精制阿司匹林空调总结

1、2005年度精制阿司匹林产品空调系统总结(05-007)编号：QR207.028-2005山东新华制药股份公司207车间2006.1.252005年度精制阿司匹林产品空调系统总结起草单位(Composed by): 起草人(Composer):QA审核人(Reviewed by QA):批准人(Approved by):2005年度空调系统年度总结1、设备运行情况2005年空调系统共为138批精制阿司匹林提供送风和控制温湿度，生产运行良好。操作者每班对空调系统维护检查，根据SOP对空调系统过滤器材进行清洗和更换，清洗和更换情况统计如下：1.1 初效过滤器：表1.1初效过滤器清洗更换表日期初效过

2、滤器日期初效过滤器日期初效过滤器清洗清洗清洗清洗清洗清洗清洗更换清洗清洗清洗更换清洗清洗清洗清洗清洗清洗1.2 高中效过滤器：表1.2高中效过滤器清洗更换表日期高中效过滤器日期高中效过滤器日期高中效过滤器清洗清洗清洗清洗清洗清洗清洗更换清洗2、相关检测参数 对2005年的温度、湿度和压差数值进行统计如下：2.1温度：表2.1精制阿司匹林温度表日期温度（）日期温度（）日期温度（）日期温度（）1.2191.28234.17237.1325.81.219.21.28244.1724.37.1325.71.318.71.29254.1825.17.1425.71.319.11.29254.18257.

3、1425.41.4192.17244.19257.1525.41.419.52.18235.2925.57.1525.31.519.22.19205.3024.97.1625.11.519.82.21245.3025.17.1625.31.621.12.22225.3125.77.1725.31.620.52.23235.3124.37.17251.718.22.24236.125.37.1825.71.719.22.25226.125.77.1825.31.10202.26216.224.87.1925.61.1020.13.1246.2257.1925.41.11203.2246.3257

4、.2025.61.11233.2236.324.77.2025.91.1221.23.3256.424.37.2124.51.1221.53.3266.425.17.2124.91.1321.43.4226.525.27.2225.01.1322.13.4256.524.77.2225.51.1421.33.7216.625.47.2325.11.1421.53.7206.6247.2325.41.1722.13.8246.724.27.2425.21.1720.53.8246.2624.37.2425.31.1821.24.2196.2625.27.2525.9表2.1精制阿司匹林温度表（续

5、）日期温度（）日期温度（）日期温度（）日期温度（）1.1822.34.2196.2724.77.2525.31.1920.44.3196.2725.17.2622.51.1921.54.3206.2824.97.2625.71.2023.74.3196.2824.17.2725.81.2024.04.4196.2924.37.2725.81.2120.54.4226.2925.77.2825.71.2120.14.4246.3024.97.2825.91.2219.84.524.37.125.37.2925.51.2220.54.6257.725.412.2723.51.2320.34.725

6、7.825.512.2821.61.2321.54.8237.82512.2822.11.2422.14.11247.925.212.2923.51.2422.04.12217.925.112.2922.51.2521.54.13237.1025.812.3023.81.2521.74.14247.1025.412.3021.51.2620.54.15237.1125.712.3125.01.2623.94.15237.1125.312.3124.11.27244.16217.1225.01.27254.16247.1225.42.1.1结论包装室温度平均值为23.36，最小值为18.2，最大

7、值为26，温度在18.226之间波动，数据稳定。2.1.2包装室温度趋势图如下：从趋势图看，包装室温度稳定，符合洁净区温度1826的标准。2.2湿度：表2.2精制阿司匹林湿度表日期湿度（）日期湿度（）日期湿度（）日期湿度（）1.2201.28204.16207.12551.2201.28204.17207.13561.3201.29204.17257.13601.3201.29204.18207.14601.4212.17204.18207.14571.4212.18204.19257.15561.5202.19205.29397.15561.5202.21205.30417.16561.62

8、02.22205.30407.16551.6202.23205.31437.17571.7202.24205.31527.1757表2.2精制阿司匹林湿度表（续）日期湿度（）日期湿度（）日期湿度（）日期湿度（）1.7202.25206.1517.18581.10202.26206.1467.18571.10213.1206.2437.19601.11203.2206.2347.19601.11203.2206.3377.20601.12203.3206.3407.20611.12203.3206.4397.21491.13203.4206.4377.21601.13213.4206.5337.

