Igumbi elicocekileyo yindawo elawulwa ngokukodwa apho izinto ezifana nenani leengqungquthela zomoya, umswakama, izinga lokushisa kunye nombane ongatshintshiyo unokulawulwa ukufezekisa imigangatho ethile yokucoca. Amagumbi acocekileyo asetyenziswa kakhulu kumashishini akumgangatho ophezulu afana ne-semiconductors, i-electronics, i-pharmaceuticals, i-aviation, i-aerospace kunye ne-biomedicine.
Kwiinkcukacha zolawulo lwemveliso yamayeza, igumbi elicocekileyo lahlulwe ngamanqanaba ama-4: A, B, C kunye no-D.
Udidi A: Iindawo ezinobungozi obuphezulu, ezifana neendawo zokuzalisa, iindawo apho imigqomo yokumisa irabha kunye nezikhongozeli zokupakisha ezivulekileyo zidibene ngokuthe ngqo namalungiselelo angcolileyo, kunye neendawo apho indibano ye-aseptic okanye uqhagamshelo lwenziwa khona, kufuneka ixhotyiswe ngetafile yokusebenza kwe-unidirectional. ukugcina imo yokusingqongileyo yendawo. Inkqubo ye-unidirectional flow flowing kufuneka inikeze umoya ngokulinganayo kwindawo yayo yokusebenza kunye ne-air velocity ye-0.36-0.54m / s. Kufuneka kubekho idatha yokungqina ubume bompompolo we-unidirectional kwaye ingqinwe. Kwibhokisi evaliweyo, eyedwa okanye ibhokisi yeglavu, isantya somoya esisezantsi singasetyenziswa.
Iklasi B: ibhekisela kwindawo yangasemva apho iklasi A indawo ecocekileyo ibekwe kwimisebenzi enobungozi obuphezulu njengokulungiswa kwe-aseptic kunye nokuzaliswa.
Udidi C kunye no-D: bhekisa kwiindawo ezicocekileyo ezinamanyathelo angabalulekanga kangako ekuvelisweni kweemveliso zamachiza eziyinyumba.
Ngokwemigaqo ye-GMP, ishishini lelizwe lam lamachiza lihlula iindawo ezihlambulukileyo zibe ngamanqanaba e-4 e-ABCD njengasentla ngokusekelwe kwizibonakaliso ezifana nokucoceka komoya, uxinzelelo lomoya, umthamo womoya, ukushisa kunye nomswakama, ingxolo kunye nomxholo we-microbial.
Amanqanaba eendawo ezicocekileyo ahlulwe ngokuhambelana neengqungquthela ezimisiweyo emoyeni. Ngokuqhelekileyo, ixabiso elincinci, liphezulu izinga lokucoceka.
1. Ukucoceka komoya kubhekisela kubukhulu kunye nenani leengqungquthela (kubandakanywa ne-microorganisms) eziqulethwe emoyeni ngeyunithi yomthamo wendawo, osemgangathweni wokuhlukanisa inqanaba lokucoceka kwendawo.
I-Static ibhekisela kurhulumente emva kokuba inkqubo yokucoca umoya yegumbi ecocekileyo ifakwe kwaye isebenze ngokupheleleyo, kwaye abasebenzi begumbi elicocekileyo baye bakhupha indawo kwaye bazihlambulule imizuzu engama-20.
I-Dynamic ithetha ukuba igumbi elicocekileyo likwimeko eqhelekileyo yokusebenza, isixhobo sisebenza ngokwesiqhelo, kwaye abasebenzi abachongiweyo basebenza ngokweenkcukacha.
2. Umgangatho wokuhlelwa kwe-ABCD uvela kwi-GMP epapashwe nguMbutho wezeMpilo weHlabathi (i-WHO), eyona nkcazo yolawulo lomgangatho wokuvelisa amayeza kwishishini lamachiza. Ngoku isetyenziswa kwimimandla emininzi yehlabathi, kuquka iManyano yaseYurophu kunye neTshayina.
