ULAWULO LWENGCACISO YEGUMBI LOCOCEKO NOGQILA

Ingcamango yegumbi lokucoca

Ukucoca: kubhekisa kwinkqubo yokususa ukungcola ukuze kufunyanwe ucoceko olufunekayo.

Ukucocwa komoya: isenzo sokususa ungcoliseko emoyeni ukuze kucoceke umoya.

Iinxalenye: zizinto eziqinileyo nezilulwelo ezinobukhulu obuqhelekileyo obuyi-0.001 ukuya kwi-1000μm.

Amasuntswana axhonyiweyo: amasuntswana aqinileyo nalulwelo anomlinganiselo wobukhulu obuphakathi kwe-0.1 ukuya kwi-5μm emoyeni asetyenziselwa ukwahlulahlula ucoceko lomoya.

Uvavanyo olungaguqukiyo: uvavanyo oluqhutywa xa inkqubo yomoya opholileyo kwigumbi lokucoca isebenza ngendlela eqhelekileyo, izixhobo zenkqubo zifakiwe, kwaye akukho basebenzi bemveliso kwigumbi lokucoca.

Uvavanyo olutshintshayo: uvavanyo olwenziwa xa igumbi lokucoca likwimveliso eqhelekileyo.

Ukungazali: ukungabikho kwezinto eziphilayo.

Ukucoca: indlela yokufumana imeko yokuba mdaka. Umahluko phakathi kwegumbi lokucoca kunye negumbi eliqhelekileyo elinomoya opholileyo. Amagumbi okucoca kunye namagumbi aqhelekileyo anomoya opholileyo ziindawo apho kusetyenziswa iindlela zokwenziwa ukudala nokugcina imeko-bume yomoya efikelela kubushushu obuthile, umswakama, isantya sokuhamba komoya kunye nokucocwa komoya. Umahluko phakathi kwezi zimbini ngolu hlobo lulandelayo:

Igumbi elicocekileyo, igumbi eliqhelekileyo elinomoya opholileyo

Amasuntswana omoya angaphakathi kufuneka alawulwe. Ubushushu, ukufuma, isantya sokuhamba komoya kunye nomthamo womoya kufuneka ufikelele kwisantya esithile somoya (igumbi lokucoca ukuhamba kwicala elinye amaxesha angama-400-600 ngeyure, igumbi lokucoca elingakhethi cala amaxesha ali-15-60 ngeyure).

Ngokubanzi, ubushushu buncitshiswa ngokuphindwe ka-8-10/h. Umoya ongenisayo ufana nobushushu obuqhelekileyo obuphindwe ka-10-15/h. Ukongeza ekujongeni ubushushu nokufuma, ucoceko kufuneka luvavanywe rhoqo. Ubushushu nokufuma kufuneka kuvavanywe rhoqo. Umoya kufuneka udlule kwi-filtration enamanqanaba amathathu, kwaye i-terminal kufuneka isebenzise izihluzi zomoya ze-hepa. Sebenzisa izixhobo eziphambili, eziphakathi kunye nobushushu nokufuma. Igumbi elicocekileyo kufuneka libe noxinzelelo oluthile oluqinisekileyo ≥10Pa kwindawo ejikelezileyo. Kukho uxinzelelo oluqinisekileyo, kodwa akukho mfuneko yokulinganisa. Abasebenzi abangenayo kufuneka batshintshe izihlangu ezikhethekileyo kunye neempahla ezicocekileyo baze badlule kwishawa yomoya. Yahlula ukuhamba kwabantu kunye ne-logistics.

Iinxalenye ezixhonyiweyo: ngokubanzi zibhekisa kwiinxalenye eziqinileyo nezilulwelo ezixhonywe emoyeni, kwaye ubungakanani bazo bumalunga ne-0.1 ukuya kwi-5μm. Ucoceko: lusetyenziselwa ukuchaza ubungakanani kunye nenani leenxalenye eziqulethwe emoyeni ngeyunithi nganye yomthamo wendawo, nto leyo eyindlela yokwahlula ucoceko lwendawo.

I-Airlock: Igumbi elinomoya ococekileyo elibekwe emnyango nangaphandle kwegumbi elicocekileyo ukuthintela ukuhamba komoya ongcolileyo kunye nolawulo lomahluko phakathi koxinzelelo oluvela kumagumbi angaphandle okanye akufutshane.

