Kushandiswa kwakazara kwetekinoroji yakachena ndiyo yatinowanzodaidza kuti imba yakachena yefekitori yemishonga, iyo yakakamurwa zvikuru muzvikamu zviviri: imba yakachena yeindasitiri uye imba yakachena yebhayoloji. Basa guru refekitori yekuchenesa indasitiri nderekudzora kusvibiswa kwezvimedu zvisiri zvebhayoloji, nepo basa guru refekitori yekuchenesa bhayoloji kudzora kusvibiswa kwezvimedu zvebhayoloji. GMP ndiyo mwero wekugadzirwa kwemishonga uye manejimendi yemhando, iyo inovimbisa kuchengetedzeka uye mhando yemishonga. Mukugadzira, kuvaka uye kushanda kwemakamuri akachena muindasitiri yemishonga, zviyero zvakakodzera zvemakamuri akachena uye zvinodiwa zvehunhu hwekutarisira kugadzirwa kwemishonga zvinofanirwa kuteverwa. Tevere, tichataura nezve dhizaini yefekitori yakachena yefekitori yemishonga zvinoenderana nemitemo yekushongedza mukati mu "Design Specifications for the Clean Factory of the Pharmaceutical Industry", tichibatanidza neruzivo rweShanghai IVEN mukugadzira mainjiniya emafekitori emishonga akabatanidzwa.

Dhizaini yeMakamuri Ekushambidzira eMaindasitiri
Mumakamuri akachena emaindasitiri, mafekitori emishonga ndiwo magadzirirwo einjiniya atinowanzo sangana nawo. Zvichienderana nezvinodiwa neGMP zvemakamuri akachena, kune zvinhu zvakakosha zvinofanirwa kutariswa.

1. Kuchena
Dambudziko rekuti ungasarudza sei ma parameter nemazvo mu workshop yezvigadzirwa zvemaoko. Zvichienderana nezvigadzirwa zvakasiyana zvetekinoroji, kuti ungasarudza sei ma parameter ekugadzira nemazvo ndiro dambudziko guru mukugadzira. Chiratidzo chakakosha chinoratidzwa muGMP, ndiko kuti, chiyero chekuchena kwemhepo. Chikamu chekuchena kwemhepo ndicho chiratidzo chikuru chekuongorora kuchena kwemhepo. Kana chiyero chekuchena kwemhepo chisina kururama, chiitiko chemabhiza makuru achidhonza ngoro diki chichaonekwa, izvo zvisingadhuri kana kuchengetedza simba. Semuenzaniso, kurongedza kutsva kwemazinga e300,000-level izvo zvisina kukodzera kuishandisa mukugadzirwa kukuru kwechigadzirwa parizvino, asi zvinoshanda zvikuru kune mamwe makamuri ekuwedzera.

Saka, sarudzo yekuti ndeipi nhanho ine chekuita zvakananga nemhando uye mabhenefiti ehupfumi echigadzirwa. Manyuko eguruva anokanganisa kuchena anonyanya kubva mukugadzirwa kweguruva kwezvinhu panguva yekugadzira, kufamba kwevashandisi uye zvidimbu zveguruva remumhepo zvinounzwa nemhepo yakachena yekunze. Pamusoro pekushandisa michina yakavharwa yekubvisa utsi neguruva yemidziyo yekugadzira guruva, nzira inoshanda yekudzora kupinda kwezvitubu zveguruva mukamuri ndeyekushandisa kupfapfaidza kwezvikamu zvitatu zvekutanga, zvepakati uye zvepamusoro-soro kwemhepo itsva inodzoka yesystem yekutonhodza uye imba yekugeza yekufambisa vashandi.

2. Mwero wekutsinhana kwemhepo
Kazhinji, huwandu hwekuchinja kwemhepo mumhepo inotonhodza mhepo hunongova ka8 kusvika ku10 paawa, nepo huwandu hwakaderera hwekuchinja kwemhepo mukamuri rekuchenesa remaindasitiri huchingori ka12, uye huwandu hwepamusoro huchingori kamazana. Zviri pachena kuti musiyano wekuchinjana kwemhepo unokonzera musiyano mukuru muhuwandu hwemhepo uye kushandiswa kwesimba. Mukugadzira, zvichibva pakuchena kwakakodzera, zvakakosha kuve nechokwadi chekuti nguva yekufema yakakwana. Zvikasadaro, matambudziko akawanda anogona kuoneka, akadai sekuti mhedzisiro yekushanda haisi kusvika padanho rakajairika, kugona kwekamuri rekuchenesa kwakaderera.

3. Musiyano wekumanikidzwa kwakasimba
Musiyano wekumanikidzwa pakati pemakamuri akachena nemakamuri asina kuchena pamatanho akasiyana haufanirwe kuva pasi pe5pa, uye kumanikidzwa pakati pemakamuri akachena nemakamuri ekunze hakufanirwe kuva pasi pe10Pa. Nzira yekudzora musiyano wekumanikidzwa kwesimba kwakanyanya ndeyekupa huwandu hwemhepo inomanikidzwa. Midziyo yekumanikidzwa kwesimba inowanzo shandiswa mukugadzira ivharuvhu yekumanikidzwa yakasara, regulator yemagetsi inodzvinyirira simba uye layer yekudzikisa mweya yakaiswa panzvimbo inoburitsa mweya. Mumakore achangopfuura, mukugadzira kunowanzo shandiswa kuti huwandu hwemhepo inopihwa hwakakura kupfuura huwandu hwemhepo inodzoka uye huwandu hwemhepo inobuda mumhepo pakutanga pasina mudziyo wekumanikidzwa kwesimba, uye system yekudzora otomatiki inoenderana inogona kuita zvakafanana.

