文件名稱 |
蒸汽滅菌器再驗(yàn)證 |
編 號(hào) |
SYZ03-028 |
編制依據(jù) |
設(shè)備驗(yàn)證管理制度(YZ01-002) |
共37頁(yè) |
編 制 人 |
|
審 核 人 |
|
批 準(zhǔn) 人 |
|
編制日期 |
年 月 日 |
審核日期 |
年 月 日 |
批準(zhǔn)日期 |
年 月 日 |
頒發(fā)部門 |
設(shè)備處 |
生效日期 |
|
目 錄
驗(yàn)證小組……………………………………………………………1
驗(yàn)證方案……………………………………………………………2
驗(yàn)證方案審查結(jié)論…………………………………………………8
驗(yàn)證實(shí)施計(jì)劃書……………………………………………………9
驗(yàn)證報(bào)告(1)……………………………………………………10
驗(yàn)證結(jié)果報(bào)告書(1)……………………………………………22
驗(yàn)證證書(1)……………………………………………………23
驗(yàn)證報(bào)告(2)……………………………………………………24
驗(yàn)證結(jié)果報(bào)告書(2)……………………………………………36
驗(yàn)證證書(2)……………………………………………………37
驗(yàn)證小組:
組長(zhǎng):蘇振波
組員:孫忠輝、孫桂菊、沈偉、高云峰、袁玉敏、張若萍
沈陽(yáng)同聯(lián)藥業(yè)有限公司
文件名稱 |
蒸汽滅菌柜再驗(yàn)證方案 |
編 號(hào) |
SYZ-F-03-028 |
編制依據(jù) |
設(shè)備驗(yàn)證管理制度(YZ01-002) |
共14頁(yè) |
編 制 人 |
|
審 核 人 |
|
批 準(zhǔn) 人 |
|
編制日期 |
年 月 日 |
審核日期 |
年 月 日 |
批準(zhǔn)日期 |
年 月 日 |
頒發(fā)部門 |
設(shè)備處 |
生效日期 |
|
1、概述
蒸汽
滅菌器位于口服液滅菌室。本次蒸汽滅菌柜的驗(yàn)證為再驗(yàn)證。采用同步驗(yàn)證的方式進(jìn)行,對(duì)連續(xù)三批耆鹿逐痹口服液的藥液配制生產(chǎn),對(duì)蒸汽滅菌柜進(jìn)行驗(yàn)證。本次驗(yàn)證不再進(jìn)行設(shè)計(jì)驗(yàn)證(DQ)及安裝驗(yàn)證(IQ)。本方案的制定依據(jù)蒸汽滅菌柜(120406-02-02)標(biāo)準(zhǔn)操作規(guī)程進(jìn)行制定。
由于該設(shè)備一直處于良好的運(yùn)行狀態(tài),本次確認(rèn)是在繼上次確認(rèn)結(jié)束后,無(wú)任何偏差、變更情況下對(duì)設(shè)備性能進(jìn)行的再確認(rèn),故在滅菌效果確認(rèn)時(shí),無(wú)需考察空載狀態(tài),如滿載及熱溫度分布均一性能夠達(dá)到驗(yàn)證可接受標(biāo)準(zhǔn),即可證明設(shè)備性能穩(wěn)定。
2、驗(yàn)證目的:
本再驗(yàn)證方案的目的是以文件形式證明口服液生產(chǎn)用蒸汽滅菌柜和它的附件系統(tǒng)能夠按照預(yù)定運(yùn)行范圍運(yùn)行,在預(yù)先設(shè)定好的范圍內(nèi)生產(chǎn)產(chǎn)品。
3、驗(yàn)證范圍:
口服液生產(chǎn)用蒸汽滅菌柜
4、驗(yàn)證小組職責(zé)
驗(yàn)證小組成員 |
部門及職位 |
職 責(zé) |
組長(zhǎng) |
蘇振波 |
設(shè)備處處長(zhǎng) |
負(fù)責(zé)再驗(yàn)證方案驗(yàn)證報(bào)告的審批 |
組員 |
孫忠輝 |
機(jī)修車間主任 |
負(fù)責(zé)擬定方案,實(shí)施驗(yàn)證,完成驗(yàn)證報(bào)告。 |
沈偉 |
設(shè)備員 |
負(fù)責(zé)方案的實(shí)施驗(yàn)證。 |
張若萍 |
計(jì)量室主任 |
負(fù)責(zé)儀器、儀表、器具等的校正。 |
包君 |
質(zhì)保處 |
參與和協(xié)調(diào)驗(yàn)證工作。 |
袁玉敏 |
QA |
生產(chǎn)現(xiàn)場(chǎng)監(jiān)督員 |
孫桂菊 |
二車間主任 |
監(jiān)督驗(yàn)證的實(shí)施 |
高云峰 |
生產(chǎn)技術(shù)員 |
參與驗(yàn)證實(shí)施過(guò)程。 |
李麗華 |
質(zhì)量部部長(zhǎng) |
驗(yàn)證方案及驗(yàn)證報(bào)告的批準(zhǔn) |
鞠濤 |
總工程師 |
驗(yàn)證方案及驗(yàn)證報(bào)告的批準(zhǔn)、發(fā)放驗(yàn)證證書、驗(yàn)證再驗(yàn)證周期 |
魏影 |
總經(jīng)理 |
簽發(fā)驗(yàn)證證書 |
5、驗(yàn)證正文
5.1驗(yàn)證過(guò)程中使用的儀器儀表校驗(yàn)情況
本次所用計(jì)量器具及儀表等校驗(yàn)情況。見(jiàn)附表1
5.2 運(yùn)行確認(rèn)
按蒸汽滅菌柜操作規(guī)程要求運(yùn)行,對(duì)蒸汽滅菌柜的各項(xiàng)功能進(jìn)行檢查。具體檢查項(xiàng)如下:
1)對(duì)設(shè)備外觀進(jìn)行檢查,蒸汽滅菌柜內(nèi)外表面應(yīng)無(wú)腐蝕或破損。
2)與四周、建筑物距離在0.20米以上有足夠的空間維護(hù)保養(yǎng)。
3)上蓋密封圈應(yīng)完好無(wú)撕裂或老化現(xiàn)象。
4)管路應(yīng)密封無(wú)泄漏。見(jiàn)附表2
5.3性能確認(rèn)
5.3.1熱電偶放置方式的確認(rèn)
將12支熱電偶放到滅菌鍋內(nèi)不同位置,測(cè)溫點(diǎn)不得接觸金屬表面和其它表面,具體放置位置見(jiàn)如下示意圖:
5.3.2觀察無(wú)紙記錄儀記錄運(yùn)行溫度
取樣點(diǎn)及溫度探頭位置圖示:

圖一
取樣點(diǎn)分層 |
取樣點(diǎn)位置 |
熱電偶編號(hào) |
取樣點(diǎn)位置 |
熱電偶編號(hào) |
取樣點(diǎn)位置 |
熱電偶編號(hào) |
1 |
01 |
2 |
02 |
3 |
03 |
4 |
04 |
5 |
05 |
4 |
06 |
7 |
07 |
8 |
08 |
9 |
09 |
10 |
10 |
11 |
11 |
12 |
12 |
滿載及熱力分布取樣點(diǎn)編號(hào)見(jiàn)附表1
5.3.2熱力分布溫度分布均一性確認(rèn)
熱力分布溫度均一性確認(rèn)在滿載狀態(tài)下進(jìn)行,將溫度驗(yàn)證儀探頭放在被滅菌的物品內(nèi)部,以考察滅菌效果。該項(xiàng)確認(rèn)同樣在105℃/30min每個(gè)工藝參數(shù)條件下連續(xù)進(jìn)行三次。
可接受標(biāo)準(zhǔn):各測(cè)試點(diǎn)溫度與設(shè)定值溫差≤2℃
各測(cè)試點(diǎn)溫度范圍103—107℃;
6.3 數(shù)據(jù)統(tǒng)計(jì)及分析
分別統(tǒng)計(jì)滿載熱力分布均一性確認(rèn),統(tǒng)計(jì)結(jié)果如下。
105℃滿載溫度分布統(tǒng)計(jì)結(jié)果 單位:105℃
試驗(yàn)次數(shù) |
項(xiàng)目 |
熱電偶編號(hào) |
01 |
02 |
03 |
04 |
05 |
06 |
07 |
08 |
09 |
10 |
11 |
12 |
1 |
最大值 |
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最小值 |
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2 |
最大值 |
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最小值 |
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3 |
最大值 |
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最小值 |
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6.4 驗(yàn)證合格標(biāo)準(zhǔn)
6.4.1該設(shè)備在滿載及熱力分布溫度均一性能達(dá)到相應(yīng)的可接受標(biāo)準(zhǔn)。
6.5 變更與偏差處理
確認(rèn)過(guò)程中如果出現(xiàn)偏差或變更,應(yīng)立即通知質(zhì)保處,按照偏差處理程序或變更控制程序?qū)ζ涮幚?。所有偏差和變更按照相?yīng)規(guī)程得到有效處理后,確認(rèn)方可進(jìn)入下一步驟。原始的偏差表或變更表經(jīng)過(guò)批準(zhǔn)后,其復(fù)印件必須附在最終的確認(rèn)報(bào)告中。
確認(rèn)過(guò)程無(wú)變更與偏差。
評(píng)價(jià)結(jié)果:是否有偏差。
6.7 確認(rèn)結(jié)果評(píng)定與結(jié)論
驗(yàn)證工作小組組長(zhǎng)對(duì)確認(rèn)結(jié)果進(jìn)行綜合評(píng)審,做出確認(rèn)結(jié)論。驗(yàn)證領(lǐng)導(dǎo)小組組長(zhǎng)發(fā)放驗(yàn)證證書,對(duì)確認(rèn)結(jié)果的評(píng)審應(yīng)包括:
(1) 驗(yàn)證結(jié)果是否有遺漏?
驗(yàn)證結(jié)果無(wú)遺漏
(2) 驗(yàn)證過(guò)程中的偏差、變更是否關(guān)閉?
驗(yàn)證過(guò)程無(wú)偏差及變更
(3) 驗(yàn)證實(shí)施過(guò)程中對(duì)驗(yàn)證方案有無(wú)修改,修改原因、依據(jù)、是否經(jīng)過(guò)批準(zhǔn)?
驗(yàn)證實(shí)施過(guò)程對(duì)方案無(wú)修改
(4) 驗(yàn)證記錄是否完整?
驗(yàn)證記錄完整、真實(shí)
(5) 驗(yàn)證結(jié)果是否符合標(biāo)準(zhǔn)要求?
