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2019/3/29 13:57:20 ߣ՚^V Դ

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-01-

 | OӋPIc

Ҫϵyȫÿ՚ؓxϵyOӋҪȾ΢Ă;cȾ;Ҫ5Nքeǽ|ȾwĭȾ՚ȾýȾ͎ЕrһN΢ﲡжN;՚Ⱦwĭ˺hmĂвԭ΢wĭˣ>5 mmȻ^hҸڿ՚wĭҺεıeڿ՚ѸlQҺlٶȵУҺεĴСԼ՚cҺαˮ։Ⱥ͕ܵrҺܺܿlҺl^ܽĝҺΕ׃СֱҺεˮ≺cеˮ≺ҺƽBµ͉ڴˮķ։ˮҲlҺεܽγɽYlҺΚwcԭҺͬ˵ĴСͨ5 mһСˮlrҺ|ppĶҺεijٶȜpССڿ՚ƯS\Ӷ\՚еĂȾӝȡQM՚ٶȺӵijٶȻͨLӵųٶƽoĺՄԒԺʹдͲСҺοM՚Duguid1945ČͨՄԒaֱ

ˎƷa|ϵyҪMɲˎSůͨ{ϵyҪͨ^ˎƷahĿ՚ضҸ΢ȵĿƺͱOy_hˎƷ|Ҫ՚ȾͽȾİlͬrˆTṩmĭhˎSůͨ{ϵy߀𵽜pٺͷֹˎƷa^ЌIˆTɵIJӰұo܇ĭhˎIһ坍ȫĿghtǿ{ϵyOӋб횿]PIҪÑ͹ˇaƷNڟoˎƷԭˎƷѪҺƷˎƄڷwƄǷˎƷùȸˎˎ[Wˎ΢ˎͬˎƷҪ{ϵyʽLвͬҪGMP ҎҪ_ǰ҇GMP߀ǰWGMP FDA cGMP ˜MOӋ˜ʲͬ‰QΔȿҪIJͬHM҇GMP Ҫtͬȼg10 PaW˄tҪ10Pa~15 Pa@ӕϵyLIJҲLIJϵyӝвͬӋYtˎS{ϵyOӋrˎƷa|ҎҎҎhĻҪPҎҎ{ϵyMк턝 OӋr߀Ҫֿ]ˎƷa^̺aO䌦՚Ʒ|aIJӰOӋҪϤˎƷa΢޶ȼOyһҪoˎƷ°GMPĸһڰ˗lʮlȷ֞ABCD 4e

ALU^ӑBoBĝȾ4.8LLٞ0.36 m/s~0.54 m/sֵָ]ĸxʹ^͵L

BLUA^̎ı^oB5ӑB7ͬrҎaȫYˆTxF15 min~20 minԃɄӑB7_oB5CDҪ̶^͵ĝ^CoB7ӑB8fDoB8fӑB]Ҫǟoԭˎaoԭˎaзǟoa°GMPĸ䛶lաoˎƷD^ҪOˎȡsո๤򣺲]ϵyahڷǝ^óڷʽahcƄƍλĝȼemˎע䄩ǰľƹD^Ҫֿ]ضcȌ^Ҫ󣺮ˎƷaoҪrҵĜضȷɿ18~26ȿ45%~65%]oą^΢Ⱦćԓ^IJˆTķbҪʝ^ĜضȺȿɰ”ֵOӋAB^ض20~2445%~60%CD^ض18~2645%~65%ˇͮaƷҪr@ЩҪ_ضȺ