9、22641.14203.7206.5357.22621.14213.7206.6387.23611.17213.8206.6577.23641.17213.8206.7537.24611.18214.2206.26507.24591.18204.2206.26547.25601.19204.3206.27537.25531.19204.3206.27507.26631.20204.3206.28547.26531.20204.4206.28507.27641.21204.4206.29537.27601.21204.4206.29547.28641.22204.5206.305212.2762

10、1.22204.6207.15712.28211.23204.7207.75412.28241.23204.8207.85412.29201.24204.11207.85312.29211.24204.12207.95412.30151.25204.13207.95412.30201.25204.14207.105612.31161.26204.14207.105412.3116表2.2精制阿司匹林湿度表（续）日期湿度（）日期湿度（）日期湿度（）日期湿度（）1.26204.15204.16207.11551.27204.15207.11557.12561.27202.2.1结论包装室相对湿度平

11、均值为33.65%，最小值为15%，最大值为64%，数值在1564%之间波动。2.2.2包装室湿度趋势图如下：从趋势图看，包装室湿度稳定，符合湿度65%的标准（精制阿司匹林规定相对湿度65%）。2.3压差表2.3精制阿司匹林压差表日期压差（Pa）日期压差（Pa）日期压差（Pa）日期压差（Pa）1.2252.16235.27237.14231.2252.16215.27247.14251.3242.17225.27247.15231.3252.17215.28257.15241.4232.17255.28247.16241.4252.18255.28237.16251.5242.19245.29

12、237.17241.5252.21255.29237.17251.6252.22235.30257.18231.6252.23255.30247.18231.7242.24255.31227.19241.7252.25235.31217.19241.10252.26246.1237.20241.10242.28256.1217.20231.11243.1246.2207.21241.11243.1246.2257.21251.12253.2236.3217.22241.12253.2256.3237.22201.13243.3246.4237.23231.13253.3256.4217.232

13、41.14243.4256.5257.24231.14253.4226.5247.24231.17243.7216.6247.25241.17233.7236.6237.25231.18253.8216.7227.26241.18243.8246.27237.26231.19234.2256.28237.27241.19234.2236.29227.27251.20244.3246.30217.28231.20254.3257.1207.2824表2.3精制阿司匹林压差表（续）日期压差（Pa）日期压差（Pa）日期压差（Pa）日期压差（Pa）1.21252.15234.17247.11231.2

14、1252.16224.18237.11231.22244.3234.18227.12241.22254.4214.19237.12231.23254.4227.5237.13241.23254.4237.5247.13241.24254.5257.6247.29241.24254.6257.62512.26201.25254.7257.62412.26211.25244.8237.72312.27231.26244.11237.72412.27251.26234.12237.72512.28211.27244.13247.82512.28231.27254.14247.82412.29211.

15、28254.15227.82412.29241.28234.15207.92512.30201.29254.16217.92512.30231.29254.16257.102312.31212.15254.17257.102412.31232.3.1结论包装室压差平均值为：23.60Pa，最小值为20Pa，最大值为25Pa，数值在1126Pa之间波动。2.3.2包装室压差趋势图如下：从趋势图看，包装室压差稳定，符合洁净区与外界的静压差10Pa, 与不同级别的相邻房间的静压差5Pa的标准。2.4.悬浮粒子2.4.1 0.5um的悬浮粒子0.5um的悬浮粒子表地点月份离心室内包间外包间干燥间1125575013562891500883172951741407584125160414547671708884121359717136865614022002.4.2趋势图如下：从趋势图看，0.5um的悬浮粒子最大值为17295173500000的标准，符合十万级标准。2.4.3 5um的悬浮粒子5um的悬浮粒子表地点月份离心室内包间外包间干燥间1739850378635797749364514384308352129246107969776