制藥廠潔凈室如何安裝？注意事項有哪些

　　為(wei)了適(shi)應我國藥(yao)(yao)品行(xing)業的(de)(de)(de)(de)新形勢、新發展，以更嚴(yan)格、更完(wan)善的(de)(de)(de)(de)藥(yao)(yao)品生產(chan)質(zhi)量(liang)管(guan)理規范來(lai)提高(gao)藥(yao)(yao)品的(de)(de)(de)(de)質(zhi)量(liang)，衛生部于(yu)2011年3月1日起實施(shi)(shi)2010年修訂版GMP。根據新版GMP要(yao)(yao)求(qiu)(qiu)，GMP認證(zheng)由(you)過去的(de)(de)(de)(de)靜態(tai)變更為(wei)動態(tai)，這意味著對潔凈(jing)(jing)室(shi)的(de)(de)(de)(de)要(yao)(yao)求(qiu)(qiu)越(yue)來(lai)越(yue)高(gao)，醫(yi)藥(yao)(yao)企業要(yao)(yao)從設計、施(shi)(shi)工(gong)以及(ji)后(hou)期運行(xing)管(guan)理等方(fang)面進行(xing)全方(fang)位的(de)(de)(de)(de)質(zhi)量(liang)控制才能滿足新版GMP要(yao)(yao)求(qiu)(qiu)。施(shi)(shi)工(gong)作為(wei)潔凈(jing)(jing)室(shi)形成的(de)(de)(de)(de)重要(yao)(yao)階(jie)段，要(yao)(yao)求(qiu)(qiu)施(shi)(shi)工(gong)人員嚴(yan)格按(an)照潔凈(jing)(jing)室(shi)要(yao)(yao)求(qiu)(qiu)進行(xing)制作安(an)裝(zhuang)。潔凈(jing)(jing)空調系統、凈(jing)(jing)化彩鋼(gang)板系統及(ji)潔凈(jing)(jing)地坪是(shi)潔凈(jing)(jing)室(shi)的(de)(de)(de)(de)重要(yao)(yao)組成部分(fen)，保證(zheng)高(gao)質(zhi)量(liang)高(gao)水(shui)平的(de)(de)(de)(de)施(shi)(shi)工(gong)以確保GMP認證(zheng)的(de)(de)(de)(de)順利通(tong)過。

　　-01-材料選用

　　風(feng)(feng)管(guan)材料選(xuan)用(yong)(yong)：新版GMP采用(yong)(yong)世界衛生組織和歐盟最新的A、B、C、D分(fen)級(ji)標(biao)準對潔凈等(deng)級(ji)進(jin)行(xing)劃分(fen)。一般，潔凈室潔凈等(deng)級(ji)為C級(ji)，局部(bu)A級(ji)或(huo)B級(ji)，這樣就要求(qiu)潔凈空調(diao)系(xi)統(tong)風(feng)(feng)管(guan)選(xuan)用(yong)(yong)質(zhi)(zhi)量及性(xing)能較好(hao)的鍍(du)鋅鋼板(ban)，鍍(du)鋅鋼板(ban)應(ying)(ying)選(xuan)用(yong)(yong)鍍(du)鋅層(ceng)均勻，無明顯氧化層(ceng)，無針孔(kong)、麻點(dian)、起皮(pi)、起泡(pao)和鍍(du)鋅層(ceng)脫落的優質(zhi)(zhi)板(ban)。吊架、連(lian)接螺栓、鉚釘(ding)均應(ying)(ying)采用(yong)(yong)鍍(du)鋅件。風(feng)(feng)管(guan)法(fa)蘭可采用(yong)(yong)普通角鋼加(jia)工，但要做好(hao)除銹涂防銹漆工作。風(feng)(feng)管(guan)的外保溫一般采用(yong)(yong)橡塑保溫，防排煙系(xi)統(tong)風(feng)(feng)管(guan)采用(yong)(yong)玻璃棉保溫。

