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鏂拌仦鍕�(d貌ng)鎱�(t脿i)
鐣�(d膩ng)鍓嶄綅缃細棣栭爜(y猫) > 鏂拌仦璩囪▕ > 鐢熷寲鍩归(y菐ng)绠卞湅(gu贸)妯�(bi膩o)鎶€琛�(sh霉)妾㈡脯(c猫)妯�(bi膩o)婧�(zh菙n)
鐢熷寲鍩归(y菐ng)绠卞湅(gu贸)妯�(bi膩o)鎶€琛�(sh霉)妾㈡脯(c猫)妯�(bi膩o)婧�(zh菙n)
鐧�(f膩)甯冩檪(sh铆)闁擄細2017-07-26   榛�(di菐n)鎿婃鏁�(sh霉)锛�637娆�

                                              

 

 

鐢ㄦ埗闇€姹傛(bi膩o)婧�(zh菙n)

锛�URS锛�

 

 

绯荤当(t菕ng)鍚嶇ū :鐢熷寲鍩归(y菐ng)绠�

瑷�(sh猫)鍌欑法铏�(h脿o): NA         

 

 

璧疯崏/瀵╂牳/ 鎵规簴(zh菙n)

绨藉悕

鏃ユ湡

璧疯崏鑰�

 

     骞�    鏈�    鏃�

璩�(zh矛)閲忕鐞嗛儴瀵╂牳

 

     骞�    鏈�    鏃�

宸ョ▼閮�瀵╂牳

 

     骞�    鏈�    鏃�

GMP 绗﹀悎鎬у鏍�

 

     骞�    鏈�    鏃�

QA 瀵╂牳

 

     骞�    鏈�    鏃�

璩�(zh矛)閲忕鐞嗛儴闁€(m茅n)鎵规簴(zh菙n)

 

     骞�    鏈�    鏃�


 

鐩寗

1.0 鑳屾櫙浠嬬垂

2.0 鐩殑鍜岃寖鍦�

3.0 鍙冭€冭硣鏂�

4.0 绺(xi臎)

5.0 鐢ㄦ埗闇€姹�

  

1.0 鑳屾櫙浠嬬垂

    鐝�(xi脿n)鏈夌殑1鑷�(t谩i)鐢熷寲鍩归(y菐ng)绠遍渶瑕佺敤浜庢ā鎿亴瑁濇ǎ鍝佸煿椁�(y菐ng)锛屾墍浠ョ従(xi脿n)鏈夌殑鐢熷寲鍩归(y菐ng)绠变笉鑳芥豢瓒虫棩甯哥殑瀵�(sh铆)椹�(y脿n)闇€瑕侊紝闇€璩�(g貌u)璨�(m菐i)涓€鑷�(t谩i)瀹归噺鍦�600L鑷�800L鐨勭敓鍖栧煿椁�(y菐ng)绠�銆�

2.0 鐩殑鍜岃寖鍦�

鐐轰簡婊胯冻寰敓鐗╁(sh铆)椹�(y脿n)瀹ゆ棩甯告椹�(y脿n)鐨勮姹�锛屾墍浠ラ渶璩�(g貌u)涓€鍊�(g猫)鍩归(y菐ng)绠辨豢瓒充笂杩拌姹�銆傛摤閲囪臣(g貌u)鐨勭敓鍖栧煿椁�(y菐ng)绠卞皣鎳�(y墨ng)鐢ㄤ簬鍩归(y菐ng)瀹や腑灏�(du矛)姘寸郴绲�(t菕ng)銆佹垚鍝佹垨涓枔鐢�(ch菐n)鍝佺殑寰敓鐗╅檺搴�锛屼互鍙婂皪(du矛)鐒�(w煤)鑿屾娓�(c猫)妯e搧鐨勫井鐢熺墿鍩归(y菐ng)銆�

3.0 鍙冭€冭硣鏂�

鍦ㄤ笅琛ㄤ腑鍒楀嚭鎵€鏈夊弮鑰冪殑鏂囦欢锛屽琛屾キ(y猫)妯�(bi膩o)婧�(zh菙n)锛屽湅(gu贸)瀹舵(bi膩o)婧�(zh菙n)锛屽叕鍙告斂绛栵紱姝ょ珷绡€(ji茅)涔熻ū鍙互妯�(bi膩o)娉ㄧ偤“NA”骞跺埅闄や笅琛�銆�

 

鏂囦欢

鎻忚堪

 

