压力蒸汽灭菌器验证报告

第页压力蒸汽灭菌器再验证报告文件名称压力蒸汽灭菌器验证报告文件编号：VR-02-004编制审核批准编制日期审核日期批准日期第2页，共18页版本号生效日期1.验证目的通过验证活动，证明我司压力蒸汽灭菌器能够正常稳定的运行，满足试验需求。2.验证时间本验证从2019年06月06日开始，至2019年06月26日结束。验证参与人员4.验证内容4.1运行确认对压力蒸汽灭菌器的运行进行确认，包括设备运行情况检查、温度分布均匀性等。证明我司压力蒸汽灭菌器的运行稳定，功能正常。检测结果见附表3《设备运行检查表》、附表4《灭菌器空载热分布试验记录》。4.2性能确认对压力蒸汽灭菌器的的热穿透能力和灭菌效果进行确认，确保压力蒸汽灭菌器能够保证灭菌产品的无菌性。检测结果见附表6《灭菌器负载热穿透试验记录》、附表7《生物指示剂试验记录表》。5.结论通过验证活动，最终确定，我司压力蒸汽灭菌器合格，能够持续稳定的运行。灭菌温度121℃，到达设定灭菌温度后，灭菌器内温度平衡时间3min，然后开始计算灭菌时间，灭菌时间≥15min，灭菌效果满足要求，压力蒸汽灭菌器可以投入使用。6.再验证6.1正常情况下，压力蒸汽灭菌器的再验证周期为1年；6.2设备大修或改变后，必须进行再验证。评价人/日期：审核人/日期：批准人/日期：验证时间2019年06月06日~2019年06月26日参与人员备注：附表1培训记录表讲师参加对象培训日期培训类别考核评价方式培训内容：《压力蒸汽灭菌器再验证方案》部门培训人员签到备注备注：培训主办人：附表2校验记录表序号名称校验结果校验单位有效期证书编号2CB1805640-00152CB1805640-00102DB1805641-00141DA1902362-00011DA1902362-00021DA1902362-00031DA1902362-00041DA1902362-00051DA1902362-0006检查人/日期：复核人/日期：附表3设备运行检查表序号检查项目及标准是否符合要求1电源开关正常，温度、压力旋钮灵活可调是□否□2指示灯能正常显示是□否□3超出设计压力后，安全阀工作正常是□否□4放气阀通气顺畅是□否□5计时功能准确是□否□6设备密封圈完好无破损是□否□7低水位报警功能正常是□否□检查人/日期：复核人/日期：附表4灭菌器空载热分布试验记录（第一次）序号测试温度（℃）最大值最小值最大偏差1234561121.42121.59121121121.21121.02121.591210.592121.48121.42121.23121.36121.72121.1121.72121.10.723121.31121.54121.33121.42121.75121.48121.75121.310.754121.46121.66121.97121.12121.8121.55121.97121.120.975121.31121.66121.99121.2121.78121.98121.99121.20.996121.41121.73121.97121.21121.6121.95121.97121.210.977121.38121.7121.96121.1121.62121.75121.96121.10.968121.46121.77121.17121.14121.14121.65121.77121.140.779121.48121.77121.99121.02121.15121.94121.99121.020.9910121.56121.8121.01121.53121.09121.78121.8121.010.811121.59121.79121.01121.23121.21121.63121.79121.010.7912121.68121.81121.05121.03121.36121.63121.81121.030.8113121.84121.84121.05121.27121.48121.54121.84121.050.8414121.84121.84121.01121.14121.69121.48121.84121.010.8415121.67121.59121.79121.05121.41121.77121.79121.050.79可接受标准：下限为灭菌温度，上限为灭菌温度温度+1℃。结论及偏差说明：检查人/日期：复核人/日期：备注：灭菌器空载热分布试验记录（第二次）序号测试温度（℃）最大值最小值最大偏差1234561121.48121.29121.19121.65121.12121.07121.65121.070.652121.48121.42121.86121.88121.78121.46121.88121.420.883121.41121.54121.89121.9121.84121.48121.9121.410.94121.46121.66121.97121.12121.84121.55121.97121.120.975121.48121.66121.99121.2121.89121.98121.99121.20.996121.51121.73121.37121.21121.9121.95121.95121.210.957121.58121.7121.36121.1121.04121.95121.95121.040.958121.46121.77121.41121.14121.04121.18121.77121.040.779121.48121.78121.59121.02121.05121.24121.78121.020.7810121.56121.8121.58121.23121.09121.38121.8121.090.811121.59121.79121.41121.23121.21121.63121.79121.210.7912121.68121.81121.35121.33121.36121.23121.81121.230.8113121.84121.84121.57121.47121.38121.54121.84121.380.8414121.84121.64121.21121.14121.69121.48121.84121.140.8415121.5121.59121.39121.25121.01121.43121.59121.010.59可接受标准：下限为灭菌温度，上限为灭菌温度温度+1℃。