Ishawa yomoya: Uhlobo lomoya ovala umoya olusebenzisa iifeni, izihluzi, kunye neenkqubo zolawulo ukuvuthela umoya ujikeleze abantu abangena kwigumbi. Yenye yeendlela ezisebenzayo zokunciphisa ungcoliseko lwangaphandle.

Iimpahla zokusebenza ezicocekileyo: Iimpahla ezicocekileyo ezingenathuli kangako ezisetyenziselwa ukunciphisa amasuntswana adalwa ngabasebenzi.

Isihluzi somoya seHepa: Isihluzi somoya esinokusebenza okungaphezulu kwe-99.9% kwiisuntswana ezinobubanzi obungaphezulu okanye obulingana ne-0.3μm kunye nokumelana nokuhamba komoya okungaphantsi kwe-250Pa kumthamo womoya olinganisiweyo.

Isihluzi somoya se-Ultra-hepa: Isihluzi somoya esisebenza kakuhle ukubamba okungaphezulu kwe-99.999% kwiisuntswana ezinobubanzi obuyi-0.1 ukuya kwi-0.2μm kunye nokumelana nokuhamba komoya okungaphantsi kwe-280Pa kumthamo womoya olinganisiweyo.

Indawo yokusebenzela ecocekileyo: Yenziwe yinkqubo yomoya opholileyo kunye nokucoca umoya, kwaye ikwayintliziyo yenkqubo yokucoca, isebenza kunye ukuqinisekisa ukuba iiparameter ezahlukeneyo zihambelana. Ulawulo lobushushu kunye nokufuma: Indawo yokusebenzela ecocekileyo yimfuno yokusingqongileyo ye-GMP kumashishini amayeza, kwaye inkqubo yomoya opholileyo (HVAC) sisiqinisekiso esisisiseko sokufezekisa indawo yokucoca. Inkqubo yomoya opholileyo yegumbi lokucoca inokwahlulwahlulwa ibe ziindidi ezimbini: Inkqubo yomoya opholileyo ye-DC: umoya wangaphandle oye wanyangwa kwaye unokuhlangabezana neemfuno zendawo uthunyelwa kwigumbi, uze emva koko wonke umoya ukhutshwe. Ikwabizwa ngokuba yinkqubo epheleleyo yokukhupha umoya, esetyenziselwa iiworkshops ezineemfuno zenkqubo ezikhethekileyo. Indawo evelisa uthuli kumgangatho wesine weworkshop ekhoyo yeyale hlobo, njengegumbi lokomisa i-granulation, indawo yokuzalisa iithebhulethi, indawo yokugquma, indawo yokutyumza kunye nokulinganisa. Ngenxa yokuba iworkshop ivelisa uthuli oluninzi, kusetyenziswa inkqubo yomoya opholileyo ye-DC. Inkqubo yomoya opholileyo: oko kukuthi, unikezelo lomoya wegumbi elicocekileyo ngumxube wenxalenye yomoya ococekileyo wangaphandle ocociweyo kunye nenxalenye yomoya obuyayo ovela kwindawo ecocekileyo yegumbi. Umthamo womoya omtsha wangaphandle udla ngokubalwa njenge-30% yomthamo womoya uphela kwigumbi elicocekileyo, kwaye kufuneka uhlangabezane nesidingo sokubuyisela umoya ophumayo kwigumbi. Ukujikeleza kwakhona kwahlulwe ngomoya obuyayo oyintloko kunye nomoya obuyayo wesibini. Umahluko phakathi komoya obuyayo oyintloko kunye nomoya obuyayo wesibini: Kwinkqubo yomoya opholileyo kwigumbi elicocekileyo, umoya obuyayo oyintloko ubhekisa kumoya obuyayo wangaphakathi oxutywe kuqala nomoya omtsha, uze uphathwe yi-surface cooler (okanye igumbi lokutshiza amanzi) ukuze ufikelele kwimeko ye-machine dew point, uze ufudunyezwe yi-primary heater ukuze ufikelele kwimeko yonikezelo lomoya (kwinkqubo yobushushu obungaguqukiyo kunye nomswakama). Indlela yomoya obuyayo oyintloko kukuba umoya obuyayo oyintloko uxutywe nomoya omtsha kwaye uphathwe yi-surface cooler (okanye igumbi lokutshiza amanzi) ukuze ufikelele kwimeko ye-machine dew point, uze uxutywe nomoya obuyayo ongaphakathi kube kanye, kwaye imeko yonikezelo lomoya wangaphakathi inokufezekiswa ngokulawula umlinganiselo wokuxuba (ngokuyintloko inkqubo yokususa ubumanzi).

