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style="margin-top:0;margin-bottom:31px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:黑體;font-size:21px"></span></strong></h2><p style="text-align: center"><br/></p><h2 style="margin-top:0;margin-bottom:31px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:黑體;font-size:21px">前言</span></strong><strong></strong></h2><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:楷體;font-size:20px"><span style="font-family:楷體">在多數(shù)藥企無(wú)菌制劑車(chē)間內(nèi)，工藝流程中確保無(wú)菌要求、藥品</span><span style="font-family:楷體">API無(wú)損是重中之重，生產(chǎn)過(guò)程中發(fā)生污染是致命的錯(cuò)失，其中在粉針、水針?biāo)庮?lèi)等產(chǎn)品中更為重要，面對(duì)國(guó)家標(biāo)準(zhǔn)推進(jìn)下，我們?nèi)绾胃玫拇_保工藝流程中無(wú)菌環(huán)境的質(zhì)量控制、保護(hù)是我們藥企所面臨的巨大難題。</span></span></p><p style="margin-bottom:31px;text-indent:20px"><span style="font-family: 楷體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:楷體">本文關(guān)鍵詞；</span></span><span style=";font-family:楷體;font-size:20px">BFS系統(tǒng)、微生物、微生物控制、無(wú)菌車(chē)間、潔凈區(qū)消毒、潔凈區(qū)消毒方式、</span><span style="font-family: 楷體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:楷體">微生物限度、</span></span><span style="font-family: 楷體;font-size: 20px">微生物菌落控制、</span><span style="font-family: 楷體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:楷體">潔凈區(qū)殺孢子劑、潔凈區(qū)、控制區(qū)、潔凈區(qū)消毒滅菌、無(wú)菌室、</span></span><span style="font-family: 楷體;font-size: 20px">醫(yī)藥、殺孢子劑、</span><span style="font-family: 楷體;font-size: 20px"><span style="font-family:楷體">工廠潔凈室微生物控制、生物工程</span><span style="font-family:楷體">GMP車(chē)間、芽孢、腐蝕性、有效性、空氣物表消毒、一站式消毒滅菌解決方案、技術(shù)咨詢(xún)服務(wù)。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family: 宋體;font-size: 20px"><span style="font-family:宋體">面對(duì)標(biāo)準(zhǔn)推進(jìn)，許多藥企面對(duì)</span><span style="font-family:宋體">BFS系統(tǒng)無(wú)法滿(mǎn)足標(biāo)準(zhǔn)無(wú)菌，最終滅菌不達(dá)標(biāo)影響藥品質(zhì)量，工藝流程區(qū)段無(wú)菌防治不到位等問(wèn)題，針對(duì)以上問(wèn)題從多維度給出以下解決建議：</span></span></p><h3 style="margin-bottom:31px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:21px">一．無(wú)菌環(huán)境的設(shè)計(jì)與建設(shè)</span></strong><strong></strong></h3><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:20px">- 合理規(guī)劃布局</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">：根據(jù)</span><span style="font-family:宋體">BFS系統(tǒng)的工藝流程和操作要求，對(duì)無(wú)菌車(chē)間進(jìn)行合理布局。將人流、物流通道分開(kāi)，避免交叉污染。設(shè)置不同潔凈級(jí)別的區(qū)域，如一般區(qū)、D級(jí)控制區(qū)、C級(jí)潔凈區(qū)、B級(jí)潔凈區(qū)（無(wú)菌室人員操作區(qū)）和核心潔凈區(qū)（BFS系統(tǒng)操作區(qū)域），確保從原料進(jìn)入到成品產(chǎn)出的過(guò)程中，污染風(fēng)險(xiǎn)逐步降低。其中需要注意的是在B級(jí)與核心的隔斷窗口鏈接處，我們需要著重管理，</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:20px">- 建筑材料選擇：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">選用符合</span><span style="font-family:宋體">GMP要求的建筑材料，如墻面和天花板采用不產(chǎn)塵、不吸附、易清潔的材料，如彩鋼板；地面采用耐磨、防滑、耐腐蝕的環(huán)氧樹(shù)脂自流平地面（拒絕采用白色，防止清潔滅菌過(guò)程中，原粉灑落無(wú)法目視發(fā)現(xiàn)及清潔）。