驗(yàn)證結(jié)果能夠達(dá)到驗(yàn)證合格標(biāo)準(zhǔn)。
附表1
序號(hào) |
儀器儀表名稱 |
型號(hào) |
編號(hào) |
范圍 |
校正日期 |
有效期 |
1 |
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2 |
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3 |
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4 |
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5 |
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6 |
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7 |
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8 |
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9 |
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10 |
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11 |
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12 |
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附表2:
設(shè)備運(yùn)行確認(rèn)表
項(xiàng)目 |
可接受標(biāo)準(zhǔn) |
結(jié)果 |
結(jié)論 |
設(shè)備情況 |
蒸汽滅菌柜內(nèi)外表面應(yīng)無(wú)腐蝕或破損。 |
|
|
位置 |
與四周、建筑物距離在0.20米以上有足夠的空間維護(hù)保養(yǎng) |
|
密封圈 |
上蓋密封圈應(yīng)完好無(wú)撕裂或老化現(xiàn)象 |
|
管路 |
管路應(yīng)密封無(wú)泄漏 |
|
檢查人 |
|
復(fù)核人 |
|
檢查日期 |
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附表3:
105℃滿載熱分布測(cè)試記錄(第1次)
設(shè)備編號(hào): 105℃
位置
時(shí)間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
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測(cè)試人 復(fù)核人: 日期:
再驗(yàn)證方案審查結(jié)論
方案名稱:
蒸汽滅菌柜再驗(yàn)證方案
審查結(jié)果:經(jīng)驗(yàn)證領(lǐng)導(dǎo)小組討論認(rèn)為該方案設(shè)計(jì)合理,能夠達(dá)到驗(yàn)證目的。
批準(zhǔn)執(zhí)行。
驗(yàn)證小組:
批準(zhǔn)人:
批準(zhǔn)日期: 年 月 日
再驗(yàn)證實(shí)施計(jì)劃書
題目 |
蒸汽滅菌柜再驗(yàn)證方案 |
目的/概要 |
檢查并驗(yàn)證設(shè)備運(yùn)行及性能符合生產(chǎn)工藝要求,符合GMP規(guī)定。 |
預(yù)期結(jié)果 |
設(shè)備的運(yùn)行及性能符合GMP要求,滿足工藝生產(chǎn)要求。 |
驗(yàn)證方法 |
按規(guī)范、生產(chǎn)技術(shù)資料、標(biāo)準(zhǔn)生產(chǎn)操作規(guī)程、技術(shù)要求檢測(cè)各項(xiàng)性能。 |
計(jì)劃實(shí)施時(shí)間 |
2013年10月 |
負(fù)責(zé)者(部門) |
驗(yàn)證小組 |
變更記錄(改定者、改定日、變更事項(xiàng)、理由) |
|
責(zé)任者 |
驗(yàn)證小組組長(zhǎng) |
完成人 |
|
|
|
沈陽(yáng)同聯(lián)藥業(yè)有限公司
文件名稱 |
蒸汽滅菌柜再驗(yàn)證報(bào)告(1) |
編 號(hào) |
SYZ-B-03-028-01 |
編制依據(jù) |
設(shè)備驗(yàn)證管理制度(YZ01-002) |
共14 頁(yè) |
編 制 人 |
|
審 核 人 |
|
批 準(zhǔn) 人 |
|
編制日期 |
年 月 日 |
審核日期 |
年 月 日 |
批準(zhǔn)日期 |
年 月 日 |
頒發(fā)部門 |
設(shè)備處 |
生效日期 |
|
1、概述
蒸汽滅菌柜(YXQ-WF22)位于口服液滅菌室,生產(chǎn)廠家長(zhǎng)春市醫(yī)用設(shè)備廠。本次蒸汽滅菌柜的驗(yàn)證為再驗(yàn)證。采用同步驗(yàn)證的方式進(jìn)行,對(duì)連續(xù)三批耆鹿逐痹口服液的藥液配制生產(chǎn),對(duì)蒸汽滅菌柜進(jìn)行驗(yàn)證。本次驗(yàn)證不再進(jìn)行設(shè)計(jì)驗(yàn)證(DQ)及安裝驗(yàn)證(IQ)。本方案的制定依據(jù)蒸汽滅菌柜(120406-02-02)標(biāo)準(zhǔn)操作規(guī)程進(jìn)行制定。
由于該設(shè)備一直處于良好的運(yùn)行狀態(tài),本次確認(rèn)是在繼上次確認(rèn)結(jié)束后,無(wú)任何偏差、變更情況下對(duì)設(shè)備性能進(jìn)行的再確認(rèn),故在滅菌效果確認(rèn)時(shí),無(wú)需考察空載狀態(tài),如滿載及熱力分布溫度分布均一性能夠達(dá)到驗(yàn)證可接受標(biāo)準(zhǔn),即可證明設(shè)備性能穩(wěn)定。
2、驗(yàn)證目的:
本再驗(yàn)證方案的目的是以文件形式證明口服液生產(chǎn)用蒸汽滅菌柜和它的附件系統(tǒng)能夠按照預(yù)定運(yùn)行范圍運(yùn)行,在預(yù)先設(shè)定好的范圍內(nèi)生產(chǎn)產(chǎn)品。
3、驗(yàn)證范圍:
口服液生產(chǎn)用蒸汽滅菌柜
4、驗(yàn)證小組職責(zé)
驗(yàn)證小組成員 |
部門及職位 |
職 責(zé) |
組長(zhǎng) |
蘇振波 |
設(shè)備處處長(zhǎng) |
負(fù)責(zé)再驗(yàn)證方案驗(yàn)證報(bào)告的審批 |
組員 |
孫忠輝 |
機(jī)修車間主任 |
負(fù)責(zé)擬定方案,實(shí)施驗(yàn)證,完成驗(yàn)證報(bào)告。 |
沈偉 |
設(shè)備員 |
負(fù)責(zé)方案的實(shí)施驗(yàn)證。 |
張若萍 |
計(jì)量室主任 |
負(fù)責(zé)儀器、儀表、器具等的校正。 |
包君 |
質(zhì)保處 |
參與和協(xié)調(diào)驗(yàn)證工作。 |
袁玉敏 |
QA |
生產(chǎn)現(xiàn)場(chǎng)監(jiān)督員 |
孫桂菊 |
二車間主任 |
監(jiān)督驗(yàn)證的實(shí)施 |
高云峰 |
生產(chǎn)技術(shù)員 |
參與驗(yàn)證實(shí)施過(guò)程。 |
李麗華 |
質(zhì)量部部長(zhǎng) |
驗(yàn)證方案及驗(yàn)證報(bào)告的批準(zhǔn) |
鞠濤 |
總工程師 |
驗(yàn)證方案及驗(yàn)證報(bào)告的批準(zhǔn)、發(fā)放驗(yàn)證證書、驗(yàn)證再驗(yàn)證周期 |
魏影 |
總經(jīng)理 |
簽發(fā)驗(yàn)證證書 |
5、驗(yàn)證正文
5.1驗(yàn)證過(guò)程中使用的儀器儀表校驗(yàn)情況
本次所用計(jì)量器具及儀表等校驗(yàn)情況。見(jiàn)附表1
5.2 運(yùn)行確認(rèn)
按蒸汽滅菌柜操作規(guī)程要求運(yùn)行,對(duì)蒸汽滅菌柜的各項(xiàng)功能進(jìn)行檢查。具體檢查項(xiàng)如下:
1)對(duì)設(shè)備外觀進(jìn)行檢查,蒸汽滅菌柜內(nèi)外表面應(yīng)無(wú)腐蝕或破損。
2)與四周、建筑物距離在0.20米以上有足夠的空間維護(hù)保養(yǎng)。
3)上蓋密封圈應(yīng)完好無(wú)撕裂或老化現(xiàn)象。
4)管路應(yīng)密封無(wú)泄漏。見(jiàn)附表2
5.3性能確認(rèn)
5.3.1熱電偶放置方式的確認(rèn)
將12支熱電偶放到滅菌鍋內(nèi)不同位置,測(cè)溫點(diǎn)不得接觸金屬表面和其它表面,具體放置位置見(jiàn)如下示意圖:
5.3.2觀察無(wú)紙記錄儀記錄運(yùn)行溫度
取樣點(diǎn)及溫度探頭位置圖示:

圖一
取樣點(diǎn)分層 |
取樣點(diǎn)位置 |
熱電偶編號(hào) |
取樣點(diǎn)位置 |
熱電偶編號(hào) |
取樣點(diǎn)位置 |
熱電偶編號(hào) |
1 |
01 |
2 |
02 |
3 |
03 |
4 |
04 |
5 |
05 |
4 |
06 |
7 |
07 |
8 |
08 |
9 |
09 |
10 |
10 |
11 |
11 |
12 |
12 |
滿載及熱力分布取樣點(diǎn)編號(hào)見(jiàn)附表1
5.3.2熱力分布溫度分布均一性確認(rèn)
熱力分布溫度均一性確認(rèn)在滿載狀態(tài)下進(jìn)行,將溫度驗(yàn)證儀探頭放在被滅菌的物品內(nèi)部,以考察滅菌效果。該項(xiàng)確認(rèn)同樣在105℃/30min每個(gè)工藝參數(shù)條件下連續(xù)進(jìn)行三次。
可接受標(biāo)準(zhǔn):各測(cè)試點(diǎn)溫度與設(shè)定值溫差≤2℃
各測(cè)試點(diǎn)溫度范圍103—107℃;
6.3 數(shù)據(jù)統(tǒng)計(jì)及分析
分別統(tǒng)計(jì)滿載熱力分布均一性確認(rèn),統(tǒng)計(jì)結(jié)果如下。
105℃滿載溫度分布統(tǒng)計(jì)結(jié)果 單位:105℃
試驗(yàn)次數(shù) |
項(xiàng)目 |
熱電偶編號(hào) |
01 |
02 |
03 |
04 |
05 |
06 |
07 |
08 |
09 |
10 |
11 |
12 |
1 |
最大值 |
106.8 |
105.6 |
106.2 |
106.7 |
106.5 |
105.6 |
106.5 |
106.6 |
106.5 |
105.5 |
105.4 |
106.7 |
最小值 |
105.0 |
105.0 |
105.0 |
105.1 |
104.9 |
105.0 |
105.0 |
105.1 |
105.2 |
105.0 |
104.7 |
105.0 |
2 |
最大值 |
106.8 |
105.7 |
106.4 |
106.7 |
106.8 |
105.7 |
106.5 |
106.6 |
106.5 |
105.8 |
105.6 |
106.7 |
最小值 |
105.2 |
105.1 |
105.0 |
105.1 |
104.9 |
105.0 |
104.8 |
105.1 |
105.2 |
104.8 |
104.5 |
104.8 |
3 |
最大值 |
106.8 |
105.8 |
106.3 |
106.7 |
106.8 |
106.2 |
106.5 |
106.5 |
106.5 |
105.8 |
105.6 |
106.7 |
最小值 |
105.2 |
105.1 |
105.0 |
105.1 |
104.9 |
105.0 |
104.9 |
105.0 |
105.2 |
104.8 |
104.2 |
105.0 |
6.4 驗(yàn)證合格標(biāo)準(zhǔn)
6.4.1該設(shè)備在滿載及熱力分布溫度均一性能達(dá)到相應(yīng)的可接受標(biāo)準(zhǔn)。
6.5 變更與偏差處理
確認(rèn)過(guò)程中如果出現(xiàn)偏差或變更,應(yīng)立即通知質(zhì)保處,按照偏差處理程序或變更控制程序?qū)ζ涮幚?。所有偏差和變更按照相?yīng)規(guī)程得到有效處理后,確認(rèn)方可進(jìn)入下一步驟。原始的偏差表或變更表經(jīng)過(guò)批準(zhǔn)后,其復(fù)印件必須附在最終的確認(rèn)報(bào)告中。
確認(rèn)過(guò)程無(wú)變更與偏差。
評(píng)價(jià)結(jié)果:__________________。
6.7 確認(rèn)結(jié)果評(píng)定與結(jié)論
驗(yàn)證工作小組組長(zhǎng)對(duì)確認(rèn)結(jié)果進(jìn)行綜合評(píng)審,做出確認(rèn)結(jié)論。驗(yàn)證領(lǐng)導(dǎo)小組組長(zhǎng)發(fā)放驗(yàn)證證書,對(duì)確認(rèn)結(jié)果的評(píng)審應(yīng)包括:
(1) 驗(yàn)證結(jié)果是否有遺漏?