Uxinzelelo oluhle: Ngokwesiqhelo, amagumbi acocekileyo kufuneka agcine uxinzelelo oluhle ukuthintela ungcoliseko lwangaphandle ukuba lungangeni, kwaye lunceda ekukhupheni uthuli lwangaphakathi. Ixabiso loxinzelelo oluhle ngokubanzi lilandela le mizobo mibini ilandelayo: 1) Umahluko woxinzelelo phakathi kwamagumbi acocekileyo amanqanaba ahlukeneyo naphakathi kweendawo ezicocekileyo kunye neendawo ezingacocekanga akufuneki ube ngaphantsi kwe-5Pa; 2) Umahluko woxinzelelo phakathi kweeworkshops ezicocekileyo zangaphakathi nezangaphandle akufuneki ube ngaphantsi kwe-10Pa, ngokubanzi yi-10~20Pa. (1Pa=1N/m2) Ngokwe-"Cleanroom Design Specification", ukukhethwa kwezinto zokwakha ulondolozo lwegumbi lokucoca kufuneka kuhlangabezane neemfuno zokuthintela ubushushu, ukuthintela ubushushu, ukuthintela umlilo, ukumelana nokufuma, kunye nothuli oluncinci. Ukongeza, iimfuno zobushushu kunye nokufuma, ulawulo lomahluko woxinzelelo, ukuhamba komoya kunye nomthamo wonikezelo lomoya, ukungena nokuphuma kwabantu, kunye nonyango lokucoca umoya ziyacwangciswa kwaye ziyasebenzisana ukwenza inkqubo yegumbi lokucoca.

1. Iimfuneko zobushushu kunye nokufuma

Ubushushu kunye nokufuma okunxulumene negumbi lokucoca kufuneka kuhambelane neemfuno zemveliso yemveliso, kwaye imeko-bume yemveliso yemveliso kunye nentuthuzelo yomqhubi kufuneka kuqinisekiswe. Xa kungekho mfuneko ikhethekileyo yokuveliswa kwemveliso, uluhlu lobushushu lwegumbi lokucoca lunokulawulwa kwi-18-26℃ kwaye ukufuma okunxulumeneyo kunokulawulwa kwi-45-65%. Xa kujongwa ulawulo olungqongqo longcoliseko lweentsholongwane kwindawo ephambili yokusebenza kwe-aseptic, kukho iimfuno ezikhethekileyo zempahla yabaqhubi kule ndawo. Ke ngoko, ubushushu kunye nokufuma okunxulumeneyo kwendawo ecocekileyo kunokugqitywa ngokweemfuno ezikhethekileyo zenkqubo kunye nemveliso.

1. Ulawulo lomahluko kuxinzelelo

Ukuze kuthintelwe ukucoceka kwegumbi elicocekileyo ekungcolisweni ligumbi elisecaleni, ukuhamba komoya ecaleni kwezithuba zesakhiwo (izithuba zomnyango, ukungena eludongeni, imibhobho, njl.njl.) kwicala elichaziweyo kunokunciphisa ukujikeleza kweesuntswana eziyingozi. Indlela yokulawula icala lokuhamba komoya kukulawula uxinzelelo lwendawo ekufutshane. I-GMP ifuna umahluko woxinzelelo olulinganiswayo (DP) oza kugcinwa phakathi kwegumbi elicocekileyo nendawo ekufutshane ngococeko oluphantsi. Ixabiso le-DP phakathi kwamanqanaba omoya ahlukeneyo kwi-GMP yaseTshayina lichazwe ukuba lingabi ngaphantsi kwe-10Pa, kwaye umahluko woxinzelelo olulungileyo okanye olubi kufuneka ugcinwe ngokweemfuno zenkqubo.

