Indlela epheleleyo yokubonakalisa ubuchwepheshe obucocekileyo yinto esidla ngokuyibiza ngokuba ligumbi elicocekileyo lefektri yamayeza, elahlulwe kakhulu kwiindidi ezimbini: igumbi elicocekileyo lemizi-mveliso kunye negumbi elicocekileyo lezinto eziphilayo. Umsebenzi ophambili wegumbi elicocekileyo lemizi-mveliso kukulawula ungcoliseko lweesuntswana ezingezizo ezebhayoloji, ngelixa umsebenzi ophambili wegumbi elicocekileyo lezinto eziphilayo kukulawula ungcoliseko lweesuntswana zebhayoloji. I-GMP ngumgangatho wokwenziwa kwamayeza kunye nolawulo lomgangatho, oqinisekisa ngokufanelekileyo ukhuseleko kunye nomgangatho wamayeza. Kwinkqubo yoyilo, ukwakhiwa kunye nokusebenza kwamagumbi acocekileyo kwishishini lamayeza, kufuneka kulandelwe imigangatho efanelekileyo yamagumbi acocekileyo kunye neemfuno zolawulo lomgangatho wemveliso yamayeza. Okulandelayo, siza kuthetha ngoyilo lwegumbi elicocekileyo lefektri ecocekileyo yamayeza ngokuhambelana nemigaqo yokuhombisa ngaphakathi kwi-"Design Specifications for the Clean Factory of the Pharmaceutical Industry", idibene namava eShanghai IVEN kuyilo lobunjineli lweefektri zamayeza ezidibeneyo.

Uyilo lweNdawo yokucoca iMizi-mveliso
Kumagumbi acocekileyo kwimizi-mveliso, izityalo zamayeza zezona zakhiwo zobunjineli esihlala sidibana nazo. Ngokweemfuno ze-GMP kumagumbi acocekileyo, kukho iiparameter ezininzi ezibalulekileyo ekufuneka ziqwalaselwe.

1. Ucoceko
Ingxaki yokuba ungayikhetha njani ngokuchanekileyo iparameters kwindawo yokusebenzela imveliso yobugcisa. Ngokweemveliso ezahlukeneyo zobuchwepheshe, indlela yokukhetha iparameters yoyilo 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, kuya kuvela imeko yamahashe amakhulu etsala inqwelo encinci, nto leyo engabizi kakhulu kwaye ingagcini amandla. Umzekelo, iinkcukacha ezintsha zokupakisha zomgangatho we-300,000-level ezingafanelekanga ukuyisebenzisa kwinkqubo yemveliso ephambili okwangoku, kodwa ezisebenzayo kakhulu kwamanye amagumbi ancedisayo.

Ngoko ke, ukhetho lokuba loluphi udidi oluhambelana ngqo nomgangatho kunye neenzuzo zoqoqosho zemveliso. Imithombo yothuli echaphazela ucoceko ikakhulu ivela ekuvelisweni kothuli lwezinto kwinkqubo yokuvelisa, ukuhamba kwabaqhubi kunye namasuntswana othuli olusemoyeni oluziswa ngumoya ococekileyo wangaphandle. Ukongeza ekusebenziseni izixhobo zokukhupha uthuli ezivaliweyo kwizixhobo zenkqubo yokuvelisa uthuli, indlela esebenzayo yokulawula ukungena kwemithombo yothuli kwigumbi kukusebenzisa ukuhluza okuphambili, okuphakathi kunye nokusebenza kakuhle kwamanqanaba amathathu omoya omtsha obuyayo wenkqubo yokupholisa umoya kunye negumbi lokuhlambela ukuze kudlule abasebenzi.

2. Izinga lokutshintshiselana komoya
Ngokubanzi, inani lotshintsho lomoya kwinkqubo yomoya opholileyo liphindwe ka-8 ukuya ku-10 ngeyure, ngelixa elona nqanaba liphantsi lotshintsho lomoya kwigumbi elicocekileyo lemizi-mveliso liphindwe ka-12, kwaye elona nqanaba liphezulu liphindwe kalikhulu. Ngokucacileyo, umahluko kwizinga lokutshintshiselana komoya ubangela umahluko omkhulu kumthamo womoya kunye nokusetyenziswa kwamandla. Kuyilo, ngokusekelwe kwindawo echanekileyo yococeko, kuyimfuneko ukuqinisekisa amaxesha okungenisa umoya aneleyo. Ngaphandle koko, uthotho lweengxaki lunokuvela, njengokuba iziphumo zokusebenza azifikeleli kumgangatho oqhelekileyo, amandla okuchasana nokuphazamiseka kwegumbi elicocekileyo aphantsi.

3. Umahluko woxinzelelo oluqinileyo
Umahluko woxinzelelo phakathi kwamagumbi acocekileyo namagumbi angacocekanga kumanqanaba ahlukeneyo akufuneki ube ngaphantsi kwe-5pa, kwaye uxinzelelo phakathi kwamagumbi acocekileyo namagumbi angaphandle akufuneki lube ngaphantsi kwe-10Pa. Indlela yokulawula umahluko woxinzelelo oluzinzileyo ikakhulu kukubonelela ngomthamo othile woxinzelelo lomoya. Izixhobo zoxinzelelo ezilungileyo ezisetyenziswa rhoqo kuyilo yivalvu yoxinzelelo eseleyo, umlawuli womthamo womoya wombane oxinzelelweyo kunye nomaleko wokudambisa umoya ofakwe kwindawo yokukhupha umoya obuyayo. Kwiminyaka yakutshanje, kudla ngokwamkelwa kuyilo ukuba umthamo womoya obonelelwayo mkhulu kunomthamo womoya obuyayo kunye nomthamo womoya ophumayo ekuqaliseni ukusebenza ngaphandle kwesixhobo soxinzelelo esihle, kwaye inkqubo yolawulo oluzenzekelayo ehambelanayo inokufezekisa isiphumo esifanayo.