　　凈(jing)化彩(cai)(cai)(cai)(cai)鋼(gang)板(ban)(ban)材(cai)料(liao)選用(yong)：為(wei)了(le)達到潔(jie)凈(jing)室不易積(ji)塵(chen)的(de)要求(qiu)，潔(jie)凈(jing)廠房的(de)圍護結構(gou)均采(cai)用(yong)不燃性凈(jing)化彩(cai)(cai)(cai)(cai)鋼(gang)板(ban)(ban)。凈(jing)化壁板(ban)(ban)應耐腐蝕、不易積(ji)塵(chen)、平整度(du)(du)好、強(qiang)度(du)(du)高、密封(feng)效果好，一(yi)般(ban)多采(cai)用(yong)50(76)型和100型金(jin)屬壁板(ban)(ban)。壁板(ban)(ban)面板(ban)(ban)材(cai)料(liao)為(wei)聚脂(zhi)涂層彩(cai)(cai)(cai)(cai)色鋼(gang)板(ban)(ban)，內部為(wei)石(shi)膏板(ban)(ban)，石(shi)膏板(ban)(ban)外面加貼防潮鍍(du)鋅(xin)鋼(gang)板(ban)(ban)。凈(jing)化吊(diao)(diao)(diao)頂(ding)板(ban)(ban)要求(qiu)有韌性、平整度(du)(du)好、強(qiang)度(du)(du)高，一(yi)般(ban)多采(cai)用(yong)55型氧(yang)(yang)化鎂內襯(chen)紙(zhi)蜂(feng)窩(wo)凈(jing)化彩(cai)(cai)(cai)(cai)鋼(gang)板(ban)(ban)吊(diao)(diao)(diao)頂(ding)。吊(diao)(diao)(diao)頂(ding)面板(ban)(ban)材(cai)料(liao)為(wei)聚脂(zhi)涂層彩(cai)(cai)(cai)(cai)色鋼(gang)板(ban)(ban)，內部為(wei)5 mm厚(hou)氧(yang)(yang)化鎂板(ban)(ban)加紙(zhi)蜂(feng)窩(wo)加5 mm厚(hou)氧(yang)(yang)化鎂板(ban)(ban)，用(yong)膠(jiao)粘接，通過這樣的(de)加強(qiang)結構(gou)且吊(diao)(diao)(diao)裝牢固，能滿足檢修人員的(de)行走(zou)荷載。凈(jing)化彩(cai)(cai)(cai)(cai)鋼(gang)板(ban)(ban)之間的(de)縫隙采(cai)用(yong)食品級密封(feng)膠(jiao)進行密封(feng)，以(yi)盡(jin)量減少積(ji)塵(chen)區域。

　　潔(jie)凈地(di)(di)坪材料(liao)(liao)選用(yong)(yong)(yong)：潔(jie)凈室潔(jie)凈地(di)(di)坪通常由環氧砂漿(jiang)自(zi)流地(di)(di)坪和(he)PVC地(di)(di)坪組(zu)成(cheng)。一般環氧自(zi)流地(di)(di)坪主要(yao)由砂漿(jiang)及(ji)面涂層(ceng)組(zu)成(cheng)。環氧砂漿(jiang)系統選用(yong)(yong)(yong)由環氧樹(shu)脂(zhi)、胺固(gu)化(hua)劑和(he)級配混(hun)合(he)了無(wu)機顏料(liao)(liao)的骨料(liao)(liao)組(zu)成(cheng)。根(gen)據施工要(yao)求，該系統的施工厚度為(wei)3-?6mm。該系統的砂漿(jiang)層(ceng)固(gu)化(hua)后非(fei)常堅硬，耐(nai)沖擊，具(ju)(ju)(ju)有優(you)良的耐(nai)磨(mo)、耐(nai)用(yong)(yong)(yong)和(he)耐(nai)化(hua)學腐蝕的特性。面涂層(ceng)選用(yong)(yong)(yong)具(ju)(ju)(ju)有雙組(zu)分、100%堅固(gu)通用(yong)(yong)(yong)的環氧涂層(ceng)，通過(guo)獨特的配方提供了對眾多化(hua)學品的防護功能(neng)，還有耐(nai)磨(mo)和(he)易(yi)清潔(jie)性能(neng)。PVC地(di)(di)坪以聚氯乙烯及(ji)其共聚樹(shu)脂(zhi)為(wei)主要(yao)原料(liao)(liao)，加入填料(liao)(liao)、增塑劑、穩定(ding)劑、著色劑等輔料(liao)(liao)，具(ju)(ju)(ju)有耐(nai)磨(mo)、耐(nai)刮(gua)擦、防火阻(zu)燃、吸(xi)音、無(wu)縫焊接等特點。

