福建鼎成凈(jing)化(hua)科(ke)技有(you)限公(gong)司歡迎您！
||||
- $
潔凈廠房外部壞境是否需要驗證？
來源：hardcandy99.cn 發布時間：2023/9/8 16:04:34
潔(jie)凈(jing)廠房驗證理應依據藥(yao)物種類、生產制造實際操(cao)作(zuo)規(gui)定(ding)及外部自然環境情況(kuang)等(deng)配備(bei)空(kong)氣(qi)凈(jing)化系統(tong)系統(tong)軟(ruan)件，使(shi)廠區合理自然通風(feng)，并有溫度(du)、環境濕(shi)度(du)操(cao)縱和空(kong)氣(qi)過(guo)濾(lv)過(guo)慮，確保藥(yao)物的(de)工作(zuo)環境符合規(gui)定(ding)。潔(jie)凈(jing)區和非(fei)潔(jie)凈(jing)區中間(jian)(jian)、不(bu)一(yi)樣(yang)等(deng)級潔(jie)凈(jing)區中間(jian)(jian)的(de)壓力差(cha)理應不(bu)少(shao)于(yu)10帕(pa)斯卡(ka)。必需時，同樣(yang)潔(jie)凈(jing)度(du)等(deng)級等(deng)級的(de)不(bu)一(yi)樣(yang)作(zuo)用地區（操(cao)作(zuo)室）中間(jian)(jian)也(ye)理應維持適(shi)度(du)的(de)壓力差(cha)梯度(du)方向。
潔凈廠房制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)的調節工(gong)程驗收(shou)（參考GB/T14294-2008整(zheng)體式制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)），1、文檔查(cha)驗（現行標準(zhun)、合理、齊備(bei)），2、安裝記錄(lu)查(cha)驗（工(gong)程監理紀錄(lu)），3、關鍵零部件查(cha)驗（規(gui)格型(xing)號恰當(dang)，構件齊備(bei)），4、構造和外型(xing)查(cha)驗（符合規(gui)定），5、公共工(gong)程項目查(cha)驗（當(dang)場安裝與(yu)設計方案保持一致），6、制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)透風(feng)量(liang)(liang)檢測。取一外部離(li)心(xin)風(feng)機(ji)(ji)，與(yu)制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)連(lian)接，將制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)其他(ta)張(zhang)口(kou)一部分堵漏嚴實，應用外補離(li)心(xin)風(feng)機(ji)(ji)對制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)開展打(da)擊，在保壓(ya)1000Pa的標準(zhun)下，精細測量(liang)(liang)外部離(li)心(xin)風(feng)機(ji)(ji)送排風(feng)量(liang)(liang)。
對(dui)于潔(jie)凈區凈化(hua)室(shi)技術專業(ye)產品(pin)研發(fa)生產制造的(de)(de)潔(jie)凈區專用(yong)(yong)型監(jian)(jian)(jian)控(kong)(kong)攝像(xiang)(xiang)頭(tou)(tou)，潔(jie)凈區專用(yong)(yong)型監(jian)(jian)(jian)控(kong)(kong)攝像(xiang)(xiang)頭(tou)(tou)是維遠澳波對(dui)于潔(jie)凈區、凈化(hua)車(che)間的(de)(de)獨特應用(yong)(yong)自(zi)然環(huan)境，專業(ye)為制藥廠、五(wu)金廠、醫院門診診室(shi)、食品(pin)加(jia)工廠等(deng)的(de)(de)潔(jie)凈區/無(wu)(wu)菌車(che)間/凈化(hua)車(che)間開(kai)發(fa)設(she)計(ji)的(de)(de)專用(yong)(yong)型網絡攝像(xiang)(xiang)頭(tou)(tou)。該(gai)監(jian)(jian)(jian)控(kong)(kong)攝像(xiang)(xiang)頭(tou)(tou)能夠(gou)無(wu)(wu)縫拼接置入彩鋼瓦安(an)裝，全平環(huan)形外(wai)表層(ceng)與(yu)彩鋼瓦齊(qi)平，無(wu)(wu)臟亂差，易清理易消毒殺菌。該(gai)監(jian)(jian)(jian)控(kong)(kong)攝像(xiang)(xiang)頭(tou)(tou)可對(dui)重要工藝流程、重要職(zhi)位(wei)開(kai)展(zhan)24小時的(de)(de)指定監(jian)(jian)(jian)管。監(jian)(jian)(jian)控(kong)(kong)攝像(xiang)(xiang)頭(tou)(tou)與(yu)維遠澳波OPCMES手機軟(ruan)件融(rong)合應用(yong)(yong)可完成(cheng)潔(jie)凈區檢測警(jing)報事情與(yu)視頻短片關系。
一(yi)般來(lai)說，有清潔(jie)規定(ding)(ding)的(de)潔(jie)凈廠房及有關的(de)空氣凈化系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)都將被判斷(duan)為(wei)立(li)(li)(li)即(ji)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)；一(yi)部(bu)分(fen)(fen)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)盡管(guan)無(wu)清潔(jie)規定(ding)(ding)，但系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)中(zhong)的(de)一(yi)部(bu)分(fen)(fen)主要(yao)(yao)參數將做為(wei)生(sheng)產工藝(yi)流程的(de)關鍵性要(yao)(yao)素，如溫度(du)智能管(guan)理系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)，包含凍庫、溫室大棚等(deng)，該類系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)也在立(li)(li)(li)即(ji)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)之列。除立(li)(li)(li)即(ji)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)以外(wai)的(de)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)，可依照其實際作用界定(ding)(ding)為(wei)間(jian)接性危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)或無(wu)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)。立(li)(li)(li)即(ji)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)遵照GEP規定(ding)(ding)設計方案(an)和(he)(he)調節，并依據GMP規定(ding)(ding)驗證，間(jian)接性危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)和(he)(he)無(wu)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)僅(jin)遵照GEP規定(ding)(ding)開(kai)展(zhan)設計方案(an)和(he)(he)調節。
