Ukubonakaliswa okupheleleyo kobuchwephesha obucocekileyo yinto esiyibiza ngokuba ligumbi elicocekileyo lomzi-mveliso wamachiza, elahlulwe ikakhulu laziindidi ezimbini: igumbi elicocekileyo lemizi-mveliso kunye negumbi elicocekileyo lebhayoloji.Umsebenzi ophambili wegumbi elicocekileyo lemizi-mveliso kukulawula ungcoliseko lwe-non- amasuntswana ebhayoloji, ngelixa umsebenzi ophambili wegumbi elicocekileyo lebhayoloji kukulawula ukungcoliseka kwamasuntswana ebhayoloji.GMP ngumgangatho wokuvelisa amayeza kunye nolawulo lomgangatho, oqinisekisa ngokufanelekileyo ukhuseleko kunye nomgangatho. yamayeza. Kwinkqubo yokuyila, ukwakhiwa kunye nokusebenza kwamagumbi acocekileyo kwishishini lamachiza, imigangatho efanelekileyo yamagumbi ahlambulukileyo kunye neemfuno zokulawulwa kwemigangatho yokulawulwa komgangatho wokuvelisa amayeza kufuneka ilandelwe. Okulandelayo, siya kuthetha malunga noyilo lwegumbi elicocekileyo lomzi-mveliso ococekileyo wamachiza ngokuhambelana nemimiselo yokuhlobisa kwangaphakathi kwi "Iinkcukacha zoYilo lweFactory ecocekileyo yoShishino lwaMayeza", ukudibanisa namava kaShanghai IVEN kuyilo lobunjineli. iifektri ezihlanganisiweyo zamayeza.

Uyilo lweGumbi lokucoca
Kumagumbi acocekileyo oshishino, izityalo ezixuba amayeza ziziyilo zobunjineli esihlala sidibana nazo. Ngokweemfuno ze-GMP zamagumbi acocekileyo, kukho iiparitha ezininzi ezibalulekileyo ekufuneka ziqwalaselwe.

1. Ukucoceka
Ingxaki yendlela yokukhetha ngokuchanekileyo iiparamitha kwiworkshop yemveliso yobugcisa. Ngokweemveliso ezahlukeneyo zobuchwepheshe, indlela yokukhetha iiparamitha zoyilo ngokuchanekileyo yingxaki esisiseko kuyilo. Isalathisi esibalulekileyo sicetywayo kwi-GMP, oko kukuthi, inqanaba lokucoceka komoya. Inqanaba lokucoceka komoya luphawu oluphambili lokuvavanya ukucoceka komoya. Ukuba inqanaba lokucoceka komoya alichanekanga, isenzeko samahashe amakhulu atsala inqwelo encinane iya kubonakala, engeyomali okanye eyonga amandla. Ngokomzekelo, inkcazo entsha yokupakisha yomgangatho we-300,000-level engafanelekanga ukuyisebenzisa kwinkqubo yemveliso ephambili okwangoku, kodwa esebenza kakhulu kumagumbi athile ancedisayo.

Ngoko ke, ukhetho lweliphi inqanaba elihambelana ngokuthe ngqo nomgangatho kunye neenzuzo zezoqoqosho zemveliso. Imithombo yothuli echaphazela ukucoceka ikakhulu ivela kwimveliso yothuli yezinto kwinkqubo yokuvelisa, ukuhamba kwabaqhubi kunye neengqungquthela zothuli lwe-atmospheric eziziswa ngumoya ococekileyo wangaphandle. Ukongeza kusetyenziso lwezixhobo zokukhupha uthuli oluvaliweyo kunye nokususwa kothuli lwezixhobo zenkqubo yokuvelisa uthuli, iindlela ezisebenzayo zokulawula ukungena kwemithombo yothuli kwigumbi kukusebenzisa ukuhluza okuphambili, okuphakathi kunye nokuphumelela okuphezulu kwamanqanaba amathathu entsha. ukubuyisela umoya we-air-conditioning system kunye negumbi lokuhlambela lokuhamba kwabasebenzi.

2. Ixabiso lokutshintshiselana ngomoya
Ngokuqhelekileyo, inani leenguqu zomoya kwi-air-conditioning system kuphela ngamaxesha angama-8 ukuya kwi-10 ngeyure, ngelixa iqondo eliphantsi lokutshintsha komoya kwigumbi elicocekileyo lemizi-mveliso ngamaxesha angama-12, kwaye inqanaba eliphezulu ngamakhulu amaxesha. Ngokucacileyo, ulwahlulo kwizinga lokutshintshiselana komoya libangela ukubahluko omkhulu kumthamo womoya kunye nokusetyenziswa kwamandla.Kuyilo, ngesiseko sokubeka ngokuchanekileyo ukucoceka, kuyimfuneko ukuqinisekisa amaxesha aneleyo omoya. Ngaphandle koko, uchungechunge lweengxaki lunokuvela, njengokuba iziphumo zokusebenza azikho kumgangatho, amandla okuchasana nokuphazamiseka kwegumbi elicocekileyo lihlwempu.

