Igumbi elicocekileyo yimeko elawulwa ngokukodwa kwizinto ezinje ngenani lamasuntswana emoyeni, umswakama, ubushushu kunye nombane obekiweyo bunokulawulwa ukufezekisa imigangatho ethile yokucoca. Amagumbi acocekileyo asetyenziswa ngokubanzi kwimizi-mveliso ye-teknoloji efana ne-semicontuctors, i-elektroniki, amayeza, inqwelo moya, i-aerospace kunye ne-biodicine.
Kumgaqo wolawulo lwemveliso yamayeza, igumbi elicocekileyo lahlulwe laba ngamanqanaba ama-4: A, B, C kunye D.
Iklasi A: Iindawo ezinomngcipheko omkhulu, ezinjengeendawo zokugcwalisa irabha kunye nezikhongozelo zokumisa irabha zinokudibana ngokuthe ngqo namalungiselelo e-Aseptic okanye imisebenzi yoqhakamshelwano, kufuneka ixhotywe ngetheyibhile yokusebenza engacacanga ukugcina imeko yendalo esingqongileyo yendawo. Inkqubo yokuhamba okungafunekiyo kufuneka ibonelele ngomoya ngokulinganayo kwindawo yayo yokusebenza kunye ne-velocity yomoya ye-0.36-0.54m / s. Kuya kufuneka kubekho idatha yokubonisa imeko yokuhamba okungafunekiyo kwaye iqinisekiswe. Kwi-operator evaliweyo, ekwanti okanye ibhokisi yegloves, i-velocity yendawo ephantsi inokusetyenziswa.
Iklasi B: ibhekisa kwindawo yangasemva apho indawo ecocekileyo ikwindawo ecocekileyo yomngcipheko omkhulu njengolungiselelo lwe-ASEptic kunye nokuzalisa.
Iklasi c no-D: Jonga iindawo ezicocekileyo ngamanyathelo amancinci ekuvelisweni kweemveliso zamayeza ezi-phamb.
Ngokwemigaqo ye-GMP, ishishini lasekhaya lasekhaya lahlulahlula iindawo ezicocekileyo kwimigangatho emi-4 ye-ABCD njengoko ingentla ngokusekwe kwizalathiso zomoya, umthamo womoya, iqondo lokuhlaselwa, ingxolo kunye nomxholo we-ronimo.
Amanqanaba eendawo ezicocekileyo aziwa ngokwamanqanaba oxinzelelo omiswe emoyeni. Ngokubanzi, incinci ixabiso, eliphezulu inqanaba lokucoca.
I-1. Ukucoceka komoya kubhekisa kubungakanani kunye nenani lamasuntswana (kubandakanya i-microorganisms) equlethwe kwi-moya kwi-oyile yecandelo ngalinye lendawo, enomgangatho wokwahlula inqanaba lokucoca indawo.
I-Static ibhekisela kurhulumente emva kokuba inkqubo yokucoca igumbi ecocekileyo ifakiwe kwaye isebenza ngokupheleleyo, kwaye abasebenzi begumbi elicocekileyo bakhuphele indawo kunye nokuzihlambulula imizuzu engama-20.
2. Umgangatho wokuhlelwa kwe-ABCD uvela kwi-GMP ebhengezwe nguMbutho wezeMpilo weHlabathi (i-WHO), eyona nto iqhelekileyo yolawulo lwemveliso esemgangathweni kwishishini lamayeza. Okwangoku isetyenziswa kwiindawo ezininzi zehlabathi, kubandakanya ne-European Union nase China.
Inguqulelo endala yaseTshayina ye-GMP ilandele imigangatho yokuhlela yaseMelika (iklasi ye-100, iklasi ye-10,000, iklasi ye-100,000) de kube ngummiselo we-Ginermacelical of i-ABCD ahlukane nayo amanqanaba eendawo ezicocekileyo.
Eminye imigangatho yegumbi lokucoca igumbi
Igumbi elicocekileyo linemigangatho eyahlukeneyo yokuhlela kwimimandla eyahlukeneyo kunye namashishini. Imigangatho ye-GMP iye yaziswa ngaphambili, kwaye apha sisazisa ikakhulu kwimigangatho yaseMelika kunye nenqanaba le-ISO.
(1). UMGAQO-NKQUBO
Umxholo wegumbi lokucoca amagumbi acocekileyo kuqala acetywa eUnited States. Ngo-1963, umgangatho wokuqala woburharha kwinxalenye yomkhosi wegumbi elicocekileyo yasungulwa: FS-209. Iklasi ye-100, iklasi ye-10000 nemigangatho ye-100000 yayo yonke imigangatho yonke ivela kulo mgangatho. Ngo-2001, i-United States yayeka ukusebenzisa i-FS-209E isebenzisa i-FS-209E iqale ukusebenzisa umgangatho we-ISO.
(2). Inqanaba le-ISO
Imigangatho ye-ISO icetyiswa ngumbutho wamanye amazwe wokumisela umgangatho kwaye igubungele amashishini amaninzi, hayi ishishini lamayeza nje. Kukho amanqanaba alithoba avela eklasini 9. Phakathi kwazo, iklasi 5 ilingana nodidi B, iklasi yesi-7 ilingana neklasi D.