　　-02-風管制作安裝

　　風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)制(zhi)(zhi)作：風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)制(zhi)(zhi)作應(ying)(ying)在(zai)相(xiang)對密(mi)封的(de)(de)室(shi)內(nei)進(jin)行(xing)，以保證風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)制(zhi)(zhi)作環境(jing)干凈、無灰(hui)塵(chen)、無污(wu)染(ran)。風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)下料時(shi)，應(ying)(ying)特別(bie)注(zhu)意彎頭、變(bian)徑(jing)及三(san)、四通(tong)的(de)(de)開料，這些異(yi)形管(guan)(guan)(guan)(guan)極(ji)易因下料的(de)(de)失(shi)誤使(shi)得(de)(de)風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)拼(pin)(pin)接(jie)(jie)(jie)(jie)后(hou)出(chu)現(xian)縫(feng)隙，造成(cheng)泄漏(lou)。根據新版GMP要求，為了防(fang)止風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)拼(pin)(pin)接(jie)(jie)(jie)(jie)縫(feng)處積塵(chen)，影響(xiang)潔凈室(shi)潔凈度(du)，風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)制(zhi)(zhi)作時(shi)應(ying)(ying)特別(bie)注(zhu)意矩形風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)邊(bian)長小(xiao)于或(huo)等(deng)(deng)(deng)于900 mm時(shi)底面(mian)(mian)(mian)板(ban)不(bu)(bu)(bu)應(ying)(ying)有拼(pin)(pin)接(jie)(jie)(jie)(jie)縫(feng)，邊(bian)長大(da)于900 mm時(shi)底面(mian)(mian)(mian)板(ban)不(bu)(bu)(bu)應(ying)(ying)有橫向(xiang)拼(pin)(pin)接(jie)(jie)(jie)(jie)縫(feng)。風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)與(yu)法(fa)蘭(lan)需采(cai)用翻邊(bian)連接(jie)(jie)(jie)(jie)，翻邊(bian)應(ying)(ying)平(ping)整，寬度(du)一致，且不(bu)(bu)(bu)小(xiao)于6mm，并(bing)不(bu)(bu)(bu)得(de)(de)有開裂的(de)(de)孔洞，連接(jie)(jie)(jie)(jie)后(hou)還(huan)要在(zai)風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)內(nei)部鉚(liu)釘(ding)與(yu)風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)連接(jie)(jie)(jie)(jie)處涂抹一層中(zhong)性(xing)密(mi)封膠以防(fang)泄漏(lou)。風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)咬(yao)口(kou)制(zhi)(zhi)作應(ying)(ying)盡量(liang)采(cai)用聯合角(jiao)或(huo)轉(zhuan)角(jiao)咬(yao)口(kou)不(bu)(bu)(bu)得(de)(de)使(shi)用按扣式(shi)咬(yao)口(kou)，咬(yao)口(kou)處鍍(du)鋅層損壞(huai)的(de)(de)、鉚(liu)釘(ding)孔處以及法(fa)蘭(lan)焊接(jie)(jie)(jie)(jie)處的(de)(de)鍍(du)鋅層損壞(huai)的(de)(de)必(bi)須補做防(fang)腐。規格大(da)的(de)(de)風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)應(ying)(ying)盡量(liang)以整板(ban)制(zhi)(zhi)作，盡可能減少加強(qiang)筋(jin)，必(bi)須設加強(qiang)筋(jin)的(de)(de)也不(bu)(bu)(bu)得(de)(de)使(shi)用壓筋(jin)加強(qiang)和(he)風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)內(nei)加強(qiang)筋(jin)。制(zhi)(zhi)作完成(cheng)的(de)(de)風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)應(ying)(ying)用中(zhong)性(xing)洗滌劑進(jin)行(xing)清洗，去(qu)除(chu)鋼板(ban)表面(mian)(mian)(mian)的(de)(de)油(you)污(wu)和(he)污(wu)漬，沖洗干凈后(hou)用干凈白綢(chou)布擦拭，晾(liang)干后(hou)用塑料薄膜將風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)兩端密(mi)封，以防(fang)止灰(hui)塵(chen)等(deng)(deng)(deng)進(jin)入風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)，造成(cheng)內(nei)壁污(wu)染(ran)。風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)制(zhi)(zhi)作時(shi)的(de)(de)質量(liang)通(tong)病如風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)大(da)邊(bian)上下有不(bu)(bu)(bu)同程度(du)下沉、兩側面(mian)(mian)(mian)小(xiao)邊(bian)稍向(xiang)外凸出(chu)、有明(ming)顯(xian)變(bian)形、法(fa)蘭(lan)翻邊(bian)四角(jiao)漏(lou)風(feng)(feng)(feng)(feng)(feng)(feng)、鉚(liu)釘(ding)脫(tuo)落、風(feng)(feng)(feng)(feng)(feng)(feng)管(guan)(guan)(guan)(guan)法(fa)蘭(lan)連接(jie)(jie)(jie)(jie)不(bu)(bu)(bu)方等(deng)(deng)(deng)應(ying)(ying)進(jin)行(xing)重點控制(zhi)(zhi)。