所有材料應(yīng)能耐受常用消毒劑的侵蝕，且不會(huì)釋放有害物質(zhì)影響藥品質(zhì)量。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:20px">- 高效空氣凈化系統(tǒng)：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">安裝先進(jìn)的空氣凈化系統(tǒng)，配備多級(jí)空氣過(guò)濾器，包括初效、中效和高效過(guò)濾器（</span><span style="font-family:宋體">HEPA）。高效過(guò)濾器的過(guò)濾效率應(yīng)達(dá)到99.99%（對(duì)≥0.3μm粒子），確保進(jìn)入無(wú)菌車(chē)間的空氣達(dá)到規(guī)定的潔凈度要求。合理設(shè)計(jì)送風(fēng)口和回風(fēng)口的位置（高度一般為離地15cm厘米為優(yōu)，減少干擾上層操作的空氣流動(dòng)），形成合理的氣流組織，如單向流或非單向流，以有效排除塵埃粒子和微生物。</span></span></p><h2 style="margin-bottom:31px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:黑體;font-size:21px">二. </span><strong><span style=";font-family:黑體;font-size:21px">無(wú)菌環(huán)境的日常質(zhì)量監(jiān)測(cè)與維護(hù)</span></strong><strong></strong></h2><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 清潔與消毒：</span></strong><span style="font-family: 宋體;font-size: 20px"><span style="font-family:宋體">在設(shè)備拆卸裝載過(guò)程中，會(huì)直接觸其內(nèi)部</span><span style="font-family:宋體">環(huán)境，破壞其穩(wěn)定，對(duì)于設(shè)備層面我們面對(duì)新標(biāo)準(zhǔn)推行，如果設(shè)備無(wú)法進(jìn)行更有效的更進(jìn)，那么就需要消毒劑來(lái)進(jìn)行輔助修正（工藝流程滿(mǎn)足，內(nèi)部SOP通過(guò)），可以采用奧克泰士產(chǎn)品精準(zhǔn)定向處理問(wèn)題，對(duì)于內(nèi)部環(huán)境層面，我們可以使用化學(xué)藥劑進(jìn)行區(qū)域噴灑，利用層流循環(huán)滅菌，從側(cè)面來(lái)輔助我們到達(dá)標(biāo)準(zhǔn)。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 塵埃粒子監(jiān)測(cè)：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">在無(wú)菌車(chē)間的不同區(qū)域，尤其是</span><span style="font-family:宋體">BFS系統(tǒng)操作區(qū)域，安裝塵埃粒子計(jì)數(shù)器，實(shí)時(shí)監(jiān)測(cè)空氣中的塵埃粒子數(shù)量和粒徑分布。定期進(jìn)行靜態(tài)和動(dòng)態(tài)監(jiān)測(cè)，靜態(tài)監(jiān)測(cè)在車(chē)間無(wú)人且設(shè)備停止運(yùn)行時(shí)進(jìn)行，動(dòng)態(tài)監(jiān)測(cè)則在生產(chǎn)過(guò)程中進(jìn)行（動(dòng)態(tài)時(shí)效通常不超過(guò)12H生產(chǎn)時(shí)間，特殊按照內(nèi)部SOP處理）。根據(jù)監(jiān)測(cè)結(jié)果，及時(shí)調(diào)整空氣凈化系統(tǒng)的運(yùn)行參數(shù)或更換過(guò)濾器。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 微生物監(jiān)測(cè)：</span></strong><span style=";font-family:宋體;font-size:20px">采用多種方法對(duì)無(wú)菌車(chē)間的微生物進(jìn)行監(jiān)測(cè)，包括傳統(tǒng)三項(xiàng)：沉降菌測(cè)試、浮游菌測(cè)試和表面微生物測(cè)試。沉降菌測(cè)試通過(guò)在車(chē)間內(nèi)放置瓊脂平板，暴露一定時(shí)間后進(jìn)行培養(yǎng)計(jì)數(shù)；浮游菌測(cè)試使用空氣采樣器收集空氣中的微生物；表面微生物測(cè)試則對(duì)設(shè)備表面、墻壁、地面等進(jìn)行擦拭采樣。定期進(jìn)行監(jiān)測(cè)，并設(shè)定警戒限和行動(dòng)限，一旦超出范圍，立即采取措施進(jìn)行處理。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 氣流組織控制：</span></strong><span style=";font-family:宋體;font-size:20px">合理設(shè)計(jì)潔凈區(qū)內(nèi)的氣流組織形式，如單向流或非單向流。單向流氣流（對(duì)于空間操作方式有一定要求，多為從上到下，小幅度緩慢操作）可使空氣以均勻的速度平行流動(dòng)，將塵埃粒子和微生物迅速帶走，常用于關(guān)鍵操作區(qū)域；非單向流則通過(guò)稀釋作用降低空氣中污染物濃度。根據(jù)不同生產(chǎn)環(huán)節(jié)的要求，選擇合適的氣流組織方式，確保無(wú)菌環(huán)境。