实用标准文档文案大全消毒剂消毒效果验证报告验证编号：药业有限公司2013年11月实用标准文档文案大全验证报告确定报告确定部门姓名签名日期起草QC复核QC审核QCQA批准Quality实用标准文档文案大全目录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实用标准文档文案大全1.0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）设备型号编号校验有效期至生化培养箱（30~35℃）BPH-9272S-08-H-112272011.09.24霉菌培养箱（20~25℃）SPX-250S-08-H-112032011.06.09精密移液器Thermo1000ulYY-08-0082011.08.18生物安全柜BCC-1800IIS-08-H-111282011.02.10高压蒸汽灭菌柜3170ELVS-08-H-112242011.10.152.2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）试验用品批号来源有效期至无菌塑料吸头（1.0ml）201101北京牛牛基因技术有限公司2013.12.31无菌空平皿（90mm）20110103青岛金典生化器材有限公司2013.01.02大豆胰蛋白琼脂（TSA）M101110-01自制2010.12.09大豆胰蛋白肉汤（TSB）M100912-01自制2010.12.11萨布罗琼脂（SDA）M101110-01自制2010.12.09萨布罗肉汤（SDB）M100912-01自制2010.12.1165TSAWLP+0.25%酶65101208-1连云港端峰生物科技有限公司2011.02.07pH7.0氯化钠蛋白胨缓冲液B100912-01自制2010.12.11含0.05%聚山梨酯80的pH7.0B100912-01自制2010.12.11实用标准文档文案大全试验用品批号来源有效期至氯化钠蛋白胨缓冲液2.3菌种及菌液：（菌液制备详见原始记录）菌种名称菌种代号菌种批号菌液批号金黄色葡萄球菌（Staphylococcusaureus）ATCC6538W101113-Sa-2BNA101114-Sa-3NA101115-Sa-3NA101116-Sa-3大肠埃希菌（Escherichiacoli）ATCC8739W101113-Ec-2BNA101114-Ec-3NA101115-Ec-3NA101116-Ec-3铜绿假单胞菌（Pseudomonasaeruginosa）ATCC9027W101113-Pa-2BNA101114-Pa-3NA101115-Pa-3NA101116-Pa-3枯草芽孢杆菌（Bacillussubtilis）ATCC6633W101113-Bs-2BW101113-Bs-2CNA白色念珠菌（Candidaalbicans）ATCC10231W101113-Ca-2BNA101113-Ca-3NA101114-Ca-3NA101115-Ca-3黑曲霉（Aspergillusniger）ATCC16404W101109-An-4BW101109-An-4CNA人表皮葡萄球菌(Staphylocococcushominis)N/AW101113-Sh-2BNA101114-Sh-3NA101115-Sh-3NA101116-Sh-32.4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自制消毒剂效期75%乙醇国药集团20100715启封后一年75%101115-W-05临用新制实用标准文档文案大全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化学试剂有限公司101116-W-05临用新制101117-W-05临用新制0.1%新洁尔灭南昌华鑫医药化工有限公司1006012012.050.1%101115-W-06临用新制10...
