75%乙醇、0.1%新洁尔灭消毒效果验证报告(2)

苏州万庆药业有限公司QC-VAL-535-012.5菌液计数：（菌液计数详见原始记录）试验菌金黄色葡萄球菌大肠埃希菌铜绿假单胞菌枯草芽孢杆菌白色念珠菌黑曲霉人表皮葡萄球菌稀释级10-710-710-710-710-610-510-7计数结果cfu/皿6568435231397174613256243477平均值69.564.537.55427.536.574浓菌液菌数cfu/ml6.95×1086.45×1083.75×1085.40×1082.75×1073.65×1067.40×108确认人/日期：复核人/日期：2.6菌片的制备：详见原始记录。2.7菌片菌数复核：试验菌载体结果细菌10-5Ca:10-4An:10-3平均菌片菌数细菌10-5Ca:10-4An:10-3平均菌片菌数细菌10-5Ca:10-4An:10-3平均菌片菌数金黄色葡萄球菌567163.56350000596461.561500007472737300000大肠埃希菌584752.55250000524347.547500006563646400000铜绿假单胞菌223528.52850000354238.53850000424744.54450000枯草芽孢杆菌6351575700000735865.565500005367606000000白色念株菌182521.5215000432634.5345000244132.5325000黑曲霉233629.52950036323434000263530.530500人表皮葡萄球菌658273.57350000626764.564500007367707000000软塑料硬质塑料不锈钢第3页共19页苏州万庆药业有限公司QC-VAL-535-01试验菌载体结果细菌10-5Ca:10-4An:10-3平均菌片菌数细菌10-5Ca:10-4An:10-3平均菌片菌数细菌10-5Ca:10-4An:10-3平均菌片菌数细菌10-5Ca:10-4An:10-3平均菌片菌数细菌10-5Ca:10-4An:10-3平均菌片菌数金黄色葡萄球菌7569727200000647368.56850000364239390000063576060000006246545400000大肠埃希菌53635858000004662545400000423538.53850000535252.552500006652595900000铜绿假单胞菌364641410000042464444000002434292900000342529.529500004331373700000枯草芽孢杆菌626664640000067576262000004236393900000464947.547500004953515100000白色念株菌322729.5295000282426260000162118.5185000353032.5325000292125250000黑曲霉423136.536500383134.534500211618.5185004125333300034524343000人表皮葡萄球菌678576760000067737070000004745464600000455650.55050000412834.53450000纸张玻璃洁净服面料橡胶铝合金2.7.1合格标准：回收菌片的含菌量应不小于105cfu/片。2.7.2结论：上述结果显示，每个菌片的含菌量均不小于105cfu/片，符合验证试验要求。确认人/日期：复核人/日期：3.0载体喷洒消毒杀菌效力试验第4页共19页苏州万庆药业有限公司QC-VAL-535-013.1载体喷洒消毒杀菌效力试验结果：结果试验菌载体名称消毒剂消毒剂批号101115-W-0575%乙醇金黄色葡萄球菌0.1%新洁尔灭101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-0575%乙醇大肠埃希菌0.1%新洁尔灭101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-0575%乙醇铜绿假单胞菌0.1%新洁尔灭101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-0575%乙醇枯草芽孢杆菌0.1%新洁尔灭101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05白色念珠菌75%乙醇101116-W-05101117-W-05结果cfu/皿15736136156214426142252451516361软塑料杀灭对数值6.806.105.966.336.026.806.245.946.726.025.946.426.455.855.856.155.686.455.135.365.386.065.585.554.864.555.33阴性对照000000000000000000000000000结论符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定第5页共19页苏州万庆药业有限公司QC-VAL-535-01结果试验菌载体名称消毒剂消毒剂批号101115-W-060.1%新洁尔灭101116-W-06101117-W-06101115-W-0575%乙醇101116-W-05101117-W-05结果cfu/皿361553452361553软塑料杀灭对数值4.864.555.333.773.773.993.873.774.176.396.096.876.176.176.39阴性对照000000000000000结论符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定黑曲霉101115-W-060.1%新洁尔灭101116-W-06101117-W-06101115-W-0575%乙醇人表皮葡萄球菌0.1%新洁尔灭101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06合格标准：要求各次试验的杀灭对数值均≥3，可判定消毒合格。结论：上述各次实验结果显示，经消毒剂喷洒消毒后，软塑料载体菌片的杀灭对数值均大于3，符合标准要求。确认人/日期：结果试验菌载体名称消毒剂消毒剂批号101115-W-0575%乙醇金黄色葡萄球菌0.1%新洁尔灭101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06复核人/日期：硬质塑料结果cfu/皿351235杀灭对数值6.316.096.796.496.316.09阴性对照000000结论符合规定符合规定符合规定符合规定符合规定符合规定第6页共19页苏州万庆药业有限公司QC-VAL-535-01结果试验菌载体名称消毒剂消毒剂批号101115-W-0575%乙醇101116-W-05101117-W-05101115-W-060.1%新洁尔灭101116-W-06101117-W-06101115-W-0575%乙醇101116-W-05101117-W-05101115-W-060.1%新洁尔灭101116-W-06101117-W-06101115-W-0575%乙醇101116-W-05101117-W-05101115-W-060.1%新洁尔灭101116-W-06101117-W-06101115-W-0575%乙醇101116-W-05101117-W-05101115-W-060.1%新洁尔灭101116-W-06101117-W-06101115-W-05结果cfu/皿4276863426621214735411235427613硬质塑料杀灭对数值6.076.385.835.905.775.906.115.986.285.815.816.285.745.675.975.276.215.775.245.064.844.945.244.693.754.534.05阴性对照000000000000000000000000000结论符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定大肠埃希菌铜绿假单胞菌枯草芽孢杆菌白色念珠菌黑曲霉75%乙醇101116-W-05101117-W-05第7页共19页