醫療器械潔凈廠房布局需以生(sheng)產工藝(yi)流程為(wei)依據，流線(xian)盡量(liang)要短以方便操作(zuo)和過程控制。

1、人、物流各行其道，禁止交叉(cha)往復，避免污染。

2、潔凈生產區內只設(she)置必要的工藝設(she)備(bei)和設(she)施，需(xu)有(you)與(yu)生產規模(mo)相適(shi)應(ying)的空間存放潔凈區內生產的零配件或產品，且(qie)盡可能靠近與(yu)其相聯系的生產區域。

3、不同潔(jie)凈度等級的潔(jie)凈區(qu)按從高到低，由里及外布置(zhi)，空氣潔(jie)凈度高的潔(jie)凈區(qu)要布置(zhi)在最(zui)少(shao)人員到達或經過的區(qu)域。

4、空氣凈化符合GB 50457-2008《醫藥工業潔凈廠房設計規范》第九章的(de)要求，潔凈室里的(de)新(xin)鮮空氣量，應取下列最大值：

1）補償室內排風量(liang)和保持室內正壓(ya)所需(xu)新鮮空氣(qi)量(liang)；

2）室內(nei)沒(mei)人新(xin)鮮空氣(qi)不應小(xiao)于40立方米/h。

6、潔(jie)凈室(shi)人均(jun)面積不少于4㎡（除走廊、設備等物品(pin)外(wai)），保證有(you)安(an)全的操作區域。

潔凈廠房凈化空調施工要求:

1、風管(guan)和部(bu)件(jian)應采(cai)(cai)用(yong)優質鍍辭鋼板，風管(guan)內表面(mian)必(bi)須(xu)(xu)平整光(guang)滑，不得在管(guan)內加固(gu)風管(guan)，咬(yao)接(jie)應采(cai)(cai)用(yong)聯合角咬(yao)口，接(jie)縫必(bi)須(xu)(xu)涂密(mi)封(feng)膠(jiao)。風管(guan)連接(jie)不應采(cai)(cai)用(yong)內法蘭。風管(guan)必(bi)須(xu)(xu)設(she)密(mi)封(feng)清掃孔(kong)，總(zong)管(guan)上(shang)(shang)應有風量測定孔(kong)(支(zhi)干(gan)管(guan)上(shang)(shang)根據需要(yao)(yao)設(she)置）過(guo)濾(lv)器前后要(yao)(yao)有測壓孔(kong)。防爆區排風管(guan)咬(yao)口縫要(yao)(yao)用(yong)焊錫密(mi)封(feng)。

2、風管安裝之(zhi)后(hou)、保溫之(zhi)前(qian)應(ying)(ying)進行(xing)漏(lou)風檢查。送回(hui)風管用(yong)漏(lou)光法(fa)檢查應(ying)(ying)無漏(lou)光，系統(tong)空(kong)調器漏(lou)風率不應(ying)(ying)大(da)于2%。擦(ca)拭(shi)空(kong)調系統(tong)內表面采用(yong)不易掉纖(xian)維(wei)的材料。

3、**過濾(lv)器(qi)安裝前(qian)必須對(dui)潔凈房(fang)間和凈化(hua)空(kong)調系(xi)統(tong)**清(qing)掃、擦(ca)洗，達到(dao)清(qing)潔要(yao)求后，開(kai)啟凈化(hua)空(kong)調系(xi)統(tong)連續(xu)試(shi)運行(xing)12小時以(yi)上，再次清(qing)掃，擦(ca)洗潔凈室，立即安裝**過濾(lv)器(qi)。

7、標明回風(feng)、送風(feng)及(ji)制水管道(dao)的走向。

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