3. Umahluko woxinzelelo oluzinzileyo
Umahluko woxinzelelo phakathi kwamagumbi acocekileyo kunye namagumbi angacocekanga kumanqanaba ahlukeneyo akayi kuba ngaphantsi kwe-5pa, kwaye uxinzelelo phakathi kwamagumbi acocekileyo kunye namagumbi angaphandle angabi ngaphantsi kwe-10Pa. Indlela yokulawula umahluko we-static yoxinzelelo kukubonelela ngomthamo othile womoya woxinzelelo olulungileyo. Izixhobo zoxinzelelo ezilungileyo ezihlala zisetyenziswa kuyilo yivalve yoxinzelelo olushiyekileyo, isilawuli somthamo wombane woxinzelelo olwahlukileyo kunye nomgangatho wokudambisa umoya ofakwe kwindawo yokuphuma komoya. Kwiminyaka yakutshanje, isoloko yamkelwa kuyilo ukuba umthamo womoya wonikezelo mkhulu kunomthamo womoya wokubuya kunye nomthamo womoya wokukhupha kwi-commission yokuqala ngaphandle kwesixhobo soxinzelelo olulungileyo, kunye nenkqubo yolawulo oluzenzekelayo ehambelanayo inokufezekisa umphumo ofanayo.

4. Ukuhanjiswa komoya
Ifomu yokusabalalisa umoya wegumbi elicocekileyo yinto ephambili yokuqinisekisa ukucoceka. Ifom yokusasazwa komoya ehlala yamkelwa kuyilo lwangoku igqitywe ngokwezinga lokucoceka. Ngokomzekelo, igumbi elicocekileyo le-300,000-class lihlala lithatha indlela ephezulu yokuthumela kunye ne-top-back, i-100,000-class kunye ne-10,000-class amagumbi acocekileyo ahlala amkela indlela yokuhamba komoya yokubuyela kwicala eliphezulu nasezantsi, kunye nomgangatho ophezulu ococekileyo. igumbi lamkela ukuqukuqela okuthe tye okanye ngokuthe nkqo kwendlela enye.

5. Ubushushu kunye nokufuma
Ukongeza kwiinkqubo ezikhethekileyo, ukusuka kumbono wokufudumeza, ukungena komoya kunye ne-air conditioning, ngokukodwa ukugcina induduzo yabaqhubi, oko kukuthi, ukushisa okufanelekileyo kunye nomswakama. Ukongezelela, kukho izibonakaliso ezininzi ezimele zivuse ingqalelo yethu, njengesantya somoya esinqamlezayo sombhobho womoya, ingxolo, ukukhanya kunye nomlinganiselo womthamo womoya omtsha njl njl, zonke ezingenakungahoywa kuyilo.

Uyilo lwegumbi elicocekileyo
Amagumbi acocekileyo ebhayoloji ahlulwe kakhulu abe ziindidi ezimbini; amagumbi acocekileyo ebhayoloji kunye nokhuseleko lwebhayoloji amagumbi acocekileyo acocekileyo. Kumagumbi acocekileyo amashishini, kuyilo lobuchwephesha bokufudumeza, ukungena komoya kunye ne-air conditioning, iindlela ezibalulekileyo zokulawula inqanaba lokucoceka ngokucoca kunye noxinzelelo oluhle. Kumagumbi acocekileyo ebhayoloji, ukongeza ekusebenziseni iindlela ezifanayo njengamagumbi acocekileyo akwimizi-mveliso, kufuneka kwakhona athathelwe ingqalelo ngokwembono yokhuseleko lwebhayoloji, kwaye ngamanye amaxesha kuyafuneka ukusebenzisa uxinzelelo olubi ukuthintela ukungcoliseka kwemveliso kokusingqongileyo.
Ukusebenza kwezinto ezinomngcipheko ophezulu we-pathogenic kubandakanyeka kwinkqubo yokuvelisa imveliso yenkqubo, kunye nenkqubo yokucoca umoya kunye nezinye izixhobo kufuneka zihlangabezane neemfuno ezizodwa. Umahluko phakathi kwegumbi elicocekileyo le-biosafety kunye negumbi elicocekileyo lemizi-mveliso kukuqinisekisa ukuba indawo yokusebenza igcina imeko yoxinzelelo olubi. Nangona inqanaba lendawo yemveliso enjalo aliphezulu kakhulu, liya kuba nenqanaba eliphezulu le-biohazard. Ngokuphathelele umngcipheko webhayoloji, kukho imigangatho ehambelanayo eTshayina, i-WTO nakwamanye amazwe emhlabeni. Ngokuqhelekileyo, amanyathelo amkelweyo kukuba yedwa okwesibini. Okokuqala, i-pathogen ihlukaniswe kumqhubi ngekhabhinethi yokhuseleko okanye ibhokisi yodwa, eyona nto ingumqobo wokuthintela ukugqithiswa kwee-microorganisms eziyingozi. Ukwahlulwa okwesibini kubhekiselele kukwahlulwa kwelabhoratri okanye indawo yokusebenza ngaphandle ngokuyijika ibe yindawo yoxinzelelo olubi. Kwinkqubo yokucoca umoya, amanyathelo athile nawo athathwa ngokufanelekileyo, njengokugcina uxinzelelo olubi lwe-30Pa ~ 10Pa ngaphakathi, kwaye ukuseta indawo yesithinteli soxinzelelo olungalunganga phakathi kwendawo esecaleni engacocekanga.

I-Shanghai VEN ihlala igcina imvakalelo ephezulu yoxanduva kwaye ithobela yonke imigangatho ngelixa inceda abathengi bakhe iifektri zamayeza. Njengenkampani enamashumi eminyaka yamava ekuboneleleni ngobunjineli bezobunjineli bamayeza, i-IVEN inamakhulu amava kwintsebenziswano yehlabathi jikelele. Yonke iprojekthi ye-Shanghai VEN ihambelana ne-EU GMP / US FDA GMP, i-WHO GMP, i-PIC / S GMP kunye neminye imigaqo esemgangathweni. Ngaphandle kokubonelela abathengi ngeenkonzo eziphezulu, i-VEN iphinda ilandele ingcamango "yokubonelela ngempilo kubantu" .

UShanghai VEN ujonge phambili ekusebenzeni nawe.