75%乙醇、0%新洁尔灭消毒效果验证报告

-消毒剂消毒效果验证报告验验证2013年11月草核QCQAQualityQCQC准签名名1.0验证概述·····························1-1919.0验证结论191.0验证概述1.1对75%乙醇、0.1%新洁尔灭消毒效果进展验证，验证中根据干净区不同材质选择规毒效果验证方案)，验证后总结数据形成报告。2.0验证准备2.1试验仪器设备：〔设备的检验情况详见校验记录〕设备设备生化培养箱〔30~35℃〕霉菌培养箱〔20~25℃〕精细移液器生物平安柜高压蒸汽灭菌柜BPH-9272SP*-250Thermo1000ulBCC-1800II3170ELVS-08-H-11227S-08-H-11203YY-08-008S-08-H-11128S-08-H-11224校验有效期至2.2试验用品：〔培养基的制备及适用性检查详见制备及适用性检查记录〕试验用试验用品无菌塑料吸头〔1.0ml〕无菌空平皿〔90mm〕大豆胰蛋白琼脂〔TSA〕大豆胰蛋白肉汤〔TSB〕萨布罗琼脂〔SDA〕萨布罗肉汤〔SDB〕65TSAWLP+0.25%酶号20110120110103M101110-01M100912-01M101110-01M100912-0165101208-1来源牛牛基因技术金典生化器材端峰生物科技有效期至2013.12.31-试验用试验用品pH7.0氯化钠蛋白胨缓冲液pH7.0氯化钠蛋白胨缓冲液号B100912-01B100912-01来源有效期至〔菌液制备详见原始记录〕菌种名菌种名称〔Staphylococcusaureus〕〔Pseudomonasaeruginosa〕aalbican(Staphylocococcushominis)菌液批号NA101114-Sa-3NA101115-Sa-3NA101116-Sa-3NA101114-Ec-3NA101115-Ec-3NA101116-Ec-3NA101114-Pa-3NA101115-Pa-3NA101116-Pa-3NANA101113-Ca-3NA101114-Ca-3NA101115-Ca-3NANA101114-Sh-3NA101115-Sh-3NA101116-Sh-3菌种批号W101113-Sa-2BW101113-Ec-2BW101113-Pa-2BW101113-Bs-2BW101113-Bs-2CW101113-Ca-2BW101109-An-4BW101109-An-4CW101113-Sh-2B菌种代号ATCC6538ATCC8739ATCC9027ATCC6633ATCC10231ATCC16404N/A毒剂的配制详见原始记录〕配制批号101115-W-0有效期至启封后一年原始批号2010071来源名称75%乙醇配制浓度75%-配制批号5101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06名称0.1%新洁尔灭原始批号5100601来源化学试剂华鑫医药化工有效期至2012.05配制浓度0.1%始记录〕浓菌液菌数浓菌液菌数cfu/ml6.95×1086.45×1083.75×1085.40×1082.75×1073.65×1067.40×108计数结果cfu/皿74613256243477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黑曲霉人表皮葡萄球菌稀释级10-710-710-710-710-610-510-7平均值69.564.537.55427.536.57465684352313971确认人/日期：复核人/日期：2.6菌片的制备：详见原始记录。菌数复核：试试验菌载体菌铜绿假单胞菌22枯草芽孢杆菌63金黄色葡萄球菌56人表皮葡萄球菌65大肠埃希菌58株菌18黑曲霉23软硬硬质塑料不锈钢纸玻璃干净服面-载体料试验菌10-5Ca:10-4An:10-3平均菌片菌数菌10-5Ca:10-4An:10-3平均菌片菌数菌10-5Ca:10-4An:10-3平均菌片菌数菌10-5Ca:10-4An:10-3平均菌片菌数菌10-5Ca:10-4An:10-3平均菌片菌数菌10-5Ca:10-4An:10-3金黄色葡萄球菌7163.56350000596461.5615000074727373000007569727200000647368.568500003642大肠埃希菌4752.55250000524347.547500006563646400000536358580000046625454000004235铜绿假单胞菌3528.52850000354238.53850000424744.54450000364641410000042464444000002434枯草芽孢杆菌51575700000735865.565500005367606000000626664640000067576262000004236株菌2521.5215000432634.5345000244132.5325000322729.52950002824262600001621黑曲霉3629.52950036323434000263530.530500423136.536500383134.5345002116人表皮葡萄球菌8273.57350000626764.564500007367707000000678576760000067737070000004745-试试验菌均菌片菌数菌10-5Ca:10-4An:10-3平均菌片菌数菌10-5Ca:10-4An:10-3平均菌片菌数铜绿假单胞菌292900000342529.529500004331373700000金黄色葡萄球菌39390000063576060000006246545400000枯草芽孢杆菌393900000464947.547500004953515100000大肠埃希菌38.53850000535252.552500006652595900000人表皮葡萄球菌464600000455650.55050000412834.53450000株菌18.5185000353032.5325000292125250000黑曲霉18.5185004125333300034524343000载体料橡胶铝合金合格标准：回收菌片的含菌量应不小于105cfu/片。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载载体名称剂75%乙醇0.1%新洁尔灭75%乙醇消毒剂批号101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05试验菌金黄色葡萄球菌大肠埃希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软塑料杀灭对数值6.806.105.966.336.026.806.24cfu/皿1573613对照0000000-试验菌菌铜绿假单胞菌枯草芽孢杆菌菌黑曲霉载体名称剂0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭消毒剂批号101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06果cfu/皿61562144261422524515163613615534软塑料杀灭对数值5.946.726.025.946.426.455.855.856.155.686.455.135.365.386.065.585.554.864.555.334.864.555.333.773.773.993.87对照000000000000000000000000000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-载载体名称剂75%乙醇0.1%新洁尔灭消毒剂批号101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06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试验菌人表皮葡萄球菌软塑料杀灭对数值3.774.176.396.096.876.176.176.39cfu/皿52361553对照00000000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对数值均大于3，符合标准要求。载载体名称剂75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇消毒剂批号101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05试验菌金黄色葡萄球菌大肠埃希菌铜绿假单硬质塑料杀灭对数值6.316.096.796.496.316.096.076.385.835.905.775.906.11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cfu/皿3512354276863对照0000000000000-试验菌胞菌枯草芽孢杆菌菌黑曲霉人表皮葡萄球菌载体名称剂0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭消毒剂批号101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06cfu/皿4266212147354112354276133344276硬质塑料杀灭对数值5.986.285.815.816.285.745.675.975.276.215.775.245.064.844.945.244.693.754.534.054.054.053.936.216.515.966.03对照000000000000000000000000000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-消毒剂批号消毒剂批号101116-W-06101117-W-06硬质塑料杀灭对数值6.816.33论符合规定符合规定cfu/皿13试验菌载体名称剂对照00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，硬质塑料载体菌片的杀灭对数值均大于3，符合标准要求。