UKULAWULWA KOMQONDO WOKUHLANZA NOKUNGCOLISWA KWENDLU

Umqondo wegumbi lokuhlanza

Ukuhlanzwa: kubhekisela enkambisweni yokususa ukungcola ukuze kutholakale ukuhlanzeka okudingekayo.

Ukuhlanzwa komoya: isenzo sokususa ukungcola emoyeni ukuze kuhlanzeke umoya.

Izinhlayiya: izinto eziqinile neziwuketshezi ezinobukhulu obujwayelekile obungu-0.001 kuya ku-1000μm.

Izinhlayiya ezilengayo: izinhlayiya eziqinile neziwuketshezi ezinobubanzi obungu-0.1 kuya ku-5μm emoyeni ezisetshenziselwa ukuhlukaniswa kokuhlanza umoya.

Ukuhlolwa okuqinile: ukuhlolwa okwenziwa lapho uhlelo lokupholisa umoya lwegumbi lokuhlanza lusebenza kahle, imishini yokucubungula isifakiwe, futhi kungekho basebenzi bokukhiqiza egumbini lokuhlanza.

Ukuhlolwa okuguqukayo: ukuhlolwa okwenziwa lapho igumbi lokuhlanza likhiqizwa ngendlela evamile.

Ukungazali: ukungabikho kwezinto eziphilayo.

Ukuhlanza: indlela yokufinyelela isimo esingenamagciwane. Umehluko phakathi kwegumbi lokuhlanza negumbi elijwayelekile elinomoya opholile. Amagumbi okuhlanza namakamelo ajwayelekile anomoya opholile yizindawo lapho kusetshenziswa khona izindlela zokwenziwa ukudala nokugcina indawo yomoya efinyelela izinga lokushisa elithile, umswakama, ijubane lokugeleza komoya kanye nokuhlanzwa komoya. Umehluko phakathi kwalokhu okubili ungokulandelayo:

Igumbi elihlanzekile, igumbi elijwayelekile elinomoya opholile

Izinhlayiya zomoya ezilenga ngaphakathi kumele zilawulwe. Izinga lokushisa, umswakama, isivinini sokugeleza komoya kanye nomthamo womoya kumele kufinyelele imvamisa ethile yokungenisa umoya (igumbi lokuhlanza ukugeleza okuqondile izikhathi ezingu-400-600/ihora, igumbi lokuhlanza elingaqondile izikhathi ezingu-15-60/ihora).

Ngokuvamile, izinga lokushisa lincishiswa izikhathi ezingu-8-10/h. Umoya opholile uyigumbi lokushisa elihlala njalo izikhathi ezingu-10-15/h. Ngaphezu kokuqapha izinga lokushisa nomswakama, ukuhlanzeka kumele kuhlolwe njalo. Izinga lokushisa nomswakama kumele kuhlolwe njalo. Ukunikezwa komoya kumele kudlule ekuhlungeni kwezigaba ezintathu, futhi i-terminal kumele isebenzise izihlungi zomoya ze-hepa. Sebenzisa imishini yokushintshanisa ukushisa nomswakama eyinhloko, ephakathi nendawo. Igumbi elihlanzekile kumele libe nomfutho othile omuhle ≥10Pa endaweni ezungezile. Kukhona umfutho omuhle, kodwa akukho mfuneko yokulinganisa. Abasebenzi abangenayo kumele bashintshe izicathulo ezikhethekile nezingubo ezihlanzekile futhi badlule eshaweni lomoya. Hlukanisa ukuhamba kwabantu kanye nezinhlelo zokusebenza.

Izinhlayiya ezilengayo: ngokuvamile zibhekisela ezinhlayiya eziqinile neziwuketshezi ezilenga emoyeni, futhi ububanzi bobukhulu bezinhlayiya zayo bungaba ngu-0.1 kuya ku-5μm. Ukuhlanzeka: kusetshenziselwa ukuchaza ubukhulu nenani lezinhlayiya eziqukethwe emoyeni ngeyunithi ngayinye yomthamo wesikhala, okuyindinganiso yokuhlukanisa ukuhlanzeka kwendawo.