Uguqulelo oludala lwaseTshayina lwe-GMP lulandele imigangatho yokuhlela yaseMelika (iklasi ye-100, iklasi ye-10,000, iklasi ye-100,000) de kwaphunyezwa uguqulelo olutsha lwemigangatho ye-GMP ngo-2011. Ushishino lwamayeza aseTshayina luqalisile ukusebenzisa imigangatho yokuhlela ye-WHO kunye nokusebenzisa i-ABCD ukwahlula amanqanaba eendawo ezicocekileyo.
Eminye imigangatho yokuhlela igumbi elicocekileyo
Igumbi elicocekileyo linemigangatho eyahlukeneyo yokuhlela kwimimandla eyahlukeneyo kunye namashishini. Imigangatho ye-GMP iye yaziswa ngaphambili, kwaye apha sazisa ubukhulu becala imigangatho yaseMelika kunye nemigangatho ye-ISO.
(1). Umgangatho waseMelika
Ingcinga yokuhlelwa kwegumbi elicocekileyo yacetywa kuqala yi-United States. Ngomnyaka we-1963, umgangatho wokuqala we-federal wecandelo lomkhosi wegumbi elicocekileyo lasungulwa: FS-209. Iklasi eqhelekileyo ye-100, iklasi ye-10000 kunye nemigangatho yeklasi ye-100000 zonke zithathwe kulo mgangatho. Ngo-2001, iUnited States yayeka ukusebenzisa umgangatho weFS-209E yaza yaqalisa ukusebenzisa umgangatho we-ISO.
(2). Imigangatho ye-ISO
Imigangatho ye-ISO icetywayo nguMbutho waMazwe ngaMazwe we-ISO woMgangatho we-ISO kwaye ibandakanya amashishini amaninzi, hayi nje ishishini lamayeza. Kukho amanqanaba asithoba ukusuka kwiklasi yoku-1 ukuya kwiklasi yesi-9. Phakathi kwawo, iklasi 5 lilingana neklasi B, iklasi 7 lilingana neklasi C, yaye iklasi 8 lilingana neklasi D.
(3). Ukuqinisekisa inqanaba leKlasi A kwindawo ecocekileyo, umthamo wesampulu yendawo nganye yeesampuli awuyi kuba ngaphantsi kwe-1 cubic meter. Inqanaba leengqungquthela zomoya kwiklasi A iindawo ezicocekileyo yi-ISO 5, kunye neengqungquthela ezimisiweyo ≥5.0μm njengomgangatho olinganiselweyo. Umgangatho wamasuntswana omoya kwiklasi B indawo ecocekileyo (static) yi-ISO 5, kwaye ibandakanya amasuntswana anqunyanyiswayo obungakanani obubini kwitheyibhile. Kwiindawo ezicocekileyo zeklasi C (i-static kunye ne-dynamic), amanqanaba amaqhekeza asemoyeni yi-ISO 7 kunye ne-ISO 8 ngokulandelanayo. Kwiindawo ezicocekileyo zeklasi D (ezimile) umgangatho wamasuntswana omoya yi-ISO 8.
(4). Xa uqinisekisa umgangatho, i-counter portable particle particle counter kunye ne-tube yesampula emfutshane kufuneka isetyenziswe ukukhusela i-≥5.0μm i-particle emisiweyo ekuhlaliseni kwi-tube yesampula ende ye-remote sampling system. Kwiinkqubo zokuhamba ngokungaqhelekanga, iintloko zeesampuli ze-isokinetic kufuneka zisetyenziswe.
(5) Uvavanyo oluguquguqukayo lunokwenziwa ngexesha lemisebenzi yesiqhelo kunye nenkqubo yenkcubeko efanisiweyo yokuzalisa ukubonisa ukuba inqanaba lococeko oluguquguqukayo luyafezekiswa, kodwa uvavanyo lokuzalisa oluphakathi lwenkcubeko lufuna uvavanyo oluguquguqukayo phantsi kwe "meko embi kakhulu".
