表面残留物限度计算(新修订)100813

各产品的一些基本数据产品名称乙酰螺旋霉素片酒石酸罗格列酮片麦迪霉素片辛代伐汀胶囊塞曲司特片制霉菌素片洛伐他汀片虫草头抱菌胶囊L-谷氨酰胺胶囊规格（mg）7041005408620250250每日最低使用次数（次）414113133每日最高使用次数（次）414114133每次最少使用制剂数（片或粒）2122210.522每次最多使用制剂数（片或粒）3131622422最低日治疗剂量/1000（mg）560480010802581015001500最小批量（万片/粒）240201002010100202020最小批产量（kg）3002424033.618255385052单片（粒）重（g）0.1250.1200.2400.1680.1800.2550.1900.2500.260日最多使用制剂数（片/粒）121121628466最小批产量*1000/（单片重*日最多使用制剂数）20000020000083333.312500500001250005000033333.333333.3各产品所使用的设备及设备表面积产品名称乙酰螺旋霉素片酒石酸罗格列酮片麦迪霉素片辛代伐汀胶囊塞曲司特片制霉菌素片洛伐他汀片虫草头抱菌胶囊L-谷氨酰胺胶囊规格0.ig4mg0.1g5mg40mg50万单位20mg0.25g0.25g振荡筛1.51.51.51.51.51.51.51.51.5槽形混合机1.92颗粒机A0.7沸腾床11.5整粒机0.5湿法混合制粒机1.11.11.11.11.11.11.11.1颗粒机B0.70.70.70.70.70.70.70.7烘箱53.453.453.453.453.453.453.453.4万向混合机6.16.16.16.16.16.16.16.16.1压片机（13#）6.36.36.3压片机（4#）2.12.12.1胶囊充填机444糖衣机（16#）11.411.411.4铝塑包装机0.50.50.50.50.50.50.50.5单个品种的总表面积累计（m2）40.4265.48167.365.480.565.467.367.3下一品种产品名称乙酰螺旋霉素片酒石酸罗格列酮片麦迪霉素片辛代伐汀胶囊塞曲司特片制霉菌素片洛伐他汀片虫草头抱菌胶囊L-谷氨酰胺胶囊规格0.1g4mg0.1g5mg40mg50万单位20mg0.25g0.25g生产前产品为0.1g乙酰螺旋霉素片的公用面积40.428.125.88.18.125.38.18.18.1生产前产品为4mg酒石酸罗格列酮片的公用面积8.165.463.363.365.462.865.463.363.3生产前产品为0.1g麦迪霉素片的公用面积25.863.38163.363.380.563.363.363.3生产前产品为5mg辛伐他汀胶囊的公用面积8.163.363.367.363.362.863.367.367.3生产前产品为40mg塞曲司特片的公用面积8.165.463.363.365.462.865.463.363.3生产前产品为50万单位制霉菌素片的公用面积25.362.880.562.862.880.562.862.862.8生产前产品为20mg洛伐他汀片的公用面积8.165.463.363.365.462.865.463.363.3生产前产品为0.25g虫草头抱菌胶囊的公用面积8.163.363.367.363.362.863.367.367.3生产前产品为0.25gL-谷氨酰胺胶囊的公用面积8.163.363.367.363.362.863.367.367.3备注：公用面积的单位为 m2B产品（下一品种）产品名称乙酰螺旋霉素片酒石酸罗格列酮片麦迪霉素片辛代伐汀胶囊塞曲司特片制霉菌素片洛伐他汀片虫草头抱菌胶囊L-谷氨酰胺胶囊规格0.1g4mg0.1g5mg40mg50万单位20mg0.25g0.25g生产前产品为0.1g乙酰螺旋霉素片的残留总量11200000011200000046666666.7700000028000000700000002800000018666666.6718666666.67生产前产品为4mg酒石酸罗格列酮片的残留总量800000800000333333.33350000200000500000200000133333.3333133333.3333生产前产品为0.1g麦迪霉素片的残留总量16000000016000000066666666.710000000400000001000000004000000026666666.6726666666.67生产前产品为5mg辛伐他汀胶囊的残留总量20000002000000833333.3331250005000001250000500000333333.3333333333.3333生产前产品为40mg塞曲司特片的残留总量16000000160000006666666.67100000040000001000000040000002666666.6672666666.667生产前产品为50万单位制霉菌素片的残留总量516000005160000021500000322500012900000322500001290000086000008600000生产前产品为20m洛伐他汀片的残留总量20000002000000833333.3331250005000001250000500000333333.3333333333.3333生产前产品为0.25g虫草头抱菌胶囊的残留总量3000000003000000001250000001875000075000000187500000750000005000000050000000生产前产品为0.25gL 