I-Airlock: Igumbi le-buffer elibekwe emnyango nasemphumeni wegumbi elihlanzekile ukuvimba ukugeleza komoya ongcolile kanye nokulawulwa komehluko wokucindezela kusuka emakamelweni angaphandle noma aseduze.

Ishawa yomoya: Uhlobo lokuvala umoya olusebenzisa amafeni, izihlungi, kanye nezinhlelo zokulawula ukuvuthela umoya uzungeze abantu abangena ekamelweni. Kungenye yezindlela ezisebenzayo zokunciphisa ukungcola kwangaphandle.

Izingubo zokusebenza ezihlanzekile: Izingubo ezihlanzekile ezikhiqiza uthuli oluncane ezisetshenziselwa ukunciphisa izinhlayiya ezikhiqizwa yizisebenzi.

Isihlungi somoya se-Hepa: Isihlungi somoya esinekhono lokubamba elingaphezu kuka-99.9% lezinhlayiya ezinobubanzi obukhulu noma obulingana no-0.3μm kanye nokumelana nokugeleza komoya okungaphansi kuka-250Pa ngevolumu yomoya elinganisiwe.

Isihlungi somoya se-Ultra-hepa: Isihlungi somoya esinekhono lokubamba elingaphezu kuka-99.999% lezinhlayiya ezinobubanzi obungu-0.1 kuya ku-0.2μm kanye nokumelana nokugeleza komoya okungaphansi kuka-280Pa ngevolumu yomoya elinganisiwe.

Indawo yokusebenzela ehlanzekile: Yakhiwe uhlelo lokupholisa umoya oluphakathi nendawo kanye nokuhlanza umoya, futhi futhi iyinhliziyo yesistimu yokuhlanza, isebenza ndawonye ukuqinisekisa ukujwayelekile kwemingcele ehlukahlukene. Ukulawula izinga lokushisa kanye nomswakama: Indawo yokusebenzela ehlanzekile iyisidingo semvelo se-GMP yezinkampani zemithi, kanti uhlelo lokupholisa umoya oluhlanzekile (i-HVAC) luyisiqinisekiso esiyisisekelo sokufeza indawo yokuhlanza. Uhlelo lokupholisa umoya oluphakathi nendawo oluhlanzekile lungahlukaniswa ngezigaba ezimbili: Uhlelo lokupholisa umoya oluphakathi nendawo oluhlanzekile lungahlukaniswa ngezigaba ezimbili: Uhlelo lokupholisa umoya oluphakathi nendawo oluhlanzekile lwe-DC: umoya ongaphandle oye waphathwa futhi ongahlangabezana nezidingo zesikhala uthunyelwa egumbini, bese wonke umoya ukhishwa. Lubizwa nangokuthi uhlelo oluphelele lokukhipha umoya, olusetshenziselwa ama-workshop anezidingo ezikhethekile zenqubo. Indawo ekhiqiza uthuli esitezi sesine se-workshop ekhona ingeyalolu hlobo, njengegumbi lokomisa i-granulation, indawo yokugcwalisa amaphilisi, indawo yokumboza, indawo yokuchoboza kanye neyokulinganisa. Ngenxa yokuthi i-workshop ikhiqiza uthuli oluningi, kusetshenziswa uhlelo lokupholisa umoya oluphakathi nendawo lwe-DC. Uhlelo lokupholisa umoya olujikelezayo: okungukuthi, ukuphakelwa komoya ohlanzekile wegumbi kuyingxube yengxenye yomoya omusha ohlanzekile ohlinziwe ngaphandle kanye nengxenye yomoya obuyayo ovela endaweni ehlanzekile yegumbi. Umthamo womoya omusha wangaphandle uvame ukubalwa njengo-30% womthamo womoya ophelele egumbini elihlanzekile, futhi kufanele futhi uhlangabezane nesidingo sokubuyisela umoya ophumayo egumbini. Ukujikeleza kabusha kuhlukaniswe ngomoya obuyayo oyinhloko nomoya obuyayo wesibili. Umehluko phakathi komoya obuyayo oyinhloko nomoya obuyayo wesibili: Ohlelweni lomoya opholile lwegumbi elihlanzekile, umoya obuyayo oyinhloko ubhekisela emoyeni obuyayo wangaphakathi ohlanganiswe kuqala nomoya omusha, bese uphathwa yi-surface cooler (noma igumbi lokufafaza amanzi) ukuze kufinyelelwe isimo se-dew point yomshini, bese kufudunyezwa yi-heater eyinhloko ukuze kufinyelelwe isimo somoya (sokushisa okuhlala njalo kanye nohlelo lomswakama). Indlela yomoya obuyayo wesibili ukuthi umoya obuyayo oyinhloko uxutshwa nomoya omusha bese uphathwa yi-surface cooler (noma igumbi lokufafaza amanzi) ukuze kufinyelelwe isimo se-dew point yomshini, bese kuxutshwa nomoya obuyayo wangaphakathi kanye, futhi isimo somoya wangaphakathi singatholakala ngokulawula isilinganiso sokuxuba (ikakhulukazi uhlelo lokususa umswakama).

