Yintoni igumbi elicocekileyo?
Amagumbi acocekileyo, awaziwa ngokuba ngamagumbi angenalo uthuli, asetyenziswa ngokuqhelekileyo njengenxalenye yemveliso yobuchwephesha okanye uphando lwezenzululwazi, kubandakanywa ukwenziwa kwamayeza, ukutya, iiCRT, iiLCDs, ii-OLED, kunye neziboniso ze-microLED.Amagumbi acocekileyo enzelwe ukugcina amanqanaba aphantsi kakhulu eenxalenye, ezifana nothuli, izinto eziphilayo ezihamba emoyeni, okanye iintsholongwane ezifakwe ngumphunga.
Ukuchaneka, igumbi elicocekileyo linezinga lokungcola elilawulwayo, elichazwe ngenani leengqungquthela kwi-cubic meter / cubic feet kwi-particle echaziweyo.Igumbi elicocekileyo linokuthi libhekiselele kuyo nayiphi na indawo yokuhlala apho ungcoliseko oluthile luncitshisiwe kunye nezinye iiparamitha zokusingqongileyo ezifana nobushushu, ukufuma kunye noxinzelelo zilawulwa.
Yintoni igumbi elicocekileyo le-GMP?
Kwimeko yoxubo-mayeza, igumbi elicocekileyo libhekisa kwigumbi elihlangabezana neenkcukacha ze-GMP ezichazwe kwi-GMP sterility specifications (okt, iSihlomelo 1 se-EU kunye ne-PIC/S GMP Izikhokelo, kunye neminye imigangatho kunye nezikhokelo ezifunwa ngabasemagunyeni bezempilo basekhaya. ).Yindibaniselwano yobunjineli, ukuvelisa, ukugqitywa, kunye nokulawula ukusebenza (izicwangciso zokulawula) ezifunekayo ukuguqula igumbi eliqhelekileyo libe yindawo ecocekileyo.
Ngokwemigangatho efanelekileyo yee-arhente ze-FDA, baye baseka imimiselo engqongqo kunye nechanekileyo kubavelisi bamayeza kwishishini lamachiza.IiNdlela eziLungileyo zokuVelisa (GMP) zokwenziwa kweemveliso zoxubo mayeza ziyilelwe ukuqinisekisa ukuba amachiza akhuselekile kwaye anezithako ezibangwayo kunye nezixa zawo.Le migangatho ijolise ekunciphiseni umngcipheko we-microbial, particulate, kunye ne-pyrogen contamination.Lo mmiselo, okwaziwa ngokuba zizenzo ezilungileyo zangoku (cGMP), ubandakanya iinkqubo zemveliso, ulawulo lomgangatho, ukupakishwa, abasebenzi, kunye nezibonelelo ze-GMP.
Ekwenziweni kwamachiza angeyontsholongwane kunye nezixhobo zonyango, akukho mfuneko ngokubanzi yamagumbi acocekileyo akumgangatho ophezulu, ngelixa ukuveliswa kwamachiza angenazintsholongwane, njengamachiza emolekyuli kunye namachiza okwenziwa, kukho imfuneko engenakuphepheka yamagumbi acocekileyo akwinqanaba eliphezulu. - amagumbi acocekileyo e-GMP.Sinokuyichaza indawo engqongileyo yokuveliswa kwamachiza oyinyumba kunye neemveliso zebhayoloji ezisekelwe kumgangatho womoya ococekileyo we-GMP kunye nokuhlelwa.
Ngokweemfuno ezifanelekileyo zemigaqo ye-GMP, ukuveliswa kwamachiza angenazintsholongwane okanye iimveliso zebhayoloji zahlulwe ikakhulu ngamanqanaba amane: A, B, C, kunye noD.