结论及偏差说明：检查人/日期：复核人/日期：备注：灭菌器空载热分布试验记录（第三轮）序号测试温度（℃）最大值最小值最大偏差1234561121.06121.59121.09121.05121121121.591210.592121.08121.42121.16121.18121.08121.06121.42121.060.423121.21121.54121.19121.19121.14121.08121.54121.080.544121.26121.66121.37121.12121.24121.15121.66121.120.665121.38121.66121.36121.2121.29121.28121.66121.20.666121.51121.73121.37121.21121.39121.45121.73121.210.737121.58121.7121.36121.1121.44121.45121.7121.10.78121.46121.77121.41121.14121.42121.18121.77121.140.779121.52121.78121.59121.02121.45121.31121.78121.020.7810121.56121.8121.58121.23121.49121.38121.8121.230.811121.59121.79121.41121.23121.61121.63121.79121.230.7912121.68121.48121.35121.33121.46121.23121.68121.230.6813121.64121.38121.57121.47121.38121.24121.64121.240.6414121.6121.34121.61121.14121.25121.18121.61121.140.6115121.49121.13121.39121.25121.05121.13121.49121.050.49可接受标准：下限为灭菌温度，上限为灭菌温度温度+1℃。结论及偏差说明：检查人/日期：复核人/日期：备注：附表5运行确认评价表验证时间运行确认结果评价：评价人/日期：备注：附表6灭菌器负载热穿透试验记录（第一次）序号测试温度（℃）最大值最小值最大偏差1234561120.26120.09120.09120.05120.41121.19121.19120.050.952120.68120.62120.66120.28120.88121.26121.26120.280.723121.01121.04121.09120.89121.14121.28121.28120.890.284121.06121.06121.17121.02121.24121.25121.25121.020.255121.18121.16121.26121.2121.29121.28121.29121.160.296121.21121.23121.27121.21121.29121.35121.35121.210.357121.28121.3121.36121.31121.34121.45121.45121.280.458121.46121.37121.41121.34121.42121.48121.48121.340.489121.52121.48121.59121.52121.45121.51121.59121.450.5910121.56121.38121.58121.53121.49121.58121.58121.380.5811121.59121.59121.61121.53121.51121.63121.63121.510.6312121.68121.48121.65121.57121.56121.63121.68121.480.6813121.64121.48121.67121.57121.58121.54121.67121.480.6714121.6121.54121.61121.44121.55121.58121.61121.440.6115121.49121.53121.59121.55121.45121.53121.59121.450.59可接受标准：下限为灭菌温度，上限为灭菌温度温度+3℃。结论及偏差说明：检查人/日期：复核人/日期：备注：灭菌器负载热穿透试验记录（第二次）序号测试温度（℃）最大值最小值最大偏差1234561120.06120.12120.09120.02120.21120.59120.59120.020.982120.28120.32120.16120.38120.67121.07121.07120.160.843120.46121.04121.19120.79121.04121.18121.19120.460.544121121.16121.17121.02121.24121.15121.241210.245121.08121.18121.26121.12121.26121.18121.26121.080.266121.11121.23121.27121.11121.29121.15121.29121.110.297121.18121.26121.26121.21121.24121.18121.26121.180.268121.16121.27121.31121.14121.22121.18121.31121.140.319121.22121.25121.29121.22121.25121.21121.29121.210.2910121.16121.28121.28121.23121.29121.18121.29121.160.2911121.19121.29121.31121.23121.21121.23121.31121.190.3112121.18121.28121.35121.27121.26121.21121.35121.180.3513121.24121.38121.27121.17121.28121.24121.38121.170.3814121.26121.34121.31121.24121.31121.18121.34121.180.3415121.29121.33121.29121.25121.35121.23121.35121.230.35可接受标准：下限为灭菌温度，上限为灭菌温度温度+3℃。结论及偏差说明：检查人/日期：复核人/日期：备注：灭菌器负载热穿透试验记录（第三轮）序号测试温度（℃）最大值最小值偏差1234561120.26120.42120.09120.42120.21120.49120.49120.090.912120.58121.02120.56121.08120.86121.07121.08120.560.443121.06121.14121.09121.39121.14121.16121.39121.060.394121.12121.26121.12121.42121.24121.15121.42121.120.425121.18121.28121.26121.42121.26121.18121.42121.180.426121.11121.23121.31121.41121.27121.15121.41121.110.417121.18121.25121.26121.36121.24121.18121.36121.180.368121.18121.27121.31121.4121.22121.16121.4121.160.49121.22121.25121.27121.42121.25121.21121.42121.210.4210121.19121.28121.28121.33121.29121.15121.33121.150.3311121.2121.29121.31121.33121.31121.23121.33121.20.3312121.18121.28121.33121.37121.26121.21121.37121.180.3713121.2121.28121.27121.3121.28121.24121.3121.20.314121.21121.34121.31121.24121.31121.18121.34121.180.3415121.19121.33121.29121.29121.35121.23121.3