Ukucindezela okuhle: Ngokuvamile, amakamelo ahlanzekile adinga ukugcina ukucindezela okuhle ukuvimbela ukungcola kwangaphandle ukuthi kungangeni, futhi kusiza ekukhipheni uthuli lwangaphakathi. Inani lokucindezela okuhle ngokuvamile lilandela imiklamo emibili elandelayo: 1) Umehluko wokucindezela phakathi kwamakamelo ahlanzekile anamazinga ahlukene naphakathi kwezindawo ezihlanzekile nezindawo ezingahlanzekile akufanele ube ngaphansi kuka-5Pa; 2) Umehluko wokucindezela phakathi kwama-workshop ahlanzekile angaphakathi nangaphandle akufanele ube ngaphansi kuka-10Pa, ngokuvamile u-10~20Pa. (1Pa=1N/m2) Ngokusho kwe-"Cleanroom Design Specification", ukukhethwa kwezinto zokwakha isakhiwo sokulungisa segumbi lokuhlanza kufanele kuhlangabezane nezidingo zokuvimbela ukushisa, ukuvimbela ukushisa, ukuvimbela umlilo, ukumelana nomswakama, kanye nothuli oluncane. Ngaphezu kwalokho, izidingo zokushisa nomswakama, ukulawula umehluko wokucindezela, ukugeleza komoya kanye nomthamo wokunikezwa komoya, ukungena nokuphuma kwabantu, kanye nokwelashwa kokuhlanza umoya kuyahlelwa futhi kubanjiswana ukwakha uhlelo lwegumbi lokuhlanza.

1. Izidingo zokushisa nomswakama

Izinga lokushisa kanye nomswakama ohlobene wegumbi lokuhlanza kufanele kuhambisane nezidingo zokukhiqiza zomkhiqizo, futhi indawo yokukhiqiza yomkhiqizo kanye nenduduzo yomqhubi kufanele kuqinisekiswe. Uma kungekho zidingo ezikhethekile zokukhiqiza umkhiqizo, izinga lokushisa legumbi lokuhlanza lingalawulwa ku-18-26℃ kanye nomswakama ohlobene ungalawulwa ku-45-65%. Uma kucatshangelwa ukulawulwa okuqinile kokungcola kwamagciwane endaweni eyinhloko yokusebenza kwe-aseptic, kunezidingo ezikhethekile zezingubo zabaqhubi kule ndawo. Ngakho-ke, izinga lokushisa kanye nomswakama ohlobene wendawo ehlanzekile kunganqunywa ngokuya ngezidingo ezikhethekile zenqubo nomkhiqizo.

1. Ukulawula umehluko wokucindezela

Ukuze kugwenywe ukuhlanzeka kwegumbi elihlanzekile ekungcolisweni yigumbi eliseduze, ukugeleza komoya eduze kwezikhala zesakhiwo (izikhala zeminyango, ukungena kodonga, imigudu, njll.) ohlangothini olucacisiwe kunganciphisa ukugeleza kwezinhlayiya eziyingozi. Indlela yokulawula isiqondiso sokugeleza komoya ukulawula ingcindezi yendawo eseduze. I-GMP idinga umehluko wokucindezela olinganisekayo (DP) ukuze ugcinwe phakathi kwegumbi elihlanzekile nendawo eseduze ngokuhlanzeka okuphansi. Inani le-DP phakathi kwamazinga omoya ahlukene ku-GMP yaseShayina lichazwe ukuthi lingabi ngaphansi kuka-10Pa, futhi umehluko wokucindezela omuhle noma omubi kufanele ugcinwe ngokwezidingo zenqubo.