1. Ipateni yokuhamba komoya kunye nomthamo womoya. Ulungelelwaniso lokuhamba komoya olufanelekileyo lolunye lweziqinisekiso ezibalulekileyo zokuthintela ungcoliseko kunye nongcoliseko olunqamlezileyo kwindawo ecocekileyo. Ulungelelwaniso lokuhamba komoya olufanelekileyo kukwenza umoya wegumbi elicocekileyo uthunyelwe ngokukhawuleza nangokulinganayo okanye usasazwe kwindawo yonke ecocekileyo, ukunciphisa imisinga ye-eddy kunye neekona ezifileyo, ukunciphisa uthuli kunye neebhaktheriya ezikhutshwa lungcoliseko lwangaphakathi, kunye nokuzikhupha ngokukhawuleza nangokufanelekileyo, ukunciphisa amathuba okuba uthuli kunye neebhaktheriya zingcolise imveliso, kunye nokugcina ucoceko olufunekayo kwigumbi. Ekubeni iteknoloji ecocekileyo ilawula ukuxinana kwamasuntswana axhonyiweyo emoyeni, kwaye umthamo womoya oziswa kwigumbi elicocekileyo mkhulu kakhulu kunowo ufunekayo kumagumbi aqhelekileyo anomoya opholileyo, indlela yawo yokuhlela ukuhamba komoya yahlukile kakhulu kuwo. Ipateni yokuhamba komoya yahlulwe ngokubanzi kwiindidi ezintathu:
2. Ukuhamba komoya ngakwelinye icala: ukuhamba komoya okuhamba ngendlela efanayo kwicala elinye kunye nesantya somoya esihambelanayo kwicandelo elinqamlezileyo; (Kukho iintlobo ezimbini: ukuhamba komoya ngokuthe nkqo kunye nokuhamba komoya ngakwelinye icala.)
3. Ukuhamba komoya okungahambelaniyo nolwalathiso olunye: kubhekisa ekuhambeni komoya okungahambelaniyo nenkcazelo yokuhamba komoya okuya kwicala elinye.

3. Ukuhamba okuxutyiweyo: ukuhamba komoya oqulunqwe ukuhamba okungqalileyo kunye nokuhamba okungqalileyo. Ngokubanzi, ukuhamba okungqalileyo kuhamba kakuhle ukusuka kwicala lomoya wangaphakathi ukuya kwicala lomoya obuyayo, kwaye ucoceko lunokufikelela kwiklasi ye-100. Ucoceko lwamagumbi acocekileyo angangqalanga luphakathi kweklasi ye-1,000 kunye neklasi ye-100,000, kwaye ucoceko lwamagumbi acocekileyo angangqalanga lunokufikelela kwiklasi ye-100 kwezinye iindawo. Kwinkqubo yokuhamba okungqalileyo, ukuhamba komoya kuhamba ukusuka kolunye udonga ukuya kolunye. Kwinkqubo yokuhamba okuthe nkqo, ukuhamba komoya kuhamba ukusuka eluphahleni ukuya emhlabeni. Imeko yomoya wegumbi elicocekileyo idla ngokubonakaliswa ngendlela eqondakala ngakumbi "ngemva kokutshintsha komoya": "utshintsho lomoya" ngumthamo womoya ongena kwindawo ngeyure owahlulwe ngumthamo wendawo. Ngenxa yobuninzi obahlukeneyo bomoya ococekileyo othunyelwa kwigumbi elicocekileyo, ucoceko lwegumbi nalo lwahlukile. Ngokwezibalo zethiyori kunye namava asebenzayo, amava aqhelekileyo amaxesha okungenisa umoya alandelayo, njengoqikelelo lokuqala lomthamo womoya ococekileyo kwigumbi: 1) Kwiklasi ye-100,000, amaxesha okungenisa umoya ngokubanzi angaphezu kwe-15 amaxesha/iyure; 2) Kwiklasi ye-10,000, amaxesha okungenisa umoya ngokubanzi angaphezu kwe-25 amaxesha/iyure; 3) Kwiklasi ye-1000, amaxesha okungenisa umoya ngokubanzi angaphezu kwe-50 amaxesha/iyure; 4) Kwiklasi ye-100, umthamo wokuhambisa umoya ubalwa ngokusekelwe kwisantya somoya esiwela phakathi kwe-0.2-0.45m/s. Uyilo lomthamo womoya olufanelekileyo yinxalenye ebalulekileyo yokuqinisekisa ukucoceka kwendawo ecocekileyo. Nangona ukwandisa inani lokungenisa umoya kwigumbi kuluncedo ekuqinisekiseni ukucoceka, umthamo womoya ogqithisileyo uya kubangela inkunkuma yamandla. Ucoceko lomoya oluphezulu oluvumelekileyo lwenani lamasuntswana othuli (static) inani eliphezulu elivumelekileyo leentsholongwane (static) ukuphindaphinda komoya (ngeyure)