　　風管(guan)安(an)裝(zhuang)：潔(jie)凈風管(guan)的(de)吊裝(zhuang)必須(xu)在建(jian)筑專業(ye)(包括地面、墻面、樓(lou)板)油漆、吸(xi)聲高架(jia)地板等完成后進(jin)行(xing)，否則風管(guan)的(de)潔(jie)凈度(du)難以得(de)到保證。風管(guan)各(ge)管(guan)段連接時，應(ying)邊拆密封(feng)(feng)薄(bo)膜(mo)邊連接，盡量(liang)保持(chi)風管(guan)的(de)潔(jie)凈度(du)。法蘭(lan)墊片的(de)搭接處(chu)必須(xu)采(cai)用(yong)楔形接口(kou)(kou)，以免在墊片搭接處(chu)發(fa)生泄(xie)漏(lou)。安(an)裝(zhuang)后開口(kou)(kou)末端仍要保持(chi)封(feng)(feng)口(kou)(kou)狀態。風管(guan)保溫應(ying)在系統管(guan)路(lu)安(an)裝(zhuang)及漏(lou)光、漏(lou)風檢測合格后進(jin)行(xing)，保溫完成后室內(nei)衛生必須(xu)徹底打掃干凈。

　　-03-凈化彩鋼板安裝

　　凈化(hua)彩鋼(gang)板(ban)(ban)安(an)裝(zhuang)：施(shi)工(gong)(gong)(gong)時(shi)，技術(shu)夾層內(nei)(nei)水電等主要管(guan)線(xian)已完(wan)成，吊(diao)頂(ding)(ding)(ding)內(nei)(nei)除少量設備接(jie)線(xian)的(de)安(an)裝(zhuang)工(gong)(gong)(gong)程(cheng)外，均應(ying)基(ji)(ji)本(ben)結(jie)束，吊(diao)頂(ding)(ding)(ding)施(shi)工(gong)(gong)(gong)后(hou)，不應(ying)繼續有較多(duo)(duo)的(de)吊(diao)頂(ding)(ding)(ding)內(nei)(nei)的(de)安(an)裝(zhuang)工(gong)(gong)(gong)作。凈化(hua)彩鋼(gang)板(ban)(ban)有先安(an)裝(zhuang)墻板(ban)(ban)后(hou)安(an)裝(zhuang)頂(ding)(ding)(ding)板(ban)(ban)和先安(an)裝(zhuang)頂(ding)(ding)(ding)板(ban)(ban)后(hou)安(an)裝(zhuang)墻板(ban)(ban)兩(liang)種安(an)裝(zhuang)工(gong)(gong)(gong)藝(yi)。后(hou)者施(shi)工(gong)(gong)(gong)工(gong)(gong)(gong)藝(yi)有利于(yu)其(qi)他專業的(de)后(hou)續施(shi)工(gong)(gong)(gong)，比如(ru)風(feng)管(guan)高效過濾口位(wei)置的(de)預留、潔凈燈具位(wei)置的(de)預留等，因此，目前(qian)大(da)多(duo)(duo)采用后(hou)者施(shi)工(gong)(gong)(gong)工(gong)(gong)(gong)藝(yi)。彩板(ban)(ban)安(an)裝(zhuang)時(shi)從房(fang)(fang)間選擇一(yi)點作為基(ji)(ji)準(zhun)點向四周(zhou)放(fang)線(xian)，一(yi)般從兩(liang)條走(zou)廊的(de)交界處的(de)柱子開始放(fang)線(xian)，不僅(jin)可(ke)以避免潔凈度要求高的(de)房(fang)(fang)間出(chu)現(xian)較多(duo)(duo)的(de)非標板(ban)(ban)，導致接(jie)縫變多(duo)(duo)，影響潔凈等級，而且(qie)從兩(liang)條走(zou)廊的(de)交點出(chu)發，可(ke)分別(bie)往兩(liang)個方向同時(shi)放(fang)線(xian)，施(shi)工(gong)(gong)(gong)進(jin)度快。

　　凈化頂(ding)板(ban)安裝：通(tong)過龍骨(gu)連(lian)接(jie)件(jian)，將吊桿絲桿和(he)比龍骨(gu)小一個型(xing)號的(de)C型(xing)鋼(gang)連(lian)接(jie)，然后直接(jie)將龍骨(gu)套(tao)在(zai)小C型(xing)鋼(gang)上，完(wan)成(cheng)頂(ding)板(ban)龍骨(gu)的(de)安裝。通(tong)過調節吊桿絲桿長度，將吊頂(ding)龍骨(gu)盡量位(wei)于同(tong)一水(shui)平面(mian)上。吊頂(ding)龍骨(gu)安裝完(wan)畢，將吊頂(ding)板(ban)通(tong)過自攻螺釘固定在(zai)龍骨(gu)下表(biao)面(mian)。頂(ding)板(ban)安裝應平整(zheng)、嚴(yan)密(mi)、均勻一致，縫(feng)隙控制在(zai)2 mm以內，以保證(zheng)后續打膠(jiao)密(mi)封質量。