1. Iphethini yokuhamba komoya kanye nomthamo wokunikezwa komoya. Inhlangano yokuhamba komoya efanelekile ingenye yeziqinisekiso ezibalulekile zokuvimbela ukungcola kanye nokungcola okuwela endaweni ehlanzekile. Inhlangano yokuhamba komoya efanelekile ukwenza umoya wegumbi elihlanzekile uthunyelwe ngokushesha nangokulinganayo noma usakazeke endaweni yonke ehlanzekile, unciphise imisinga ye-eddy kanye namakhona afile, unciphise uthuli namagciwane akhishwa ukungcola kwangaphakathi, futhi uwakhiphe ngokushesha nangendlela ephumelelayo, unciphise amathuba okuba uthuli namagciwane angcolise umkhiqizo, futhi agcine ukuhlanzeka okudingekayo ekamelweni. Njengoba ubuchwepheshe obuhlanzekile bulawula ukugcwala kwezinhlayiya ezilengayo emkhathini, futhi umthamo womoya olethwa egumbini elihlanzekile mkhulu kakhulu kunalowo odingwa amakamelo ajwayelekile anomoya opholile, isimo sawo sokuhlela ukuhamba komoya sihluke kakhulu kuwo. Iphethini yokuhamba komoya ihlukaniswe kakhulu ngezigaba ezintathu:
2. Ukugeleza okuqondile: ukugeleza komoya okuneziqondiso ezifanayo ohlangothini olulodwa kanye nesivinini somoya esihambisanayo esigabeni esiphambeneyo; (Kunezinhlobo ezimbili: ukugeleza okuqondile okuqondile kanye nokugeleza okuqondile okuqondile.)
3. Ukugeleza okungahambisani nohlangothi olulodwa: kubhekisela ekugelezeni komoya okungahlangabezani nencazelo yokugeleza okungahambisani nohlangothi olulodwa.

3. Ukugeleza okuxubile: ukugeleza komoya okwakhiwa ukugeleza okuqondile kanye nokugeleza okuqondile. Ngokuvamile, ukugeleza okuqondile kugeleza kahle kusuka ohlangothini lokunikezwa komoya wangaphakathi kuya ohlangothini lomoya olubuyelayo oluhambisanayo, futhi ukuhlanzeka kungafinyelela isigaba 100. Ukuhlanzeka kwamakamelo ahlanzekile angaqondile kuphakathi kwesigaba 1,000 kanye nesigaba 100,000, kanti ukuhlanzeka kwamakamelo ahlanzekile angaqondile kungafinyelela isigaba 100 kwezinye izindawo. Ohlelweni lokugeleza oluvundlile, ukugeleza komoya kugeleza kusuka odongeni olulodwa kuya kolunye. Ohlelweni lokugeleza oluqondile, ukugeleza komoya kugeleza kusuka ophahleni kuya phansi. Isimo somoya wegumbi elihlanzekile ngokuvamile singavezwa ngendlela eqondakalayo ngokuthi "imvamisa yokushintsha komoya": "ukushintsha komoya" yivolumu yomoya engena esikhaleni ngehora ehlukaniswe yivolumu yesikhala. Ngenxa yamanani ahlukene okunikezwa komoya ohlanzekile athunyelwa ekamelweni elihlanzekile, ukuhlanzeka kwegumbi nakho kuhlukile. Ngokwezibalo zethiyori kanye nokuhlangenwe nakho okusebenzayo, ulwazi olujwayelekile lwezikhathi zokungenisa umoya lulandelayo, njengokulinganisa kokuqala kwevolumu yokunikezwa komoya egumbini elihlanzekile: 1) Ekilasini 100,000, izikhathi zokungenisa umoya ngokuvamile zingaphezu kwezikhathi ezingu-15/ihora; 2) Ekilasini 10,000, izikhathi zokungenisa umoya ngokuvamile zingaphezu kwezikhathi ezingu-25/ihora; 3) Ekilasini 1000, izikhathi zokungenisa umoya ngokuvamile zingaphezu kwezikhathi ezingu-50/ihora; 4) Ekilasini 100, umthamo wokunikezwa komoya ubalwa ngokusekelwe esivinini somoya esiwela phakathi kokunikezwa komoya esingu-0.2-0.45m/s. Ukwakheka komthamo womoya okunengqondo kuyingxenye ebalulekile yokuqinisekisa ukuhlanzeka kwendawo ehlanzekile. Nakuba ukwandisa inani lokungenisa umoya ekamelweni kuzuzisa ekuqinisekiseni ukuhlanzeka, umthamo womoya oweqile uzodala imfucuza yamandla. Izinga lokuhlanzeka komoya inani eliphakeme elivumelekile lezinhlayiya zothuli (static) inani eliphakeme elivumelekile lama-microorganisms (static) imvamisa yokungenisa umoya (ngehora)