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 溫濕度與壓差控制：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">嚴(yán)格控制無(wú)菌車(chē)間的溫濕度，溫度一般控制在</span><span style="font-family:宋體">16-22℃，相對(duì)濕度控制在45%-65%，以確保藥品質(zhì)量和設(shè)備正常運(yùn)行。同時(shí)，保持不同潔凈級(jí)別區(qū)域之間的壓差，一般相鄰區(qū)域壓差應(yīng)不小于10Pa，防止空氣逆流和交叉污染。安裝溫濕度傳感器和壓差表，實(shí)時(shí)監(jiān)測(cè)并記錄數(shù)據(jù)，及時(shí)調(diào)整空調(diào)系統(tǒng)的運(yùn)行參數(shù)。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 操作人員管理：</span></strong><span style=";font-family:宋體;font-size:20px">操作人員是無(wú)菌車(chē)間微生物污染的重要來(lái)源，進(jìn)入車(chē)間前，需嚴(yán)格按更衣程序更換無(wú)菌工作服、鞋套、帽子、口罩，確保全身包裹嚴(yán)密。操作過(guò)程中，盡量減少不必要?jiǎng)幼?，避免產(chǎn)生過(guò)多塵埃和微生物。定期對(duì)操作人員進(jìn)行微生物知識(shí)培訓(xùn)和健康檢查，防止患病人員進(jìn)入車(chē)間。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 工藝用水處理：</span></strong><span style=";font-family:宋體;font-size:20px">BFS 系統(tǒng)使用的工藝用水（如注射用水），要嚴(yán)格控制微生物。采用蒸餾法制備注射用水，并在 80℃以上保溫儲(chǔ)存和循環(huán)輸送，防止微生物滋生。定期對(duì)工藝用水進(jìn)行微生物檢測(cè)，如每批檢測(cè)細(xì)菌內(nèi)毒素，每周檢測(cè)微生物限度。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:20px"> </span></p><p style="margin-bottom:21px;margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-weight:bold;font-size:21px">三. </span><strong><span style="font-family: 宋體;font-size: 21px">BFS體系總滅菌處理</span></strong><strong></strong></p><p style="margin-bottom:31px;text-indent:40px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-weight:bold;font-size:20px">1. </span><strong><span style="font-family: 宋體;font-size: 20px">設(shè)備滅菌</span></strong><strong></strong></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 濕熱滅菌：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">對(duì)于能耐受高溫高濕的設(shè)備部件，如管道、容器等，可采用濕熱滅菌法。常用的設(shè)備是高壓蒸汽滅菌器，通過(guò)高溫飽和蒸汽進(jìn)行滅菌。設(shè)定合適的滅菌溫度（多為</span><span style="font-family:宋體">121℃）、壓力和時(shí)間（多為15-30分鐘，根據(jù)上一批次藥品品種來(lái)規(guī)定調(diào)節(jié)使用，有利于節(jié)能），確保微生物被殺滅。滅菌前需將設(shè)備內(nèi)的空氣排盡，保證蒸汽能夠充分接觸被滅菌物品。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 干熱滅菌</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">：對(duì)于一些耐高溫但不宜接觸水分的部件，如玻璃器皿、金屬工具等，采用干熱滅菌法。在干熱滅菌箱中，將物品加熱到較高溫度（如</span><span style="font-family:宋體">160-180℃）并保持一定時(shí)間（如2-4小時(shí)），以殺滅微生物和破壞熱原。干熱滅菌過(guò)程中要注意控制溫度均勻性和通風(fēng)情況。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 化學(xué)滅菌：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">使用化學(xué)消毒劑對(duì)設(shè)備表面進(jìn)行擦拭或熏蒸滅菌，如奧克泰士消毒劑等。但需注意化學(xué)消毒劑的殘留問(wèn)題，使用后要進(jìn)行充分的清洗和通風(fēng)，確保無(wú)殘留。對(duì)于</span><span style="font-family:宋體">BFS系統(tǒng)的一些關(guān)鍵部位，如灌裝頭，分裝頭（粉針類(lèi)藥品應(yīng)用），需要進(jìn)行消毒劑噴霧控制</span></span></p><p style="margin-bottom:31px;margin-left:0;text-indent:40px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-weight:bold;font-size:20px">2. </span><strong><span style="font-family: 宋體;font-size: 20px">生產(chǎn)用具滅菌</span></strong><strong></strong></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 容器與器具：</span></strong><span style=";font-family:宋體;font-size:20px">直接接觸藥品的容器和器具，如藥瓶、膠塞等，需進(jìn)行嚴(yán)格滅菌?？