Chimiro chakakwana cheteknolojia yakachena ndiyo yatinowanzo kudana kamuri yakachena yefekitari yemishonga, iyo inonyanya kukamurwa kuva mapoka maviri: indasitiri yakachena yekamuri uye biological clean room.Basa guru reimba yeindasitiri yakachena nderekudzora kusvibiswa kwevasiri- biological particles, nepo basa guru reBiological yakachena kamuri kudzora kusvibiswa kwebiological particles.GMP ndiyo chiyero chekugadzirwa kwemishonga uye manejimendi emhando, izvo zvinonyatso chengetedza kuchengetedzeka uye mhando. yemishonga. Mukugadzirisa, kuvaka uye kushanda kwemakamuri akachena muindasitiri yemishonga, zviyero zvakakodzera zvemakamuri akachena uye zvinodiwa zvehutano hwehutano hwekugadzirwa kwemishonga zvinofanira kuteverwa. Tevere, tichazotaura nezve dhizaini yekamuri yakachena yefekitori yakachena yemishonga zvinoenderana nemirairo yekushongedza kwemukati mu "Design Specifications yeYakachena Factory yeIndustry Yemishonga", tichibatanidza neShanghai IVEN ruzivo mukugadzira engineering dhizaini. mafekitari emishonga akabatanidzwa.

Industrial Cleanroom Dhizaini
Mumakamuri akachena maindasitiri, zvidyarwa zvemishonga ndiwo magadzirirwo einjiniya atinowanzo kusangana nawo. Zvinoenderana nezvinodiwa zveGMP kumakamuri akachena, kune akati wandei akakosha ma paramita anofanirwa kutariswa.

1. Rucheno
Dambudziko rekuti unganyatso sarudza sei maparamendi mumusangano wechigadzirwa chechigadzirwa. Zvinoenderana neakasiyana zvigadzirwa zvetekinoroji, nzira yekusarudza dhizaini paramita nenzira kwayo ndiro dambudziko rakakosha mukugadzira. Chiratidzo chakakosha chinotsanangurwa muGMP, ndiko kuti, mwero wehutsanana hwemhepo. Chiyero chehutsanana hwemhepo ndicho chiratidzo chikuru chekuongorora kuchena kwemhepo. Kana hutsanana hwemhepo husina kurongeka, chiitiko chemabhiza mahombe anodhonza ngoro diki chinozoonekwa, izvo zvisiri zvehupfumi kana kuchengetedza simba. Semuyenzaniso, iyo nyowani yekurongedza yakasarudzika ye300,000-level standard iyo isina kukodzera kuishandisa muchirongwa chikuru chechigadzirwa parizvino, asi inoshanda zvakanyanya kune mamwe makamuri ebetsero.

Nokudaro, kusarudzwa kwehuwandu hupi hunoenderana zvakananga nehutano nehupfumi hwechigadzirwa. Zvitubu zveguruva zvinokanganisa utsanana zvinonyanya kubva mukugadzirwa kweguruva kwezvinhu mukugadzirwa, kuyerera kwevashandisi uye guruva remuchadenga rinounzwa nemhepo yakachena yekunze. Pamusoro pekushandiswa kwekuvharwa kwemhepo uye kubvisa guruva zvishandiso zvekugadzira guruva, nzira inoshanda yekudzora kupinda kweguruva masosi mukamuri ndeye kushandisa yekutanga, yepakati uye yakakwirira-inogoneka matatu-nhanho kusefa kune itsva. kudzorera mhepo ye air-conditioning system uye imba yekugezera yevashandi.

2. Air exchange rate
Kazhinji, nhamba yekuchinja kwemhepo mu-air-conditioning system inongori ka8 kusvika ku10 paawa, nepo shanduko yemhepo yakaderera muimba yakachena yeindasitiri ka12, uye yepamusoro-soro kane mazana. Zviripachena, mutsauko muyero yekutsinhana kwemhepo unokonzera mutsauko mukuru muhuwandu hwemhepo uye kushandiswa kwesimba.Mukugadzira, pahwaro hwekumisikidza kwakaringana kwehutsanana, zvinodikanwa kuve nechokwadi chekuti nguva dzemhepo dzakakwana. Zvikasadaro, nhevedzano yezvinetso inogona kuoneka, senge mhedzisiro yekushanda isiri kusvika pachiyero, iyo anti-kupindira kugona kwekamuri yakachena haina kunaka.

3. Static pressure musiyano
Musiyano wekumanikidza pakati pemakamuri akachena nemakamuri asina kuchena pamatanho akasiyana haafanire kunge ari pasi pe5pa, uye kudzvanywa pakati pemakamuri akachena nemakamuri ekunze hakuzove pasi pe10Pa. Iyo nzira yekudzora iyo static pressure mutsauko ndeyekunyanya kupa imwe yakanaka yekumanikidza mweya vhoriyamu. Iyo yakanaka yekumanikidza midziyo inowanzoshandiswa mudhizaini ndiyo yakasara yekumanikidza vharafu, iyo yekusiyanisa kudzvanywa magetsi emhepo vhoriyamu regulator uye yemhepo damping layer yakaiswa painodzoka mhepo yekubuda. Mumakore achangopfuura, inowanzogamuchirwa mukugadzira kuti mhepo yekugovera vhoriyamu yakakura kupfuura iyo yekudzoka mhepo vhoriyamu uye exhaust mhepo vhoriyamu mukutanga kutumwa pasina yakanaka yekumanikidza mudziyo, uye inoenderana otomatiki control system inogona kuita zvakafanana.

