壓力蒸汽滅菌器驗(yàn)證報(bào)告

第頁(yè)壓力蒸汽滅菌器再驗(yàn)證報(bào)告文件名稱壓力蒸汽滅菌器驗(yàn)證報(bào)告文件編號(hào)：VR-02-004編制審核批準(zhǔn)編制日期審核日期批準(zhǔn)日期第2頁(yè)，共18頁(yè)版本號(hào)生效日期1.驗(yàn)證目的通過(guò)驗(yàn)證活動(dòng)，證明我司壓力蒸汽滅菌器能夠正常穩(wěn)定的運(yùn)行，滿足試驗(yàn)需求。2.驗(yàn)證時(shí)間本驗(yàn)證從2019年06月06日開(kāi)始，至2019年06月26日結(jié)束。驗(yàn)證參與人員4.驗(yàn)證內(nèi)容4.1運(yùn)行確認(rèn)對(duì)壓力蒸汽滅菌器的運(yùn)行進(jìn)行確認(rèn)，包括設(shè)備運(yùn)行情況檢查、溫度分布均勻性等。證明我司壓力蒸汽滅菌器的運(yùn)行穩(wěn)定，功能正常。檢測(cè)結(jié)果見(jiàn)附表3《設(shè)備運(yùn)行檢查表》、附表4《滅菌器空載熱分布試驗(yàn)記錄》。4.2性能確認(rèn)對(duì)壓力蒸汽滅菌器的的熱穿透能力和滅菌效果進(jìn)行確認(rèn)，確保壓力蒸汽滅菌器能夠保證滅菌產(chǎn)品的無(wú)菌性。檢測(cè)結(jié)果見(jiàn)附表6《滅菌器負(fù)載熱穿透試驗(yàn)記錄》、附表7《生物指示劑試驗(yàn)記錄表》。5.結(jié)論通過(guò)驗(yàn)證活動(dòng)，最終確定，我司壓力蒸汽滅菌器合格，能夠持續(xù)穩(wěn)定的運(yùn)行。滅菌溫度121℃，到達(dá)設(shè)定滅菌溫度后，滅菌器內(nèi)溫度平衡時(shí)間3min，然后開(kāi)始計(jì)算滅菌時(shí)間，滅菌時(shí)間≥15min，滅菌效果滿足要求，壓力蒸汽滅菌器可以投入使用。6.再驗(yàn)證6.1正常情況下，壓力蒸汽滅菌器的再驗(yàn)證周期為1年；6.2設(shè)備大修或改變后，必須進(jìn)行再驗(yàn)證。評(píng)價(jià)人/日期：審核人/日期：批準(zhǔn)人/日期：驗(yàn)證時(shí)間2019年06月06日~2019年06月26日參與人員備注：附表1培訓(xùn)記錄表講師參加對(duì)象培訓(xùn)日期培訓(xùn)類別考核評(píng)價(jià)方式培訓(xùn)內(nèi)容：《壓力蒸汽滅菌器再驗(yàn)證方案》部門培訓(xùn)人員簽到備注備注：培訓(xùn)主辦人：附表2校驗(yàn)記錄表序號(hào)名稱校驗(yàn)結(jié)果校驗(yàn)單位有效期證書編號(hào)2CB1805640-00152CB1805640-00102DB1805641-00141DA1902362-00011DA1902362-00021DA1902362-00031DA1902362-00041DA1902362-00051DA1902362-0006檢查人/日期：復(fù)核人/日期：附表3設(shè)備運(yùn)行檢查表序號(hào)檢查項(xiàng)目及標(biāo)準(zhǔn)是否符合要求1電源開(kāi)關(guān)正常，溫度、壓力旋鈕靈活可調(diào)是□否□2指示燈能正常顯示是□否□3超出設(shè)計(jì)壓力后，安全閥工作正常是□否□4放氣閥通氣順暢是□否□5計(jì)時(shí)功能準(zhǔn)確是□否□6設(shè)備密封圈完好無(wú)破損是□否□7低水位報(bào)警功能正常是□否□檢查人/日期：復(fù)核人/日期：附表4滅菌器空載熱分布試驗(yàn)記錄（第一次）序號(hào)測(cè)試溫度（℃）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可接受標(biāo)準(zhǔn)：下限為滅菌溫度，上限為滅菌溫度溫度+1℃。結(jié)論及偏差說(shuō)明：檢查人/日期：復(fù)核人/日期：備注：滅菌器空載熱分布試驗(yàn)記錄（第二次）序號(hào)測(cè)試溫度（℃）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可接受標(biāo)準(zhǔn)：下限為滅菌溫度，上限為滅菌溫度溫度+1℃。結(jié)論及偏差說(shuō)明：檢查人/日期：復(fù)核人/日期：備注：滅菌器空載熱分布試驗(yàn)記錄（第三輪）序號(hào)測(cè)試溫度（℃）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可接受標(biāo)準(zhǔn)：下限為滅菌溫度，上限為滅菌溫度溫度+1℃。結(jié)論及偏差說(shuō)明：檢查人/日期：復(fù)核人/日期：備注：附表5運(yùn)行確認(rèn)評(píng)價(jià)表驗(yàn)證時(shí)間運(yùn)行確認(rèn)結(jié)果評(píng)價(jià)：評(píng)價(jià)人/日期：備注：附表6滅菌器負(fù)載熱穿透試驗(yàn)記錄（第一次）序號(hào)測(cè)試溫度（℃）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可接受標(biāo)準(zhǔn)：下限為滅菌溫度，上限為滅菌溫度溫度+3℃。結(jié)論及偏差說(shuō)明：檢查人/日期：復(fù)核人/日期：備注：滅菌器負(fù)載熱穿透試驗(yàn)記錄（第二次）序號(hào)測(cè)試溫度（℃）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可接受標(biāo)準(zhǔn)：下限為滅菌溫度，上限為滅菌溫度溫度+3℃。結(jié)論及偏差說(shuō)明：檢查人/日期：復(fù)核人/日期：備注：滅菌器負(fù)載熱穿透試驗(yàn)記錄（第三輪）序號(hào)測(cè)試溫度（℃）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