Amaqumrhu alawulayo akhoyo aquka: ISO, USP 800, kunye ne-US Federal Standard 209E (yangaphambili, isasebenza).UMthetho woBulunga noKhuseleko lweZiyobisi (DQSA) waphunyezwa ngoNovemba 2013 ukujongana nokufa okunxulumene neziyobisi kunye neziganeko ezimbi kakhulu.Umthetho we-Federal Food, Drug, and Cosmetic Act (FD & C Act) useka izikhokelo kunye nemigaqo-nkqubo yefomula yabantu.I-503A iveliswa ngurhulumente okanye i-arhente egunyazisiweyo yombuso phantsi kolawulo lwabasebenzi abagunyazisiweyo (oosokhemisti/oogqirha) 503B inxulumene nezibonelelo zangaphandle kwaye ifuna ukulawulwa ngokuthe ngqo ngoosokhemesti abanelayisenisi, hayi iikhemesti ezinelayisenisi.Umzi-mveliso unikwe ilayisenisi ngoLawulo lokuTya kunye neDrugs (FDA).
I-DERSION Igumbi elicocekileyo leModyuli
1. UKUFAKA NGOKUKHAWUZIYO KWAYE KULULA
Inzuzo ebonakalayo yamagumbi acocekileyo emodyuli kukuba alula kwaye akhawuleza ukuyifaka.Akunyanzelekanga ukuba zakhiwe ukusuka ekuqaleni kwaye aziyi kuphazamisa ukusebenza kwakho ngeeveki okanye iinyanga zexesha lokwakha.Zenziwe kwiipaneli ezenziwe ngaphambili kunye nefreyimu, ngoko zinokusetwa phakathi kweentsuku okanye iiveki.Ngokukhetha igumbi elicocekileyo lemodyuli ye-DERSION, umbutho wakho unokunqanda ukulibaziseka kwaye uqale ukusebenzisa igumbi lakho lokucoca ngokukhawuleza.
Ngaphezu koko, uyilo lwelungelo elilodwa lomenzi we-DERSION lwenza kube lula ukuhlanganisa okanye ukuqhawula amagumbi ethu acocekileyo akwimodyuli kwaye ukonga ukongeza kuwo.Oku kuthetha ukuba abathengi bethu banakho ukongeza, okanye ukuthabatha, kwigumbi labo elicocekileyo elimiselwe njengoko iimfuno zombutho wabo zitshintsha.Ngenxa yokuba amagumbi ethu acocekileyo emodyuli ayizozakhiwo ezisisigxina, axabisa kancinci ukuwathenga kunye neendleko eziphantsi zolondolozo.
2. UMGANGATHO WOKUSEBENZA
Amagumbi okucoca akwimodyuli asebenzisa i-HEPA kunye ne-ULPA yeeyunithi zesihluzi zefeni ukususa i-particle emoyeni kwaye ugcine ungcoliseko lube buncinci obufunekayo.I-DERSION inikezela ngamagumbi acocekileyo ahlukeneyo kunye nezixhobo zokucoca ezinokunceda umbutho wakho uthobele i-ISO, i-FDA, okanye imigangatho ye-EU.Zombini ii-softwall zethu kunye ne-rigidwall cleanrooms yethu idibana ne-ISO 8 ukuya kwi-ISO 3 okanye iBanga A ukuya kwiBanga D lococeko lomoya.Amagumbi ethu okucoca i-rigidwall sisisombululo esinexabiso eliphantsi lokuhlangabezana neemfuno ze-USP797.
Iingenelo zamagumbi acocekileyo emodyuli ngaphezulu kwamagumbi acocekileyo esintu zininzi.Ukufikeleleka kwabo, ukufakwa lula kunye nokugcinwa lula, kunye nokusebenza ekuhambeni kwexesha kubenza babe lolona khetho lubalaseleyo kwiinkampani okanye imibutho efuna indawo ecocekileyo yegumbi ukuze isebenze kwangoko.E-DERSION sikholelwa kumgangatho weemveliso zethu zegumbi elicocekileyo kunye nokuguquguquka abazinikela kubathengi bethu.Ukufumana iinkcukacha ezithe kratya malunga nokuba ezi mveliso zinokuwunceda njani umbutho wakho ukuba uhlangabezane neemfuno zawo, jonga i-softwall yethu kunye ne-rigidwall imodyuli ecocekileyo amaphepha egumbi.