4. Kugoverwa kwemhepo
Iyo mhepo yekugovera fomu yekamuri yakachena ndicho chinhu chakakosha kuti uve nechokwadi chehutsanana. Chimiro chekugovera mhepo chinowanzogamuchirwa mukugadzirwa kwezvino kunotarirwa maererano nehuwandu hwehutsanana. Semuenzaniso, iyo 300,000-kirasi-yakachena kamuri inowanzotora iyo yepamusoro-yekutumira uye yepamusoro-kumashure nzira, iyo 100,000-kirasi uye 10,000-kirasi-yakachena makamuri anowanzo tora nzira yekuyerera kwemhepo yekumusoro uye yezasi nzira yekudzoka, uye yepamusoro-kirasi yakachena. kamuri rinotora yakachinjika kana yakatwasuka nzira yekuyerera.

5. Tembiricha uye mwando
Pamusoro pemaitiro akakosha, kubva pakuona kwekudziya, kufefetedza uye mhepo yekumisikidza, inonyanya kuchengetedza kunyaradza kwevashandisi, ndiko kuti, tembiricha yakakodzera uye hunyoro. Uye zvakare, kune akati wandei zviratidzo zvinofanirwa kumutsa kutarisisa kwedu, senge muchinjiko-chikamu mhepo kumhanya kwemhepo duct, ruzha, kupenya uye reshiyo yemhepo yakachena vhoriyamu nezvimwe, izvo zvese zvisingakwanisi kufuratirwa mukugadzira.

Yakachena kamuri dhizaini
Biological clean rooms anonyanya kukamurwa kuita mapoka maviri; general biological yakachena makamuri uye biological kuchengetedza akachena makamuri. Kune maindasitiri akachena makamuri, muhunyanzvi dhizaini yekudziya, kufefetedza uye kufefetera mhepo, nzira dzakakosha dzekudzora hutsanana nhanho ndeyekusefa uye kudzvanywa kwakanaka. Kune makamuri akachena ebhayoloji, pamusoro pekushandisa nzira dzakafanana nemakamuri akachena maindasitiri, inofanirwawo kutariswa kubva pakuona kwekuchengetedzwa kwebiology, uye dzimwe nguva zvinodikanwa kushandisa nzira dzisina kunaka dzekudzivirira kusvibiswa kwechigadzirwa kune zvakatipoteredza.
Kushanda kwepamusoro-ngozi pathogenic zvinhu zvinobatanidzwa mukugadzirwa kwechigadzirwa che-in-process, uye hurongwa hwayo hwekuchenesa mhepo uye zvimwe zvivako zvinofanirawo kusangana zvakakosha. Musiyano uripo pakati pekamuri rakachena rebiosafety nekamuri rakachena remaindasitiri nderokuona kuti nzvimbo yekushanda inochengetedza mamiriro asina kunaka. Kunyangwe iyo nhanho yenzvimbo yekugadzira yakadaro isiri yakanyanya kukwirira, ichave neyakakura yebiohazard. Nezve njodzi yebhayoloji, kune zviyero zvinoenderana muChina, WTO nedzimwe nyika pasirese. Kazhinji, matanho anotorwa ndechechipiri chekuzviparadzanisa nevamwe. Kutanga, iyo pathogen inoparadzaniswa nemushandi nekabhineti yekuchengetedza kana bhokisi rekuzviparadzanisa, iro rinonyanya chipingamupinyi chekudzivirira kupfachukira kwehutachiona hunotyisa. Secondary isolation inoreva kuparadzaniswa kwerabhoritari kana nzvimbo yebasa kubva kunze nekuishandura kuti ive nzvimbo isina kunaka yekumanikidza. kumisikidza nzvimbo isina kusimba yekumanikidza pakati penzvimbo iri padyo isina kuchena.

Shanghai VEN inogara ichichengeta pfungwa yepamusoro yemutoro uye inonamatira kune yega chiyero ichibatsira vatengi kuvaka mafekitori emishonga. Sekambani ine makumi emakore eruzivo mukupa yakasanganiswa yeinjiniya yemishonga, IVEN ine mazana echiitiko mukudyidzana kwenyika dzese. Yese purojekiti yeShanghai IVEN inoenderana neEU GMP/US FDA GMP, WHO GMP, PIC/S GMP uye mamwe masimboti akajairwa. Mukuwedzera pakupa vatengi mabasa epamusoro-soro, VEN inoteererawo pfungwa ye "kupa hutano kuvanhu" .

Shanghai VEN iri kutarisira kushanda newe.