取样口分别置于各采样点进行检测，每个采样点连续检测3次，采样量为29 L(选择0.5 μm和5 μm粒径)；④记录数据，计算结果。, http://www.100md.com(方朝东 史长军 王永智 邱文娜 吴宏斌 李健峰)
[关键词] 洁净室；悬浮粒子；不确定度
[中图分类号] R134+.2 [文献标识码] A [文章编号] 1674-4721(2016)04(c)-0145-04
Uncertainty degree evaluation of suspended particle test in vaccine production clean room
FANG Chao-dong SHI Chang-jun WANG Yong-zhi QIU Wen-na WU Hong-bin LI Jian-feng
Vaccine Engineering Center，Taizhou Medicine High-Tech Industrial Park of Jiangsu Province，Taizhou 225300，China
[Abstract] Objective To evaluate the uncertainty degree of suspended particle test in vaccine production clean room. Methods Uncertainty factors that impacted the suspended particle test results were analyzed，mathematical model was established to evaluate and quantificat the related standard uncertainty of each term by term.Synthetic criterion uncertainty was counted and then expanded uncertainty of determination results was got and the report of determination results uncertainty was provided. Results When k was equal to 2 (the confidence probability was 95%)，the expanded uncertainty of particle size greater than or equal to 0.5 μm suspended particle test results was 672/m3 and the number of suspended particle was (1781±672)/m3.The expanded uncertainty of particle size greater than or equal to 5 μm suspended particle test results was 672/m3 and the number of suspended particle was (270±138)/m3. Conclusion This evaluation method is suitable for uncertainty evaluate of suspended particle test results in clean room.
[Key words] Clean room；Suspended particle；Uncertainty degree
悬浮粒子是医药工业(如疫苗无菌生产)洁净环境中最重要的监测指标之一[1]，空气中的微生物大都以其为载体在空气中传播，因此定期对悬浮粒子进行检测显得尤为重要[2-3]，常通过检测洁净室环境单位体积空气中某特定粒径的悬浮粒子数，评定洁净室中的悬浮粒子洁净度级别[4]。非单向流洁净室气流紊乱，影响悬浮粒子浓度的因素较多，导致各局部环境中的悬浮粒子分布不均，在进行测试时，各采样点的检测值可能会出现较大偏差。本实验参考《测量不确定度的要求》[5]和《测量不确定度评定与表示》[6]中的有关要求，测试方法参照《医药工业洁净室(区)悬浮粒子的测试方法》[7]和ISO14644-1[8]，对非单向流洁净室中悬浮粒子的测量不确定度进行评定，分析影响其测量不确定度的主要因素，旨在提高检测结果的准确性。
1 仪器与测试对象
1.1 测试仪器
激光粒子计数器品牌(美国CLIMET，规格型号：CI-750t)。
1.2 仪器主要性能参数
取样流量：75 L/min；粒径：4通道，0.3、0.5、1.0、5.0 μm。
1.3 测试对象
选择疫苗原液中试生产车间接种室，洁净级别为C级，面积约15 m2，气流为非单向流。
2 方法与结果
2.1 测试方法
依据GB/T16292-2010《医药工业洁净室(区)悬浮粒子的测试方法》[7]中的相关要求，静态测试。具体步骤：①开启净化空调系统，正常运行至少30 min，使环境达稳定状态，温度为(23±2)℃，湿度为55%±2%，静压差为(15±0.5) Pa；②尘埃粒子计数器开机预热、自净至少5 min，使之达到自净要求；③尘埃粒子计数器取样口分别置于各采样点进行检测，每个采样点连续检测3次，采样量为29 L(选择0.5 μm和5 μm粒径)；④记录数据，计算结果。, http://www.100md.com(方朝东 史长军 王永智 邱文娜 吴宏斌 李健峰)