筛鶕?jù)其材質(zhì)和性質(zhì)選擇合適的滅菌方法，如采取高效的消毒劑奧克泰士等。對(duì)于一次性使用的器具，在使用前應(yīng)檢查其包裝的完整性和滅菌標(biāo)識(shí)。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 工器具：</span></strong><span style=";font-family:宋體;font-size:20px">生產(chǎn)過(guò)程中使用的工器具，如鑷子、剪刀等，應(yīng)在每次使用前后進(jìn)行滅菌處理。可采用濕熱滅菌、干熱滅菌或化學(xué)消毒的方法，確保工器具的無(wú)菌狀態(tài)。</span></p><p style="margin-bottom:31px;margin-left:0;text-indent:40px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-weight:bold;font-size:20px">3. </span><strong><span style="font-family: 宋體;font-size: 20px">滅菌驗(yàn)證</span></strong><strong></strong></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 生物指示劑：</span></strong><span style=";font-family:宋體;font-size:20px">在滅菌過(guò)程中放置生物指示劑，如嗜熱脂肪芽孢桿菌孢子懸液或菌片等。滅菌后對(duì)生物指示劑進(jìn)行培養(yǎng)，觀察是否有微生物生長(zhǎng)，以此判斷滅菌效果。生物指示劑的放置位置應(yīng)具有代表性，覆蓋整個(gè)滅菌區(qū)域（多為隔斷鏈接處）。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 熱分布測(cè)試：</span></strong><span style=";font-family:宋體;font-size:20px">使用溫度傳感器對(duì)滅菌設(shè)備內(nèi)的溫度分布進(jìn)行測(cè)試，確保滅菌過(guò)程中各個(gè)部位的溫度均勻性符合要求。通過(guò)熱分布測(cè)試，可以發(fā)現(xiàn)設(shè)備可能存在的溫度死角，及時(shí)調(diào)整滅菌參數(shù)。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 滅菌效果評(píng)估：</span></strong><span style=";font-family:宋體;font-size:20px">定期對(duì)滅菌效果進(jìn)行評(píng)估，根據(jù)生物指示劑的培養(yǎng)結(jié)果、熱分布測(cè)試數(shù)據(jù)以及產(chǎn)品的無(wú)菌檢查結(jié)果等，綜合判斷滅菌工藝的有效性。如果發(fā)現(xiàn)滅菌效果不符合要求，應(yīng)及時(shí)分析原因并采取糾正措施?？梢圆扇∧M灌裝進(jìn)行實(shí)質(zhì)性驗(yàn)證。</span></p><h5 style="margin-bottom:31px;margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">五. </span><strong><span style=";font-family:宋體;font-size:20px">奧克泰士殺孢子劑優(yōu)勢(shì)：</span></strong><strong></strong></h5><p style="margin-left:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:Wingdings;font-size:20px">l </span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">符合</span><span style="font-family:宋體">2025《中國(guó)藥典》規(guī)范，符合新規(guī)理念，對(duì)BFS系統(tǒng)設(shè)備友好，不影響設(shè)備精密準(zhǔn)確性。</span></span></p><p style="margin-left:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:Wingdings;font-size:20px">l </span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">無(wú)殘留、無(wú)毒衍生物、對(duì)人體健康無(wú)害，不影響設(shè)備元件、藥品</span><span style="font-family:宋體">API、包材、輔料穩(wěn)定性。</span></span></p><p style="margin-left:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:Wingdings;font-size:20px">l </span><span style=";font-family:宋體;font-size:20px">良好的材料兼容性，可以長(zhǎng)期規(guī)劃使用。