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载体名称剂75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇消毒剂批号101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05果cfu/皿13412163383575443234不锈钢杀灭对数值6.866.396.266.866.566.866.036.336.335.906.336.115.805.956.056.056.176.355.25对照0000000000000000000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-试验菌杆菌菌黑曲霉人表皮葡萄球菌载体名称剂0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭消毒剂批号101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06果cfu/皿23115145121633856254633856不锈钢杀灭对数值5.426.785.605.636.085.515.215.514.735.035.033.583.793.714.183.793.886.076.376.375.946.156.07对照00000000000000000000000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。3，符合标准要求。-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菌载体名称剂75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇消毒剂批号101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05果cfu/皿53131534523525462371124234521315纸杀灭对数值6.166.386.866.386.866.166.296.166.066.466.296.066.315.916.015.836.316.145.965.765.435.445.155.484.995.474.77对照000000000000000000000000000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-消毒剂批号消毒剂批号101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06载体名称剂0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭试验菌黑曲霉人表皮葡萄球菌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纸杀灭对数值4.994.874.774.264.093.864.263.863.966.406.286.186.586.406.18cfu/皿345235254345235对照000000000000000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，纸载体菌片的杀灭对数值均大于3，载载体名称剂75%乙醇0.1%新洁尔灭消毒剂批号101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06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试验菌金黄色葡萄球菌璃杀灭对数值6.366.846.236.146.536.84cfu/皿314521对照000000-试验菌大肠埃希菌铜绿假单胞菌枯草芽孢杆菌菌黑曲霉载体名称剂75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇消毒剂批号101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05果cfu/皿333463465254463123154241521333463璃杀灭对数值6.266.266.266.135.956.266.045.875.946.345.946.045.135.305.435.625.175.184.725.115.414.944.944.943.943.764.06对照000000000000000000000000000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-载载体名称剂0.1%新洁尔灭75%乙醇0.1%新洁尔灭消毒剂批号101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06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试验菌人表皮葡萄球菌璃杀灭对数值3.943.763.846.376.376.376.246.076.37cfu/皿465333463对照000000000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玻璃载体菌片的杀灭对数值均大于3，消毒剂批号消毒剂批号101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06载体名称毒剂75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭干净服面料杀灭对数值5.895.996.595.996.595.895.816.285.895.986.116.28试验菌金黄色葡萄球菌大肠埃希菌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cfu/皿541415625432对照000000000000-试验菌铜绿假单胞菌枯草芽孢杆菌菌黑曲霉人表皮葡萄球菌载体名称毒剂75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇消毒剂批号101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05cfu/皿532263413423251618415625432532632干净服面料杀灭对数值5.765.996.166.165.685.994.985.065.235.195.395.344.675.274.574.494.974.573.673.793.973.573.793.975.886.196.36对照000000000000000000000000000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-干干净服面料cfu/皿532杀灭对数值5.966.196.36对照000载体名称毒剂0.1%新洁尔灭消毒剂批号101115-W-06101116-W-06101117-W-06论符合规定符合规定符合规定试验菌合格标准：要求各次试验的杀灭对数值均≥3，可判定消毒合格。确认人/日期：复核人/日期：消毒剂批号消毒剂批号101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06载体名称剂75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭试验菌金黄色葡萄球菌大肠埃希菌铜绿假单胞菌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橡胶杀灭对数值6.306.306.306.186.486.085.945.886.026.026.246.425.695.775.995.996.175.87cfu/皿333425675532653324对照000000000000000000-试验菌枯草芽孢杆菌菌黑曲霉人表皮葡萄球菌载体名称剂75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭消毒剂批号101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06果cfu/皿132214113124425675532653632653橡胶杀灭对数值5.565.335.535.645.195.304.915.214.814.734.674.813.824.044.223.743.824.045.936.236.405.936.006.23对照000000000000000000000000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，橡胶载体的杀灭对数值均大于3，符-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菌载体名称剂75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇0.1%新洁尔灭75%乙醇消毒剂批号101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05101115-W-06101116-W-06101117-W-06101115-W-05101116-W-05101117-W-05果cfu/皿214634664214263462133141124634铝合金杀灭对数值6.436.736.135.956.266.135.995.996.176.476.776.176.275.796.095.975.796.275.596.235.565.676.416.114.624.924.80对照000000000000000000000000000论符合规定符合规定符合规