驗(yàn)證結(jié)果: __________________。
(2) 驗(yàn)證過(guò)程中的偏差、變更是否關(guān)閉?
驗(yàn)證過(guò)程: __________________。
(3) 驗(yàn)證實(shí)施過(guò)程中對(duì)驗(yàn)證方案有無(wú)修改,修改原因、依據(jù)、是否經(jīng)過(guò)批準(zhǔn)?
驗(yàn)證實(shí)施過(guò)程: __________________。
(4) 驗(yàn)證記錄是否完整?
驗(yàn)證記錄完整、真實(shí)
(5) 驗(yàn)證結(jié)果是否符合標(biāo)準(zhǔn)要求?
驗(yàn)證結(jié)果能夠達(dá)到驗(yàn)證合格標(biāo)準(zhǔn)。
附表1
序號(hào) |
儀器儀表名稱 |
型號(hào) |
編號(hào) |
范圍 |
校正日期 |
有效期 |
1 |
熱電偶 |
HSB-600R |
TI10-15-1-1 |
0~300℃ |
2013-03-26 |
一年 |
2 |
熱電偶 |
HSB-600R |
TI10-15-1-2 |
0~300℃ |
2013-03-26 |
一年 |
3 |
熱電偶 |
HSB-600R |
TI10-15-1-3 |
0~300℃ |
2013-03-26 |
一年 |
4 |
熱電偶 |
HSB-600R |
TI10-15-1-4 |
0~300℃ |
2013-03-26 |
一年 |
5 |
熱電偶 |
HSB-600R |
TI10-15-1-5 |
0~300℃ |
2013-03-26 |
一年 |
6 |
熱電偶 |
HSB-600R |
TI10-15-1-6 |
0~300℃ |
2013-03-26 |
一年 |
7 |
熱電偶 |
HSB-600R |
TI10-15-1-7 |
0~300℃ |
2013-03-26 |
一年 |
8 |
熱電偶 |
HSB-600R |
TI10-15-1-8 |
0~300℃ |
2013-03-26 |
一年 |
9 |
熱電偶 |
HSB-600R |
TI10-15-1-9 |
0~300℃ |
2013-03-26 |
一年 |
10 |
熱電偶 |
HSB-600R |
TI10-15-1-10 |
0~300℃ |
2013-03-26 |
一年 |
11 |
熱電偶 |
HSB-600R |
TI10-15-1-11 |
0~300℃ |
2013-03-26 |
一年 |
12 |
熱電偶 |
HSB-600R |
TI10-15-1-12 |
0~300℃ |
2013-03-26 |
一年 |
附表2:
設(shè)備運(yùn)行確認(rèn)表
項(xiàng)目 |
可接受標(biāo)準(zhǔn) |
結(jié)果 |
結(jié)論 |
設(shè)備情況 |
蒸汽滅菌柜內(nèi)外表面應(yīng)無(wú)腐蝕或破損。 |
|
|
位置 |
與四周、建筑物距離在0.20米以上有足夠的空間維護(hù)保養(yǎng) |
|
密封圈 |
上蓋密封圈應(yīng)完好無(wú)撕裂或老化現(xiàn)象 |
|
管路 |
管路應(yīng)密封無(wú)泄漏 |
|
檢查人 |
|
復(fù)核人 |
|
檢查日期 |
|
|
|
|
|
|
|
附表3:
105℃滿載熱分布測(cè)試記錄(第1次)
設(shè)備編號(hào):120406-02-01
溫度:105℃
位置
時(shí)間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-10 17:12 |
105.0 |
105.3 |
105.0 |
105.1 |
105.2 |
105.2 |
105.1 |
105.2 |
106.1 |
105.3 |
104.9 |
105.1 |
1.2 |
2013-10-10 17:13 |
105.1 |
105.2 |
105.2 |
105.1 |
105.4 |
105.1 |
105.2 |
105.3 |
105.5 |
105.2 |
104.8 |
105.0 |
0.7 |
2013-10-10 17:14 |
105.3 |
105.4 |
105.2 |
105.3 |
105.6 |
105.2 |
105.3 |
105.2 |
106.2 |
105.4 |
105.2 |
105.1 |
1.1 |
2013-10-10 17:15 |
106.2 |
105.2 |
105.0 |
105.4 |
105.3 |
105.3 |
105.1 |
105.4 |
106.4 |
105.2 |
105.2 |
105.4 |
1.4 |
2013-10-10 17:16 |
106.5 |
105.4 |
105.3 |
105.2 |
105.2 |
105.2 |
105.4 |
105.2 |
106.5 |
105.4 |
105.3 |
105.2 |
1.3 |
2013-10-10 17:17 |
105.3 |
105.3 |
105.2 |
105.3 |
105.1 |
105.1 |
105.5 |
105.6 |
106.4 |
105.3 |
105.4 |
105.3 |
1.3 |
2013-10-10 17:18 |
106.5 |
105.2 |
105.1 |
105.6 |
105.4 |
105.4 |
105.2 |
105.5 |
106.5 |
105.2 |
105.2 |
105.2 |
1.4 |
2013-10-10 17:19 |
106.4 |
105.4 |
105.0 |
105.4 |
105.5 |
105.4 |
105.5 |
105.2 |
105.2 |
105.4 |
105.3 |
105.1 |
1.4 |
2013-10-10 17:20 |
106.8 |
105.0 |
106.1 |
105.3 |
105.2 |
105.0 |
105.2 |
105.4 |
106.3 |
105.0 |
105.2 |
105.2 |
1.8 |
2013-10-10 17:21 |
105.5 |
105.2 |
106.2 |
105.2 |
106.2 |
105.1 |
105.4 |
105.2 |
106.5 |
105.2 |
105.2 |
106.7 |
1.6 |
2013-10-10 17:22 |
105.2 |
105.1 |
105.7 |
105.2 |
106.0 |
105.4 |
105.3 |
105.2 |
106.4 |
105.1 |
105.4 |
106.3 |
1.3 |
2013-10-10 17:23 |
105.2 |
105.3 |
105.4 |
105.2 |
105.4 |
105.5 |
105.2 |
105.3 |
105.5 |
105.3 |
105.2 |
106.4 |
1.2 |
2013-10-10 17:24 |
105.3 |
105.2 |
105.1 |
105.3 |
105.2 |
105.6 |
105.2 |
105.2 |
105.6 |
105.2 |
105.1 |
106.0 |
0.9 |
2013-10-10 17:25 |
105.2 |
105.4 |
105.2 |
106.7 |
105.2 |
105.4 |
105.4 |
105.4 |
105.4 |
105.4 |
105.1 |
105.8 |
1.6 |
2013-10-10 17:26 |
105.4 |
105.1 |
105.3 |
106.2 |
105.5 |
105.5 |
105.0 |
105.4 |
105.5 |
105.1 |
105.2 |
106.3 |
1.3 |
2013-10-10 17:27 |
105.6 |
105.2 |
105.2 |
106.1 |
105.2 |
105.2 |
105.4 |
105.2 |
105.2 |
105.2 |
105.3 |
105.4 |
0.9 |
2013-10-10 17:28 |
105.7 |
105.3 |
106.2 |
105.7 |
105.2 |
105.2 |
105.2 |
105.1 |
105.2 |
105.3 |
105.2 |
105.2 |
1.1 |
2013-10-10 17:29 |
105.2 |
105.4 |
105.2 |
105.2 |
106.2 |
105.3 |
105.2 |
105.2 |
105.3 |
105.4 |
105.3 |
105.2 |
1.0 |
2013-10-10 17:30 |
105.4 |
105.2 |
105.3 |
105.4 |
105.0 |
105.2 |
105.3 |
105.3 |
105.2 |
105.2 |
105.2 |
105.1 |
0.4 |
2013-10-10 17:31 |
105.3 |
105.6 |
105.2 |
105.3 |
104.9 |
105.4 |
105.2 |
106.5 |
105.4 |
105.5 |
105.2 |
105.2 |
1.6 |
2013-10-10 17:32 |
106.4 |
105.2 |
105.4 |
105.2 |
105.6 |
105.2 |
105.4 |
106.4 |
105.2 |
105.2 |
105.1 |
105.2 |
1.3 |
2013-10-10 17:33 |
106.6 |
105.1 |
105.3 |
105.4 |
105.4 |
105.4 |
105.2 |
106.6 |
105.4 |
105.1 |
104.8 |
105.3 |
1.8 |
2013-10-10 17:34 |
106.7 |
105.2 |
105.2 |
105.6 |
105.7 |
105.2 |
105.2 |
105.2 |
105.2 |
105.2 |
104.7 |
105.2 |
2.0 |
2013-10-10 17:35 |
105.2 |
105.2 |
105.2 |
105.2 |
105.8 |
105.3 |
105.3 |
105.3 |
105.3 |
105.2 |
105.4 |
106.5 |
1.3 |
2013-10-10 17:36 |
105.4 |
105.3 |
105.1 |
105.4 |
106.5 |
105.4 |
105.2 |
105.2 |
105.4 |
105.3 |
105.4 |
105.4 |
1.4 |
2013-10-10 17:37 |
105.3 |
105.2 |
105.4 |
105.3 |
106.4 |
105.6 |
105.4 |
106.5 |
105.7 |
105.2 |
105.2 |
105.2 |
1.3 |
2013-10-10 17:38 |
105.2 |
105.0 |
106.2 |
105.2 |
105.8 |
105.2 |
105.4 |
105.1 |
105.2 |
105.0 |
105.4 |
105.6 |
1.2 |
2013-10-10 17:39 |
105.0 |
105.4 |
105.2 |
105.1 |
105.4 |
105.3 |
106.3 |
105.4 |
105.3 |
105.4 |
105.3 |
105.4 |
1.3 |
2013-10-10 17:40 |
105.1 |
105.2 |
105.1 |
105.1 |
105.2 |
105.2 |
106.5 |
105.4 |
105.2 |
105.2 |
105.2 |
105.5 |
1.4 |
2013-10-10 17:41 |
105.3 |
105.3 |
105.2 |
105.3 |
105.3 |
105.4 |
106.4 |
105.2 |
105.4 |
105.3 |
105.4 |
105.2 |
1.2 |
2013-10-10 17:42 |
105.4 |
105.2 |
105.3 |
105.4 |
105.2 |
105.2 |
106.2 |
105.2 |
105.2 |
105.2 |
105.2 |
105.4 |
1.0 |
最大值 |
106.8 |
105.6 |
106.2 |
106.7 |
106.5 |
105.6 |
106.5 |
106.6 |
106.5 |
105.5 |
105.4 |
106.7 |
— |
最小值 |
105.0 |
