75%乙醇、0.1%新洁尔灭消毒效果验证报告

药业有限公司QC-VAL-535-01消毒剂消毒效果验证报告

验证编号：

药业有限公司2013年11月

药业有限公司QC-VAL-535-01验证报告确定

报告确定起复

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QCQCQC门姓名签名日期

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QA批准Quality药业有限公司QC-VAL-535-01目录

1.0验证概述································································································································12.0验证准备································································································································12.1试验仪器设备·····················································································································12.2试验用品······························································································································12.3菌种及菌液··························································································································22.4消毒剂··································································································································22.5菌液计数······························································································································32.6菌片制备······························································································································32.7菌片菌数复核·····················································································································33.0载体喷洒消毒杀菌效力试验······························································································43.1载体喷洒消毒杀菌效力试验结果·····················································································43.2载体喷洒消毒杀菌效力试验结论··················································································194.0人员培训······························································································································195.0变更及偏差··························································································································196.0验证结论······························································································································19

苏州万庆药业有限公司QC-VAL-535-011.0验证概述1.1对75%乙醇、0.1%新洁尔灭消毒效果进行验证，验证中根据洁净区不同材质选择规则表面载体(详见消毒剂消毒效果验证方案)，验证后总结数据形成报告。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）设备生化培养箱（30~35℃）霉菌培养箱（20~25℃）精密移液器生物安全柜高压蒸汽灭菌柜型号BPH-9272SPX-250Thermo1000ulBCC-1800II3170ELV编号S-08-H-11227S-08-H-11203YY-08-008S-08-H-11128S-08-H-11224校验有效期至2011.09.242011.06.092011.08.182011.02.102011.10.152.2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）试验用品无菌塑料吸头（1.0ml）批号201101来源北京牛牛基因技术有限公司青岛金典生化器材有限公司自制自制自制自制连云港端峰生物科技有限公司自制自制有效期至2013.12.31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pH7.0氯化钠蛋白胨缓冲液含0.05%聚山梨酯80的pH7.0氯化钠蛋白胨缓冲液20110103M101110-01M100912-01M101110-01M100912-0165101208-1B100912-01B100912-012013.01.022010.12.092010.12.112010.12.092010.12.112011.02.072010.12.112010.12.11第1页共19页苏州万庆药业有限公司QC-VAL-535-012.3菌种及菌液：（菌液制备详见原始记录）菌种名称金黄色葡萄球菌（Staphylococcusaureus）菌种代号菌种批号菌液批号NA101114-Sa-3ATCC6538W101113-Sa-2BNA101115-Sa-3NA101116-Sa-3NA101114-Ec-3ATCC8739W101113-Ec-2BNA101115-Ec-3NA101116-Ec-3NA101114-Pa-3ATCC9027W101113-Pa-2BNA101115-Pa-3NA101116-Pa-3ATCC6633W101113-Bs-2BW101113-Bs-2CNANA101113-Ca-3ATCC10231W101113-Ca-2BNA101114-Ca-3NA101115-Ca-3ATCC16404W101109-An-4BW101109-An-4CNANA101114-Sh-3N/AW101113-Sh-2BNA101115-Sh-3NA101116-Sh-3大肠埃希菌（Escherichiacoli）铜绿假单胞菌（Pseudomonasaeruginosa）枯草芽孢杆菌（Bacillussubtilis）白色念珠菌（Candidaalbicans）黑曲霉（Aspergillusniger）人表皮葡萄球菌(Staphylocococcushominis)2.4消毒剂：（消毒剂的配制详见原始记录）名称来源原始批号有效期至配制浓度配制批号101115-W-0575%乙醇国药集团化学试剂有限公司20100715启封后一年751116-W-05101117-W-05101115-W-060.1%新洁尔灭南昌华鑫医药化工有限公司1006012012.050.11116-W-06101117-W-06自制消毒剂效期临用新制临用新制临用新制临用新制临用新制临用新制第2页共19页

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