楂樻晥閬庢烤鍣�DOP妾㈡紡娉曞湪鍒惰棩浼佹キ(y猫)涓殑鎳�(y墨ng)鐢�
鎽樿嚜:
楂樻晥閬庢烤鍣紙HEPA锛変竴鑸槸鎸囧皪绮掑緫澶т簬绛変簬0.3um绮掑瓙鐨勬崟闆嗘晥鐜囧湪99.97锛呬互涓婄殑閬庢烤鍣紝閫氬父浣滅偤鍒惰棩浼佹キ(y猫)娼斿噲杌婇枔鐨勬湯绔亷婵捐缃紝鐢ㄤ互鎻愪緵娼斿噲鐨勭┖姘c€傛綌鍑堝鏄惁鑳介仈鍒板拰淇濇寔瑷�(sh猫)瑷堢殑娼斿噲绱氬垾鍦ㄤ竴瀹氱▼搴︿笂鑸囬珮鏁堥亷婵惧櫒鐨勬€ц兘鍙婂叾瀹夎鏈夐棞(gu膩n)銆傚洜姝ゅ皪娼斿噲杌婇枔鐨勯珮鏁堥亷婵惧櫒閫茶妾㈡紡娓│锛岀⒑淇濆叾绗﹀悎瑕佹眰锛屾槸淇濊瓑杌婇枔娼斿噲鐠�(hu谩n)澧冪殑閲嶈鎵嬫涔嬩竴銆�,FDA鍦ㄧ劇鑿岃棩鍝佺敓鐢�(ch菐n)鎸囧崡涓篃鎸囧嚭鍦ㄩ珮鏁堥亷婵惧櫒瀹夎鍚庢噳(y墨ng)閫茶妾㈡紡娓│锛屼互妾㈡煡閬庢烤鍣ㄥ瘑灏佸銆佹鏋跺強閬庢烤鍣ㄦ烤鏉愮瓑铏曠殑瀵嗗皝鎬�锛屽皪浜庣劇鑿屽埗鍔戠敓鐢�(ch菐n)杌婇枔鎳�(y墨ng)瀹氭湡閫茶楂樻晥閬庢烤鍣ㄧ殑妾㈡紡瑭﹂銆�
1 楂樻晥閬庢烤鍣ㄦ婕忕洰鐨�
楂樻晥閬庢烤鍣ㄦ湰韬殑閬庢烤鏁堢巼涓€鑸敱鐢熺敘(ch菐n)寤犲妾㈡脯锛屽嚭寤犳檪闄勬湁婵惧櫒閬庢烤鏁堢巼鍫卞憡鍠拰鍚堟牸璀夋槑銆傚皪鍒惰棩浼佹キ(y猫)渚嗚锛岄珮鏁堥亷婵惧櫒妾㈡紡鏄寚楂樻晥閬庢烤鍣ㄥ強鍏剁郴绲�(t菕ng)瀹夎鍚庣殑鐝�(xi脿n)鍫存婕�锛屼富瑕佹槸妾㈡煡閬庢烤鍣ㄦ烤鏉愪腑鐨勫皬閲濆瓟鍜屽叾浠栨悕澹�锛屽妗嗘灦瀵嗗皝銆佸鍦堝瘑灏佷互鍙婇亷婵惧櫒妲�(g貌u)鏋朵笂鐨勬紡绺瓑銆傛婕忕殑鐩殑鏄€氶亷妾㈡煡楂樻晥閬庢烤鍣ㄥ強鍏惰垏瀹夎妗嗘灦閫f帴閮ㄤ綅绛夎檿鐨勫瘑灏佹€э紝鍙婃檪鐧�(f膩)鐝�(xi脿n)楂樻晥閬庢烤鍣ㄦ湰韬強瀹夎涓瓨鍦ㄧ殑缂洪櫡锛岄噰鍙栫浉鎳�(y墨ng)鐨勮鏁戞帾鏂斤紝淇濊瓑鍗€(q奴)鍩熺殑娼斿噲搴�銆�
2 DOP 妾㈡紡娉曞師鐞�
