型凈化工作臺(tái)驗(yàn)證方案

1、SW-CJ-2FD凈化工作臺(tái)驗(yàn)證方案起 草 人：審 核 人：批 準(zhǔn) 人：起草部門：起草日期：審核日期：批準(zhǔn)日期：執(zhí)行日期：驗(yàn)證小組會(huì)簽部門崗位簽名簽名日期頒發(fā)部門： 質(zhì)量部Copy ： 行政部 物供部 質(zhì)量部QA 質(zhì)量部QC 研發(fā)部 生技部 疫苗車間 分包裝車間 工程部 保安部 營(yíng)銷部 財(cái)務(wù)部 變更記載：修訂號(hào) 批準(zhǔn)日期 執(zhí)行日期00變更原因及目的：建立驗(yàn)證文件，并通過驗(yàn)證證明所驗(yàn)證對(duì)象有效、穩(wěn)定、可靠。目 錄驗(yàn)證方案···············

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35、標(biāo)準(zhǔn)附件2：資料檔案確認(rèn)表附件3：安裝確認(rèn)記錄表附件4：運(yùn)行確認(rèn)記錄表附件5：靜態(tài)塵埃粒子確認(rèn)記錄表附件6：靜態(tài)沉降菌確認(rèn)記錄表驗(yàn)證方案1 概述凈化工作臺(tái)主要用于為試驗(yàn)提供百級(jí)試驗(yàn)環(huán)境，減少試驗(yàn)過程中微生物污染的機(jī)率，為試驗(yàn)檢測(cè)數(shù)據(jù)的準(zhǔn)確性提供重要的保障。因此必須對(duì)凈化工作臺(tái)進(jìn)行驗(yàn)證，以確保該設(shè)備能提供一個(gè)長(zhǎng)期穩(wěn)定的潔凈環(huán)境，確保檢驗(yàn)數(shù)據(jù)的真實(shí)可靠。本方案規(guī)定了凈化工作臺(tái)的驗(yàn)證方案及接受標(biāo)準(zhǔn)，依據(jù)是凈化工作臺(tái)的使用說明書和SW-CJ-2FD型凈化工作臺(tái)使用、維護(hù)保養(yǎng)標(biāo)準(zhǔn)操作規(guī)程2 目的對(duì)該設(shè)備進(jìn)行驗(yàn)證，以確保該設(shè)備能提供穩(wěn)定的潔凈環(huán)境，確保檢驗(yàn)數(shù)據(jù)的真實(shí)可靠。3 職責(zé)質(zhì)量部QC室：負(fù)責(zé)起草質(zhì)量部QC室凈化工作臺(tái)的驗(yàn)證方案，報(bào)告及驗(yàn)證實(shí)施。工程部：協(xié)助質(zhì)量部進(jìn)行凈化工作臺(tái)的驗(yàn)證實(shí)施。驗(yàn)證小組：負(fù)責(zé)驗(yàn)證方案的實(shí)施、驗(yàn)證方案與驗(yàn)證報(bào)告的審核會(huì)簽。驗(yàn)證管理員：負(fù)責(zé)對(duì)驗(yàn)證過程進(jìn)行協(xié)調(diào)檢查。QC檢驗(yàn)員：負(fù)責(zé)驗(yàn)證中的取樣檢驗(yàn)，測(cè)試檢驗(yàn)數(shù)據(jù)，并出具準(zhǔn)確的檢驗(yàn)報(bào)告。4 驗(yàn)證內(nèi)容4.1 預(yù)確認(rèn)：見附件14.2 安裝確認(rèn)4.2.1 資料檔案：確認(rèn)內(nèi)容見附件2。4.2.2 安裝確認(rèn)：確認(rèn)內(nèi)容見附件3。4.2.3 儀表檢驗(yàn) 塵埃粒子計(jì)數(shù)器由生產(chǎn)廠家進(jìn)行校驗(yàn)。4.3 運(yùn)行確認(rèn)4.3.1 目的4.3.1.1 對(duì)標(biāo)準(zhǔn)操作規(guī)程的適用性進(jìn)行確認(rèn)。4.3.1.2 檢查確認(rèn)系統(tǒng)運(yùn)轉(zhuǎn)是否正常，并符合技術(shù)參數(shù)要求。對(duì)操作