谷氨酰胺胶囊的残留总量3000000003000000001250000001875000075000000187500000750000005000000050000000产品序号产品名称规格生产前产品为0.1g乙酰螺旋霉素片的残留限度生产前产品为4mg酒石酸罗格列酮片的残留限度生产前产品为0.1g麦迪霉素片的残留限度生产前产品为5mg辛伐他汀胶囊的残留限度生产前产品为40mg塞曲司特片的残留限度生产前产品为50万单位制霉菌素片的残留限度生产前产品为20m洛伐他汀片的残留限度生产前产品为0.25g虫草头抱菌胶囊的残留限度生产前产品为0.25gL-谷氨酰胺胶囊的残留限度B产品（下一品种）123456789乙酰螺旋霉素片酒石酸罗格列酮片麦迪霉素片辛代伐汀胶囊塞曲司特片制霉菌素片洛伐他汀片虫草头抱菌胶囊L-谷氨酰胺胶囊0.1g4mg0.1g5mg40mg50万单位20mg0.25g0.25g277.09054921382.716049180.87855386.41975309345.6790123276.6798419345.67901230.4526749230.45267499.876543211.223241590.526592940.0789889420.3058103980.7961783440.30581040.2106371770.210637177620.1550388252.76461382.304526715.7977883163.19115324124.223602563.19115342.1274354942.1274354924.691358023.1595576621.316482360.1857355130.7898894151.990445860.78988940.49529470.4952947197.530864224.464831810.53185891.5797788316.11620795115.923566886.1162084.2127435494.212743549203.952569282.165605126.70807455.13535031820.5414012740.062111820.54140113.6942675213.6942675224.691358023.0581039761.316482360.1974723540.7645259941.990445860.7645260.5265929440.5265929443703.703704473.9336493197.47235427.86032689118.4834123298.566879118.4834174.2942050574.294205053703.703704473.9336493197.47235427.86032689118.4834123298.566879118.4834174.2942050574.29420505B） /总表面积备注：单位面积表面残留物限度=0.001 * MTDD（ A）*最小批产量（B） / （日最多使用制剂数*单片重）（单位1： g/cm2备注：残留总量的单位为卩g从上表可以查岀，单位面积表面残留物限度最小值0.078988942 卩 g/cm2该限度值是4mg酒石酸罗格列酮片清场后生产 5mg辛伐他汀胶囊所允许的限度值，可作为本次设备清洗 的限度值取样棉签共4个，取样面积100cm2,在20ml纯化水中洗涤。B产品（下一品种）产品序号123456789产品名称|乙酰螺旋霉素片酒石酸罗格列酮片麦迪霉素片|辛代伐汀胶囊塞曲司特片制霉菌素片洛伐他汀片|虫草头抱菌胶囊L-谷氨酰胺胶囊规格0.ig4mg0.1g5mg40mg50万单位20mg0.25g0.25g0.1g乙酰螺旋霉素片的棉签洗涤水滤液浓度692.72637313456.790123452.196382216.0493827864.1975309691.6996047864.19753576.1316872576.13168724mg酒石酸罗格列酮片的棉签洗涤水滤液浓度24.691358023.0581039761.316482360.1974723540.7645259941.990445860.7645260.5265929440.5265929440.1g麦迪霉素片的棉签洗涤水滤液浓度1550.387597631.9115324205.76131739.49447077157.9778831310.5590062157.97788105.3185887105.31858875mg辛伐他汀胶囊的棉签洗涤水滤液浓度61.728395067.8988941553.29120590.4643387821.9747235394.976114651.97472351.2382367511.23823675140mg塞曲司特片的棉签洗涤水滤液浓度493.827160561