75%乙醇、0%新洁尔灭消毒效果验证报告

--z.z.消毒剂消毒效果验证报告验证编号：验证编号：药业2023年11验证报告确定验证报告确定报告确定部门姓名签名日期起复草核QCQC审核QCQA批准Quality名目1.0验证概述 1.0验证概述 12.0验证预备12.112.212.322.42.322.422.532.632.732.733.0载体喷洒消毒杀菌效力试验43.143.23.2194.0人员培训4.0人员培训195.0变更及偏差196.06.0验证结论19验证概述对75%乙醇、0.1%洁尔灭消毒效果进展验证，验证中依据干净区不同材质选择规章外表载体(详见消毒剂消毒效果验证方案)，验证后总结数据形成报告。验证预备试验仪器设备：〔设备的检验状况详见校验记录〕设备型号编号校验有效期至生化培育箱〔30~35℃〕BPH-9272S-08-H-112272023.09.24霉菌培育箱〔20~25℃〕SP*-250S-08-H-112032023.06.09精细移液器Thermo1000ulYY-08-0082023.08.18生物平安柜BCC-1800IIS-08-H-111282023.02.10高压蒸汽灭菌柜3170ELVS-08-H-112242023.10.152.2试验用品：〔培育基的制备及适用性检查详见制备及适用性检查记录〕试验用品批号来源有效期至无菌塑料吸头〔1.0ml〕202301牛牛基因技术2023.12.31无菌空平皿〔90mm〕20230103金典生化器材2023.01.02大豆胰蛋白琼脂〔TSA〕M101110-01自制2023.12.09大豆胰蛋白肉汤〔TSB〕M100912-01自制2023.12.11萨布罗琼脂〔SDA〕M101110-01自制2023.12.09萨布罗肉汤〔SDB〕M100912-01自制2023.12.1165TSAWLP+0.25%酶65101208-1端峰生物科技2023.02.07pH7.0氯化钠蛋白胨缓冲液B100912-01自制2023.12.11名称名称来源原始批号有效期至配制浓度配制批号自制消毒剂效期101115-W-0575%乙醇国药集团化学试剂临用制20230715启封后一年75%101116-W-05临用制试验用品试验用品批号来源有效期至含0.05%聚山梨酯80的pH7.0氯化钠蛋白胨缓冲液B100912-01自制2023.12.11菌种名称金黄色葡萄球菌菌种名称金黄色葡萄球菌〔Staphylococcusaureus大肠埃希菌铜绿假单胞菌〔Pseudomonasaeruginosa枯草芽孢杆菌ATCC6633W101113-Bs-2BW101113-Bs-2CNA白色念珠菌ATCC10231W101113-Ca-2BNA101113-Ca-3NA101114-Ca-3NA101115-Ca-3黑曲霉ATCC16404W101109-An-4BW101109-An-4CNA人表皮葡萄球菌(Staphylocococcushominis)N/AW101113-Sh-2BNA101114-Sh-3NA101115-Sh-3NA101116-Sh-3菌种代号菌种批号菌液批号ATCC6538W101113-Sa-2BNA101114-Sa-3NA101115-Sa-3NA101116-Sa-3ATCC8739W101113-Ec-2BNA101114-Ec-3NA101115-Ec-3NA101116-Ec-3ATCC9027W101113-Pa-2BNA101114-Pa-3NA101115-Pa-3NA101116-Pa-3消毒剂：〔消毒剂的配制详见原始记录〕名称名称来源0.1%洁尔灭华鑫医药化工原始批号有效期至配制浓度配制批号自制消毒剂效期101117-W-05临用制101115-W-06临用制1006012023.050.1%101116-W-06临用制101117-W-06临用制试验菌稀释级试验菌稀释级计数结果cfu/皿平均值浓菌液菌数cfu/ml金黄色葡萄球菌10-7657469.56.95×108大肠埃希菌10-7686164.56.45×108铜绿假单胞菌10-7433237.53.75×108枯草芽孢杆菌10-75256545.40×108白色念珠菌10-6312427.52.75×107黑曲霉10-5393436.53.65×106人表皮葡萄球菌10-77177747.40×108确认人/日期：复核人/日期：菌片的制备：详见原始记录。试验菌金黄色葡萄球试验菌金黄色葡萄球黑曲霉人表皮葡萄球载体 结果细菌10-5Ca:10-4软塑料 An:10-3平均硬质塑料菌片菌数细菌10-5Ca:10-4An:10-3平均大肠埃铜绿假枯草芽白色念希菌单胞菌孢杆菌株菌菌565822631823菌657147355125368263.552.528.55721.529.573.56350000525000028500005700000215000295007350000595235734336626443425826326761.547.538.565.534.53464.5试验菌 金黄色葡萄球

