Igumbi elicocekileyo yindawo elawulwa ngokukodwa apho izinto ezifana nenani lamasuntswana emoyeni, ukufuma, ubushushu kunye nombane ongashukumiyo zinokulawulwa khona ukuze kufezekiswe imigangatho ethile yokucoca. Amagumbi acocekileyo asetyenziswa kakhulu kumashishini akumgangatho ophezulu afana nee-semiconductors, ii-elektroniki, amayeza, iindiza, i-aerospace kunye ne-biomedicine.
Kwiinkcukacha zolawulo lwemveliso yamayeza, igumbi elicocekileyo lahlulwe langama-4 amanqanaba: A, B, C kunye no-D.
Udidi A: Iindawo zokusebenza ezinobungozi obukhulu, ezifana neendawo zokuzalisa, iindawo apho iibharele zerabha zokumisa kunye nezikhongozeli zokupakisha ezivulekileyo zidibana ngqo namalungiselelo angenazintsholongwane, kunye neendawo apho kwenziwa khona imisebenzi yokuhlanganisa okanye yokudibanisa, kufuneka zixhotyiswe ngetafile yokusebenza yokuhamba okuhambayo okuya kwicala elinye ukugcina imeko yokusingqongileyo yendawo. Inkqubo yokuhamba okuhambayo okuya kwicala elinye kufuneka inike umoya ngokulinganayo kwindawo yayo yokusebenza ngesantya somoya se-0.36-0.54m/s. Kufuneka kubekho idatha yokuqinisekisa imeko yokuhamba okuhambayo okuya kwicala elinye kwaye iqinisekiswe. Kwibhokisi yokusebenza evaliweyo, eyodwa okanye yeglavu, isantya somoya esiphantsi singasetyenziswa.
Udidi B: lubhekisa kwindawo engasemva apho indawo ecocekileyo yodidi A ifumaneka khona kwimisebenzi enomngcipheko ophezulu efana nokulungiselela kunye nokuzalisa inkunkuma.
Udidi C no-D: lubhekisa kwiindawo ezicocekileyo ezingenamanyathelo angabalulekanga kangako ekuvelisweni kweemveliso zamayeza ezingeyongozi.
Ngokwemigaqo ye-GMP, ishishini lamayeza lelizwe lam lahlula iindawo ezicocekileyo zibe ngamanqanaba ama-4 e-ABCD njengoko kuchazwe ngasentla ngokusekelwe kwizalathisi ezifana nokucoceka komoya, uxinzelelo lomoya, umthamo womoya, ubushushu kunye nokufuma, ingxolo kunye nomxholo weentsholongwane.
Amanqanaba eendawo ezicocekileyo ahlulwe ngokwengxinano yamasuntswana axhonyiweyo emoyeni. Ngokubanzi, ixabiso lincinci, kokukhona inqanaba lococeko liphezulu.
1. Ukucoceka komoya kubhekisa kubungakanani kunye nenani lamasuntswana (kuquka neentsholongwane) aqulethwe emoyeni ngeyunithi nganye yomthamo wendawo, nto leyo eyindlela yokwahlula inqanaba lokucoceka kwendawo.
I-Static ibhekisa kwimeko emva kokuba inkqubo yomoya opholileyo kwigumbi ecocekileyo ifakiwe kwaye isebenza ngokupheleleyo, kwaye abasebenzi begumbi elicocekileyo baphume kwindawo kwaye bazihlambulula imizuzu engama-20.
I-Dynamic ithetha ukuba igumbi elicocekileyo likwimeko yokusebenza eqhelekileyo, izixhobo zisebenza ngokwesiqhelo, kwaye abasebenzi abamiselweyo basebenza ngokweemfuno.
2. Umgangatho wokubeka amanqaku we-ABCD uvela kwi-GMP epapashwe yi-World Health Organisation (WHO), eyinkcazo eqhelekileyo yolawulo lomgangatho wemveliso yamayeza kwishishini lamayeza. Okwangoku isetyenziswa kwiindawo ezininzi kwihlabathi liphela, kuquka i-European Union kunye ne-China.