銆婁腑鑿汉姘戝叡鍜屽湅(gu贸)钘ュ吀锛�2010骞寸増浜岄儴锛夈€嬮檮閷�XIX Q钘ュ搧寰敓鐗╁(sh铆)椹�(y脿n)瀹よ(gu墨)鑼冩寚灏�(d菐o)鍘熷墖

JJF1101-2003

銆婄挵(hu谩n)澧冭│椹�(y脿n)瑷�(sh猫)鍌欐韩搴�銆佹韩搴︽牎婧�(zh菙n)瑕�(gu墨)鑼冦€�

YY0027-1990

銆婇浕鐔辨亽婧煿椁�(y菐ng)绠便€嬪湅(gu贸)瀹惰妤�(y猫)妯�(bi膩o)婧�(zh菙n)

 

銆婁腑鍦�(gu贸)钘ュ搧妾㈤(y脿n)妯�(bi膩o)婧�(zh菙n)鎿嶄綔瑕�(gu墨)鑼冿紙2010骞寸増锛夈€�

4.0 绺(xi臎)

    鎵€鏈夊湪鏂囦欢涓敤鍒扮殑绺(xi臎)鍙婂叾瀹氱京鎳�(y墨ng)鍒楀湪涓嬭〃涓�; 鎸夊瓧姣嶉爢搴忔帓鍒楋紱姝ょ珷绡€(ji茅)涔熻ū鍙互妯�(bi膩o)娉ㄧ偤“NA”骞跺埅闄や笅琛�銆�

 

琛�(sh霉)瑾�(y菙)

瀹氱京

IQ

Installation Qualification
瀹夎纰鸿獚(r猫n)

OQ

Operation Qualification
閬�(y霉n)琛岀⒑瑾�(r猫n)

PQ

Performance Qualification
鎬ц兘纰鸿獚(r猫n)

5.0 鐢ㄦ埗闇€姹�

   浠ヤ笅鍒楀嚭浜嗕竴浜涘湪濉(xi臎)鐢ㄦ埗闇€姹傛槸闇€鑰冩叜鐨勯儴鍒�锛屽皪(du矛)浜庝笉閬╃敤鐨勯儴鍒嗗彲濉(xi臎)“NA”锛屼絾涓嶅緱鍒櫎銆�

5.1 渚涙噳(y墨ng)鍟嗚硣璩�(zh矛)

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

URS 5.1.1

鐢熺敘(ch菐n)鍟嗙偤鍦�(gu贸)鍏�(n猫i)澶栬硣娣辩殑娓�(c猫)瑭﹀剙鍣ㄧ敓鐢�(ch菐n)寤犲晢锛屽叿鍌欒壇濂界殑鍞悗鏈嶅嫏(w霉)鑳藉姏锛屽湪妤�(y猫)鐣屼韩鏈夎純濂界殑鑱茶(y霉)銆�

鏈熸湜

 

5.2 浜よ波鍦板潃

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

URS 5.2.1

寤e窞甯傞珮鏂版妧琛�(sh霉)鐢�(ch菐n)妤�(y猫)闁�(k膩i)鐧�(f膩)鍗€(q奴)绉戝(xu茅)鍩庣憺娉拌矾5铏�(h脿o)

蹇呴渶

 

5.3 瀹夎瑕佹眰

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

URS 5.3.1

瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鍏嶈不(f猫i)鎻愪緵鐝�(xi脿n)鍫�(ch菐ng)瀹夎瑾�(di脿o)瑭�銆�

蹇呴渶

URS 5.3.2

瑷�(sh猫)鍌欏畨瑁濆湪寰敓鐗╂椹�(y脿n)瀹ょ殑鍩归(y菐ng)瀹ょ挵(hu谩n)澧冩韩搴﹀湪30鈩冩垨浠ヤ笅銆備繚璀夊湴闈㈠钩鏁�銆�

蹇呴渶

5.4 绯荤当(t菕ng)鍔熻兘瑕佹眰

5.4.1 绯荤当(t菕ng)瑷�(sh猫)瑷�(j矛)鐨勮(w猫i)鐢熷(xu茅)瑕佹眰

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

URS5.4.1 .1

瑷�(sh猫)鍌欐潗璩�(zh矛)鍜岀祼(ji茅)妲�(g貌u)銆佹车銆侀枼闁€(m茅n)銆佸鍦堛€佹瑙�銆佺剨鎺ャ€佸櫞娣�

鐞冪瓑瑕佹眰绗﹀悎琛�(w猫i)鐢熷(xu茅)瑷�(sh猫)瑷�(j矛)銆�

蹇呴渶

URS5.4.1 .2

 瑷�(sh猫)鍌欒〃闈㈠強鍏�(n猫i)閮ㄤ究浜庢竻娼旓紝涓嶈兘鏈夋竻娼旀瑙�

蹇呴渶

5.4.2 绯荤当(t菕ng)鍔熻兘瑕佹眰

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

URS5.4.2.1

鎺ф韩鑼冨湇鍖呮嫭锛�0鈩冭嚦50鈩�锛屽伐浣滄韩搴︾偤20-40

鈩冿紝鎺ф韩绮惧害瑕佹眰鐐�±1鈩�锛屾韩搴﹀潎鍕绘€�±1

鈩�銆傛韩搴﹀垎杈ㄧ巼鐐�0.1鈩�銆�

 

蹇呴渶

URS5.4.2.2

鍏锋湁4灞や笉閵归嫾闅旀澘锛屾湁寮�(qi谩ng)鍒舵€х┖姘e皪(du矛)娴�銆�

蹇呴渶

URS5.4.2.3

閲囩敤寰檿鐞嗘韩搴︽帶鍒跺櫒锛屾湁婧害椤ず骞跺彲瑾�(di脿o)銆�

蹇呴渶

URS5.4.2.4

鍏�(n猫i)鑵斿绌嶈姹�600L鑷�800L锛涢珨绌嶇偤锛氬搴�1250mm浠ヤ笅锛岄珮搴�2000mm浠ヤ笅锛屾繁搴︼紙涓嶅付闁€(m茅n)鎶婃墜锛�900mm浠ヤ笅銆�

蹇呴渶

URS5.4.2.5

鍏锋湁婧害鎺㈤牠闋�(y霉)鐣欏瓟锛堜笉寰楄ō(sh猫)鍦ㄧ┖姘e惊鐠�(hu谩n)鍑洪ⅷ(f膿ng)銆侀€�(j矛n)棰�(f膿ng)鍙e強鍩归(y菐ng)绠卞収(n猫i)缃韩搴︽帰闋梺锛夈€�

蹇呴渶

URS5.4.2.6

鎿嬫澘鍎�(y艒u)鍏堥伕鐢ㄩ€忔槑鐜荤拑鏉愯唱(zh矛)锛屽彲閫忛亷(gu貌)鎿嬫澘瑙€瀵熷煿椁�(y菐ng)绠卞収(n猫i)寰敓鐗╁煿椁�(y菐ng)鎯呮硜銆�

 

鏈熸湜

URS5.4.2.8

鍏锋湁婧害涓婁笅闄愬牨(b脿o)璀﹀姛鑳�銆�

蹇呴渶

URS5.4.2.9

鍏锋湁绋嬪簭闄嶆韩鍔熻兘锛屽彲鍦ㄨ(gu墨)瀹氭檪(sh铆)闁撳収(n猫i)闄嶅埌瑷�(sh猫)瀹氭韩搴﹀悗淇濇寔涓嶈畩锛屽叿鏈夌┖姘e惊鐠�(hu谩n)鍔熻兘銆�

鏈熸湜

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

URS5.5.1

220V锛�50Hz銆傛噳(y墨ng)鏈夌鍚堝湅(gu贸)瀹跺畨鍏�3C瑕佹眰銆�

蹇呴渶

URS5.5.2

闃查潨闆�锛岄槻婕忛浕銆�

蹇呴渶

 

 

 

 

 

5.5 闆绘埃瑕佹眰

5.6 鑷嫊(d貌ng)鎺у埗绯荤当(t菕ng)瑕佹眰

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

URS5.6.1

鍏锋湁婧害瓒呭嚭瑷�(sh猫)瀹氳寖鍦嶆檪(sh铆)鑷嫊(d貌ng)瑾�(di脿o)绡€(ji茅)鎺у埗鍔熻兘

蹇呴渶

5.7 鍎€琛ㄨ姹�

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

NA

NA

NA

5.8 椹�(y脿n)璀夎姹�

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

URS5.8.1

鍎€鍣ㄨ兘閫氶亷(gu貌)寤e窞瑷�(j矛)閲忛櫌鐨勬牎婧�(zh菙n)锛�绗﹀悎JJF1101-2003銆�YY0027-1990鐨�瑕佹眰銆�

蹇呴渶

URS5.8.2

鎻愪緵IQ銆�OQ銆侀(y脿n)璀夋湇鍕�(w霉)锛屽苟涓旈(y脿n)璀夊悎鏍�銆傚繀闋堥仈(d谩)鍒�URS瑕�(gu墨)瀹氱殑闇€姹傛(bi膩o)婧�(zh菙n)锛屼緵鎳�(y墨ng)鍟嗗厛鎻愪緵椹�(y脿n)璀夋柟妗�銆�

蹇呴渶

5.9 鏂囦欢瑕佹眰

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

URS5.9.1

瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鎻愪緵2浠借ō(sh猫)鍌欐搷浣滆(shu艒)鏄庡強缍(h霉)淇濋(y菐ng)鎵嬪唺(c猫)銆�

蹇呴渶

URS5.9.2

渚涙噳(y墨ng)鍟嗘噳(y墨ng)鎻愪緵鍎€鍣ㄧ殑鍑哄粻鍚堟牸璀夋槑鏂囦欢銆侀(y脿n)璀夊牨(b脿o)鍛�銆�

蹇呴渶

URS5.9.3

鎻愪緵鍦�(gu贸)瀹惰獚(r猫n)鍙殑閼掑畾姗�(j墨)妲�(g貌u)鎻愪緵鐨勮┎鍎€鍣ㄧ殑鏍¢(y脿n)銆�

蹇呴渶

5.10 鏈嶅嫏(w霉)鑸囩董淇姹�

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

URS5.10.1

瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鍏嶈不(f猫i)鎻愪緵鐝�(xi脿n)鍫�(ch菐ng)鎿嶄綔鍜岀董璀�(h霉)淇濋(y菐ng)鐨勫煿瑷�(x霉n)銆�

蹇呴渶

URS5.10.2

瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鏄庣⒑瑭崇窗(x矛)鐨勪繚淇収(n猫i)瀹瑰強鏅�(sh铆)闁�銆�

蹇呴渶

URS5.10.3

瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鎻愪緵鍞悗鏈嶅嫏(w霉)鑱�(li谩n)绯绘柟寮�銆�

蹇呴渶

URS5.10.4

瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鑳戒繚璀夌董淇€侀浂閰嶄欢鐨勪緵鎳�(y墨ng)銆�

蹇呴渶

URS5.10.5

鎳�(y墨ng)鎻愪緵鑷冲皯1骞寸殑鏁存(j墨)淇濅慨锛屾瘡骞村崝(xi茅)鍔╂湰鍏徃閫�(j矛n)琛岀董璀�(h霉)鏈嶅嫏(w霉)銆備緵鎳�(y墨ng)鍟嗚兘鏍规摎(j霉)URS鎻愪緵FS銆�

蹇呴渶

5.11 瀹夊叏鏂归潰瑕佹眰

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

蹇呴渶锛忔湡鏈�

URS5.11.1

瑷�(sh猫)鍌欎笂鏄撳皪(du矛)鎿嶄綔浜哄摗閫犳垚鍌峰鐨勯亱(y霉n)鍕�(d貌ng)閮ㄤ綅鎳�(y墨ng)鏈夊畨鍏ㄧ僵锛�

蹇呴渶

URS5.11.2

 瑷�(sh猫)鍌欓儴浣嶄换浣曚笉鑳芥湁閶掑埄鐨勯倞绶e拰灏栬銆�

蹇呴渶

URS5.11.3

闄ら伒瀹堝挤(qi谩ng)鐢熷叕鍙稿畨鍏ㄥ悎鍚屽収(n猫i)鐨勬渚嬪锛屽皪(du矛)涓彲浜烘皯鍏卞拰鍦�(gu贸)鍜屽唬鏉辩渷鍚勯儴闁€(m茅n)鎵€闋掑竷鐨勬湁闂�(gu膩n)瑕�(gu墨)瀹氫篃蹇呴爤浜堜互閬靛畧銆�

蹇呴渶

5.12 鐠�(hu谩n)澧冩柟闈�

 

绶ㄨ櫉(h脿o) 

鍏�(n猫i)瀹�

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URS5.12.1

鍣煶鍦ㄨō(sh猫)鍌�1绫冲収(n猫i)锛�65dBA锛岃ō(sh猫)鍌欏琛ㄦ韩搴︿笉澶т簬35鈩�锛屼緵鎳�(y墨ng)鍟嗘彁渚涚浉闂�(gu膩n)璀夋槑銆�

蹇呴渶

URS5.12.2

鎵€閬哥敤鐨勬潗鏂欎笉寰椾娇鐢ㄧ煶妫夊強鍏跺埗鍝�銆�

蹇呴渶