大肠埃铜绿假大肠埃铜绿假枯草芽白色念希菌单胞菌孢杆菌株菌

人表皮葡萄球菌6150000菌615000047500003850000655000034500034000菌64500007465425324267372634767413567736444.56032.530.570730000064000004450000600000032500030500700000075533662324267696346662731857258416429.536.5767202300580000041000006400000295000365007600000644642672838677362465724317368.55444622634.570685000054000004400000620230026000034500700000036422442162147423534362116453938.5293918.518.546390000038500002900000390000018500018500460000063533446354145575225493025566052.529.547.532.53350.56000000525000029500004750000325000330005050000626643492934414652315321522854593751254334.55400000590000037000005100000250000430003450000菌片菌数细菌10-5Ca:10-4不锈钢纸玻璃干净服面料橡胶铝合金

An: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平均菌片菌数细菌10-5Ca:10-4An:10-3平均菌片菌数合格标准：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：载体喷洒消毒杀菌效力试验载体喷洒消毒杀菌效力试验结果：结果试验菌

载体名称

软塑料消毒剂消毒剂批号消毒剂消毒剂批号结果cfu/皿杀灭对数值阴性比照结论101115-W-0516.800符合规定75%乙醇101116-W-0556.100符合规定101117-W-0575.960符合规定101115-W-0636.330符合规定0.1%洁尔灭101116-W-0666.020符合规定101117-W-0616.800符合规定101115-W-0536.240符合规定75%乙醇101116-W-0565.940符合规定101117-W-0516.720符合规定101115-W-0656.020符合规定0.1%洁尔灭101116-W-0665.940符合规定101117-W-0626.420符合规定101115-W-0516.450符合规定75%乙醇101116-W-0545.850符合规定101117-W-0545.850符合规定101115-W-0626.150符合规定0.1%洁尔灭101116-W-0665.680符合规定101117-W-0616.450符合规定101115-W-05425.130符合规定75%乙醇101116-W-05255.360符合规定101117-W-05245.380符合规定101115-W-0656.060符合规定0.1%洁尔灭101116-W-06155.580符合规定101117-W-06165.550符合规定75%乙醇101115-W-0534.860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消毒剂消毒剂批号结果cfu/皿杀灭对数值阴性比照结论101116-W-0564.550符合规定101117-W-0515.330符合规定101115-W-0634.860符合规定0.1%洁尔灭101116-W-0664.550符合规定101117-W-0615.330符合规定101115-W-0553.770符合规定75%乙醇101116-W-0553.770符合规定101117-W-0533.990符合规定101115-W-0643.870符合规定0.1%洁尔灭101116-W-0653.770符合规定101117-W-0624.170符合规定101115-W-0536.390符合规定75%乙醇101116-W-0566.090符合规定101117-W-0516.870符合规定101115-W-0656.170符合规定0.1%洁尔灭101116-W-0656.170符合规定101117-W-0636.390符合规定结果载体名称软塑料试验菌结果载体名称软塑料试验菌菌黑曲霉人表皮葡萄球菌结论：上述各次试验结果显示，经消毒剂喷洒消毒后，软塑料载体菌片的杀3，符合标准要求。结果载体名称结果载体名称结果硬质塑料杀灭对 阴性试验菌消毒剂消毒剂批号结论金黄色葡萄球菌cfu/皿数值比照101115-W-0536.310符合规定75%乙醇101116-W-0556.090符合规定101117-W-0516.790符合规定0.1%洁尔灭101115-W-0626.490符合规定结果试验菌大肠埃希菌铜绿假单胞菌枯草芽孢杆菌白色念珠菌