</span></p><p style="margin-left:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:Wingdings;font-size:20px">l </span><span style=";font-family:宋體;font-size:20px">滅菌效率無(wú)差異，</span><span style="font-family: 宋體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:宋體">其主要成分是過(guò)氧化氫</span></span><span style="font-family: 宋體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:宋體">與銀離子</span></span><span style="font-family: 宋體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:宋體">，使用后能夠分解為水和氧氣，</span></span><span style="font-family: 宋體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:宋體">不需要后續(xù)沖洗。</span></span></p><p style="margin-bottom:31px;margin-left:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family: Wingdings;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)">l </span><span style="font-family: 宋體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:宋體">滅菌效期長(zhǎng)，滿(mǎn)足生產(chǎn)批次生產(chǎn)時(shí)間，確保流程正常進(jìn)行，進(jìn)一步保證了生產(chǎn)效率。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><i><span style="font-family: 宋體;font-size: 20px"><span style="font-family:宋體">針對(duì)新規(guī)推進(jìn)，面對(duì)</span><span style="font-family:宋體">BFS微生物，終端滅菌問(wèn)題，建議采用奧克泰士產(chǎn)品！為生產(chǎn)環(huán)境穩(wěn)定、工作效率、微生物控制保駕護(hù)航！我們也將竭誠(chéng)為您提供專(zhuān)業(yè)技術(shù)服務(wù)：</span></span></i></strong><strong><i></i></strong></p><p style="text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（1）</span><span style=";font-family:宋體;font-size:20px">根據(jù)客戶(hù)需求，指導(dǎo)和協(xié)助客戶(hù)建立和完善</span><span style=";font-family:宋體;font-size:20px">BFS</span><span style=";font-family:宋體;font-size:20px">系統(tǒng)</span><span style=";font-family:宋體;font-size:20px">殘留溶劑、</span><span style=";font-family:宋體;font-size:20px">微生物</span><span style=";font-family:宋體;font-size:20px">檢驗(yàn)</span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">體系，包括采樣計(jì)劃、預(yù)防性消毒程序等工作。</span><span style="font-family:宋體"> </span></span></p><p style="margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（2）</span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">指導(dǎo)和協(xié)助客戶(hù)對(duì)實(shí)際生產(chǎn)過(guò)程中微生物污染進(jìn)行分析查。</span><span style="font-family:宋體"> </span></span></p><p style="margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（3）</span><span style=";font-family:宋體;font-size:20px">對(duì)各類(lèi)微生物污染問(wèn)題提供針對(duì)性解決方案，指導(dǎo)和協(xié)助客戶(hù)執(zhí)行方案直至解決微生物污染問(wèn)題，提供閉合鏈條式服務(wù)。</span></p><p style="margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（4）</span><span style=";font-family:宋體;font-size:20px">提供后續(xù)管控方案，防范微生物污染的再次發(fā)生。</span></p><p style="margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（5）</span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">對(duì)客戶(hù)現(xiàn)用消毒產(chǎn)品</span><span style="font-family:宋體">/方式的驗(yàn)證評(píng)估提供技術(shù)建議。</span></span></p><p style="margin-bottom:33px;margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（6）</span><span 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