潔凈廠房制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)的調節工(gong)程驗收(shou)（參考GB/T14294-2008整(zheng)體式制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)），1、文檔查(cha)驗（現行標準(zhun)、合理、齊備(bei)），2、安裝記錄(lu)查(cha)驗（工(gong)程監理紀錄(lu)），3、關鍵零部件查(cha)驗（規(gui)格型(xing)號恰當(dang)，構件齊備(bei)），4、構造和外型(xing)查(cha)驗（符合規(gui)定），5、公共工(gong)程項目查(cha)驗（當(dang)場安裝與(yu)設計方案保持一致），6、制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)透風(feng)量(liang)(liang)檢測。取一外部離(li)心(xin)風(feng)機(ji)(ji)，與(yu)制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)連(lian)接，將制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)其他(ta)張(zhang)口(kou)一部分堵漏嚴實，應用外補離(li)心(xin)風(feng)機(ji)(ji)對制(zhi)冷(leng)(leng)(leng)機(ji)(ji)組(zu)(zu)開展打(da)擊，在保壓(ya)1000Pa的標準(zhun)下，精細測量(liang)(liang)外部離(li)心(xin)風(feng)機(ji)(ji)送排風(feng)量(liang)(liang)。
對(dui)于潔(jie)凈區凈化(hua)室(shi)技術專業(ye)產品(pin)研發(fa)生產制造的(de)(de)潔(jie)凈區專用(yong)(yong)型監(jian)(jian)(jian)控(kong)(kong)攝像(xiang)(xiang)頭(tou)(tou)，潔(jie)凈區專用(yong)(yong)型監(jian)(jian)(jian)控(kong)(kong)攝像(xiang)(xiang)頭(tou)(tou)是維遠澳波對(dui)于潔(jie)凈區、凈化(hua)車(che)間的(de)(de)獨特應用(yong)(yong)自(zi)然環(huan)境，專業(ye)為制藥廠、五(wu)金廠、醫院門診診室(shi)、食品(pin)加(jia)工廠等(deng)的(de)(de)潔(jie)凈區/無(wu)(wu)菌車(che)間/凈化(hua)車(che)間開(kai)發(fa)設(she)計(ji)的(de)(de)專用(yong)(yong)型網絡攝像(xiang)(xiang)頭(tou)(tou)。該(gai)監(jian)(jian)(jian)控(kong)(kong)攝像(xiang)(xiang)頭(tou)(tou)能夠(gou)無(wu)(wu)縫拼接置入彩鋼瓦安(an)裝，全平環(huan)形外(wai)表層(ceng)與(yu)彩鋼瓦齊(qi)平，無(wu)(wu)臟亂差，易清理易消毒殺菌。該(gai)監(jian)(jian)(jian)控(kong)(kong)攝像(xiang)(xiang)頭(tou)(tou)可對(dui)重要工藝流程、重要職(zhi)位(wei)開(kai)展(zhan)24小時的(de)(de)指定監(jian)(jian)(jian)管。監(jian)(jian)(jian)控(kong)(kong)攝像(xiang)(xiang)頭(tou)(tou)與(yu)維遠澳波OPCMES手機軟(ruan)件融(rong)合應用(yong)(yong)可完成(cheng)潔(jie)凈區檢測警(jing)報事情與(yu)視頻短片關系。
一(yi)般來(lai)說，有清潔(jie)規定(ding)(ding)的(de)潔(jie)凈廠房及有關的(de)空氣凈化系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)都將被判斷(duan)為(wei)立(li)(li)(li)即(ji)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)；一(yi)部(bu)分(fen)(fen)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)盡管(guan)無(wu)清潔(jie)規定(ding)(ding)，但系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)中(zhong)的(de)一(yi)部(bu)分(fen)(fen)主要(yao)(yao)參數將做為(wei)生(sheng)產工藝(yi)流程的(de)關鍵性要(yao)(yao)素，如溫度(du)智能管(guan)理系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)，包含凍庫、溫室大棚等(deng)，該類系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)也在立(li)(li)(li)即(ji)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)之列。除立(li)(li)(li)即(ji)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)以外(wai)的(de)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)，可依照其實際作用界定(ding)(ding)為(wei)間(jian)接性危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)或無(wu)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)。立(li)(li)(li)即(ji)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)遵照GEP規定(ding)(ding)設計方案(an)和(he)(he)調節，并依據GMP規定(ding)(ding)驗證，間(jian)接性危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)和(he)(he)無(wu)危(wei)害(hai)(hai)(hai)(hai)系(xi)(xi)(xi)(xi)統(tong)(tong)(tong)軟(ruan)(ruan)(ruan)件(jian)(jian)(jian)(jian)僅(jin)遵照GEP規定(ding)(ding)開(kai)展(zhan)設計方案(an)和(he)(he)調節。
上一條：
無塵車間凈化工程的優缺點及特點
下一條：
潔凈區廠房對回風口有要求嗎？