105.0 |
105.0 |
105.1 |
104.9 |
105.0 |
105.0 |
105.1 |
105.2 |
105.0 |
104.7 |
105.0 |
— |
測(cè)試人 復(fù)核人: 日期:
105℃滿載熱分布測(cè)試記錄(第2次)
設(shè)備編號(hào):120406-02-01
溫度:℃
位置
時(shí)間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-11 17:12 |
105.4 |
105.7 |
105.4 |
105.7 |
105.2 |
105.3 |
105.1 |
105.2 |
105.8 |
105.2 |
104.9 |
105.2 |
0.9 |
2013-10-11 17:13 |
105.4 |
105.3 |
105.2 |
105.1 |
105.4 |
105.1 |
105.2 |
105.3 |
105.5 |
105.2 |
104.8 |
105.0 |
0.7 |
2013-10-11 17:14 |
105.2 |
105.4 |
105.2 |
106.0 |
105.6 |
105.2 |
105.3 |
105.2 |
106.2 |
105.4 |
105.2 |
105.1 |
1.1 |
2013-10-11 17:15 |
106.2 |
105.3 |
105.0 |
106.2 |
105.3 |
105.3 |
105.1 |
105.4 |
106.4 |
105.2 |
105.2 |
105.4 |
1.4 |
2013-10-11 17:16 |
106.5 |
105.4 |
105.3 |
105.2 |
105.2 |
105.2 |
105.4 |
105.2 |
106.5 |
105.4 |
105.3 |
105.2 |
1.3 |
2013-10-11 17:17 |
106.2 |
105.5 |
105.2 |
106.4 |
105.1 |
105.0 |
105.5 |
105.6 |
106.4 |
105.3 |
105.4 |
105.3 |
1.4 |
2013-10-11 17:18 |
106.5 |
105.2 |
105.4 |
105.6 |
105.4 |
105.4 |
105.2 |
105.5 |
106.5 |
105.1 |
105.2 |
105.2 |
1.4 |
2013-10-11 17:19 |
106.4 |
105.4 |
105.0 |
106.1 |
105.5 |
105.4 |
105.5 |
105.2 |
105.2 |
105.3 |
105.5 |
105.1 |
1.4 |
2013-10-11 17:20 |
106.8 |
105.2 |
106.1 |
106.2 |
105.2 |
105.0 |
105.2 |
105.4 |
106.3 |
105.1 |
105.2 |
105.2 |
1.8 |
2013-10-11 17:21 |
106.4 |
105.2 |
106.2 |
105.8 |
106.2 |
105.1 |
105.4 |
105.2 |
106.5 |
105.2 |
105.2 |
106.7 |
1.6 |
2013-10-11 17:22 |
106.3 |
105.2 |
105.2 |
105.3 |
106.0 |
105.4 |
105.3 |
105.6 |
106.4 |
105.1 |
105.4 |
106.3 |
1.3 |
2013-10-11 17:23 |
106.0 |
105.3 |
105.4 |
105.6 |
105.4 |
105.5 |
105.2 |
105.3 |
106.2 |
105.4 |
105.2 |
106.4 |
1.2 |
2013-10-11 17:24 |
105.9 |
105.5 |
105.5 |
105.4 |
105.2 |
105.7 |
105.2 |
105.2 |
106.1 |
105.2 |
105.1 |
106.0 |
1.0 |
2013-10-11 17:25 |
105.8 |
105.3 |
105.2 |
106.7 |
106.4 |
105.4 |
105.4 |
105.5 |
105.4 |
105.4 |
104.7 |
105.8 |
2.0 |
2013-10-11 17:26 |
105.7 |
105.4 |
105.4 |
106.2 |
106.8 |
105.5 |
104.8 |
105.4 |
105.5 |
105.1 |
104.8 |
106.3 |
2.0 |
2013-10-11 17:27 |
105.4 |
105.2 |
106.4 |
106.1 |
105.3 |
105.2 |
105.4 |
105.2 |
105.2 |
105.2 |
105.3 |
105.4 |
1.2 |
2013-10-11 17:28 |
105.4 |
105.3 |
106.2 |
105.7 |
105.2 |
105.2 |
105.1 |
105.1 |
105.2 |
105.8 |
105.6 |
105.2 |
1.1 |
2013-10-11 17:29 |
105.3 |
105.6 |
105.2 |
105.9 |
106.2 |
105.3 |
105.3 |
105.2 |
105.3 |
105.4 |
105.3 |
105.2 |
1.0 |
2013-10-11 17:30 |
105.6 |
105.2 |
105.3 |
105.4 |
106.5 |
105.2 |
105.5 |
105.3 |
105.2 |
105.2 |
105.2 |
104.9 |
1.6 |
2013-10-11 17:31 |
105.8 |
105.6 |
105.2 |
105.3 |
104.9 |
105.4 |
105.2 |
106.5 |
105.4 |
105.5 |
105.2 |
104.8 |
1.7 |
2013-10-11 17:32 |
106.4 |
105.2 |
105.8 |
105.8 |
105.6 |
105.2 |
105.4 |
106.4 |
105.2 |
105.2 |
105.1 |
105.2 |
1.3 |
2013-10-11 17:33 |
106.2 |
105.4 |
105.4 |
106.5 |
105.4 |
105.4 |
105.3 |
106.6 |
105.4 |
105.1 |
104.8 |
105.0 |
1.8 |
2013-10-11 17:34 |
106.6 |
105.2 |
105.2 |
105.6 |
105.7 |
105.2 |
105.2 |
105.2 |
105.2 |
105.2 |
104.5 |
105.2 |
2.1 |
2013-10-11 17:35 |
105.7 |
105.3 |
105.6 |
105.2 |
105.8 |
105.5 |
105.3 |
105.3 |
105.3 |
105.2 |
105.4 |
106.5 |
1.3 |
2013-10-11 17:36 |
105.8 |
105.3 |
105.1 |
105.4 |
106.5 |
105.4 |
105.2 |
105.2 |
105.4 |
105.3 |
105.4 |
105.4 |
1.4 |
2013-10-11 17:37 |
105.3 |
105.2 |
105.4 |
105.3 |
106.4 |
105.6 |
105.4 |
106.5 |
105.7 |
105.2 |
105.2 |
105.2 |
1.3 |
2013-10-11 17:38 |
105.4 |
105.1 |
106.2 |
105.2 |
105.8 |
105.2 |
105.4 |
105.1 |
105.2 |
104.8 |
104.6 |
105.2 |
1.6 |
2013-10-11 17:39 |
105.5 |
105.4 |
105.2 |
105.1 |
106.7 |
105.3 |
106.3 |
105.4 |
105.3 |
105.4 |
105.3 |
105.4 |
1.6 |
2013-10-11 17:40 |
105.6 |
105.4 |
106.2 |
105.1 |
105.2 |
105.2 |
106.5 |
105.4 |
105.2 |
105.2 |
104.9 |
105.5 |
1.6 |
2013-10-11 17:41 |
105.3 |
105.3 |
106.2 |
105.3 |
105.3 |
105.4 |
106.4 |
105.2 |
105.4 |
105.3 |
105.4 |
105.2 |
1.2 |
2013-10-11 17:42 |
105.6 |
105.6 |
105.3 |
105.4 |
105.2 |
105.2 |
106.2 |
105.2 |
105.2 |
105.2 |
105.2 |
105.4 |
1.0 |
最大值 |
106.8 |
105.7 |
106.4 |
106.7 |
106.8 |
105.7 |
106.5 |
106.6 |
106.5 |
105.8 |
105.6 |
106.7 |
— |
最小值 |
105.2 |
105.1 |
105.0 |
105.1 |
104.9 |
105.0 |
104.8 |
105.1 |
105.2 |
104.8 |
104.5 |
104.8 |
— |
測(cè)試人 復(fù)核人 日期:
105℃滿載熱分布測(cè)試記錄(第3次)
設(shè)備編號(hào):120406-02-01 溫度:105℃
位置
時(shí)間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-12 17:12 |
105.4 |
105.7 |
105.4 |
105.7 |
105.2 |
105.3 |
105.1 |
105.2 |
105.8 |
105.2 |
104.9 |
105.2 |
0.9 |
2013-10-12 17:13 |
105.4 |
105.3 |
105.2 |
105.1 |
105.4 |
105.1 |
105.2 |
105.3 |
105.5 |
105.2 |
104.8 |
105.0 |
0.7 |
2013-10-12 17:14 |
105.3 |
105.4 |
105.2 |
106.0 |
105.6 |
105.2 |
105.3 |
105.2 |
106.2 |
105.4 |
105.2 |
105.1 |
1.1 |
2013-10-12 17:15 |
106.1 |
105.3 |
105.0 |
106.2 |
105.3 |
105.3 |
105.1 |
105.4 |
106.4 |
105.2 |
105.2 |
105.4 |
1.4 |
2013-10-12 17:16 |
106.2 |
105.4 |
105.3 |
105.2 |
105.2 |
105.2 |
105.4 |
105.0 |
106.5 |
105.4 |
105.3 |
105.2 |
1.5 |
2013-10-12 17:17 |
106.5 |
105.5 |
105.2 |
106.4 |
105.1 |
105.0 |
105.5 |
105.6 |
106.4 |
105.3 |
104.6 |
105.3 |
1.9 |
2013-10-12 17:18 |
106.3 |
105.2 |
105.4 |
105.6 |
105.4 |
105.4 |
105.2 |
105.5 |
106.5 |
105.1 |
104.8 |
105.2 |
1.7 |
2013-10-12 17:19 |
105.8 |
105.4 |
105.2 |
106.2 |
105.5 |
105.4 |
105.5 |
105.6 |
105.2 |
105.3 |
104.2 |
105.1 |
2.0 |
2013-10-12 17:20 |
106.8 |
105.4 |
106.1 |
106.5 |
105.2 |
105.0 |
105.2 |
105.2 |
106.3 |
105.1 |
105.1 |
105.2 |
1.8 |
2013-10-12 17:21 |
106.4 |
105.3 |