-02-

 |ؓxOӋҪc

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2.1 {ϵyĄtˎS{ϵyOӋҪ_֮҃ȅʹÕrga^؁턝ֿ{ϵyOӋ{ϵyּҪGMPҪ⽻Ⱦͬr߀ҪM㹝ܺ\йıwϵyֵԭt飺1ͬĮaƷҪaƷȾ򌦃{Ҫͬ2ͬȼ؝Ҫ󄝷ͬȼĝһ؝Ȍ҃ȭhҪͬͨABCDgϵyO3ǃϵyЧϵyЧϵyҪ_O̫һϵyyƽ4cdžґ_QΔe^һLز^ٟ^˷_O5njƽօ^ˇ΄@ӿSІΪ\вaڹ6ҪaȾĭhҪOĿ{ϵyˎˎ[Wˎ΢ˎa^ۉmκ๤η_7aڲͬ횄ɲͬϵyLrgaκͲ֕rgaarge_畺惦؅^ϵyca^_tˎS{ϵyִڃɷNʽKoˎƷĿ{ϵyͷǟoˎƷĿ{ϵyҊD1KoˎƷĿ{ϵyABCD^Oÿ{ϵyw^ΪOÿ{ϵyKoˎƷĿ{ϵyABOÿ{ϵyCDx_Oÿ{ϵyeСrԺһ׿{ϵyǟoˎƷĿ{ϵy^e^rǰӹ^D^ͅ^Ȱb^օ^Oÿ{ϵy^e^СrȾ^صą^ÿ{ϵyɃ^ÿ{ϵy^ͷǷ^誚ﰲȫҪą^ͷﰲȫą^ϵy_ˎa^ϵyc^ϵy_˱ϵya^҃ȭh{{ϵy̫һԡ50000 m3/hLҊD12.2 LLx˰GB50457-20089.2.5l߀‘Tˎˎ[Wˎ΢ˎ^ȑOӋȫLϵy^ɢgϴʹɢ᷿gûLrԼQЬam^ķgͨȫŷʽLۉmܲȡЧʩmLϵyҲÃĻL_Ŀ 

2.3 ȾˎƷa^aۉmкwζȾҪЧȾӰOӋr߀Ҫֿ]՚Ʒ|OaIJӰȴ_ȾԴλٸȾԴλߴaʽa_LʽLʽСLֲLȫLȾnjȾԴ]СLʹС܇hؓ@NyԌFcϵҪf{ǾֲLڿȾԴ̎ɢlȾLbòHҪбҪij߀һҪͬȾmijbȫL@NʽҪ^Ŀ՚ԴM^ֻɷNoʩrԿ]ųĚw߀Ҫк|M̎ҪҪ_кwķN||ͻW|ЩҪΪ̎Щ̎ЩҪ̎ЩҪm̎ȵùصȸԹLΪ̎ҴȼױЙCýw̎ܮaWķۉmwܺϲ̎ۉmwcˮȝϲ̎ӡˢЮζЙCwҪ̎ˮ͸gԚwҪ̎Yϭhu͹ˇҪ_ůͨ{ϵyKǞ鹤ˇaԿ{ϵyֱ횺͹ˇIͬӑՓQCϹˇaůͨϵyc2.4 ggƌڱCg⽻ȾİlPIЩĿHHՓQΔӋB͸LҊ12PJķǾCӋ㷿goYB͸LTĝB͸@ӲܱC_ķgƽ׃Lyx_LCLx ڬFڝ҇oYܷԵĸÂyQΔL㷨@òʴ_]½򞹫ʽmСgӋTpB͸СgLռ^2.5 ՚̎^ͨЃɷNʽһLA̎+L̎˷ʽc̎Pܞ@ؓ̎HМˮؼ^С^m҃ȝؓ^ķgؓ^yӋĈݔҺĿһ»LϼП̎@Nʽmԏ҃ȝؓ^mȱcܺ^зʽԲöλLԹsٟ


-03-

 | ş

OӋc͏SeլFнOӋҎşgҎ̈Ҫ^eڝ^ʹðʽş]ʹð~LҪԭǜpٷemcڝҵ]Ա^Jǵ]>50m2e>200 m2迼]ş^Ȇ΂ge<50 m2e>200 m2tһȃOşͬr횿]aLrr3ﰲȫҲOӋCеşϵyҪ]DZyT`ĉMʹȾ|LU 

-04-

 | ş

OӋc͏SeլFнOӋҎşgҎ̈Ҫ^eڝ^ʹðʽş]ʹð~LҪԭǜpٷemcڝҵ]Ա^Jǵ]>50m2e>200 m2迼]ş^Ȇ΂ge<50 m2e>200 m2tһȃOşͬr횿]aLrr3ﰲȫҲOӋCеşϵyҪ]DZyT`ĉMʹȾ|LU 

-04-

 | ˮϵycԿ

tˎҺИIˮϵy^eҪУؓɷͨ]ΪʹÿɿԲߵԴϵyʹʹҲ횽YϳҎɿϵyaڱֲߝ¼LȲ^ߣ˳^90%Lز^ٟؓ^ͨһ׃ˮϵyһζO׃ϵy׃ϵyԿϵyͨPLCܱOϵyOϵyĿ{MмбOԈDηʽ@ʾOϵy\Рrr@ʾϵy\РB͹rҹψ@ʾҪOվϵyó  ֧  WINDOWS2000 ӑBWINDOWSXPĿͬctˎИI{ԿطBMSEMSϵyEMSҪGMPPıOҕcEMSϵy횽^CBMSϵyGMPϵyͨOԜpC

-05-

 | 

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