4. Ukungena nokuphuma kwabantu nezinto

Ukuze kuhlungwe amakamelo ahlanzekile, ngokuvamile abekwa emnyango nasemphumeni wegumbi elihlanzekile ukuze kuvinjwe ukugeleza komoya ongcolile wangaphandle futhi kulawulwe umehluko wokucindezela. Igumbi le-buffer lisethiwe. Lawa makamelo edivayisi axhumene alawula isikhala sokungena nokuphuma ngeminyango eminingana, futhi ahlinzeka ngezindawo zokugqoka/zokukhipha izingubo ezihlanzekile, ukubulala amagciwane, ukuhlanza kanye neminye imisebenzi. Ama-interlock avamile kagesi kanye nama-air lock.

Ibhokisi lokudlula: Ukungena nokuphuma kwezinto egumbini elihlanzekile kufaka phakathi ibhokisi lokudlula, njll. Lezi zingxenye zidlala indima yokubopha ekudlulisweni kwezinto phakathi kwendawo ehlanzekile nendawo engahlanzekile. Iminyango yazo emibili ayikwazi ukuvulwa ngesikhathi esisodwa, okuqinisekisa ukuthi umoya wangaphandle awukwazi ukungena nokuphuma eshabhu lapho izinto zilethwa. Ngaphezu kwalokho, ibhokisi lokudlula elihlonyiswe ngedivayisi yesibani se-ultraviolet alikwazi nje ukugcina ingcindezi enhle ekamelweni izinzile, livimbele ukungcola, lihlangabezane nezidingo ze-GMP, kodwa futhi lidlala indima ekuhlanzeni nasekubulaleni amagciwane.

Ishawa yomoya: Igumbi leshawa yomoya liyindlela yokungena nokuphuma kwezimpahla egumbini elihlanzekile futhi lidlala indima yegumbi elivaliwe elivaliwe elihlanzekile. Ukuze kuncishiswe inani elikhulu lezinhlayiya zothuli ezilethwa yizimpahla zingena futhi ziphuma, ukugeleza komoya ohlanzekile okuhlungiwe yisihlungi se-hepa kufafazwa kuzo zonke izinkomba nge-nozzle ejikelezayo kuya ezimpahleni, kususwe ngempumelelo nangokushesha izinhlayiya zothuli. Uma kukhona ishawa yomoya, kumele ivuthelwe futhi ishawe ngokwemigomo ngaphambi kokungena endaweni yokuhlanza engenalo uthuli. Ngesikhathi esifanayo, landela ngokuqinile imininingwane kanye nezidingo zokusebenzisa ishawa yomoya.