4. Ukungena nokuphuma kwabantu nezinto

Kwiindawo zokutshixa ezicocekileyo, zihlala zibekwe emnyango nasemphumeni wegumbi elicocekileyo ukuthintela ukuhamba komoya ongcolileyo wangaphandle nokulawula umahluko woxinzelelo. Igumbi le-buffer limiselwe. La magumbi ezixhobo zokutshixa alawula indawo yokungena nokuphuma ngeengcango ezahlukeneyo, kwaye akwabonelela ngeendawo zokunxiba/zokukhulula impahla ecocekileyo, ukubulala iintsholongwane, ukucoca kunye neminye imisebenzi. Iindawo zokutshixa eziqhelekileyo ze-elektroniki kunye nezitshixa zomoya.

Ibhokisi yeepasi: Ukungena nokuphuma kwezinto kwigumbi elicocekileyo kuquka ibhokisi yeepasi, njl. Ezi zinto zidlala indima yokuthintela ukudluliselwa kwezinto phakathi kwendawo ecocekileyo nendawo engacocekanga. Iingcango zazo ezimbini azinakuvulwa ngaxeshanye, nto leyo eqinisekisa ukuba umoya wangaphandle awukwazi ukungena nokuphuma kwindawo yokusebenzela xa izinto zisiwa. Ukongeza, ibhokisi yeepasi exhotyiswe ngesixhobo sesibane se-ultraviolet ayinakugcina uxinzelelo oluhle kwigumbi luzinzile, ithintele ungcoliseko, ihlangabezane neemfuno ze-GMP, kodwa ikwadlala indima ekubulaleni nasekubulaleni iintsholongwane.

Ishawa yomoya: Igumbi leshawa yomoya yindlela yokungena nokuphuma kwempahla kwigumbi elicocekileyo kwaye ikwadlala indima yegumbi elivaliweyo elicocekileyo elivaliweyo. Ukuze kuncitshiswe inani elikhulu lamasuntswana othuli aziswa zimpahla ngaphakathi nangaphandle, ukuhamba komoya ococekileyo okuhluzwe yi-hepa filter kutshizwa kuzo zonke iindlela nge-nozzle ejikelezayo ukuya kwimpahla, ngokufanelekileyo nangokukhawuleza ukususa amasuntswana othuli. Ukuba kukho ishawa yomoya, kufuneka ivuthelwe kwaye ihlanjwe ngokwemigaqo ngaphambi kokuba ingene kwindawo yokusebenzela ecocekileyo engenaluthuli. Kwangaxeshanye, landela ngokungqongqo iinkcukacha kunye neemfuno zokusetyenziswa kweshawa yomoya.