.1620795126.32964723.94944707715.2905198839.808917215.2905210.5318588710.5318588750万单位制霉菌素片的棉签洗涤水滤液浓度509.8814229205.414012766.770186312.838375851.35350318100.155279551.35350334.2356687934.2356687920m洛伐他汀片的棉签洗涤水滤液浓度61.728395067.6452599393.29120590.4936808851.9113149854.976114651.9113151.3164823591.3164823590.25g虫草头抱菌胶囊的棉签洗涤水滤液浓度9259.2592591184.834123493.68088569.65081724296.2085308746.4171975296.20853185.7355126185.73551260.25gL -谷氨酰胺胶囊的棉签洗涤水滤液浓度9259.2592591184.834123493.68088569.65081724296.2085308746.4171975296.20853185.7355126185.7355126备注：表中浓度均为子项，其母项均为106浓度按升序排序0.1g乙酰螺旋霉素片的棉签洗涤水滤液浓度308.6419753617.2839506645.994832823.0452675823.0452675989.60910441234.56791234.5679011237.0113810.2g乙酰螺旋霉素片的棉签洗涤水滤液浓度308.6419753617.2839506645.994832823.0452675823.0452675989.60910441234.56791234.5679011237.0113810.1g麦迪霉素片的棉签洗涤水滤液浓度107.2961373214.5922747406.504065286.1230329286.12303291550.387597429.18455429.18454941937.9844965mg辛伐他汀胶囊的棉签洗涤水滤液浓度1.1446886452.2893772898.941344783.0525030533.05250305361.728395064.57875465.36480686777.1604938340mg塞曲司特片的棉签洗涤水滤液浓度1.1446886452.2893772898.941344783.0525030533.05250305361.728395064.57875465.36480686777.1604938350万单位制霉菌素片的棉签洗涤水滤液浓度1.1446886452.2893772898.941344783.0525030533.05250305361.728395064.57875465.36480686777.1604938320m洛伐他汀片的棉签洗涤水滤液浓度1.3412017172.6824034338.941344783.5765379113.57653791161.728395065.36480694.92125984377.160493830.25g虫草头抱菌胶囊的棉签洗涤水滤液浓度171.7032967343.40659341341.20172457.8754579457.87545799259.259259686.81319804.7210311574.074070.25gL -谷氨酰胺胶囊的棉签洗涤水滤液浓度171.7032967343.40659341341.20172457.8754579457.87545799259.259259686.81319804.7210311574.07407备注：表中浓度均为子项，其母项均为106浓度按升序排序0.1g乙酰螺旋霉素片的棉签洗涤水滤液浓度0.310.620.650.820.820.991.231.231.244mg酒石酸罗格列酮片的棉签洗涤水滤液浓度0.310.620.650.820.820.991.231.231.240.1g麦迪霉素片的棉签洗涤水滤液浓度0.110.210.410.290.291.550.430.431.945mg辛伐他汀胶囊的棉签洗涤水滤液浓度1.142.298.943.053.0561.734.585.3677.1640mg塞曲司特片的棉签洗涤水滤液浓度1.142.298.943.053.0561.734.585.3677.1650万单位制霉菌素片的棉签洗涤水滤液浓度1.142.298.943.053.0561.734.585.3677.1620m洛伐他汀片的棉签洗涤水滤液浓度1.342.688.943.583.5861.735.364.9277.160.25g虫草头抱菌胶囊的棉签洗涤水滤液浓度171.70343.411341.20457.88457.889259.26686.81804.7211574.070.25gL -谷氨酰胺胶囊的棉签洗涤水滤液浓度171.70343.411341.20457.88457.889259.26686.81804.7211574.07备注：乙酰、麦迪的浓度单位为mg/g ;其余产品的浓度单位为卩g/mg，即百万分之几