　　凈化墻(qiang)(qiang)(qiang)板(ban)(ban)安(an)(an)裝(zhuang)(zhuang)(zhuang)：頂板(ban)(ban)安(an)(an)裝(zhuang)(zhuang)(zhuang)的(de)(de)(de)(de)同(tong)時(shi)，對(dui)墻(qiang)(qiang)(qiang)板(ban)(ban)的(de)(de)(de)(de)天軌(gui)、地(di)(di)(di)(di)軌(gui)進行安(an)(an)裝(zhuang)(zhuang)(zhuang)。地(di)(di)(di)(di)軌(gui)分(fen)(fen)(fen)為(wei)(wei)兩部(bu)分(fen)(fen)(fen)，一(yi)部(bu)分(fen)(fen)(fen)利用(yong)自攻釘固定在地(di)(di)(di)(di)面的(de)(de)(de)(de)地(di)(di)(di)(di)槽上(shang)，高(gao)度為(wei)(wei)5 cm;另一(yi)部(bu)分(fen)(fen)(fen)蓋(gai)在地(di)(di)(di)(di)槽H型鋼(gang)(gang)的(de)(de)(de)(de)地(di)(di)(di)(di)軌(gui)上(shang)，利用(yong)自攻釘固定在地(di)(di)(di)(di)槽上(shang)，高(gao)度為(wei)(wei)5 cm。通(tong)過(guo)(guo)調節(jie)蓋(gai)在地(di)(di)(di)(di)槽H型鋼(gang)(gang)上(shang)的(de)(de)(de)(de)地(di)(di)(di)(di)軌(gui)，以達(da)到調節(jie)地(di)(di)(di)(di)軌(gui)標高(gao)的(de)(de)(de)(de)目的(de)(de)(de)(de)。墻(qiang)(qiang)(qiang)板(ban)(ban)安(an)(an)裝(zhuang)(zhuang)(zhuang)時(shi)，利用(yong)激光水平(ping)儀(yi)及時(shi)調整墻(qiang)(qiang)(qiang)板(ban)(ban)的(de)(de)(de)(de)垂直(zhi)(zhi)度，防(fang)止(zhi)彩板(ban)(ban)安(an)(an)裝(zhuang)(zhuang)(zhuang)時(shi)產(chan)生較大(da)的(de)(de)(de)(de)誤差(cha)。為(wei)(wei)了(le)防(fang)止(zhi)累(lei)積(ji)誤差(cha)造成(cheng)(cheng)墻(qiang)(qiang)(qiang)板(ban)(ban)傾斜扭曲，墻(qiang)(qiang)(qiang)板(ban)(ban)之間(jian)縫(feng)隙應控制(zhi)在2 mm之內，墻(qiang)(qiang)(qiang)板(ban)(ban)安(an)(an)裝(zhuang)(zhuang)(zhuang)應平(ping)整、嚴(yan)密、均勻一(yi)致，墻(qiang)(qiang)(qiang)角(jiao)垂直(zhi)(zhi)交接(jie)，立板(ban)(ban)垂直(zhi)(zhi)偏差(cha)不大(da)于2%。內三維陰角(jiao)安(an)(an)裝(zhuang)(zhuang)(zhuang)前(qian)應在內側(ce)作加固處理，防(fang)止(zhi)以后(hou)潔凈室使(shi)用(yong)清掃時(shi)將其碰掉(diao)。待墻(qiang)(qiang)(qiang)板(ban)(ban)安(an)(an)裝(zhuang)(zhuang)(zhuang)完成(cheng)(cheng)后(hou)，重(zhong)新校核吊(diao)頂板(ban)(ban)的(de)(de)(de)(de)標高(gao)，通(tong)過(guo)(guo)調節(jie)吊(diao)桿，使(shi)吊(diao)頂板(ban)(ban)與墻(qiang)(qiang)(qiang)板(ban)(ban)的(de)(de)(de)(de)頂板(ban)(ban)靠(kao)在一(yi)起(qi)，以加強吊(diao)頂板(ban)(ban)的(de)(de)(de)(de)承載力。