Igumbi elicocekileyo Igumbi
Igumbi elicocekileyo Igumbi, elaziwa ngokuba ligumbi le-100 elicocekileyo okanye igumbi elicocekileyo kakhulu, lelinye lawona magumbi acocekileyo anococeko oluphezulu. Iyakwazi ukulawula inani lamasuntswana kwi-cubic foot nganye emoyeni ukuya ngaphantsi kwe-35.5, oko kukuthi, inani lamasuntswana amakhulu okanye alingana ne-0.5um kwi-cubic meter nganye yomoya ayinakudlula i-3,520 (i-static kunye ne-dynamic). Igumbi elicocekileyo Igumbi lineemfuno ezingqongqo kakhulu kwaye zifuna ukusetyenziswa kweefilitha ze-hepa, ukulawulwa koxinzelelo oluhlukeneyo, iinkqubo zokujikeleza komoya kunye neenkqubo zokulawula ubushushu kunye nobushushu obuqhubekayo ukufezekisa iimfuno zabo zokucoceka okuphezulu. Iklasi A amagumbi acocekileyo asetyenziswa ikakhulu kwi-microelectronics processing, biopharmaceuticals, ukuveliswa kwezixhobo ezichanekileyo, i-aerospace kunye nezinye iindawo.
Igumbi elicocekileyo loKlasi B
Amagumbi acocekileyo eKlasi B ikwabizwa ngokuba ngamagumbi acocekileyo eklasi ye-1000. Inqanaba labo lokucoceka liphantsi, livumela inani leengqungquthela ezinkulu okanye ezilingana ne-0.5um nge-cubic meter yomoya ukufikelela kwi-3520 (static) kunye ne-352000 (dynamic). Amagumbi acocekileyo oKlasi B adla ngokusebenzisa izihluzi eziphezulu kunye neenkqubo zokukhupha ukulawula ukufuma, iqondo lobushushu kunye noxinzelelo lwemeko yendawo yangaphakathi. Amagumbi acocekileyo oKlasi B asetyenziswa ikakhulu kwi-biomedicine, ukuveliswa kwamachiza, oomatshini abachanekileyo kunye nokuveliswa kwezixhobo kunye neminye imimandla.
Igumbi elicocekileyo leClass C
Amagumbi acocekileyo eKlasi C akwabizwa ngokuba ngamagumbi acocekileyo eklasi ye-10,000. Inqanaba labo lokucoceka liphantsi, livumela inani leengqungquthela ezinkulu okanye ezilingana ne-0.5um nge-cubic meter yomoya ukufikelela kwi-352,000 (static) kunye ne-352,0000 (eguquguqukayo). Amagumbi acocekileyo eklasi C ahlala asebenzisa izihluzi ze-hepa, ulawulo oluhle loxinzelelo, ukujikeleza komoya, ubushushu kunye nolawulo lokufuma kunye nobunye ubuchwepheshe bokufikelela kwimigangatho yabo yococeko ethile. Amagumbi acocekileyo oKlasi C asetyenziswa ikakhulu kumayeza, ukwenziwa kwezixhobo zonyango, oomatshini abachanekileyo kunye nokwenziwa kwecandelo lombane kunye neminye imimandla.
Igumbi elicocekileyo likaKlasi D
Amagumbi acocekileyo eklasi D abizwa ngokuba ngamagumbi acocekileyo eklasi ye-100,000. Inqanaba labo lokucoceka liphantsi, livumela inani leengqungquthela ezinkulu okanye ezilingana ne-0.5um nge-cubic meter yomoya ukufikelela kwi-3,520,000 (static). Amagumbi acocekileyo oKlasi D adla ngokusebenzisa izihluzi zehepa eziqhelekileyo kunye nesiseko solawulo olulungileyo loxinzelelo kunye neenkqubo zokujikeleza komoya ukulawula imeko yangaphakathi. Amagumbi acocekileyo eKlasi D asetyenziswa ikakhulu kwimveliso yemizi-mveliso jikelele, ukulungiswa kokutya kunye nokupakishwa, ukuprinta, ukugcinwa kwempahla kunye neminye imimandla.
Amanqanaba ahlukeneyo amagumbi acocekileyo anomda wawo wokusetyenziswa, omele ukhethwe ngokweemfuno zangempela. Kwizicelo eziphathekayo, ukulawulwa kokusingqongileyo kwamagumbi acocekileyo ngumsebenzi obaluleke kakhulu, obandakanya ukuqwalaselwa ngokubanzi kwezinto ezininzi. Kuphela isayensi kunye noyilo olufanelekileyo kunye nokusebenza kunokuqinisekisa umgangatho kunye nokuzinza kwendawo ecocekileyo yegumbi.
Ixesha lokuposa: Mar-07-2024