1. Unyango lokucoca umoya kunye neempawu zalo

Itekhnoloji yokucoca umoya yitekhnoloji ebanzi yokudala indawo yomoya ococekileyo nokuqinisekisa nokuphucula umgangatho wemveliso. Eyona nto iphambili kukucoca amasuntswana emoyeni ukuze kufunyanwe umoya ococekileyo, uze emva koko uhambe ngendlela efanayo ngesantya esifanayo okanye ngokuthe nkqo, uze uhlambe umoya ngamasuntswana ajikelezileyo, ukuze kufezekiswe injongo yokucoca umoya. Inkqubo yokupholisa umoya kwigumbi elicocekileyo kufuneka ibe yinkqubo yokupholisa umoya ecocekileyo eneendlela ezintathu zokucoca: isihluzo sokuqala, isihluzo esiphakathi kunye nesihluzo se-hepa. Qinisekisa ukuba umoya othunyelwa kwigumbi ngumoya ococekileyo kwaye ungawunciphisi umoya ongcolileyo kwigumbi. Isihluzo sokuqala sifanelekile kakhulu ekuhluzweni kokuqala kweenkqubo zokupholisa umoya kunye nokungenisa umoya kunye nokubuyisela ukuhluzwa komoya kumagumbi acocekileyo. Isihluzo senziwe ngeefayibha zokwenziwa kunye nentsimbi egqunyiweyo. Singakwazi ukuthintela amasuntswana othuli ngaphandle kokwenza ukumelana kakhulu nokuhamba komoya. Iifayibha ezidityaniswe ngokungacwangciswanga zenza imiqobo emininzi kumasuntswana, kwaye indawo ebanzi phakathi kweefayibha ivumela ukuhamba komoya ukuba kudlule kakuhle ukukhusela inqanaba elilandelayo lezihluzo kwinkqubo nakwinkqubo ngokwayo. Kukho iimeko ezimbini zokuhamba komoya ongcolileyo ngaphakathi: enye yi-laminar (oko kukuthi, zonke iinxalenye ezixhonyiweyo kwigumbi zigcinwa kumaleko we-laminar); enye ayi-laminar (oko kukuthi, ukuhamba komoya wangaphakathi kuyadubaduba). Kumagumbi amaninzi acocekileyo, ukuhamba komoya wangaphakathi aku-laminar (kudubaduba), okungenakuxuba ngokukhawuleza iinxalenye ezixhonyiweyo ezifakwe emoyeni, kodwa kunokwenza iinxalenye ezimiyo egumbini ziphinde zibhabhe, kwaye umoya othile unokuma.

6. Ukuthintela umlilo kunye nokukhupha kwiindawo zokusebenzela ezicocekileyo

1) Inqanaba lokumelana nomlilo kwiindawo zokusebenzela ezicocekileyo akufuneki libe ngaphantsi kwenqanaba lesi-2;

2) Ingozi yomlilo kwiindawo zokusebenzela ezicocekileyo kufuneka ihlelwe kwaye iphunyezwe ngokuhambelana nomgangatho wesizwe wangoku "uMgaqo woThintelo loMlilo woYilo lweZakhiwo".

3) Iipaneli zophahla nodonga zegumbi elicocekileyo mazingabi nakutsha, kwaye izinto ezidityanisiweyo zendalo aziyi kusetyenziswa. Umda wokumelana nomlilo wesilingi awuyi kuba ngaphantsi kwe-0.4h, kwaye umda wokumelana nomlilo wesilingi sendlela yokuphuma awuyi kuba ngaphantsi kwe-1.0h.

4) Kwisakhiwo esibanzi somzi-mveliso ngaphakathi kwendawo yomlilo, amanyathelo okwahlulahlula umzimba angatshiyo kufuneka abekwe phakathi kwemveliso ecocekileyo kunye neendawo zemveliso ngokubanzi. Umda wokumelana nomlilo wodonga lokwahlulahlula kunye nophahla oluhambelanayo akufuneki ube ngaphantsi kweyure e-1. Izixhobo ezingatshiyo okanye ezingatshiyo mazisetyenziswe ukuzalisa imibhobho edlula eludongeni okanye eluphahleni ngokuqinileyo;

5) Iindawo zokuphuma zokhuseleko mazisasazeke, kwaye akufuneki kubekho iindlela ezigosogoso ukusuka kwindawo yemveliso ukuya kwindawo yokuphuma yokhuseleko, kwaye kufuneka kubekwe imiqondiso ecacileyo yokuphuma.

6) Ucango lokhuseleko lokuphuma oludibanisa indawo ecocekileyo nendawo engacocekanga kunye nendawo ecocekileyo yangaphandle kufuneka luvulwe kwicala lokuphuma. Ucango olukhuselekileyo lokuphuma alufanele lube lucango oluxhonyiweyo, ucango olukhethekileyo, ucango olutyibilikayo ecaleni okanye ucango oluzenzekelayo lombane. Udonga lwangaphandle lwe-workshop ecocekileyo kunye nendawo ecocekileyo kumgangatho omnye kufuneka luxhotyiswe ngeengcango kunye neefestile ukuze abacimi-mlilo bangene kwindawo ecocekileyo ye-workshop, kwaye kufuneka kubekwe indlela yokuphuma ekhethekileyo yomlilo kwindawo efanelekileyo yodonga lwangaphandle.