楂樻晥閬庢烤鍣ㄧ殑妾㈡紡閫氬父閲囩敤PAO鐧�(f膩)鐢熷櫒鍦ㄦ烤鍣ㄤ笂娓哥櫦(f膩)濉碉紝浣跨敤鍏夊害瑷堬紙photometer锛夋娓烤鍣ㄤ笂涓嬫父姘f憾鑶犳績搴︿締鍒ゅ畾婵惧櫒鏄惁鏈夋硠婕�銆傜櫦(f膩)濉电殑鐩殑鏄洜楂樻晥閬庢烤鍣ㄤ笂娓稿〉绮掓績搴﹁純浣庯紝鍍呯敤绮掑瓙瑷堟暩(sh霉)鍣ㄥ湪涓嶇櫦(f膩)濉电殑鎯呮硜涓嬫娓�锛岃純闆g櫦(f膩)鐝�(xi脿n)鏈夋硠婕忥紝闇€瑁滃厖鐧�(f膩)濉垫墠鑳芥槑椤�銆佸鏄撳湴鐧�(f膩)鐝�(xi脿n)娉勬紡銆�
浜哄伐姘f憾鑶�DOP 宸叉湁杩�40 骞存鍙�锛屼竴娈垫檪闁撲互渚�锛屽洜琚嚪鐤戝皪浜烘湁鑷寸檶浣滅敤锛岀従(xi脿n)甯镐互DOS锛�Dioctylsebaeate鐧镐簩閰镐簩杈涜剛锛変害绋�DEHS[di(2- ethylexyl)sebacate]鍙�PAO(polyaphaolefin鑱�a鐑兇锛夌瓑浠f浛锛屼絾瀵﹂鏂规硶浠嶇ū鈥�DOP娉曗€�銆傚ぇ姘e〉鐢变簬鍏舵績搴﹂毃鍦伴粸鍙婃檪闁撶瓑璁婂寲锛屾湁鏅傝純澶�锛屾湁鏅傝純浣�锛屼竴鑸笉鐢ㄤ締浣滅偤妾㈡紡鐢�銆�FDA鎸囧嚭鍦ㄩ€茶妾㈡紡鏅�锛岄伕鐢ㄧ殑姘f憾鑶犳噳(y墨ng)绗﹀悎涓€瀹氱殑鐞嗗寲瑕佹眰锛屼笉鎳�(y墨ng)浣跨敤鏈冨紩璧峰井鐢熺墿姹℃煋銆侀€犳垚寰敓鐗╂粙鐢熺殑姘f憾鑶�銆�
PAO鐧�(f膩)鐢熷櫒鍙垎鐐虹啽鐧�(f膩)鐢熷拰鍐风櫦(f膩)鐢熷叐绋�锛岀啽鐧�(f膩)鐢熷櫒鏄埄鐢ㄨ捀鐧�(f膩)鍐峰嚌鐨勫師鐞�锛岃闇у寲鐨勬埃婧惰啝绮掑瓙鐢ㄥ姞鐔卞櫒钂哥櫦(f膩)锛屽苟鍦ㄧ壒瀹氭浠朵笅鍐峰嚌鎴愬井灏忔恫婊达紝鍘绘帀閬庡ぇ鍜岄亷灏忕殑娑叉淮鍚庣暀涓�0.3um宸﹀彸鐨勯湩鐙€DOP閫插叆棰�(f膿ng)閬�锛岀矑寰戝垎甯冨湪0.1锝�0.3um銆傚喎鐧�(f膩)鐢熷櫒鏄寚鍒╃敤澹撶府绌烘埃鍦ㄦ恫楂斾腑榧撴埃娉�锛岀稉(j墨ng)laskin鍣寸椋涙亢鐢�(ch菐n)鐢熺墿鎱�(t脿i)鐨勫鍒嗘暎鐩�DOP姘f憾鑶�锛屾渶澶у垎甯冪矑寰戝湪0.65um宸﹀彸銆傚湪灏嶉亷婵惧櫒閫茶鎺冩弿妾㈡紡鏅�锛岀稉(j墨ng)甯镐娇鐢ㄥ喎DOP.