Inguqulelo endala yaseTshayina ye-GMP ilandele imigangatho yaseMelika yokubeka amanqaku (iklasi ye-100, iklasi ye-10,000, iklasi ye-100,000) de kwaqaliswa inguqulelo entsha yemigangatho ye-GMP ngo-2011. Ishishini leyeza laseTshayina liqalise ukusebenzisa imigangatho yokwahlulahlula ye-WHO kwaye lisebenzisa i-ABCD ukwahlula amanqanaba eendawo ezicocekileyo.
Eminye imigangatho yokwahlulwahlulwa kwegumbi elicocekileyo
Igumbi elicocekileyo linemigangatho eyahlukeneyo yokubeka amanqaku kwimimandla eyahlukeneyo nakwimizi-mveliso. Imigangatho ye-GMP yaziswa ngaphambili, kwaye apha sikwazisa kakhulu imigangatho yaseMelika kunye nemigangatho ye-ISO.
(1). Umgangatho waseMelika
Ingcamango yokubeka umgangatho kwigumbi elicocekileyo yaqala ukucetywa yi-United States. Ngo-1963, umgangatho wokuqala karhulumente wecandelo lomkhosi kwigumbi elicocekileyo waqaliswa: i-FS-209. Imigangatho eqhelekileyo yeklasi ye-100, iklasi ye-10000 kunye neklasi ye-100000 zonke zithathwe kulo mgangatho. Ngo-2001, i-United States yayeka ukusebenzisa umgangatho we-FS-209E yaza yaqala ukusebenzisa umgangatho we-ISO.
(2). Imigangatho ye-ISO
Imigangatho ye-ISO icetywayo yi-International Organisation for Standardization ISO kwaye igubungela amashishini amaninzi, kungekuphela nje ishishini lamayeza. Kukho amanqanaba alithoba ukusuka kwiklasi yoku-1 ukuya kwiklasi yesi-9. Phakathi kwawo, iklasi yesi-5 ilingana neklasi B, iklasi yesi-7 ilingana neklasi C, kwaye iklasi yesi-8 ilingana neklasi D.
(3). Ukuqinisekisa inqanaba lendawo ecocekileyo yeKlasi A, umthamo wesampuli yendawo nganye yokuvavanya akufuneki ube ngaphantsi kwe-1 cubic meter. Inqanaba lamasuntswana ahamba emoyeni kwiindawo ezicocekileyo zeKlasi A yi-ISO 5, kunye namasuntswana axhonyiweyo ≥5.0μm njengomgangatho omiselweyo. Inqanaba lamasuntswana ahamba emoyeni kwindawo ecocekileyo yeKlasi B (static) yi-ISO 5, kwaye ibandakanya amasuntswana axhonyiweyo anobukhulu obubini kwitheyibhile. Kwiindawo ezicocekileyo zeKlasi C (static kunye ne-dynamic), amanqanaba amasuntswana ahamba emoyeni yi-ISO 7 kunye ne-ISO 8 ngokulandelelanayo. Kwiindawo ezicocekileyo zeKlasi D (static) inqanaba lamasuntswana ahamba emoyeni yi-ISO 8.
(4). Xa kuqinisekiswa inqanaba, kufuneka kusetyenziswe ikhawuntara yothuli oluphathwayo enetyhubhu yokuvavanya emfutshane ukuthintela ukuba amasuntswana axhonyiweyo angama-≥5.0μm angahlali kwityhubhu ende yokuvavanya yenkqubo yokuvavanya ekude. Kwiinkqubo zokuhamba kwe-unidirectional, kufuneka kusetyenziswe iintloko zokuvavanya ze-isokinetic.
(5) Uvavanyo olunamandla lunokwenziwa ngexesha lemisebenzi yesiqhelo kunye neenkqubo zokuzalisa ezilinganisiweyo ze-culture medium ukubonisa ukuba inqanaba lokucoceka elinamandla liyafezekiswa, kodwa uvavanyo lokuzalisa olulinganisiweyo lwe-culture medium lufuna uvavanyo olunamandla phantsi "kwemeko embi kakhulu".