1. Ukwelashwa kokuhlanza umoya kanye nezici zawo

Ubuchwepheshe bokuhlanza umoya buwubuchwepheshe obuphelele bokudala indawo yomoya ohlanzekile nokuqinisekisa nokuthuthukisa ikhwalithi yomkhiqizo. Ngokuyinhloko ukuhlunga izinhlayiya emoyeni ukuze kutholakale umoya ohlanzekile, bese kugeleza ngendlela efanayo ngesivinini esifanayo noma ngokuvundlile, bese kugezwa umoya ngezinhlayiya ezizungezile, ukuze kufezwe injongo yokuhlanza umoya. Uhlelo lokupholisa umoya lwegumbi elihlanzekile kumele lube uhlelo lokupholisa umoya oluhlanzekile olunezindlela zokuhlunga zezigaba ezintathu: isihlungi esiyinhloko, isihlungi esiphakathi kanye nesihlungi se-hepa. Qinisekisa ukuthi umoya othunyelwa ekamelweni ungumoya ohlanzekile futhi unganciphisa umoya ongcolile ekamelweni. Isihlungi esiyinhloko sifanelekile kakhulu ekuhlungeni okuyinhloko kwezinhlelo zokupholisa umoya kanye nokungenisa umoya kanye nokubuyisela ukuhlunga komoya emakamelweni ahlanzekile. Isihlungi sakhiwe ngemicu yokwenziwa kanye nensimbi ehlanganisiwe. Singakwazi ukuvimba ngempumelelo izinhlayiya zothuli ngaphandle kokwakha ukumelana okukhulu nokugeleza komoya. Imicu ehlanganiswe ngokungahleliwe yakha izithiyo ezingenakubalwa ezinhlayiyeni, futhi isikhala esibanzi phakathi kwemicu sivumela ukuhamba komoya kudlule kahle ukuvikela izinga elilandelayo lezihlungi ohlelweni kanye nohlelo ngokwalo. Kunezimo ezimbili zokugeleza komoya wangaphakathi ongenamagciwane: esinye siyi-laminar (okungukuthi, zonke izinhlayiya ezilengayo egumbini zigcinwa kungqimba lwe-laminar); esinye asiyi-laminar (okungukuthi, ukugeleza komoya wangaphakathi kuyaphithizela). Emakamelweni amaningi ahlanzekile, ukugeleza komoya wangaphakathi akugcini nje ngokuxuba izinhlayiya ezilengayo emoyeni, kodwa futhi kwenze izinhlayiya ezimile ekamelweni ziphinde zindize, futhi omunye umoya ungaphinde umile.

6. Ukuvimbela umlilo kanye nokususwa kwezindawo zokusebenzela ezihlanzekile

1) Izinga lokumelana nomlilo ezindaweni zokusebenzela ezihlanzekile akufanele libe ngaphansi kwezinga lesi-2;

2) Ingozi yomlilo yama-workshop okukhiqiza ezindaweni zokusebenzela ezihlanzekile kufanele ihlukaniswe futhi isetshenziswe ngokuhambisana nezindinganiso zamanje zikazwelonke "zoMthetho Wokuvimbela Umlilo Wokuklama Isakhiwo".

3) Amaphaneli ophahleni nodonga lwegumbi elihlanzekile akufanele ashise, futhi izinto ezihlanganisiwe eziphilayo akufanele zisetshenziswe. Umkhawulo wokumelana nomlilo wophahleni akufanele ube ngaphansi kwamahora angu-0.4, futhi umkhawulo wokumelana nomlilo wophahleni lwendlela yokuphuma akufanele ube ngaphansi kwamahora angu-1.0.

4) Esakhiweni sefektri esibanzi ngaphakathi kwendawo yomlilo, izinyathelo zokuhlukanisa umzimba ezingashi kufanele zibekwe phakathi kwezindawo zokukhiqiza ezihlanzekile nezindawo zokukhiqiza ezijwayelekile. Umkhawulo wokumelana nomlilo wodonga lokuhlukanisa kanye nophahla oluhambisanayo akufanele ube ngaphansi kwehora eli-1. Izinto ezingashi noma ezingashi kufanele zisetshenziswe ukugcwalisa amapayipi adlula odongeni noma ophahleni ngokuqinile;

5) Izindawo zokuphuma zokuphepha kumele zihlakazeke, futhi akufanele kube nemizila egobile esuka endaweni yokukhiqiza iye endaweni yokuphuma zokuphepha, futhi kufanele kubekwe izimpawu zokuphuma ezisobala.

6) Umnyango wokuphuma ophephile oxhumanisa indawo ehlanzekile nendawo engahlanzekile kanye nendawo ehlanzekile yangaphandle kufanele uvulwe ngendlela yokuphuma. Umnyango wokuphuma ophephile akufanele ube umnyango olengisiwe, umnyango okhethekile, umnyango oshelelayo ohlangothini noma umnyango kagesi ozenzakalelayo. Udonga lwangaphandle lwe-workshop ehlanzekile kanye nendawo ehlanzekile esitezi esifanayo kufanele lufakwe iminyango namafasitela ukuze abacimi bomlilo bangene endaweni ehlanzekile ye-workshop, futhi kufanele kubekwe indawo yokungena ekhethekile yomlilo engxenyeni efanele yodonga lwangaphandle.

