I-Eberation epheleleyo yetekhnoloji ecocekileyo yile nto sidla ngokubiza igumbi elicocekileyo lomzi-mveliso wasekhaya, igumbi elicocekileyo le-biological kunye nendawo ecocekileyo yegumbi lokucoca amayeza. Kwinkqubo yoyilo, ukwakhiwa nokusebenza kwamagumbi acocekileyo kumzi-mveliso wamachiza, imigangatho efanelekileyo yamagumbi acocekileyo kunye neemfuno zolawulo olusemgangathweni kufuneka zilandelwe. Okulandelayo, siza kuthetha ngoyilo lwegumbi elicocekileyo lomzi-mveliso ococekileyo wamayeza ngokungqinelana neMigaqo yoThombo oluSure kwiShishini leMidlalo yamayeza ", ukudityaniswa kunye noyilo lobunjineli bezinto ezihlanganisiweyo ze-shanghai.

Uyilo lwegumbi lokucoca amashishini
Kwigumbi elicocekileyo lemizi-mveliso, izityalo ezizilwanyana zamayeza ziingcibi zobunjineli sihlala sidibana rhoqo. Ngokweemfuno ze-GMP kumagumbi acocekileyo, kukho iiparamitha ezininzi ezifanele ziqwalaselwe.

1. Ukucoceka
Ingxaki yendlela yokukhetha ngokufanelekileyo iiparameter kwiworkshop yemveliso yobugcisa. Ngokweemveliso ezahlukeneyo zetekhnoloji, indlela yokukhetha iiparamitha zoyilo ngokuchanekileyo yingxaki esisiseko kuyilo. Isalathiso esibalulekileyo sicetywa kwi-GMP, oko kukuthi, inqanaba lokucoceka komoya. Inqanaba lokucoceka lomoya luyinto ephambili yokuvavanya ukucoceka komoya. Ukuba inqanaba lokucoceka lomoya alichanekanga, i-phenomenon yamahashe amakhulu atsala inqwelwana amancinci aya kuvela, engagcinwanga uqoqosho okanye ukusindisa amandla. Umzekelo, indawo yokupakisha entsha yamanqanaba angama-300,000, engafanelekanga ukuyisebenzisa kwinkqubo ephambili yemveliso okwangoku, kodwa esebenza kakhulu kumagumbi ancedileyo.

Ke ngoko, ukhetho lokukhetha kweliphi inqanaba lunxulumene ngokuthe ngqo kwimeko yezibonelelo zemveliso kunye nezoqoqosho. Imithombo yothuli echaphazela ukucoceka ikakhulu ivela kwimveliso yezinto kwinkqubo yemveliso, ukuhamba kwabaqhubi kunye namasuntswana okuthula awaziswa ngumoya ongaphandle. Ukongeza kokusetyenziswa kokupheliswa okuvandlayo kunye nezixhobo zokususa uthuli kwizixhobo zokuvelisa uthuli, iindlela ezisebenzayo zokulawula imithombo yenqanaba lokuyilolonga kwi-moya yokubuya kwenkqubo yenkqubo yokuphila kunye negumbi lokuhlambela.

I-2. Ixabiso lokutshintsha komoya
Ngokubanzi, inani lotshintsho lomoya kwinkqubo yokupaka umoya ngamaxesha angama-8 ukuya kweli-10 ngeyure, ngelixa inqanaba elisezantsi lotshintsho lomoya kwigumbi elicocekileyo le-12, kwaye olona nqanaba uphakamileyo ngamaxesha aphezulu. Ngokucacileyo, umahluko kwixabiso lotshintshiselwano lomoya lubangela umahluko omkhulu kwivolumu yomoya kunye nokusetyenziswa kwamandla.Isoyilo, kwisiseko sokulungisa ngokuchanekileyo, kuyafuneka ukuqinisekisa amaXesha amaninzi ongena moya. Ngaphandle koko, uthotho lweengxaki lungavela, ezinje ngeziphumo zomsebenzi iziphumo azikho kumgangatho, umthamo we-anti-surfer yegumbi elicocekileyo lihlwempuzekile.

3. Umahluko woxinzelelo
Umahluko woxinzelelo phakathi kwamagumbi acocekileyo kunye namagumbi angacocekanga kwiindawo ezahlukeneyo akasayi kuba ngaphantsi kwe-5PA, kwaye uxinzelelo phakathi kwamagumbi acocekileyo kunye namagumbi angaphandle angathathi ngaphantsi kwe-10PA. Indlela yokulawula umahluko woxinzelelo olwenziwe ikakhulu kukubonelela ivolumu ethile yomoya. Izixhobo ezilungileyo zoxinzelelo zihlala zisetyenziswa kuyilo yivalve yentsalela yentsalela, umlawuli wevoti yombane wombane kunye nomoya ongcolileyo owenziwe kwindawo yokubuya. Kwiminyaka yakutshanje, idla ngokuyila uyilo lwevolumu yomoya inkulu kunevolumu yomoya wokubuya kunye nevolumu yokuthintela umoya ekwigunya lokunxibelelana, kunye nenkqubo yokulawula ngokuzenzekelayo inokufezekisa isiphumo esifanayo.