妾㈡脯鍎€鍣ㄦ湁鍏╃ó锛屼竴绋槸姘f憾鑶犲厜搴﹁▓锛屽彟涓€绋槸绮掑瓙瑷堟暩(sh霉)鍣�锛岄珮鏁堥亷婵惧櫒妾㈡紡涓父鐢ㄧ殑妾㈡脯鍎€鍣ㄦ槸姘f憾鑶犲厜搴﹁▓锛堜互涓嬬啊绋卞厜搴﹁▓锛�锛屾槸涓€绋墠鏁e皠绶氭€у厜搴﹁▓锛屽畠鐢辩湡绌�娉�銆佸厜鏁e皠瀹ゃ€佸厜闆诲€嶅绠�銆佷俊铏熻檿鐞嗚綁(zhu菐n)鎻涘櫒鍜屽井铏曠悊鍣ㄧ瓑绲勬垚銆傚叾宸ヤ綔鍘熺悊鏄細鐣�(d膩ng)姘f祦琚湡绌烘车鎶借嚦鍏夋暎灏勫鏅�锛屽叾涓殑椤嗙矑鐗╄唱(zh矛)鏁e皠鍏夌窔鑷冲厜闆诲€嶅绠�銆傚湪鍏夐浕鍊嶅绠′腑锛屽厜琚綁(zhu菐n)鎻涙垚闆讳俊铏�锛屾淇¤櫉缍�(j墨ng)鏀惧ぇ鍜屾暩(sh霉)瀛楀寲鍚庣敱寰檿鐞嗗櫒鍒嗘瀽锛屽緸鑰屾脯瀹氭暎灏勫厜鐨勫挤搴�銆傞€氶亷鑸囧弮姣旂墿璩�(zh矛)鐢�(ch菐n)鐢熺殑淇¤櫉鐨勫皪姣旓紝鍙互鐩存帴娓噺姘i珨涓绮掔墿璩�(zh矛)鐨勮唱(zh矛)閲忔績搴�锛屽洜姝ゅ叾鐢ㄩ€斿崄鍒嗗唬娉�銆傝€岀矑瀛愯▓鏁�(sh霉)鍣紝瀹冪殑娓│鍊煎弽鏄犵殑鏄埃娴佷腑绮掑瓙鍊嬫暩(sh霉)鐨勬績搴�锛屽苟瑕�(gu墨)瀹氱矑寰戣寖鍦�锛屽叾闈堟晱搴﹁純楂橈紝灏嶆墍鏈夊〉婧愭埃婧惰啝閬╃敤锛岄伕鎿囦綑鍦拌純澶�锛屼絾鍦ㄩ珮鏁堥亷婵惧櫒妾㈡紡涓純灏戜娇鐢紝鍏╃ó鍎€鍣ㄦ脯瑭︾祼(ji茅)鏋滈洠浠ュ畾閲忓皪姣�銆�
3 妾㈡脯鏂规硶
纰哄畾楂樻晥閬庢烤鍣ㄦ湰韬強鍏跺畨瑁濇槸鍚︽湁鏄庨’鐨勬徊婕�锛屽繀闋堝湪鐝�(xi脿n)鍫村皪浠ヤ笅骞捐檿閫茶娓│锛氶亷婵惧櫒鐨勬烤鏉�锛涢亷婵惧櫒鐨勬烤鏉愯垏鍏舵鏋跺収(n猫i)閮ㄧ殑閫f帴锛涢亷婵惧櫒妗嗘灦鐨勫瘑灏佸鍜岄亷婵惧櫒绲勬敮鎾愭鏋朵箣闁�锛涙敮鎾愭鏋跺拰澧诲鎴栭爞妫氫箣闁撱€�
DOP妾㈡紡鐨勬潗鏂�銆佸剙鍣ㄦ湁锛氬〉婧愶紙PAO婧跺姂锛夈€佹埃婧惰啝鐧�(f膩)鐢熷櫒銆佹埃婧惰啝鍏夊害瑷堛€�
浠ユ埃婧惰啝鐧�(f膩)鐢熷櫒鐐�ATI TDA-6D.鎵嬫寔寮�Laskin鍣村槾鍨嬫埃婧惰啝鐢熷櫒鐐轰緥锛屽畠鐩存帴浣跨敤绌烘埃鑰屼笉闇€瑕佸绺埃楂斾綔鐐哄嫊鍔�銆傚湪20Pa宸ヤ綔澹撳姏涓嬶紝姘f祦閫熷害鐐�50~2025CF3/min鏅�锛屽彲鐢�(ch菐n)鐢�10~100ug/mL 婵冨害鐨勫鍒嗘暎鎬т簽寰背绱氭补濉垫埃婧惰啝銆備娇鐢ㄧ殑姘f憾鑶犲厜搴﹁▓鐐�ATI 2H鍨嬪厜搴﹁▓锛屽嫊鎱�(t脿i)娓噺鑼冨湇鐐�0.00005~120ug/L锛岄噰妯f祦閲忕偤1CF3/min(28.3L/min)銆�
3.1 鍦ㄥ緟娓�HEPA涓婃父涓€鍋�(c猫)寮曞叆PAO姘f憾鑶�
灏嶄簬HVAC绯荤当(t菕ng)涓殑HEPA, 鐐轰娇姘f憾鑶犲埌閬�HEPA鏅傛檪鐨勬績搴﹀潎鍕�锛屽彲灏囨埃婧惰啝鐩存帴寰炵郴绲�(t菕ng)棰�(f膿ng)姗熺殑璨犲涓€鍋�(c猫)寮曞叆锛屽瑕佸緸棰�(f膿ng)绠′腑寮曞叆锛屽墖鎳�(y墨ng)鍦ㄨ窛HEPA鑷冲皯10鍊嶉ⅷ(f膿ng)绠$洿寰戣檿寮曞叆锛屽苟鐩¢噺娓涘皯鎷愬綆锛堢編鍦嬬挵(hu谩n)澧冪瀛�(xu茅)鍜屾妧琛�(sh霉)瀛�(xu茅)鏈冿級銆備竴鑸儏娉佷笅锛屼繚鎸佷笂娓告埃婧惰啝閬斿埌瑕佹眰婵冨害锛屼笖婵冨害娉㈠嫊鍦ㄤ竴瀹氳寖鍦嶅嵆鍙€傚皪浜庡堡娴佺僵銆佽秴鍑堣嚭涓婄殑HEPA锛屾埃婧惰啝鐩存帴寰炵郴绲�(t菕ng)棰�(f膿ng)姗熺殑璨犲涓€鍋�(c猫)寮曞叆銆�
3.2 姘f憾鑶犲厜搴﹁▓鍒濆鍖�銆佽ō(sh猫)瀹�100%銆�0锛呭弮姣旀(bi膩o)婧�(zh菙n)鍊�
鎸夌収姘f憾鑶犲厜搴﹁▓鎿嶄綔瑕佹眰閫茶鍒濆鍖栥€佽ō(sh猫)瀹氬牨璀﹀€�銆傚皣UPSTREAM閲囨ǎ绠¤垏涓婃父閲囨ǎ鍙g浉閫�锛屾脯閲忎笂娓告埃婧惰啝鐨勬績搴�銆傛寜鐓ф埃婧惰啝鐧�(f膩)鐢熷櫒鎿嶄綔瑕佹眰瑾�(di脿o)绡€(ji茅)鐧�(f膩)鐢熺殑姘f憾鑶犳績搴�锛屼娇涓婃父姘f憾鑶犳績搴﹂仈鍒�10~20ug/mL銆�
3.3 鎺冩弿妾㈡紡
鍗镐笅HEPA鐨勬暎娴佹澘锛屽皪鏁村€嬫烤鍣ㄩ潰銆佹烤鍣ㄨ垏閭婃涔嬮枔銆侀倞妗嗚垏閭婃涔嬮枔浠ュ強閭婃鑸囬潨澹撶涔嬮枔鐨勫瘑灏侀€茶鎺冩弿銆傛巸鎻忔檪閲囨ǎ闋窛婵惧櫒闈㈢磩1鑻卞锛堢磩2.54cm锛�锛屾巸鎻忛€熷害涓嶈秴閬�5cm/s銆傛巸鎻忔寜鐩寸窔渚嗗洖寰€寰�(f霉)鍦伴€茶锛岀窔姊濋枔鎳�(y墨ng)閲嶇枈銆傛娓亷绋嬩腑锛岃嫢鏈夊牨璀﹁伈锛堝嵆%LEAKAGE锛堟硠婕忕巼锛夎秴閬�0.01%锛�锛岃〃鏄庢湁娉勬紡銆傛硠婕忚檿缍�(j墨ng)鐢ㄧ鑶犲牭婕忔垨绶婂浐浠ュ悗鍐嶉€茶鎺冩弿宸℃銆傛鏌ヤ竴鍊嬮亷婵惧櫒绱勭偤5min 宸﹀彸锛屽湪娓│鐨勯亷绋嬩腑锛屾噳(y墨ng)缍�(j墨ng)甯哥⒑瑾嶄笂娓告埃婧惰啝鐨勬績搴�锛屾敞鎰忓湪妾㈡脯閬庣▼涓噳(y墨ng)甯堕槻璀烽潰缃╁拰闃茶鐪肩僵銆�
4 绲�(ji茅)鏋滃垽瀹氬強铏曠悊