(3). Ukuqinisekisa inqanaba leklasi indawo ecocekileyo, ivolumu yesampulu yenqaku ngalinye lesampulu aliyi kuba ngaphantsi kwe-1 ye-cubic meter. Inqanaba lamasuntswana ahlukeneyo e-Airborne kwiindawo ezicocekileyo yi-ISO 5, ngee-ISETYENZISIWEYO Inqanaba lamasuntswana ahlukeneyo kwiNdawo yokuCotshelwa kweCard B (i-Static) yi-ISO 5, kwaye ibandakanya amasuntswana olwenziwe ngobukhulu obubini kwitafile. Iindawo ezicocekileyo zeklasi zeklasi (Static kunye namanqanaba amanqanaba omoya ahamba-moya yi-ISO 7 kunye ne-SO 8 ngokwahlukeneyo. Iindawo ezicocekileyo zeklasi zeklasi (Static) inqanaba lamasuntswana ahlukeneyo yi-ISO 8.
(4). Xa uqinisekisa inqanaba, i-thermation ye-pursed particle ityhubhu emfutshane yesampulu kufuneka isetyenziselwe ukuthintela i-≥5.0μm inqunyanyisiwe amasuntswana anokuhlala kwi-tube yesampulu ende yesampulu yenkqubo yesampulu. Iinkqubo zokuhamba ngokungacacanga, iintloko zesampuli ze-Isokinetic kufuneka zisetyenziswe.
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Iklasi igumbi elicocekileyo
Iklasi igumbi elicocekileyo, ekwabizwa ngokuba yigumbi elicocekileyo le-100 okanye igumbi lokucoca i-ultra, yenye yamagumbi acocekileyo ngococeko oluphezulu. Ingalawula inani lamasuntswana kumhla womoya ukuya ku-35,5, oko kukuthi, inani lamasuntswana amakhulu olungenakudlula kwi-3,520 (ilingane). Class A clean room have very strict requirements and require the use of hepa filters, differential pressure control, air circulation systems and constant temperature and humidity control systems to achieve their high cleanliness requirements. Class A clean rooms are mainly used in microelectronics processing, biopharmaceuticals, precision instrument manufacturing, aerospace and other fields.
Iklasi yeklasi yeClacki
Iklasi ecocekileyo B ikwabizwa ngokuba yiklasi ye-1000 yamagumbi acocekileyo. Inqanaba labo lokucoca liphantsi, livumela inani lamasuntswana ngaphezulu okanye alingane ne-0.5um ngemitha yomoya e-3520 (i-static) kunye ne-352000 (enamandla). Iklasi yamagumbi acocekileyo B idla ngokusebenzisa iifilters ezisebenzayo kunye neenkqubo zokuphelisa ukulawula umswakama, ubushushu kunye noxinzelelo lwemo yendawo yangaphakathi. Iklasi yeklasi B isetyenziswa ikakhulu kwi-bioddicine, imveliso yokwenziwa kwamayeza, yoomatshini abachanileyo kunye nemveliso yesixhobo kunye namanye amasimi.
Iklasi yegumbi leClacki
Amagumbi acocekileyo C acoceke akwabizwa ngokuba yiklasi ezilishumi elinamagumbi ali-10,000 acocekileyo. Inqanaba labo lokucoca liphantsi, livumela inani lamasuntswana ngaphezulu okanye alingane ne-0.5um ngemitha yomoya ukuya kwi-352,000 (i-72,0000 (enamandla). Iklasi ye-C icocekile ihlala isebenzisa iifilitha ze-HEDP, uLawulo loTyalo-mali, ukujikeleza komoya, ukujikeleza komoya, ukulawulwa kobushushu kunye nolawulo lokufumanisa kunye nolunye ubuchwephesha bokufezekisa imigangatho yabo yokucoceka. Amagumbi acocekileyo C acoceke ikakhulu asetyenziswa ikakhulu kwii-HARMACECICALS, ukwenziwa kwezakhono zezonyango, oomatshini bokuchaneka kunye nemveliso yecandelo le-elektroniki kunye namanye amasimi.
Iklasi yeklasi ye-D
Amagumbi acocekileyo d acocekileyo akwabizwa ngokuba yiklasi ezili-100,000 amagumbi acocekileyo. Inqanaba labo lokucoca liphantsi, livumela inani lamasuntswana ngaphezulu okanye alingana no-0.5um ngemitha yomoya ukuya kwi-3,520,000 (Static). Iklasi yeklasi ye-D ecocekileyo ihlala isebenzisa iifilitha zesiqhelo ze-HAPA kwaye iSiseko soLondolozo oluSiseko kunye neenkqubo zokujikeleza komoya ukulawula imeko yangaphakathi. Amagumbi acocekileyo d acoceke ikakhulu asetyenziswa ikakhulu kwimveliso ngokubanzi yemizi-mveliso, ukulungiswa kokutya kunye nokupakisha, ukuprinta, ukulungisa kunye nezinye amasimi.
Amanqanaba ahlukeneyo amagumbi acocekileyo anendawo yawo yesicelo, ekufuneka ikhethwe ngokweemfuno zokwenyani. Kwisicelo esisebenzayo, ulawulo lokusingqongileyo lwamagumbi olucocekileyo ngulo msebenzi ubalulekileyo, kubandakanya ukuqaphela izinto ezininzi. Uyilo lwesayensi kunye olufanelekileyo kunye nokusebenza kunokuqinisekisa umgangatho kunye nokuzinza kwendawo yegumbi elicocekileyo.
IXESHA LOKUQALA: UMar-07-2024