载体名称消毒剂 消毒剂批号101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06

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结果硬质塑料杀灭对结果硬质塑料杀灭对阴性cfu/皿数值比照36.31056.09046.07026.38075.83065.90085.77065.90036.11045.98026.28065.81065.81026.280125.740145.67075.970355.27046.210115.77025.24035.06054.84044.94025.24074.69063.750cfu/皿数值比照101116-W-0514.530符合规定101117-W-0534.050符合规定101115-W-0634.050符合规定0.1%洁尔灭101116-W-0634.050符合规定101117-W-0643.930符合规定101115-W-0546.210符合规定75%乙醇101116-W-0526.510符合规定101117-W-0575.960符合规定101115-W-0666.030符合规定0.1%洁尔灭101116-W-0616.810符合规定101117-W-0636.330符合规定结果载体名称结果硬质塑料结果载体名称结果硬质塑料杀灭对 阴性试验菌消毒剂消毒剂批号结论人表皮葡萄球菌结论：上述各次试验结果显示，经消毒剂喷洒消毒后，硬质塑料载体菌片的3，符合标准要求。结果载体名称结果载体名称不锈钢试验菌金黄色葡萄球菌大肠埃希菌消毒剂消毒剂批号结果cfu/皿杀灭对数值阴性比照结论101115-W-0516.860符合规定75%乙醇101116-W-0536.390符合规定101117-W-0546.260符合规定101115-W-0616.860符合规定0.1%洁尔灭101116-W-0626.560符合规定101117-W-0616.860符合规定101115-W-0566.030符合规定75%乙醇101116-W-0536.330符合规定101117-W-0536.330符合规定0.1%洁尔灭101115-W-0685.900符合规定结果试验菌铜绿假单胞菌枯草芽孢杆菌白色念珠菌黑曲霉

载体名称消毒剂 消毒剂批号101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06

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结果不锈钢杀灭对结果不锈钢杀灭对阴性cfu/皿数值比照36.33056.11075.80055.95046.05046.05036.17026.350345.250235.42016.780155.600145.63056.08015.51025.21015.51064.73035.03035.03083.58053.79063.71024.18053.79043.88066.070消毒剂消毒剂批号结果cfu/皿杀灭对数值阴性比照结论101116-W-0536.370符合规定101117-W-0536.370符合规定101115-W-0685.940符合规定0.1%洁尔灭101116-W-0656.150符合规定101117-W-0666.070符合规定结果载体名称不锈钢试验菌结果载体名称不锈钢试验菌萄球菌3，符合标准要求。结果载体名称结果载体名称纸试验菌金黄色葡萄球菌大肠埃希菌铜绿假单胞菌消毒剂消毒剂批号结果cfu/皿杀灭对数值阴性比照结论101115-W-0556.160符合规定75%乙醇101116-W-0536.380符合规定101117-W-0516.860符合规定101115-W-0636.380符合规定0.1%洁尔灭101116-W-0616.860符合规定101117-W-0656.160符合规定101115-W-0536.290符合规定75%乙醇101116-W-0546.160符合规定101117-W-0556.060符合规定101115-W-0626.460符合规定0.1%洁尔灭101116-W-0636.290符合规定101117-W-0656.060符合规定101115-W-0526.310符合规定75%乙醇101116-W-0555.910符合规定101117-W-0546.010符合规定0.1%洁尔灭101115-W-0665.830符合规定结果试验菌枯草芽孢杆菌白色念珠菌黑曲霉人表皮葡萄球菌

载体名称消毒剂 消毒剂批号101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06

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结果纸杀灭对阴性cfu/皿结果纸杀灭对阴性cfu/皿数值比照26.31036.14075.960115.760245.430235.440455.150215.48034.99015.47054.77034.99044.87054.77024.26034.09053.86024.26053.86043.96036.40046.28056.18026.58036.40056.180结论：上述各次试验结果显示，经消毒剂喷洒消毒后，纸载体菌片的杀灭对数值均大于3，符合标准要求。确认人/日期： 复核人/日期：结果试验菌

载体名称cfu/皿数值cfu/皿数值比照101115-W-0536.360符合规定75%乙醇101116-W-0516.840符合规定101117-W-0546.230符合规定101115-W-0656.140符合规定0.1%洁尔灭101116-W-0626.530符合规定101117-W-0616.840符合规定101115-W-0536.260符合规定75%乙醇101116-W-0536.260符合规定101117-W-0536.260符合规定101115-W-0646.130符合规定0.1%洁尔灭101116-W-0665.950符合规定101117-W-0636.260符合规定101115-W-0546.040符合规定75%乙醇101116-W-0565.870符合规定101117-W-0555.940符合规定101115-W-0626.340符合规定0.1%洁尔灭101116-W-0655.940符合规定101117-W-0646.040符合规定101115-W-05465.130符合规定75%乙醇101116-W-05315.300符合规定101117-W-05235.430符合规定101115-W-06155.620符合规定0.1%洁尔灭101116-W-06425.170符合规定101117-W-06415.180符合规定75%乙醇101115-W-0554.720符合规定