106.2 |
105.7 |
106.2 |
105.1 |
105.4 |
105.2 |
106.5 |
105.2 |
104.9 |
106.7 |
1.8 |
2013-10-12 17:22 |
106.2 |
105.2 |
105.2 |
105.3 |
106.0 |
105.4 |
105.3 |
105.3 |
106.4 |
105.1 |
105.1 |
105.3 |
1.3 |
2013-10-12 17:23 |
106.1 |
105.5 |
105.4 |
105.6 |
105.4 |
105.5 |
105.2 |
105.4 |
106.2 |
105.4 |
105.2 |
106.4 |
1.2 |
2013-10-12 17:24 |
105.7 |
105.2 |
105.5 |
105.4 |
105.2 |
105.7 |
105.2 |
105.2 |
106.1 |
105.2 |
105.1 |
106.0 |
1.0 |
2013-10-12 17:25 |
105.8 |
105.6 |
105.2 |
106.7 |
106.4 |
105.4 |
105.1 |
105.8 |
105.4 |
105.4 |
104.7 |
106.4 |
2.0 |
2013-10-12 17:26 |
105.6 |
105.4 |
105.4 |
106.2 |
106.8 |
105.6 |
104.9 |
105.4 |
105.4 |
105.1 |
104.8 |
106.3 |
2.0 |
2013-10-12 17:27 |
105.3 |
105.1 |
106.3 |
106.1 |
105.3 |
105.2 |
105.3 |
105.6 |
105.2 |
105.2 |
105.3 |
105.6 |
1.2 |
2013-10-12 17:28 |
105.4 |
105.3 |
106.2 |
105.7 |
105.2 |
105.3 |
105.4 |
105.4 |
105.3 |
105.8 |
105.6 |
105.4 |
1.0 |
2013-10-12 17:29 |
105.3 |
105.6 |
105.2 |
105.9 |
106.2 |
105.8 |
105.3 |
105.8 |
105.3 |
105.4 |
104.6 |
106.1 |
1.6 |
2013-10-12 17:30 |
105.8 |
105.6 |
105.3 |
105.4 |
106.5 |
106.0 |
105.2 |
105.3 |
105.2 |
105.2 |
104.8 |
106.2 |
1.7 |
2013-10-12 17:31 |
105.4 |
105.6 |
105.2 |
105.3 |
104.9 |
106.2 |
105.6 |
106.5 |
105.4 |
105.5 |
105.2 |
105.3 |
1.6 |
2013-10-12 17:32 |
106.5 |
105.5 |
105.8 |
105.8 |
105.6 |
105.8 |
105.4 |
106.2 |
105.4 |
105.2 |
105.1 |
105.4 |
1.4 |
2013-10-12 17:33 |
106.2 |
105.4 |
105.4 |
106.5 |
105.4 |
105.5 |
105.3 |
106.3 |
105.4 |
105.1 |
104.8 |
105.5 |
1.7 |
2013-10-12 17:34 |
106.6 |
105.3 |
105.2 |
105.6 |
105.7 |
105.4 |
105.2 |
105.8 |
105.2 |
105.2 |
104.5 |
105.6 |
2.1 |
2013-10-12 17:35 |
105.2 |
105.3 |
105.6 |
105.3 |
105.8 |
105.5 |
105.2 |
105.7 |
105.8 |
105.2 |
105.4 |
105.7 |
0.6 |
2013-10-12 17:36 |
105.2 |
105.4 |
105.1 |
105.2 |
106.5 |
105.4 |
105.4 |
105.2 |
105.4 |
105.3 |
105.4 |
105.2 |
1.4 |
2013-10-12 17:37 |
105.3 |
105.3 |
105.4 |
105.4 |
106.4 |
105.6 |
105.2 |
106.5 |
105.7 |
105.2 |
105.2 |
105.8 |
1.3 |
2013-10-12 17:38 |
105.4 |
105.5 |
106.2 |
105.2 |
105.8 |
105.2 |
105.6 |
105.6 |
105.2 |
104.8 |
104.6 |
105.2 |
1.6 |
2013-10-12 17:39 |
105.4 |
105.6 |
105.2 |
105.6 |
106.7 |
105.3 |
106.1 |
105.4 |
105.4 |
105.4 |
105.3 |
105.4 |
1.5 |
2013-10-12 17:40 |
105.3 |
105.8 |
106.2 |
105.4 |
105.2 |
105.2 |
106.5 |
105.4 |
105.2 |
105.2 |
104.9 |
105.6 |
1.6 |
2013-10-12 17:41 |
105.4 |
105.6 |
106.2 |
105.3 |
105.3 |
105.4 |
106.4 |
105.2 |
105.6 |
105.3 |
105.4 |
105.2 |
1.2 |
2013-10-12 17:42 |
105.6 |
105.6 |
105.3 |
105.4 |
105.2 |
105.2 |
106.2 |
105.3 |
105.2 |
105.2 |
105.2 |
105.4 |
1.0 |
最大值 |
106.8 |
105.8 |
106.3 |
106.7 |
106.8 |
106.2 |
106.5 |
106.5 |
106.5 |
105.8 |
105.6 |
106.7 |
— |
最小值 |
105.2 |
105.1 |
105.0 |
105.1 |
104.9 |
105.0 |
104.9 |
105.0 |
105.2 |
104.8 |
104.2 |
105.0 |
— |
測(cè)試人 復(fù)核人 日期:
驗(yàn)證結(jié)果報(bào)告書
題目 |
蒸汽滅菌柜驗(yàn)證 |
目的/概要 |
檢查并確認(rèn)蒸汽滅菌柜文件資料齊全,性能適應(yīng)生產(chǎn)工藝要求,符合GMP要求。 |
評(píng)定結(jié)論 |
證實(shí)蒸汽滅菌柜滿足生產(chǎn)工藝要求,符合GMP要求。 |
驗(yàn)證實(shí)施時(shí)間 |
2013年10月 |
負(fù)責(zé)者(部門) |
驗(yàn)證小組 |
變更記錄(改定者、改定日、變更事項(xiàng)、理由) |
|
責(zé)任者 |
驗(yàn)證小組組長(zhǎng) |
完成人 |
|
|
|
驗(yàn)證工作領(lǐng)導(dǎo)小組確認(rèn) |
|
驗(yàn) 證 證 書
茲證明
蒸汽滅菌柜
經(jīng)過(guò)驗(yàn)證后,符合要求,準(zhǔn)予投入生產(chǎn)使用。
驗(yàn)證文件編號(hào) |
SYZ-03-028-01 |
頒發(fā)部門 |
驗(yàn)證工作領(lǐng)導(dǎo)小組 |
驗(yàn)證部門 |
設(shè)備處 |
簽發(fā)人 |
|
簽發(fā)日期 |
年 月 日 |
批準(zhǔn)人 |
|
有效期 |
個(gè)月 |
沈陽(yáng)同聯(lián)藥業(yè)有限公司
文件名稱 |
蒸汽滅菌柜再驗(yàn)證報(bào)告(2) |
編 號(hào) |
SYZ-B-03-028-02 |
編制依據(jù) |
設(shè)備驗(yàn)證管理制度(YZ01-002) |
共14頁(yè) |
編 制 人 |
|
審 核 人 |
|
批 準(zhǔn) 人 |
|
編制日期 |
年 月 日 |
審核日期 |
年 月 日 |
批準(zhǔn)日期 |
年 月 日 |
頒發(fā)部門 |
設(shè)備處 |
生效日期 |
|
1、概述
蒸汽滅菌柜(YXQ-WF22)位于口服液滅菌室,生產(chǎn)廠家長(zhǎng)春市醫(yī)用設(shè)備廠。本次蒸汽滅菌柜的驗(yàn)證為再驗(yàn)證。采用同步驗(yàn)證的方式進(jìn)行,對(duì)連續(xù)三批耆鹿逐痹口服液的藥液配制生產(chǎn),對(duì)蒸汽滅菌柜進(jìn)行驗(yàn)證。本次驗(yàn)證不再進(jìn)行設(shè)計(jì)驗(yàn)證(DQ)及安裝驗(yàn)證(IQ)。本方案的制定依據(jù)蒸汽滅菌柜(120406-02-02)標(biāo)準(zhǔn)操作規(guī)程進(jìn)行制定。
由于該設(shè)備一直處于良好的運(yùn)行狀態(tài),本次確認(rèn)是在繼上次確認(rèn)結(jié)束后,無(wú)任何偏差、變更情況下對(duì)設(shè)備性能進(jìn)行的再確認(rèn),故在滅菌效果確認(rèn)時(shí),無(wú)需考察空載狀態(tài),如滿載及熱力分布溫度分布均一性能夠達(dá)到驗(yàn)證可接受標(biāo)準(zhǔn),即可證明設(shè)備性能穩(wěn)定。
2、驗(yàn)證目的:
本再驗(yàn)證方案的目的是以文件形式證明口服液生產(chǎn)用蒸汽滅菌柜和它的附件系統(tǒng)能夠按照預(yù)定運(yùn)行范圍運(yùn)行,在預(yù)先設(shè)定好的范圍內(nèi)生產(chǎn)產(chǎn)品。
3、驗(yàn)證范圍:
口服液生產(chǎn)用蒸汽滅菌柜
4、驗(yàn)證小組職責(zé)
驗(yàn)證小組成員 |
部門及職位 |
職 責(zé) |
組長(zhǎng) |
蘇振波 |
設(shè)備處處長(zhǎng) |
負(fù)責(zé)再驗(yàn)證方案驗(yàn)證報(bào)告的審批 |
組員 |
孫忠輝 |
機(jī)修車間主任 |
負(fù)責(zé)擬定方案,實(shí)施驗(yàn)證,完成驗(yàn)證報(bào)告。 |
沈偉 |
設(shè)備員 |
負(fù)責(zé)方案的實(shí)施驗(yàn)證。 |
張若萍 |
計(jì)量室主任 |
負(fù)責(zé)儀器、儀表、器具等的校正。 |
包君 |
質(zhì)保處 |
參與和協(xié)調(diào)驗(yàn)證工作。 |
袁玉敏 |
QA |
生產(chǎn)現(xiàn)場(chǎng)監(jiān)督員 |
孫桂菊 |
二車間主任 |
監(jiān)督驗(yàn)證的實(shí)施 |
高云峰 |
生產(chǎn)技術(shù)員 |
參與驗(yàn)證實(shí)施過(guò)程。 |
李麗華 |
質(zhì)量部部長(zhǎng) |
驗(yàn)證方案及驗(yàn)證報(bào)告的批準(zhǔn) |
鞠濤 |
總工程師 |
驗(yàn)證方案及驗(yàn)證報(bào)告的批準(zhǔn)、發(fā)放驗(yàn)證證書、驗(yàn)證再驗(yàn)證周期 |
魏影 |
總經(jīng)理 |
簽發(fā)驗(yàn)證證書 |
5、驗(yàn)證正文
5.1驗(yàn)證過(guò)程中使用的儀器儀表校驗(yàn)情況
本次所用計(jì)量器具及儀表等校驗(yàn)情況。見(jiàn)附表1
5.2 運(yùn)行確認(rèn)
按蒸汽滅菌柜操作規(guī)程要求運(yùn)行,對(duì)蒸汽滅菌柜的各項(xiàng)功能進(jìn)行檢查。具體檢查項(xiàng)如下:
1)對(duì)設(shè)備外觀進(jìn)行檢查,蒸汽滅菌柜內(nèi)外表面應(yīng)無(wú)腐蝕或破損。
2)與四周、建筑物距離在0.20米以上有足夠的空間維護(hù)保養(yǎng)。
3)上蓋密封圈應(yīng)完好無(wú)撕裂或老化現(xiàn)象。
4)管路應(yīng)密封無(wú)泄漏。見(jiàn)附表2
5.3性能確認(rèn)
5.3.1熱電偶放置方式的確認(rèn)
將12支熱電偶放到滅菌鍋內(nèi)不同位置,測(cè)溫點(diǎn)不得接觸金屬表面和其它表面,具體放置位置見(jiàn)如下示意圖:
5.3.2觀察無(wú)紙記錄儀記錄運(yùn)行溫度
取樣點(diǎn)及溫度探頭位置圖示:

圖一
取樣點(diǎn)分層 |
取樣點(diǎn)位置 |
熱電偶編號(hào) |
取樣點(diǎn)位置 |
熱電偶編號(hào) |
取樣點(diǎn)位置 |
熱電偶編號(hào) |
1 |
01 |
2 |
02 |
3 |
03 |
4 |
04 |
5 |
05 |
4 |
06 |
7 |
07 |
8 |
08 |
9 |
09 |
10 |
10 |
11 |
11 |
12 |
12 |
滿載及熱力分布取樣點(diǎn)編號(hào)見(jiàn)附表1
5.3.2熱力分布溫度分布均一性確認(rèn)
熱力分布溫度均一性確認(rèn)在滿載狀態(tài)下進(jìn)行,將溫度驗(yàn)證儀探頭放在被滅菌的物品內(nèi)部,以考察滅菌效果。該項(xiàng)確認(rèn)同樣在105℃/30min每個(gè)工藝參數(shù)條件下連續(xù)進(jìn)行三次。
可接受標(biāo)準(zhǔn):各測(cè)試點(diǎn)溫度與設(shè)定值溫差≤2℃
各測(cè)試點(diǎn)溫度范圍103—107℃;
6.3 數(shù)據(jù)統(tǒng)計(jì)及分析
分別統(tǒng)計(jì)滿載熱力分布均一性確認(rèn),統(tǒng)計(jì)結(jié)果如下。
105℃滿載溫度分布統(tǒng)計(jì)結(jié)果 單位:105℃
試驗(yàn)次數(shù) |
項(xiàng)目 |
熱電偶編號(hào) |
01 |
02 |
03 |
04 |
05 |
06 |
07 |
08 |
09 |
10 |
11 |
12 |
1 |
最大值 |
106.5 |
106.4 |
106.5 |
106.5 |
106.4 |
106.5 |
106.5 |
106.5 |
106.6 |
106.5 |
106.4 |
106.7 |
最小值 |
104.8 |
105.0 |
104.6 |
104.9 |
104.9 |
104.8 |
104.6 |
104.6 |
104.8 |
104.7 |
104.1 |
105.0 |
2 |
最大值 |
106.5 |
106.5 |
106.5 |
106.4 |
106.4 |
106.4 |
106.2 |
106.4 |
106.5 |
106.4 |
105.8 |
106.6 |
最小值 |
104.8 |
104.7 |
104.9 |
104.8 |
104.8 |
104.8 |
104.8 |
105.0 |
104.8 |
104.8 |
104.5 |
104.9 |
3 |
最大值 |
106.4 |
106.5 |
106.4 |
106.5 |
106.5 |
106.4 |
106.5 |
106.4 |
106.4 |
106.4 |
105.8 |
106.4 |
最小值 |
105.1 |
105.0 |
104.8 |
104.7 |
105.0 |
105.0 |
105.0 |
104.7 |
104.8 |
105.1 |
104.5 |
105.1 |
6.4 驗(yàn)證合格標(biāo)準(zhǔn)
6.4.1該設(shè)備在滿載及熱力分布溫度均一性能達(dá)到相應(yīng)的可接受標(biāo)準(zhǔn)。
6.5 變更與偏差處理
確認(rèn)過(guò)程中如果出現(xiàn)偏差或變更,應(yīng)立即通知質(zhì)保處,按照偏差處理程序或變更控制程序?qū)ζ涮幚?。所有偏差和變更按照相?yīng)規(guī)程得到有效處理后,確認(rèn)方可進(jìn)入下一步驟。原始的偏差表或變更表經(jīng)過(guò)批準(zhǔn)后,其復(fù)印件必須附在最終的確認(rèn)報(bào)告中。
確認(rèn)過(guò)程無(wú)變更與偏差。
評(píng)價(jià)結(jié)果:__________________。
6.7 確認(rèn)結(jié)果評(píng)定與結(jié)論
驗(yàn)證工作小組組長(zhǎng)對(duì)確認(rèn)結(jié)果進(jìn)行綜合評(píng)審,做出確認(rèn)結(jié)論。驗(yàn)證領(lǐng)導(dǎo)小組組長(zhǎng)發(fā)放驗(yàn)證證書,對(duì)確認(rèn)結(jié)果的評(píng)審應(yīng)包括:
(1) 驗(yàn)證結(jié)果是否有遺漏?
驗(yàn)證結(jié)果: __________________。
(2) 驗(yàn)證過(guò)程中的偏差、變更是否關(guān)閉?
驗(yàn)證過(guò)程__________________。
(3) 驗(yàn)證實(shí)施過(guò)程中對(duì)驗(yàn)證方案有無(wú)修改,修改原因、依據(jù)、是否經(jīng)過(guò)批準(zhǔn)?
驗(yàn)證實(shí)施過(guò)程: __________________。
(4) 驗(yàn)證記錄是否完整?
驗(yàn)證記錄完整、真實(shí)
(5) 驗(yàn)證結(jié)果是否符合標(biāo)準(zhǔn)要求?
驗(yàn)證結(jié)果能夠達(dá)到驗(yàn)證合格標(biāo)準(zhǔn)。
附表1
序號(hào) |
儀器儀表名稱 |
型號(hào) |
編號(hào) |
范圍 |
校正日期 |
有效期 |
1 |
熱電偶 |
HSB-600R |
TI10-15-1-1 |
0~300℃ |
2013-03-26 |
一年 |
2 |
熱電偶 |
HSB-600R |
TI10-15-1-2 |
0~300℃ |
2013-03-26 |
一年 |
3 |
熱電偶 |
HSB-600R |
TI10-15-1-3 |
0~300℃ |
2013-03-26 |
一年 |
4 |
熱電偶 |
HSB-600R |
TI10-15-1-4 |
0~300℃ |
2013-03-26 |
一年 |
5 |
熱電偶 |
HSB-600R |
TI10-15-1-5 |
0~300℃ |
2013-03-26 |
一年 |
6 |
熱電偶 |
HSB-600R |
TI10-15-1-6 |
0~300℃ |
2013-03-26 |
一年 |
7 |
熱電偶 |
HSB-600R |
TI10-15-1-7 |
0~300℃ |
2013-03-26 |
一年 |
8 |
熱電偶 |
HSB-600R |
TI10-15-1-8 |
0~300℃ |
2013-03-26 |
一年 |
9 |
熱電偶 |
HSB-600R |
TI10-15-1-9 |
0~300℃ |
2013-03-26 |
一年 |
10 |
熱電偶 |
HSB-600R |
TI10-15-1-10 |
0~300℃ |
2013-03-26 |
一年 |
11 |
熱電偶 |
HSB-600R |
TI10-15-1-11 |
0~300℃ |
2013-03-26 |
一年 |
12 |
熱電偶 |
HSB-600R |
TI10-15-1-12 |
0~300℃ |
2013-03-26 |
一年 |
附表2:
設(shè)備運(yùn)行確認(rèn)表
項(xiàng)目 |
可接受標(biāo)準(zhǔn) |
結(jié)果 |
結(jié)論 |
設(shè)備情況 |
蒸汽滅菌柜內(nèi)外表面應(yīng)無(wú)腐蝕或破損。 |
|
|
位置 |
與四周、建筑物距離在0.20米以上有足夠的空間維護(hù)保養(yǎng) |
|
密封圈 |
上蓋密封圈應(yīng)完好無(wú)撕裂或老化現(xiàn)象 |
|
管路 |
管路應(yīng)密封無(wú)泄漏 |
|
檢查人 |
|
復(fù)核人 |
|
檢查日期 |
|
|
|
|
|
|
|
附表3:
105℃滿載熱分布測(cè)試記錄(第1次)
設(shè)備編號(hào):120406-02-02
溫度:105℃
位置
時(shí)間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-10 17:12 |
105.2 |
105.3 |
105.3 |
105.3 |
105.0 |
105.4 |
105.2 |
105.2 |
106.2 |
105.1 |
104.8 |
105.2 |
1.4 |
2013-10-10 17:13 |
105.5 |
105.2 |
105.6 |
105.4 |
105.2 |
105.0 |
105.3 |
105.3 |
105.1 |
105.4 |
104.6 |
105.4 |
1.0 |
2013-10-10 17:14 |
105.2 |
105.4 |
105.4 |
105.2 |
105.8 |
105.6 |
105.5 |
105.4 |
105.9 |
105.1 |
105.1 |
105.6 |
0.8 |
2013-10-10 17:15 |
105.4 |
105.6 |
105.8 |
105.6 |
105.2 |
105.7 |
105.4 |
105.8 |
105.4 |
105.8 |
105.6 |
105.1 |
0.7 |
2013-10-10 17:16 |
105.6 |
105.4 |
105.2 |
105.8 |
105.4 |
105.2 |
105.2 |
105.3 |
106.1 |
105.2 |
105.8 |
105.8 |
0.9 |
2013-10-10 17:17 |
105.2 |
105.8 |
105.0 |
105.2 |
105.6 |
104.8 |
105.0 |
105.5 |
106.5 |
105.4 |
105.2 |
105.6 |
1.7 |
2013-10-10 17:18 |
105.4 |
106.4 |
105.8 |
105.0 |
105.4 |
105.2 |
105.1 |
105.0 |
106.0 |
105.9 |
105.4 |
105.0 |
1.4 |
2013-10-10 17:19 |
105.0 |
106.2 |
106.0 |
104.9 |
105.9 |
106.1 |
105.6 |
104.6 |
105.4 |
105.0 |
105.9 |
106.1 |
1.6 |
2013-10-10 17:20 |
104.8 |
106.0 |
106.2 |
105.6 |
106.1 |
106.5 |
105.3 |
104.9 |
106.1 |
105.6 |
106.2 |
106.3 |
1.7 |
2013-10-10 17:21 |
105.3 |
105.5 |
106.5 |
105.2 |
106.2 |
105.2 |
105.6 |
105.0 |
106.2 |
105.9 |
105.1 |
106.7 |
1.7 |
2013-10-10 17:22 |
105.6 |
105.3 |
105.7 |
105.0 |
106.1 |
105.6 |
105.0 |
105.6 |
106.6 |
106.1 |
105.8 |
105.7 |
1.6 |
2013-10-10 17:23 |
105.8 |
105.4 |
105.3 |
106.2 |
105.1 |
105.0 |
104.6 |
105.7 |
106.0 |
106.5 |
105.2 |
105.2 |
1.9 |
2013-10-10 17:24 |
106.2 |
105.6 |
105.6 |
104.9 |
105.6 |
105.4 |
105.8 |
105.0 |
105.3 |
106.0 |
105.7 |
105.6 |
1.3 |
2013-10-10 17:25 |
106.5 |
105.2 |
105.3 |
105.8 |
105.0 |
105.8 |
105.2 |
105.3 |
105.8 |
105.4 |
105.6 |
105.1 |
1.5 |
2013-10-10 17:26 |
105.9 |
105.7 |
105.4 |
106.2 |
105.9 |
105.3 |
105.1 |
105.6 |
105.4 |
105.9 |
106.3 |
105.8 |
1.2 |
2013-10-10 17:27 |
106.2 |
105.3 |
106.2 |
106.5 |
106.1 |
106.0 |
105.6 |
105.0 |
