閱�(y墨)钘ラ牁(l菒ng)鍩熷湪鍦�(gu贸)姘戠稉(j墨ng)婵�(j矛)涓崰鎿�(j霉)闈炲父閲嶈鐨勪綅缃紝鍦ㄥ埗钘ョ敓鐢�(ch菐n)閬�(gu貌)绋嬩腑鐢ㄦ车杓搁�佽棩娑层�佷腑闁撻珨銆佺磾姘淬�侀吀銆佸牽绛変粙璩�(zh矛)浠ラ仈(d谩)鍒拌缃伐钘濈敓鐢�(ch菐n)鐨勯渶姹傘�傛牴鎿�(j霉)瑁濈疆鍙婅几閫佷粙璩�(zh矛)鐨勪笉鍚岋紝鍦�(gu贸)鍏�(n猫i)涓�浜涘吀鍨嬮啱(y墨)钘ヨ缃�備竴鑸伕鐢ㄧ珛寮忓绱�(j铆)闆㈠績娉点�佽綁(zhu菐n)瀛愭车銆佽▓(j矛)閲忔车鍜岀湡绌烘车绛変笉鍚岀殑椤炲瀷锛岄洟蹇冩车鍗犻啱(y墨)钘ョ敤娉电附楂斾笂鐨�90%銆傝�岀鍔涢﹨(q奴)鍕�(d貌ng)闆㈠績娉垫湰韬叿鏈夌殑鐗规畩鎬ц唱(zh矛)鍜岀劇(w煤)娉勬紡銆侀浂姹℃煋銆佺挵(hu谩n)淇濈瓑鐗归粸(di菐n)锛岄潪甯搁仼鍚堥啱(y墨)钘ヨ妤�(y猫)浣跨敤銆�
閱�(y墨)钘ヨ缃敤纾佸姏娉电殑鐗规畩鎬�
鍒惰棩琛屾キ(y猫)鏄竴鍊�(g猫)鐗规畩琛屾キ(y猫)锛岀敱浜庨啱(y墨)钘ョ敓鐢�(ch菐n)閬�(gu貌)绋嬩腑浠嬭唱(zh矛)鐨勭壒鎬ч尟(cu貌)缍滃京(f霉)闆�(娉靛ぇ澶氭暩(sh霉)鐢ㄤ簬鏈夋瘨銆佹湁瀹炽�佹槗鐕冩槗鐖嗐�佹槗鑵愯潟浠嬭唱(zh矛)鐨勮几閫�)锛岀鍔涙车浣滅偤闂�(gu膩n)閸甸厤濂楄ō(sh猫)鍌欎篃瓒婁締(l谩i)瓒婂彈鍒伴棞(gu膩n)娉紝鍏剁壒娈婃�т富瑕�
琛ㄧ従(xi脿n)鍦ㄤ互涓嬪咕鍊�(g猫)鏂归潰
鈶犻啱(y墨)钘ヨ缃敤娉靛湪璩�(zh矛)閲忎笂瑕佹眰鐗瑰垾鍤�(y谩n)鏍笺�傜洝绠＄煶娌广�佸寲宸ョ瓑鍏朵粬琛屾キ(y猫)鐢�(ch菐n)鍝佷篃閮芥湁璩�(zh矛)閲忚姹傦紝浣嗗緢闆ｈ垏钘ュ搧鐩告瘮銆傝棩鍝佽唱(zh矛)閲忓繀闋堢鍚堜腑鑿汉姘戝叡鍜屽湅(gu贸)钘ュ吀瑕�(gu墨)瀹氬拰GMP(钘ュ搧鐢熺敘(ch菐n)璩�(zh矛)閲忕鐞嗚(gu墨)鑼冿紝GoodManufacturingPractice)瑕佹眰銆傞啱(y墨)钘ヨ缃敤娉典篃鎳�(y墨ng)绗﹀悎GMP瑕佹眰銆�
鈶″埗钘ヨ妤�(y猫)鍦ㄧ敓鐢�(ch菐n)閬�(gu貌)绋嬩腑鍚勬柟闈㈢殑瑕佹眰閮藉緢楂樸�傚湪钘ュ搧鐢熺敘(ch菐n)涓紝缍�(j墨ng)甯搁亣鍒版槗鐕冦�佹槗鐖嗗強鏈夋瘨銆佹湁瀹崇殑婧跺姂銆佸師鏂欎腑闁撻珨銆傚洜姝わ紝閱�(y墨)钘ヨ缃敤娉靛繀闋堟牴鎿�(j霉)浠嬭唱(zh矛)鍜屼娇鐢ㄥ牬(ch菐ng)鍚堥��(j矛n)琛岄伕鐢ㄣ��
鈶㈣棩鍝佸搧绋銆佹洿鏂�?li谩n)Q浠ｅ揩銆傜暥(d膩ng)鎵硅櫉(h脿o)鏇存彌鏅�(sh铆)锛岄渶灏�(du矛)瑷�(sh猫)鍌欑閬撶瓑閫�(j矛n)琛屾竻娲椼�佹秷姣掕檿鐞嗭紝瑕佹眰閱�(y墨)钘ヨ缃敤娉佃兘渚夸簬娓呮礂锛�
閱�(y墨)钘ヨ缃敤纾佸姏闆㈠績娉电殑鍙冩暩(sh霉)銆佸伐浣滅媭娉佽姹�
閱�(y墨)钘ヨ缃敤纾佸姏娉电殑瑕佹眰
鈶犲弮鏁�(sh霉)鑼冨湇閱�(y墨)钘ヨ缃敤娉佃垏鐭虫补銆佸寲宸ヨ缃�岃█锛屽叾鍙冩暩(sh霉)鑼冨湇杓冨皬銆傛摎(j霉)绲�(t菕ng)瑷�(j矛)锛岄啱(y墨)钘ヨ缃敤娉电殑鍙冩暩(sh霉)澶ц嚧鑼冨湇濡備笅銆�
娴侀噺<100m3/h
鎻�(y谩ng)绋�<100m
婧害<100X锛�
鍑哄彛澹撳姏<1.6MPa
鈶″伐浣滅媭娉佺煶娌广�佸寲宸ヨ缃�氬父鐐洪�ｇ簩(x霉)鎬ч亱(y霉n)杞�(zhu菐n)锛屽線寰�瑕佹眰娉电殑閫ｇ簩(x霉)閬�(y霉n)杞�(zhu菐n)鍛ㄦ湡涓嶄綆浜�8000h锛岃�岄啱(y墨)钘ヨ缃竴鑸偤闁撴瓏鎿嶄綔锛屾车鐨勯�ｇ簩(x霉)閬�(y霉n)杞�(zhu菐n)鍛ㄦ湡鑸囩煶娌广�佸寲宸ヨ缃敤娉电浉姣旇純浣庯紝涓�鑸偤4000h銆�
閱�(y墨)钘ヨ缃敤娉电殑鐗规�ц姹�
閱�(y墨)钘ヨ缃敓鐢�(ch菐n)鐨勮棩鍝佽垏浜虹殑鍋ュ悍鎭伅鐩搁棞(gu膩n)锛屾墍浠ワ紝鎵�鐢ㄧ殑娉甸瑷�(sh猫)鍌欏叿鏈変互涓嬬壒鎬х殑瑕佹眰銆�
鈶犵附楂旇姹�
鍒惰棩鐢熺敘(ch菐n)鐢ㄦ车鎳�(y墨ng)鎬ц兘鍙潬銆佸瘑灏佽壇濂姐�佺祼(ji茅)妲�(g貌u)绶婃箠銆佸昂瀵歌純灏忥紝浠ュ埄浜庢搷浣溿�佹竻娼斿拰缍(h霉)銆�
鐢ㄤ簬杓搁�佽棩娑层�佷腑闁撻珨銆佺磾姘寸瓑浠嬭唱(zh矛)鐨勬车鎳�(y墨ng)鎻愪緵鏈夐棞(gu膩n)鐨勬脯(c猫)瑭︽暩(sh霉)鎿�(j霉)锛屼互鍒ゅ畾浣跨敤瑭叉车鍙婃潗鏂欎笉褰遍熆钘ュ搧璩�(zh矛)閲忋�傞亷(gu貌)娴侀儴浠朵娇鐢ㄦ潗鏂欙紝鎳�(y墨ng)鏈夎(w猫i)鐢熼儴闁�鍏佽ū鍦ㄩ啱(y墨)钘ョ敓鐢�(ch菐n)涓娇鐢ㄧ殑娓�(c猫)瑭﹀牨(b脿o)鍛娿��
鐢ㄤ簬杓搁�佽棩娑层�佷腑闁撻珨銆佺磾姘寸瓑浠嬭唱(zh矛)鐨勬车鎳�(y墨ng)鑳芥秷姣掋�佹竻娼旓紝鐢ㄤ簬娓呮綌鐨勬潗鏂欍�佷粙璩�(zh矛)銆佽缃噳(y墨ng)淇濊瓑涓嶉�犳垚鏂扮殑姹℃煋銆�
娼斿噲鍗�(q奴)鍏�(n猫i)浣跨敤鐨勬车锛岀偤渚夸簬鍏ㄩ潰娓呮礂锛屾车鑸囩閬撲箣闁撴渶濂介噰鐢ㄦ椿鎬ч�ｆ帴锛屽叾搴曞骇鏈�濂戒篃鎳�(y墨ng)閲囩敤鑵虫敮鎾愶紝浣垮簳搴ц劔闁嬪湴闈���
鈶＄祼(ji茅)妲�(g貌u)瑕佹眰
娉甸亷(gu貌)娴侀儴浠惰〃闈㈡噳(y墨ng)鍏夋粦銆佺劇(w煤)姝昏銆佹槗娓呮礂銆佽�愯厫铦曪紝閼勪欢鎳�(y墨ng)鐒�(w煤)涓嶆槗娓呮礂鐨勭爞鐪笺�佸嚬闄峰拰瑁傜磱銆�
娉电殑绲�(ji茅)妲�(g貌u)鍦ㄤ繚璀夋�ц兘鍜屽彲闈犳�х殑鍓嶆彁涓嬫噳(y墨ng)鐩￠噺绨�(ji菐n)鍖栵紝瑁濇媶绨�(ji菐n)渚匡紝浠ュ埄娓呮綌铏曠悊鍜岀董璀�(h霉)淇濋(y菐ng)銆�
鈶㈣桓灏佽姹傞啱(y墨)钘ヨ缃敤娉电殑娉勬紡闄愬埗姣旇純鍤�(y谩n)鏍硷紝鍥�?y脿n)妯惧鈹庣矊H鏈�(hu矛)褰遍熆寤犳埧鍦伴潰娼斿噲搴︼紝婊胯冻涓嶄簡GMP鐨勮姹傦紝閭勬渻(hu矛)浣胯ō(sh猫)鍌欏拰鍦伴潰閬彈鑵愯潟锛屼娇鐠�(hu谩n)澧冮�犳垚鐮村銆傚洜姝わ紝纾佸姏椹�(q奴)鍕�(d貌ng)闆㈠績娉垫槸閱�(y墨)钘ヨ缃閬哥殑鐠�(hu谩n)淇濆瀷娉甸涔嬩竴銆�
鈶ｆ潗鏂欒姹�
閱�(y墨)钘ヨ缃敤纾佸姏椹�(q奴)鍕�(d貌ng)闆㈠績娉甸亷(gu貌)娴侀儴浠朵娇鐢ㄧ殑閲戝爆鏉愭枡鎳�(y墨ng)闃叉鑸囪棩娑茬櫦(f膩)鐢熷寲瀛�(xu茅)鍙嶆噳(y墨ng)銆佸惛钁楁徊閫忋�佹哀鍖栧墲闆㈢瓑鐝�(xi脿n)璞★紝闈為噾灞潗鏂欐噳(y墨ng)閬哥敤涓嶈垏钘ユ恫鐧�(f膩)鐢熷寲瀛�(xu茅)鍙嶆噳(y墨ng)銆佽兘鑸囪几閫佷粙璩�(zh矛)鍏卞瓨涓旈暦(zh菐ng)鏈熷伐浣滀笉閲嬫斁娣诲姞鍔戠殑鏉愭枡銆�
閱�(y墨)钘ヨ缃敤娉电殑閬�(gu貌)娴侀儴浠舵潗鏂欑敱璨锋柟纰哄畾鍚庡～瀵湪娉垫暩(sh霉)鎿�(j霉)琛ㄤ笂銆傚鏋滆常鏂硅獚(r猫n)鐐哄叾浠栨潗鏂欏彲浠ｆ浛锛岄渶寰楀埌璨锋柟鐨勭⒑瑾�(r猫n)銆�
閱�(y墨)钘ヨ缃敤娉甸亷(gu貌)娴侀儴浠堕渶閲囩敤瓒呬綆纰冲ェ姘忛珨涓嶉姽閶笺�佹盁濉戞枡F46绛夋潗鏂欍�傛綌鍑堝崁(q奴)鍏�(n猫i)浣跨敤鐨勬车锛屽叾闈為亷(gu貌)娴侀儴浠朵篃鎳�(y墨ng)閬哥敤涓嶉帄铦曠殑鏉愭枡锛屼笉鍏佽ū娑傛紗銆傛车鐨勮紨鍔╁瘑灏佹潗鏂欏彲閬哥敤鑱氬洓姘熶箼鐑寘瑕嗘潗鏂欏強绱旇仛鍥�*涔欑儻鏉愭枡銆傚毚(y谩n)绂佷娇鐢ㄥ惈鐭虫绾栫董鐨勬潗鏂欍�傝几閫佹湁姗�(j墨)婧跺姂鏅�(sh铆)锛屽毚(y谩n)绂佷娇鐢ㄦ鑶犳潗鏂欍��
鎰熻瑵瑷晱(w猫n)娉夐仈(d谩)锛屾垜鍏徃涓昏鐢熺敘(ch菐n)鑷惛娉�锛屾帓姹℃车绛夌敘(ch菐n)鍝併�� |