楂樻晥閬庢烤鍣ㄦ硠婕忕巼鎳�(y墨ng)灏忎簬绛変簬0.01%銆傝嫢HEPA鍦ㄦ娓亷绋嬩腑锛� 鎵€鏈夐粸鐨�%LEAKAGE锛� 娉勬紡鐜�%锛夐兘涓嶈秴閬�0.01%锛屽墖鍒よ┎HEPA鍚堟牸锛岃嫢鏈変竴铏曡秴閬�0.01%锛屽墖鍒ょ偤涓嶅悎鏍�锛屽苟灏囪┎榛炴(bi膩o)瑷樺嚭渚�锛岄渶淇鎴栨洿鎻�銆傞珮鏁堥亷婵惧櫒婵炬枡娉勬紡铏曞厑瑷辩敤灏堢敤鑶犳按淇锛屼絾鏄柈鍊嬫硠婕忚檿鐨勯潰绌嶄笉鑳藉ぇ浜庣附闈㈢⿳鐨�1%锛屽叏閮ㄦ硠婕忚檿鐨勯潰绌嶄笉鑳藉ぇ浜庣附闈㈢⿳鐨�5%锛屽惁鍓囧繀闋堟洿鎻�銆�
5 楂樻晥閬庢烤鍣ㄦ婕忓懆鏈�
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6 鍟忛瑷庤珫
6.1 楂樻晥閬庢烤鍣ㄦ晥鐜囪垏妾㈡紡
楂樻晥閬庢烤鍣ㄩ亷婵炬晥鐜囨槸鎸囩殑婵惧櫒鏈韩鐨勬晥鐜囷紝闅ㄥ煼(zh铆)琛岀殑妯�(bi膩o)婧�(zh菙n)鍙婃脯瑭︽柟娉曚笉鍚岃€岀暟銆傜暥(d膩ng)鍓嶅皪楂樻晥閬庢烤鍣ㄦ晥鐜囩殑娓│鏂规硶鏈夛細DOP娉�锛屼互鍏夊害瑷堟娓紝涓嶅绮掑瓙瑷堟暩(sh霉)娉曢潏鏁�锛屾湁闂�(gu膩n)妯�(bi膩o)婧�(zh菙n)鍙缇庡湅IEST-RP-CC001锛涚矑瀛愯▓鏁�(sh霉)娉�锛屼互绮掑瓙瑷堟暩(sh霉)鍣ㄤ綔鐐烘娓剙鍣�锛屼娇鐢ㄥ柈鍒嗘暎鎴栧鍒嗘暎姘f憾鑶�锛岄潏鏁忓害楂�锛� 澶氱敤浜庤秴楂樻晥閬庢烤鍣�锛岀浉闂�(gu膩n)妯�(bi膩o)婧�(zh菙n)鍙IEST-RP-CC007;鏈€鏄撶┛閫忕矑寰戞硶锛�MPPS锛夛紝閲囩敤绮掑瓙瑷堟暩(sh霉)鍣ㄤ綔鐐烘娓剙鍣�锛屼娇鐢ㄧ殑姘f憾鑶犲悓鍓�锛屾娉曟槸姝愮洘EN1822 妯�(bi膩o)婧�(zh菙n)鎵€瑕�(gu墨)瀹�锛岃垏绮掑瓙瑷堟暩(sh霉)娉曠殑鍗€(q奴)鍒ユ槸锛屼互閬庢烤鍣ㄦ渶鏄撶┛閫忕殑绮掑緫浣滅偤娓│鐢ㄧ矑寰�锛涢垑鐒版硶锛屾娉曢噰鐢ㄧ伀鐒板厜搴﹁▓锛屽皪NaCL鐕冪噿鐨勭伀鐒拌壊搴︿綔闊挎噳(y墨ng)锛岀浉闂�(gu膩n)妯�(bi膩o)婧�(zh菙n)瑕嬫垜鍦嬧€滈珮鏁堢┖姘i亷婵惧櫒GB13554-92鈥�锛岄潏鏁忓害浣庯紝涓�NaCl灏嶅井闆诲瓙鐢�(ch菐n)鍝佽唱(zh矛)閲忔湁瀹�锛屽湅澶栧凡涓嶇敤銆�
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6.2 姘f憾鑶犲厜搴﹁▓鑸囩矑瀛愯▓鏁�(sh霉)鍣�
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