105.0 |
105.2 |
106.0 |
105.4 |
1.5 |
2013-10-10 17:28 |
106.1 |
105.8 |
106.2 |
106.4 |
105.2 |
106.3 |
105.2 |
105.8 |
104.8 |
105.4 |
105.7 |
105.2 |
1.6 |
2013-10-10 17:29 |
106.3 |
105.2 |
105.8 |
105.2 |
106.2 |
105.2 |
105.6 |
105.2 |
105.4 |
104.7 |
105.3 |
105.9 |
1.6 |
2013-10-10 17:30 |
105.8 |
105.4 |
106.0 |
105.0 |
105.5 |
106.2 |
105.4 |
105.9 |
105.9 |
104.9 |
105.6 |
106.2 |
1.3 |
2013-10-10 17:31 |
105.4 |
105.9 |
106.2 |
105.3 |
104.9 |
106.4 |
105.0 |
106.1 |
105.1 |
105.2 |
105.8 |
105.2 |
1.5 |
2013-10-10 17:32 |
105.7 |
105.2 |
106.5 |
105.6 |
105.4 |
105.6 |
105.8 |
106.5 |
105.6 |
105.6 |
105.0 |
105.6 |
1.5 |
2013-10-10 17:33 |
105.3 |
105.0 |
106.0 |
105.4 |
105.1 |
106.1 |
105.0 |
106.0 |
105.4 |
105.9 |
105.4 |
105.5 |
1.1 |
2013-10-10 17:34 |
105.6 |
105.2 |
105.8 |
105.2 |
105.8 |
106.2 |
105.4 |
105.6 |
105.0 |
105.2 |
105.7 |
106.0 |
1.2 |
2013-10-10 17:35 |
105.2 |
105.4 |
105.6 |
105.6 |
105.2 |
106.4 |
104.8 |
105.3 |
105.7 |
105.7 |
106.2 |
106.4 |
1.6 |
2013-10-10 17:36 |
105.5 |
105.3 |
105.2 |
105.0 |
106.1 |
105.8 |
104.7 |
105.4 |
105.1 |
105.9 |
106.4 |
105.2 |
1.7 |
2013-10-10 17:37 |
105.8 |
105.7 |
105.3 |
105.5 |
106.4 |
105.5 |
105.0 |
106.2 |
105.8 |
106.4 |
105.2 |
105.8 |
1.4 |
2013-10-10 17:38 |
105.6 |
105.2 |
104.8 |
105.7 |
105.7 |
105.6 |
105.5 |
105.3 |
104.8 |
105.7 |
105.8 |
105.4 |
1.0 |
2013-10-10 17:39 |
105.4 |
105.6 |
104.6 |
105.0 |
105.2 |
105.1 |
105.9 |
105.9 |
105.6 |
105.2 |
105.6 |
105.6 |
1.3 |
2013-10-10 17:40 |
105.0 |
105.1 |
105.7 |
104.9 |
105.6 |
104.9 |
106.5 |
105.1 |
105.0 |
105.8 |
105.1 |
105.1 |
1.6 |
2013-10-10 17:41 |
106.2 |
105.6 |
105.2 |
105.8 |
105.0 |
105.5 |
106.2 |
105.5 |
105.8 |
105.0 |
105.0 |
105.4 |
1.2 |
2013-10-10 17:42 |
105.2 |
105.4 |
105.3 |
105.0 |
105.2 |
105.6 |
106.0 |
105.4 |
105.2 |
105.2 |
104.1 |
105.7 |
1.9 |
最大值 |
121.3 |
121.7 |
121.2 |
122.3 |
121.6 |
121.4 |
121.7 |
122.7 |
120.3 |
122.8 |
121.7 |
121.6 |
— |
最小值 |
120.6 |
121.0 |
120.6 |
121.7 |
120.8 |
120.9 |
121.1 |
122.2 |
119.3 |
121.8 |
120.7 |
121.0 |
— |
測(cè)試人 復(fù)核人: 日期:
105℃滿載熱分布測(cè)試記錄(第2次)
設(shè)備編號(hào):120406-02-02
溫度:105℃
位置
時(shí)間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-11 17:12 |
105.1 |
105.7 |
105.3 |
105.4 |
105.0 |
105.2 |
105.3 |
105.0 |
104.8 |
105.3 |
104.6 |
105.5 |
1.1 |
2013-10-11 17:13 |
105.6 |
105.3 |
105.5 |
105.1 |
105.3 |
105.6 |
105.4 |
105.4 |
105.2 |
105.5 |
104.8 |
105.4 |
0.8 |
2013-10-11 17:14 |
105.2 |
105.4 |
105.4 |
105.3 |
105.4 |
105.5 |
105.6 |
105.5 |
106.1 |
105.9 |
105.2 |
105.2 |
0.9 |
2013-10-11 17:15 |
105.8 |
105.3 |
105.8 |
105.8 |
105.6 |
105.4 |
105.8 |
105.2 |
106.4 |
105.1 |
105.2 |
105.8 |
1.3 |
2013-10-11 17:16 |
105.2 |
105.4 |
106.2 |
106.0 |
105.9 |
105.8 |
105.2 |
105.6 |
105.6 |
105.5 |
105.3 |
105.2 |
1.0 |
2013-10-11 17:17 |
105.6 |
105.5 |
106.1 |
106.2 |
106.1 |
106.2 |
105.8 |
105.9 |
105.1 |
105.8 |
105.6 |
105.6 |
1.1 |
2013-10-11 17:18 |
106.1 |
105.2 |
106.5 |
106.0 |
106.4 |
106.1 |
105.1 |
105.4 |
105.3 |
106.1 |
105.1 |
105.4 |
1.4 |
2013-10-11 17:19 |
106.5 |
105.4 |
105.7 |
105.8 |
106.0 |
105.8 |
105.6 |
105.3 |
105.6 |
106.2 |
105.8 |
105.1 |
1.4 |
2013-10-11 17:20 |
106.0 |
105.2 |
105.6 |
105.3 |
105.8 |
105.2 |
105.4 |
105.8 |
105.8 |
106.2 |
105.2 |
104.9 |
1.3 |
2013-10-11 17:21 |
105.2 |
105.4 |
105.2 |
105.6 |
105.4 |
105.6 |
105.0 |
106.2 |
105.4 |
105.8 |
105.0 |
105.2 |
1.2 |
2013-10-11 17:22 |
104.8 |
105.9 |
105.4 |
105.4 |
105.6 |
105.5 |
105.2 |
106.0 |
105.0 |
105.2 |
104.8 |
105.5 |
1.2 |
2013-10-11 17:23 |
105.2 |
105.1 |
105.8 |
105.9 |
105.2 |
105.7 |
105.4 |
105.8 |
104.9 |
105.5 |
104.9 |
105.6 |
1.0 |
2013-10-11 17:24 |
105.8 |
105.5 |
105.3 |
106.2 |
105.7 |
105.9 |
105.8 |
105.5 |
105.5 |
105.9 |
104.6 |
105.7 |
1.6 |
2013-10-11 17:25 |
105.2 |
105.6 |
105.0 |
105.4 |
105.9 |
106.2 |
105.1 |
105.1 |
105.6 |
105.4 |
104.5 |
106.1 |
1.7 |
2013-10-11 17:26 |
105.6 |
105.8 |
104.9 |
105.0 |
106.2 |
106.4 |
104.8 |
105.6 |
105.8 |
105.6 |
105.0 |
106.3 |
1.6 |
2013-10-11 17:27 |
105.7 |
106.2 |
105.2 |
104.8 |
106.4 |
106.2 |
105.5 |
105.3 |
105.2 |
105.5 |
105.5 |
106.6 |
1.8 |
2013-10-11 17:28 |
105.0 |
106.1 |
105.7 |
105.2 |
106.0 |
105.3 |
105.2 |
105.4 |
105.9 |
105.8 |
105.8 |
105.8 |
1.1 |
2013-10-11 17:29 |
104.9 |
105.2 |
105.9 |
105.6 |
105.7 |
105.8 |
105.4 |
105.8 |
105.2 |
106.1 |
105.3 |
105.3 |
1.2 |
2013-10-11 17:30 |
105.8 |
105.1 |
106.2 |
105.9 |
105.6 |
105.6 |
105.1 |
105.6 |
105.8 |
106.4 |
105.6 |
105.7 |
1.3 |
2013-10-11 17:31 |
105.2 |
105.4 |
105.2 |
105.4 |
105.1 |
105.4 |
105.6 |
105.4 |
106.1 |
105.5 |
105.4 |
105.2 |
1.0 |
2013-10-11 17:32 |
105.6 |
104.8 |
105.4 |
105.2 |
105.5 |
105.2 |
105.2 |
105.3 |
106.2 |
105.2 |
105.2 |
105.8 |
1.4 |
2013-10-11 17:33 |
105.9 |
104.7 |
105.0 |
105.6 |
105.9 |
105.5 |
105.4 |
106.2 |
106.5 |
105.6 |
104.8 |
105.5 |
1.8 |
2013-11-11 17:34 |
105.2 |
105.2 |
105.2 |
105.8 |
105.4 |
105.8 |
105.6 |
106.4 |
105.8 |
105.6 |
104.5 |
105.2 |
1.9 |
2013-10-11 17:35 |
105.9 |
105.3 |
105.4 |
105.4 |
105.2 |
106.2 |
105.0 |
106.3 |
105.2 |
105.0 |
105.2 |
105.6 |
1.3 |
2013-10-11 17:36 |
106.1 |
105.8 |
105.8 |
105.8 |
105.5 |
105.2 |
104.8 |
105.2 |
105.6 |
104.9 |
105.4 |
105.2 |
1.3 |
2013-10-11 17:37 |
106.4 |
105.4 |
105.3 |
106.2 |
105.8 |
104.9 |
104.9 |
105.5 |
105.7 |
105.2 |
105.3 |
105.9 |
1.5 |
2013-10-11 17:38 |
106.3 |
105.9 |
105.4 |
106.4 |
105.6 |
105.4 |
105.5 |
105.6 |
105.9 |
104.8 |
105.2 |