Igumbi elicocekileyo leKlasi A
Igumbi elicocekileyo leKlasi A, elaziwa ngokuba ligumbi elicocekileyo leKlasi 100 okanye igumbi elicocekileyo kakhulu, lelinye lamagumbi acocekileyo anococeko oluphezulu. Linokulawula inani lamasuntswana nge-cubic foot nganye emoyeni ukuya ngaphantsi kwe-35.5, oko kukuthi, inani lamasuntswana angaphezu okanye alingana ne-0.5um kwimitha nganye ye-cubic yomoya alinakudlula i-3,520 (engashukumiyo neguquguqukayo). Igumbi elicocekileyo leKlasi A lineemfuno ezingqongqo kakhulu kwaye lifuna ukusetyenziswa kwezihluzi ze-hepa, ulawulo loxinzelelo oluhlukeneyo, iinkqubo zokujikeleza komoya kunye neenkqubo zokulawula ubushushu kunye nokufuma rhoqo ukuze kufezekiswe iimfuno zazo zococeko oluphezulu. Amagumbi acocekileyo eKlasi A asetyenziswa kakhulu ekucutshungulweni kwe-microelectronics, kwi-biopharmaceuticals, kwimveliso yezixhobo ezichanekileyo, kwi-aerospace nakwezinye iindawo.
Igumbi elicocekileyo leKlasi B
Amagumbi acocekileyo eClass B akwabizwa ngokuba ngamagumbi acocekileyo eClass 1000. Inqanaba lawo lokucoceka liphantsi kakhulu, nto leyo evumela inani lamasuntswana angaphezu okanye alingana ne-0.5um nge cubic meter yomoya ukufikelela kwi-3520 (static) kunye ne-352000 (dynamic). Amagumbi acocekileyo eClass B adla ngokusebenzisa izihluzi ezisebenzayo kunye neenkqubo zokukhupha umoya ukulawula umswakama, ubushushu kunye nomahluko woxinzelelo lwendalo yangaphakathi. Amagumbi acocekileyo eClass B asetyenziswa kakhulu kwi-biomedicine, kwimveliso yamayeza, kwimishini echanekileyo nakwimveliso yezixhobo nakwezinye iindawo.
Igumbi lokucoca leKlasi C
Amagumbi acocekileyo eKlasi C akwabizwa ngokuba ngamagumbi acocekileyo eKlasi 10,000. Inqanaba lawo lokucoceka liphantsi kakhulu, nto leyo evumela inani lamasuntswana angaphezu okanye alingana ne-0.5um nge-cubic meter yomoya ukufikelela kwi-352,000 (engashukumiyo) kunye ne-352,0000 (eguquguqukayo). Amagumbi acocekileyo eKlasi C adla ngokusebenzisa izihluzi ze-hepa, ulawulo loxinzelelo oluhle, ukujikeleza komoya, ulawulo lobushushu kunye nokufuma kunye nezinye iiteknoloji ukufezekisa imigangatho yazo ethile yokucoceka. Amagumbi acocekileyo eKlasi C asetyenziswa kakhulu kumayeza, ukwenziwa kwezixhobo zonyango, oomatshini abachanekileyo kunye nokuveliswa kwezinto ze-elektroniki kunye nezinye iinkalo.
Igumbi lokucoca leKlasi D
Amagumbi acocekileyo eKlasi D akwabizwa ngokuba ngamagumbi acocekileyo eKlasi 100,000. Inqanaba lawo lokucoceka liphantsi kakhulu, nto leyo evumela inani lamasuntswana angaphezu okanye alingana ne-0.5um nge-cubic meter yomoya ukufikelela kwi-3,520,000 (engashukumiyo). Amagumbi acocekileyo eKlasi D adla ngokusebenzisa izihluzi ze-hepa eziqhelekileyo kunye neenkqubo zolawulo loxinzelelo oluhle kunye nokujikeleza komoya ukulawula imeko yangaphakathi. Amagumbi acocekileyo eKlasi D asetyenziswa kakhulu kwimveliso yemizi-mveliso ngokubanzi, ekulungisweni nasekupakishweni kokutya, ekuprinteni, kwiindawo zokugcina impahla nakwezinye iindawo.
Amanqanaba ahlukeneyo amagumbi acocekileyo anemida yawo yokusebenza, ekufuneka ikhethwe ngokweemfuno zokwenyani. Kwimisebenzi ebonakalayo, ulawulo lokusingqongileyo lwamagumbi acocekileyo ngumsebenzi obaluleke kakhulu, obandakanya ukuqwalaselwa ngokubanzi kwezinto ezininzi. Yindlela yesayensi nefanelekileyo kunye nokusebenza kuphela okunokuqinisekisa umgangatho kunye nozinzo lwendawo ecocekileyo yamagumbi.
Ixesha leposi: Matshi-07-2024