I-4. Ukuhanjiswa komoya
Uhlobo lokuhambisa umoya lwegumbi elicocekileyo yeyona nto iphambili ekuqinisekiseni ukucoceka. Ifomu yokusasazwa komoya ihlala ithathelwa ingqalelo uyilo lwangoku kumiselwa ngokwenqanaba lokucoca. Umzekelo, igumbi eli-300,000 elicocekileyo lihlala lithandana nendlela engasemva, i-100,000 yeklasi kunye ne-100,000 ecocekileyo i-10,000 ecocekileyo i-10,000 ecocekileyo ibuyisele igumbi lokuhamba kwendawo ephezulu kunye nendawo ecocekileyo.

I-5. Ubushushu kunye nokufuma
Ukongeza kwiinkqubo ezizodwa, ukusuka kwimbono yokufudumeza, umoya ovuthuzayo kunye nemeko yomoya, ikakhulu kukugcina intuthuzelo yabasebenzi, oko kukuthi, ubushushu obufanelekileyo kunye nokufuma ngokufanelekileyo kunye nokufuma. Ukongeza, zininzi izikhombisi ekufuneka zivuselele ingqalelo yethu, njengesantya somoya esinecandelo le-suct, ingxolo, ukuqaqamba kunye nomyinge wevolumu yomoya omtsha, yonke into engenakutyeshelwa uyilo.

Uyilo lwegumbi lokucoca
Amagumbi acocekileyo ebhayoloji ikakhulu ahlulwe ngokwamanqanaba amabini; Amagumbi acocekileyo acocekileyo acocekileyo kunye namagumbi ococeko olucocekileyo. Kwigumbi lokucoca amashishini, kuYilo loBuchule bokufudumeza, umoya ovuthuzayo kunye nemeko yomoya, iindlela ezibalulekileyo zokulawula inqanaba lokucoca zisebenzisa ifreyinti kunye noxinzelelo oluqinisekileyo. Kumagumbi acocekileyo, ukongeza ekusebenziseni iindlela ezifana namagumbi acocekileyo emveliso, nayo kufuneka ithathelwe ingqalelo kwimbono yokhuseleko lwendalo, kwaye ngamanye amaxesha kufuneka isebenzise uxinzelelo lwemveliso kwindalo esingqongileyo.
Ukusebenza kwezinto zomngcipheko omkhulu kubandakanyeka kwinkqubo yemveliso yemveliso yenkqubo, kunye nenkqubo yokuphucula umoya kunye nezinye izixhobo kufuneka zifezekise iimfuno ezizodwa. Umahluko phakathi kwegumbi elicocekileyo le-biosabity kunye negumbi elicocekileyo lemizi-mveliso kukuqinisekisa ukuba indawo yokusebenza igcina imeko engalunganga yoxinzelelo. Nangona inqanaba lendawo yemveliso ayiphezulu kakhulu, iya kuba nenqanaba eliphezulu le-biohazard. Ngokuphathelele umngcipheko webhayoloji, kukho imigangatho ehambelana ne-china, i-WTO nakwamanye amazwe ehlabathini. Ngokubanzi, amanyathelo amkelwe abenziweyo. Okokuqala, i-pathogen yodwa eyakhiwe kwi-Operator yikhabhathi yokhuseleko okanye ibhokisi yokuzahlula, eyithintelo ekuthinteleni ukugcwala kwe-microorganisms eziyingozi. I-SEARTARY I-STARY ibhekisele ekwenzeni ilabhoratri okanye indawo yomsebenzi evela ngaphandle ngokuyitshintsha ibe yindawo engekhoyo yoxinzelelo.

UShanghai Iven uhlala egcina uxanduva oluphezulu kwaye ehambelana nayo yonke imigangatho ngelixa enceda abathengi bakhe iifektri zeyeza. Njengeminyaka engamashumi amava okubonelela ngobunjineli obuthile amayeza, i-Iven inamakhulu amava kwintsebenziswano yehlabathi jikelele. Yonke iprojekthi yeShanghai Iven ihambelana ne-EU GMP / i-US FDA GMP, ngubani i-GMP, i-pic / s gmp kunye neminye imigaqo. Ukongeza ekunikezeleni abathengi kwiinkonzo eziphezulu, i-iven ikwanamathela kumxholo 'obonelela ngempilo yabantu ".

I-Shanghai Iven ijonge phambili ekusebenzeni nani.