105.5 |
1.6 |
2013-10-11 17:39 |
105.8 |
106.5 |
106.1 |
105.7 |
105.4 |
104.8 |
105.8 |
105.9 |
105.2 |
105.5 |
105.6 |
105.0 |
1.7 |
2013-10-11 17:40 |
105.6 |
106.2 |
106.2 |
105.3 |
105.2 |
105.3 |
106.0 |
106.0 |
105.2 |
105.8 |
105.2 |
105.3 |
1.0 |
2013-10-11 17:41 |
105.4 |
105.5 |
105.6 |
105.2 |
104.8 |
105.5 |
106.2 |
105.4 |
105.6 |
105.2 |
105.5 |
105.7 |
1.4 |
2013-10-11 17:42 |
105.3 |
105.6 |
105.3 |
105.6 |
104.9 |
105.6 |
106.2 |
105.2 |
105.2 |
105.6 |
105.2 |
105.4 |
1.3 |
2013-10-11 17:12 |
105.1 |
105.7 |
105.3 |
105.4 |
105.0 |
105.2 |
105.3 |
105.0 |
104.8 |
105.3 |
104.6 |
105.5 |
1.1 |
2013-10-11 17:13 |
105.6 |
105.3 |
105.5 |
105.1 |
105.3 |
105.6 |
105.4 |
105.4 |
105.2 |
105.5 |
104.8 |
105.4 |
0.8 |
測(cè)試人 復(fù)核人: 日期:
105℃滿載熱分布測(cè)試記錄(第3次)
設(shè)備編號(hào):120406-02-02 溫度:105℃
位置
時(shí)間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-12 17:12 |
105.2 |
105.2 |
105.2 |
105.6 |
105.2 |
106.2 |
105.6 |
105.2 |
105.8 |
105.6 |
105.2 |
105.2 |
1.0 |
2013-10-12 17:13 |
105.5 |
105.6 |
105.5 |
105.4 |
105.5 |
106.1 |
105.2 |
105.5 |
105.3 |
105.1 |
104.8 |
105.5 |
1.3 |
2013-10-12 17:14 |
105.6 |
105.2 |
105.8 |
105.5 |
105.0 |
105.8 |
105.5 |
105.6 |
105.6 |
105.8 |
105.2 |
105.6 |
0.8 |
2013-10-12 17:15 |
105.8 |
105.8 |
105.2 |
105.6 |
105.7 |
105.0 |
105.4 |
105.1 |
105.8 |
105.9 |
105.1 |
105.8 |
0.9 |
2013-10-12 17:16 |
105.2 |
105.2 |
105.5 |
105.8 |
105.3 |
105.5 |
105.8 |
105.0 |
105.4 |
106.2 |
105.4 |
105.7 |
1.2 |
2013-10-12 17:17 |
105.6 |
105.9 |
105.0 |
106.2 |
105.2 |
105.4 |
105.6 |
105.5 |
105.2 |
105.4 |
105.3 |
105.2 |
1.2 |
2013-10-12 17:18 |
105.9 |
106.0 |
104.8 |
106.0 |
105.6 |
105.2 |
105.4 |
105.8 |
104.8 |
105.5 |
105.8 |
105.4 |
1.2 |
2013-10-12 17:19 |
106.1 |
105.3 |
104.9 |
106.4 |
105.8 |
105.6 |
105.5 |
106.0 |
105.2 |
106.0 |
105.6 |
105.6 |
1.5 |
2013-10-12 17:20 |
105.7 |
105.8 |
105.5 |
106.5 |
106.2 |
105.8 |
105.0 |
106.2 |
105.5 |
106.1 |
105.2 |
105.2 |
1.5 |
2013-10-12 17:21 |
105.5 |
105.2 |
105.2 |
105.9 |
106.4 |
106.4 |
105.5 |
106.4 |
105.6 |
105.2 |
105.1 |
105.5 |
1.3 |
2013-10-12 17:22 |
106.2 |
105.5 |
105.6 |
105.6 |
106.0 |
106.2 |
105.9 |
106.0 |
105.4 |
105.7 |
104.6 |
105.8 |
1.6 |
2013-10-12 17:23 |
106.0 |
105.2 |
105.7 |
105.2 |
105.8 |
105.8 |
106.2 |
105.9 |
105.7 |
106.2 |
105.1 |
106.2 |
1.1 |
2013-10-12 17:24 |
106.2 |
105.8 |
105.2 |
105.0 |
105.5 |
105.2 |
106.5 |
105.2 |
105.9 |
106.4 |
104.8 |
106.0 |
1.7 |
2013-10-12 17:25 |
106.2 |
106.2 |
105.6 |
105.8 |
105.2 |
105.5 |
106.3 |
105.5 |
106.2 |
105.8 |
105.5 |
106.4 |
1.2 |
2013-10-12 17:26 |
106.4 |
106.0 |
105.4 |
106.2 |
105.6 |
105.6 |
105.8 |
105.4 |
106.4 |
105.6 |
105.2 |
105.7 |
1.2 |
2013-10-12 17:27 |
105.6 |
105.8 |
105.1 |
106.3 |
105.4 |
105.7 |
105.7 |
105.6 |
106.1 |
105.2 |
105.4 |
105.5 |
1.2 |
2013-10-12 17:28 |
105.1 |
105.0 |
105.6 |
105.7 |
105.7 |
105.9 |
105.2 |
105.7 |
105.8 |
105.7 |
105.6 |
105.3 |
0.9 |
2013-10-12 17:29 |
105.3 |
105.2 |
105.2 |
105.5 |
106.0 |
105.4 |
105.5 |
105.8 |
105.6 |
105.6 |
105.8 |
105.4 |
0.8 |
2013-10-12 17:30 |
105.4 |
105.6 |
105.8 |
105.2 |
106.2 |
105.8 |
105.6 |
105.1 |
105.4 |
105.2 |
105.2 |
105.2 |
1.1 |
2013-10-12 17:31 |
105.6 |
105.0 |
106.2 |
105.4 |
106.5 |
106.2 |
105.4 |
105.6 |
105.3 |
105.5 |
105.7 |
105.1 |
1.5 |
2013-10-12 17:32 |
105.8 |
105.3 |
106.4 |
105.6 |
106.1 |
106.4 |
105.3 |
105.4 |
105.5 |
105.5 |
105.2 |
105.4 |
1.2 |
2013-10-12 17:33 |
105.2 |
105.7 |
106.2 |
105.1 |
105.8 |
106.0 |
105.2 |
105.8 |
105.7 |
105.4 |
105.2 |
105.7 |
1.1 |
2013-10-12 17:34 |
105.9 |
106.2 |
106.0 |
105.8 |
105.3 |
105.8 |
105.5 |
105.2 |
105.9 |
105.2 |
105.0 |
105.6 |
1.2 |
2013-10-12 17:35 |
106.2 |
106.5 |
105.7 |
104.7 |
105.0 |
105.5 |
105.4 |
105.0 |
106.2 |
105.6 |
104.8 |
105.9 |
1.8 |
2013-10-12 17:36 |
105.5 |
106.0 |
105.5 |
105.2 |
105.4 |
105.2 |
105.7 |
104.9 |
106.0 |
105.8 |
104.6 |
105.4 |
1.4 |
2013-10-12 17:37 |
105.2 |
105.8 |
105.2 |
105.6 |
105.5 |
105.0 |
105.9 |
104.7 |
105.7 |
105.9 |
104.5 |
105.6 |
1.4 |
2013-10-12 17:38 |
105.5 |
105.2 |
105.4 |
105.4 |
105.6 |
105.6 |
106.2 |
105.2 |
105.3 |
105.3 |
104.9 |
105.4 |
1.3 |
2013-10-12 17:39 |
105.6 |
105.5 |
105.6 |
105.2 |
105.8 |
105.8 |
106.0 |
105.6 |
105.6 |
105.2 |
105.2 |
105.4 |
0.8 |
2013-10-12 17:40 |
105.8 |
105.2 |
105.1 |
105.6 |
105.4 |
105.5 |
106.4 |
105.8 |
105.4 |
105.3 |
105.4 |
105.6 |
1.3 |
2013-10-12 17:41 |
105.4 |
105.5 |
106.0 |
105.7 |
105.2 |
105.2 |
106.3 |
105.2 |
105.2 |
105.1 |
105.6 |
105.1 |
1.2 |
2013-10-12 17:42 |
105.6 |
105.6 |
105.3 |
105.9 |
105.2 |
105.6 |
105.8 |
105.4 |
105.8 |
105.2 |
105.2 |
105.4 |
0.7 |
2013-10-12 17:12 |
105.2 |
105.2 |
105.2 |
105.6 |
105.2 |
106.2 |
105.6 |
105.2 |
105.8 |
105.6 |
105.2 |
105.2 |
1.0 |
2013-10-12 17:13 |
105.5 |
105.6 |
105.5 |
105.4 |
105.5 |
106.1 |
105.2 |
105.5 |
105.3 |
105.1 |
104.8 |
105.5 |
1.3 |
測(cè)試人 復(fù)核人: 日期:
驗(yàn)證結(jié)果報(bào)告書
題目 |
蒸汽滅菌柜驗(yàn)證 |
目的/概要 |
檢查并確認(rèn)蒸汽滅菌柜文件資料齊全,性能適應(yīng)生產(chǎn)工藝要求,符合GMP要求。 |
評(píng)定結(jié)論 |
證實(shí)蒸汽滅菌柜滿足生產(chǎn)工藝要求,符合GMP要求。 |
驗(yàn)證實(shí)施時(shí)間 |
2013年10月 |
負(fù)責(zé)者(部門) |
驗(yàn)證小組 |
變更記錄(改定者、改定日、變更事項(xiàng)、理由) |
|
責(zé)任者 |
驗(yàn)證小組組長(zhǎng) |
完成人 |
|
|
|
驗(yàn)證工作領(lǐng)導(dǎo)小組確認(rèn) |
|
驗(yàn) 證 證 書
茲證明
蒸汽滅菌柜
經(jīng)過(guò)驗(yàn)證后,符合要求,準(zhǔn)予投入生產(chǎn)使用。
驗(yàn)證文件編號(hào) |
SYZ-03-028-02 |
頒發(fā)部門 |
驗(yàn)證工作領(lǐng)導(dǎo)小組 |
驗(yàn)證部門 |
設(shè)備處 |
簽發(fā)人 |
|
簽發(fā)日期 |
年 月 日 |
批準(zhǔn)人 |
|
有效期 |
個(gè)月 |