Incazelo ye-GMP workshop: I-GMP yisifinyezo se-Good Manufacturing Practice. Okuqukethwe kwayo okuyinhloko ukubeka phambili izidingo eziphoqelekile zokuqonda kwenqubo yokukhiqiza yebhizinisi, ukusebenza kwemishini yokukhiqiza, kanye nokunemba kanye nokulinganisa imisebenzi yokukhiqiza. Isitifiketi se-GMP sibhekisela enkambisweni lapho uhulumeni kanye neminyango efanele behlela khona ukuhlolwa kwazo zonke izici zebhizinisi, njengabasebenzi, ukuqeqeshwa, izikhungo zezitshalo, indawo yokukhiqiza, izimo zokuhlanzeka, ukuphathwa kwezinto, ukuphathwa kokukhiqiza, ukuphathwa kwekhwalithi, kanye nokuphathwa kokuthengisa, ukuhlola ukuthi ziyahlangabezana yini nezidingo zomthetho. I-GMP idinga ukuthi abakhiqizi bomkhiqizo babe nemishini yokukhiqiza emihle, izinqubo zokukhiqiza ezifanele, ukuphathwa kwekhwalithi ephelele kanye nezinhlelo zokuhlola eziqinile ukuqinisekisa ukuthi ikhwalithi yomkhiqizo wokugcina ihlangabezana nezidingo zemithetho. Ukukhiqizwa kwemikhiqizo ethile kumele kwenziwe kuma-workshop aqinisekisiwe yi-GMP. Ukusebenzisa i-GMP, ukuthuthukisa ikhwalithi yomkhiqizo, kanye nokuthuthukisa imiqondo yesevisi kuyisisekelo nomthombo wentuthuko yamabhizinisi amancane naphakathi ngaphansi kwezimo zomnotho wemakethe. Ukungcola kwegumbi elihlanzekile kanye nokulawulwa kwalo: Incazelo yokungcola: Ukungcola kubhekisela kuzo zonke izinto ezingadingekile. Kungakhathaliseki ukuthi kuyizinto ezibonakalayo noma amandla, uma nje kungeyona ingxenye yomkhiqizo, akudingekile ukuba khona futhi kuthinte ukusebenza komkhiqizo. Kunemithombo emine eyisisekelo yokungcola: 1. Izakhiwo (uphahla, phansi, udonga); 2. Amathuluzi, imishini; 3. Abasebenzi; 4. Imikhiqizo. Qaphela: Ukungcola okuncane kungalinganiswa ngama-micron, okungukuthi: 1000μm=1mm. Ngokuvamile singabona kuphela izinhlayiya zothuli ezinobukhulu bezinhlayiya ezingaphezu kuka-50μm, kanti izinhlayiya zothuli ezingaphansi kuka-50μm zingabonakala kuphela nge-microscope. Ukungcola kwamagciwane egumbi elihlanzekile kuvela kakhulu ezicini ezimbili: ukungcola komzimba womuntu kanye nokungcola kohlelo lwamathuluzi okusebenzela. Ngaphansi kwezimo ezijwayelekile zomzimba, umzimba womuntu uzohlala ukhipha izikali zamaseli, eziningi zazo ezithwala amagciwane. Njengoba umoya uvuselela inani elikhulu lezinhlayiya zothuli, uhlinzeka ngabathwali kanye nezimo zokuphila zamagciwane, ngakho-ke umkhathi ungumthombo oyinhloko wamagciwane. Abantu bawumthombo omkhulu wokungcola. Lapho abantu bekhuluma futhi benyakaza, bakhipha inani elikhulu lezinhlayiya zothuli, ezinamathela ebusweni bomkhiqizo futhi zingcolise umkhiqizo. Nakuba abasebenzi abasebenza ekamelweni elihlanzekile begqoka izingubo ezihlanzekile, izingubo ezihlanzekile azikwazi ukuvimbela ngokuphelele ukusabalala kwezinhlayiya. Izinhlayiya eziningi ezinkulu zizohlala ngokushesha ebusweni bento ngenxa yamandla adonsela phansi, kanti ezinye izinhlayiya ezincane zizowela ebusweni bento ngokuhamba komoya. Kuphela lapho izinhlayiya ezincane zifinyelela ukuhlushwa okuthile futhi zihlangana ndawonye lapho zingabonakala khona ngeso lenyama. Ukuze kuncishiswe ukungcola kwamakamelo ahlanzekile ngabasebenzi, abasebenzi kumele balandele ngokuqinile imithethonqubo lapho bengena futhi bephuma. Isinyathelo sokuqala ngaphambi kokungena ekamelweni elihlanzekile ukukhumula ijazi lakho egumbini lokuqala leshifti, ufake izihlipha ezijwayelekile, bese ungena ekamelweni lesibili leshifti ukuze ushintshe izicathulo. Ngaphambi kokungena ekamelweni lesibili, geza futhi womise izandla zakho egumbini le-buffer. Yomisa izandla zakho ngaphambili nangemuva kwezandla zakho kuze kube yilapho izandla zakho zingamanzi. Ngemva kokungena ekamelweni lesibili leshifti, shintsha izihlipha zeshifti yokuqala, gqoka izingubo zomsebenzi ezihlanzekile, bese ugqoka izicathulo zokuhlanza zeshifti yesibili. Kunamaphuzu amathathu abalulekile lapho ugqoka izingubo zomsebenzi ezihlanzekile: A. Gqoka kahle futhi ungazivezi izinwele zakho; B. Imaski kufanele imboze impumulo; C. Hlanza uthuli ezingutsheni zomsebenzi ezihlanzekile ngaphambi kokungena endaweni yokusebenzela ehlanzekile. Ekuphathweni kokukhiqiza, ngaphezu kwezinye izici eziqondile, kusenabasebenzi abaningi abangangeni endaweni ehlanzekile njengoba kudingeka futhi izinto aziphathwanga ngokuqinile. Ngakho-ke, abakhiqizi bomkhiqizo kumele badinge ngokuqinile abaqhubi bokukhiqiza futhi bahlakulele ukuqwashisa ngokuhlanzeka kwabasebenzi bokukhiqiza. Ukungcola kwabantu - amabhaktheriya:

1. Ukungcola okubangelwa abantu: (1) Isikhumba: Abantu bavame ukulahla isikhumba sabo ngokuphelele njalo ezinsukwini ezine, kanti abantu balahla izingcezu zesikhumba ezingaba yi-1,000 ngomzuzu (usayizi ojwayelekile ungama-micron angu-30*60*3) (2) Izinwele: Izinwele zabantu (ububanzi bungama-micron angaba ngu-50~100) zihlala ziwa. (3) Amathe: aqukethe i-sodium, ama-enzyme, usawoti, i-potassium, i-chloride kanye nezinhlayiya zokudla. (4) Izingubo zansuku zonke: izinhlayiya, imicu, i-silica, i-cellulose, amakhemikhali ahlukahlukene kanye namagciwane. (5) Abantu bazokhiqiza izinhlayiya eziyi-10,000 ezinkulu kune-0.3 microns ngomzuzu uma bemile noma behleli.

2. Ukuhlaziywa kwedatha yokuhlolwa kwamanye amazwe kukhombisa ukuthi: (1) Ekamelweni elihlanzekile, lapho abasebenzi begqoka izingubo ezingenamagciwane: inani lamagciwane akhishwa lapho ehleli ngokuvamile lingu-10 ~ 300/min. Inani lamagciwane akhishwa lapho umzimba womuntu usebenza ngokuvamile lingu-150 ~ 1000/min. Inani lamagciwane akhishwa lapho umuntu ehamba ngokushesha lingu-900 ~ 2500/min. umuntu. (2) Ukukhwehlela ngokuvamile kungu-70 ~ 700/min. umuntu. (3) Ukuthimula ngokuvamile kungu-4000 ~ 62000/min. umuntu. (4) Inani lamagciwane akhishwa lapho ugqoke izingubo ezivamile lingu-3300 ~ 62000/min. umuntu. (5) Inani lamagciwane akhishwa ngaphandle kwemaski: inani lamagciwane akhishwa ngemaski lingu-1:7 ~ 1:14.