4. Ukusasazwa komoya
Indlela yokusasaza umoya kwigumbi elicocekileyo yeyona nto ibalulekileyo ukuqinisekisa ucoceko. Indlela yokusasaza umoya esetyenziswa rhoqo kuyilo lwangoku imiselwa ngokwenqanaba lococeko. Umzekelo, igumbi elicocekileyo elinamaklasi angama-300,000 lidla ngokusebenzisa indlela yokuthumela phezulu kunye nendlela yokubuyisela phezulu, amagumbi acocekileyo anaklasi eyi-100,000 kunye namagumbi acocekileyo anaklasi eyi-10,000 adla ngokusebenzisa indlela yokuhamba komoya yokubuyisela phezulu nasezantsi, kwaye igumbi elicocekileyo elikumgangatho ophezulu lisebenzisa indlela ethe tye okanye ethe nkqo yokuhamba kwicala elinye.

5. Ubushushu kunye nokufuma
Ukongeza kwiinkqubo ezikhethekileyo, ngokwembono yokufudumeza, ukuphefumla kunye ne-air conditioning, ikakhulu kukugcina intuthuzelo yabaqhubi, oko kukuthi, ubushushu kunye nokufuma okufanelekileyo. Ukongeza, kukho izalathisi ezininzi ekufuneka zivuse ingqalelo yethu, ezifana nesantya somoya esinqamlezileyo se-air duct, ingxolo, ukukhanya kunye nomlinganiselo womthamo womoya omtsha njl.njl., zonke ezingenakutyeshelwa kuyilo.

Uyilo lwegumbi elicocekileyo
Amagumbi acocekileyo ngokwebhayoloji ahlulwe kakhulu abe ngamacandelo amabini; amagumbi acocekileyo ngokwebhayoloji kunye namagumbi acocekileyo ngokwebhayoloji. Kumagumbi acocekileyo ngokweshishini, kuyilo lobungcali lokufudumeza, ukuphefumla kunye nomoya opholileyo, iindlela ezibalulekileyo zokulawula inqanaba lokucoceka kukucoca kunye noxinzelelo oluhle. Kumagumbi acocekileyo ngokwebhayoloji, ukongeza ekusebenziseni iindlela ezifanayo namagumbi acocekileyo ngokweshishini, kufuneka kuqwalaselwe ngokwembono yokhuseleko ngokwebhayoloji, kwaye ngamanye amaxesha kuyimfuneko ukusebenzisa iindlela zoxinzelelo olungalunganga ukuthintela ungcoliseko lwemveliso kwindalo esingqongileyo.
Ukusebenza kwezinto ezibangela iintsholongwane ezinobungozi obukhulu kuyabandakanyeka kwinkqubo yokuvelisa imveliso esetyenziswayo, kwaye inkqubo yayo yokucoca umoya kunye nezinye izakhiwo nazo kufuneka zihlangabezane neemfuno ezikhethekileyo. Umahluko phakathi kwegumbi lokucoca ukhuseleko lwebhayoloji kunye negumbi lokucoca lemizi-mveliso kukuqinisekisa ukuba indawo yokusebenza igcina imeko yoxinzelelo olubi. Nangona inqanaba lendawo yemveliso enjalo lingekho phezulu kakhulu, liya kuba nenqanaba eliphezulu le-biohazard. Ngokuphathelele umngcipheko webhayoloji, kukho imigangatho ehambelanayo eTshayina, kwi-WTO nakwamanye amazwe ehlabathini. Ngokubanzi, amanyathelo athatyathiweyo kukwahlulwa kwesibini. Okokuqala, i-pathogen yahlulwe kumqhubi yikhabhathi yokhuseleko okanye ibhokisi yokwahlulwa, eyintloko ngumqobo wokuthintela ukugcwala kweentsholongwane eziyingozi. Ukwahlulwa kwesibini kubhekisa ekuhlukanisweni kwelebhu okanye indawo yokusebenza ngaphandle ngokuyiguqula ibe yindawo yoxinzelelo olubi. Kwinkqubo yokucoca umoya, amanyathelo athile nawo athathwa ngokufanelekileyo, njengokugcina uxinzelelo olubi lwe-30Pa~10Pa ngaphakathi, kunye nokuseta indawo yoxinzelelo olubi phakathi kwendawo ekufutshane engacocekanga.

IShanghai IVEN isoloko igcina imvakalelo yoxanduva olukhulu kwaye inamathela kuyo yonke imigangatho ngelixa inceda abathengi ukuba bakhe iifektri zamayeza. Njengenkampani enamashumi eminyaka yamava ekunikezeleni ngobunjineli bamayeza obudibeneyo, i-IVEN inamava amaninzi kwintsebenziswano yehlabathi jikelele. Yonke iprojekthi yeShanghai IVEN ihambelana nemigangatho ye-EU GMP/US FDA GMP, WHO GMP, PIC/S GMP kunye neminye imigaqo. Ukongeza ekunikezeni abathengi iinkonzo ezisemgangathweni ophezulu, i-IVEN ikwanamathela kwingcamango "yokubonelela ngempilo ebantwini".

IShanghai IVEN ijonge phambili ekusebenzeni nawe.