4. Kuparadzirwa kwemhepo
Nzira yekugovera mweya mukamuri rakachena ndiyo chinhu chakakosha kuti ive nechokwadi chekuchena. Nzira yekugovera mweya inowanzo shandiswa mukugadzirwa kwazvino inotsanangurwa zvichienderana nemazinga ekuchena. Semuenzaniso, imba yakachena ye300,000-class inowanzo shandisa nzira yekutumira kumusoro nekumusoro, makamuri akachena e100,000-class ne10,000-class anowanzo shandisa nzira yekuyerera kwemhepo yekudzoka kwepamusoro nepazasi, uye imba yakachena yepamusoro inoshandisa nzira yakatwasuka kana yakatwasuka.

5. Tembiricha nehunyoro
Pamusoro pemaitiro akakosha, kubva pakuona kwekudziya, kufefetedza uye kufefetedza kwemhepo, chinonyanya kukosha ndechekuchengetedza nyaradzo yevashandi, ndiko kuti, tembiricha yakakodzera uye hunyoro. Pamusoro pezvo, kune zviratidzo zvakawanda zvinofanira kutikwezva, zvakaita sekumhanya kwemhepo kwemugero wemhepo, ruzha, kuvhenekesa uye chiyero chehuwandu hwemhepo itsva nezvimwewo, izvo zvese zvisingafanirwe kufuratirwa mukugadzirwa.

Dhizaini yekamuri rakachena
Makamuri ekuchenesa emuviri akakamurwa kuita mapoka maviri; makamuri akachena emuviri uye makamuri ekuchengetedza emuviri. Kune makamuri ekuchenesa eindasitiri, mukugadzirwa kwehunyanzvi kwekudziyisa, kufefetera uye mhepo inotonhorera, nzira dzakakosha dzekudzora huwandu hwehutsanana ndeyekusefa nekudzvanya kwakanaka. Kune makamuri ekuchenesa emuviri, pamusoro pekushandisa nzira dzakafanana nemakamuri ekuchenesa eindasitiri, inofanirawo kufungwa nezvayo kubva pamaonero ekuchengetedza kwemuviri, uye dzimwe nguva zvinodikanwa kushandisa nzira dzisina kudzvanywa kudzivirira kusvibiswa kwechigadzirwa kunharaunda.
Kushanda kwezvinhu zvine njodzi huru kunobatanidzwa mukugadzirwa kwechigadzirwa chiri kugadzirwa, uye sisitimu yayo yekuchenesa mweya nezvimwe zvinhu zvinofanirawo kusangana nezvinodiwa zvakakosha. Musiyano uripo pakati peimba yakachena yekuchengetedzwa kwezvakatipoteredza neimba yakachena yeindasitiri ndeyekuona kuti nzvimbo yekushandira inochengetedza mamiriro ekumanikidzwa asina kunaka. Kunyangwe huwandu hwenzvimbo yakadaro yekugadzira husiri hwakanyanya, huchava nehuwandu hwakawanda hwekukuvadzwa kwezvakatipoteredza. Nezve njodzi yezvisikwa, kune zviyero zvinoenderana muChina, WTO nedzimwe nyika pasi rose. Kazhinji, matanho anoshandiswa ndeekuparadzaniswa kwechipiri. Chekutanga, utachiona hunoparadzaniswa nemushandi nekabati yekuchengetedza kana bhokisi rekuparadzanisa, iro rinonyanya kudzivirira kuwanda kwetupukanana tune njodzi. Kuparadzaniswa kwechipiri kunoreva kuparadzaniswa kwerabhoritari kana nzvimbo yebasa kubva kunze nekuita nzvimbo yekumanikidzwa isina kunaka. Kune sisitimu yekuchenesa mweya, mamwe matanho anotorwawo zvinoenderana, akadai sekuchengetedza kumanikidzwa kusina kunaka kwe30Pa~10Pa mukati, uye kuisa nzvimbo yekumanikidza isina kunaka pakati penzvimbo iri pedyo isina kuchena.

Shanghai IVEN inogara iine pfungwa yakakura yekutarisira mutoro uye inotevedzera mwero wese uku ichibatsira vatengi kuvaka mafekitori emishonga. Sekambani ine makore akawanda eruzivo mukupa mainjiniya emishonga akabatanidzwa, IVEN ine mazana eruzivo mukushandira pamwe kwenyika dzese pasi rose. Mapurojekiti ese eShanghai IVEN anoenderana neEU GMP/US FDA GMP, WHO GMP, PIC/S GMP nedzimwe nheyo. Kuwedzera pakupa vatengi masevhisi emhando yepamusoro, IVEN inotevedzerawo pfungwa ye "kupa hutano kuvanhu".

Shanghai IVEN iri kutarisira kushanda nemi.