Inkcazo yeworkshop ye-GMP: I-GMP sisifinyezo se-Good Manufacturing Practice. Umxholo wayo ophambili kukubeka phambili iimfuno eziyimfuneko zengqiqo yenkqubo yemveliso yeshishini, ukusetyenziswa kwezixhobo zemveliso, kunye nokuchaneka kunye nokubekwa emgangathweni kwemisebenzi yemveliso. Isiqinisekiso se-GMP sibhekisa kwinkqubo apho urhulumente kunye namasebe afanelekileyo bahlela khona uhlolo lwazo zonke iinkalo zeshishini, ezinje ngabasebenzi, uqeqesho, izakhiwo zezityalo, imeko yemveliso, iimeko zococeko, ulawulo lwezinto, ulawulo lwemveliso, ulawulo lomgangatho, kunye nolawulo lokuthengisa, ukuvavanya ukuba ziyahlangabezana na neemfuno zomthetho. I-GMP ifuna ukuba abavelisi bemveliso babe nezixhobo zemveliso ezilungileyo, iinkqubo zemveliso ezifanelekileyo, ulawulo lomgangatho olugqibeleleyo kunye neenkqubo zovavanyo oluqinileyo ukuqinisekisa ukuba umgangatho wemveliso yokugqibela uyahlangabezana neemfuno zemigaqo. Ukuveliswa kwezinye iimveliso kufuneka kwenziwe kwiiworkshops eziqinisekisiweyo ze-GMP. Ukusebenzisa i-GMP, ukuphucula umgangatho wemveliso, kunye nokuphucula iingcamango zenkonzo sisiseko kunye nomthombo wophuhliso lwamashishini amancinci naphakathi phantsi kweemeko zoqoqosho lwemarike. Ungcoliseko lwegumbi elicocekileyo kunye nolawulo lwayo: Inkcazo yongcoliseko: Ungcoliseko lubhekisa kuzo zonke izinto ezingafunekiyo. Nokuba zizinto eziphathekayo okanye amandla, logama nje zingeyonxalenye yemveliso, akufuneki ukuba zibekho kwaye zichaphazele ukusebenza kwemveliso. Kukho imithombo emine esisiseko yongcoliseko: 1. Izixhobo (isilingi, umgangatho, udonga); 2. Izixhobo, izixhobo; 3. Abasebenzi; 4. Iimveliso. Qaphela: Ungcoliseko oluncinci lunokulinganiswa ngee-microns, oko kukuthi: 1000μm=1mm. Ngokwesiqhelo sinokubona kuphela amasuntswana othuli anobukhulu besuntswana obungaphezulu kwe-50μm, kwaye amasuntswana othuli angaphantsi kwe-50μm anokubonwa kuphela nge-microscope. Ungcoliseko lwe-microbial egumbini elicocekileyo luvela kakhulu kwiinkalo ezimbini: ungcoliseko lomzimba womntu kunye nongcoliseko lwenkqubo yezixhobo zeworkshop. Phantsi kweemeko eziqhelekileyo zomzimba, umzimba womntu uya kuhlala ukhupha izikali zeeseli, uninzi lwazo luthwala iintsholongwane. Ekubeni umoya uphinda uvuselele inani elikhulu lamasuntswana othuli, ubonelela abathwali kunye neemeko zokuphila zeentsholongwane, ngoko ke umoya ngumthombo ophambili weentsholongwane. Abantu ngumthombo omkhulu wongcoliseko. Xa abantu bethetha kwaye beshukuma, bakhupha inani elikhulu lamasuntswana othuli, anamathela kumphezulu wemveliso kwaye angcolise imveliso. Nangona abasebenzi abasebenza kwigumbi elicocekileyo benxiba iimpahla ezicocekileyo, iimpahla ezicocekileyo azinakuthintela ngokupheleleyo ukusasazeka kwee-particles. Uninzi lwee-particles ezinkulu ziza kuhlala kumphezulu wento ngenxa yomxhuzulane, kwaye ezinye ii-particles ezincinci ziya kuwa kumphezulu wento ngokuhamba komoya. Kuphela xa ii-particles ezincinci zifikelela kuxinzelelo oluthile kwaye zidibene ndawonye apho zinokubonwa ngamehlo enyama. Ukuze kuncitshiswe ungcoliseko lwamagumbi acocekileyo ngabasebenzi, abasebenzi kufuneka balandele ngokungqongqo imigaqo xa bengena naxa bephuma. Inyathelo lokuqala ngaphambi kokungena kwigumbi elicocekileyo kukukhulula ijakethi yakho kwigumbi lokuqala lokutshintsha, unxibe ii-slippers eziqhelekileyo, uze ungene kwigumbi lesibini lokutshintsha ukuze utshintshe izihlangu. Ngaphambi kokungena kwigumbi lesibini lokutshintsha, hlamba kwaye womise izandla zakho kwigumbi le-buffer. Yomisa izandla zakho ngaphambili nangasemva kwezandla zakho de izandla zakho zingamanzi. Emva kokungena kwigumbi lesibini lokutshintsha, tshintsha ii-slippers ze-shift yokuqala, unxibe iimpahla zomsebenzi ezicocekileyo, kwaye unxibe izihlangu zokucoca zesibini lokutshintsha. Kukho amanqaku amathathu aphambili xa unxiba iimpahla zomsebenzi ezicocekileyo: A. Nxiba kakuhle kwaye ungazivezi iinwele zakho; B. Imaski kufuneka igqume impumlo; C. Coca uthuli kwiimpahla zokusebenza ezicocekileyo ngaphambi kokuba ungene kwindawo yokusebenzela ecocekileyo. Kulawulo lwemveliso, ukongeza kwezinye izinto ezijolise ekufezekiseni iinjongo, kusekho abasebenzi abaninzi abangangeni kwindawo ecocekileyo njengoko kufuneka kwaye izixhobo aziphathwa ngokungqongqo. Ke ngoko, abavelisi bemveliso kufuneka bafune ngokungqongqo abaqhubi bemveliso kwaye bahlakulele ulwazi ngococeko lwabasebenzi bemveliso. Ungcoliseko lwabantu - iibhaktheriya:

1. Ungcoliseko olubangelwa ngabantu: (1) Ulusu: Abantu badla ngokulahla ulusu lwabo ngokupheleleyo rhoqo emva kweentsuku ezine, kwaye abantu balahla malunga ne-1,000 yeziqwenga zesikhumba ngomzuzu (ubukhulu obuqhelekileyo yi-30 * 60 * 3 microns) (2) Iinwele: Iinwele zabantu (ububanzi bumalunga ne-50 ~ 100 microns) zihlala ziwa. (3) Amathe: aqulethe i-sodium, ii-enzymes, ityuwa, i-potassium, i-chloride kunye namaqhekeza okutya. (4) Impahla yemihla ngemihla: amaqhekeza, iifayibha, i-silica, i-cellulose, iikhemikhali ezahlukeneyo kunye neebhaktheriya. (5) Abantu baya kuvelisa amaqhekeza ayi-10,000 amakhulu kune-0.3 microns ngomzuzu xa behleli okanye behleli.

2. Uhlalutyo lwedatha yovavanyo lwangaphandle lubonisa ukuba: (1) Kwigumbi elicocekileyo, xa abasebenzi benxibe impahla engenazintsholongwane: ubungakanani beebhaktheriya ezikhutshwayo xa zisesekhona buqhele ukuba yi-10 ~ 300/min. Ubungakanani beebhaktheriya ezikhutshwayo xa umzimba womntu usebenza ngokubanzi yi-150 ~ 1000/min. Ubungakanani beebhaktheriya ezikhutshwayo xa umntu ehamba ngokukhawuleza yi-900 ~ 2500/min. umntu. (2) Ukukhwehlela ngokuqhelekileyo yi-70 ~ 700/min. umntu. (3) Ukuthimla ngokuqhelekileyo yi-4000 ~ 62000/min. umntu. (4) Ubungakanani beebhaktheriya ezikhutshwayo xa unxibe impahla eqhelekileyo yi-3300 ~ 62000/min. umntu. (5) Ubungakanani beebhaktheriya ezikhutshwayo ngaphandle kwemaski: ubungakanani beebhaktheriya ezikhutshwayo ngemaski yi-1:7 ~ 1:14.