玻璃结果 杀灭对 阴性 结论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cfu/皿数值比照101116-W-0525.110符合规定101117-W-0515.410符合规定101115-W-0634.940符合规定0.1%洁尔灭101116-W-0634.940符合规定101117-W-0634.940符合规定101115-W-0543.940符合规定75%乙醇101116-W-0563.760符合规定101117-W-0534.060符合规定101115-W-0643.940符合规定0.1%洁尔灭101116-W-0663.760符合规定101117-W-0653.840符合规定101115-W-0536.370符合规定75%乙醇101116-W-0536.370符合规定101117-W-0536.370符合规定101115-W-0646.240符合规定0.1%洁尔灭101116-W-0666.070符合规定101117-W-0636.370符合规定结果载体名称结果玻璃结果载体名称结果玻璃杀灭对阴性试验菌菌消毒剂消毒剂批号结论黑曲霉人表皮葡萄球菌结论：上述各次试验结果显示，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，符合标准要求。结果试验菌金黄色葡萄球菌结果试验菌金黄色葡萄球菌载体名称消毒剂消毒剂批号结果cfu/皿干净服面料杀灭对数值阴性比照结论101115-W-0555.890符合规定75%乙醇101116-W-0545.990符合规定101117-W-0516.590符合规定0.1%洁尔灭101115-W-0645.990符合规定结果试验菌大肠埃希菌铜绿假单胞菌枯草芽孢杆菌白色念珠菌

载体名称消毒剂 消毒剂批号101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06

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结果干净服面料杀灭对结果干净服面料杀灭对阴性cfu/皿数值比照16.59055.89065.81026.28055.89045.98036.11026.28055.76035.99026.16026.16065.68035.990414.980345.060235.230255.190165.390185.34044.67015.27054.57064.49024.97054.57043.670载体名称消毒剂消毒剂批号结果cfu/皿干净服面料杀灭对数值阴性比照结论101116-W-0533.790符合规定101117-W-0523.970符合规定101115-W-0653.570符合规定0.1%洁尔灭101116-W-0633.790符合规定101117-W-0623.970符合规定101115-W-0565.880符合规定75%乙醇101116-W-0536.190符合规定101117-W-0526.360符合规定101115-W-0655.960符合规定0.1%洁尔灭101116-W-0636.190符合规定101117-W-0626.360符合规定结果试验菌人表皮葡萄球菌结果试验菌人表皮葡萄球菌于3，符合标准要求。结果载体名称结果载体名称结果橡胶杀灭对阴性试验菌消毒剂消毒剂批号结论金黄色葡萄球菌大肠埃希菌cfu/皿数值比照101115-W-0536.300符合规定75%乙醇101116-W-0536.300符合规定101117-W-0536.300符合规定101115-W-0646.180符合规定0.1%洁尔灭101116-W-0626.480符合规定101117-W-0656.080符合规定101115-W-0565.940符合规定75%乙醇101116-W-0575.880符合规定101117-W-0556.020符合规定0.1%洁尔灭101115-W-0656.020符合规定结果试验菌铜绿假单胞菌枯草芽孢杆菌白色念珠菌黑曲霉

载体名称消毒剂 消毒剂批号101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06101115-W-0575%乙醇 101116-W-05101117-W-05101115-W-060.1%洁尔灭 101116-W-06101117-W-06

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结果橡胶杀灭对结果橡胶杀灭对阴性cfu/皿数值比照36.24026.42065.69055.77035.99035.99026.17045.870135.560225.330145.530115.640315.190245.30044.91025.21054.81064.73074.67054.81053.82034.04024.22063.74053.82034.04065.930cfu/皿数值比照101116-W-0536.230符合规定101117-W-0526.400符合规定101115-W-0665.930符合规定0.1%洁尔灭101116-W-0656.000符合规定101117-W-0636.230符合规定结果载体名称结果橡胶结果载体名称结果橡胶杀灭对试验菌萄球菌消毒剂消毒剂批号阴性结论结论：上述各次试验结果显示，经消毒剂喷洒消毒后，橡胶载体的杀灭对数值均大于3，符合标准要求。结果载体名称结果载体名称铝合金试验菌金黄色葡萄球菌大肠埃希菌铜绿假单胞菌消毒剂消毒剂批号结果cfu/皿杀灭对数值阴性比照结论101115-W-0526.430符合规定75%乙醇101116-W-0516.730符合规定101117-W-0546.130符合规定101115-W-0665.950符合规定0.1%洁尔灭101116-W-0636.260符合规定101117-W-0646.130符合规定101115-W-0565.990符合规定75%乙醇101116-W-0565.990符合规定101117-W-0546.170符合规定101115-W-0626.470符合规定0.1%洁尔灭101116-W-0616.770符合规定101