Ingcamango yegumbi lokucoca
Ukuhlanjululwa: kubhekisela kwinkqubo yokususa izinto ezingcolileyo ukuze kufumaneke ukucoceka okuyimfuneko.
Air purification: Ukuhlanjululwa komoya: sisenzo sokususa izinto ezingcolisa umoya ukuze umoya ucoceke.
Amacandelo: izinto eziqinileyo kunye nolwelo kunye nobukhulu ngokubanzi 0.001 ukuya 1000μm.
Iinqununu ezimisiweyo: iinqununu eziqinileyo kunye ne-liquid ezinobungakanani be-0.1 ukuya kwi-5μm emoyeni esetyenziselwa ukuhlanjululwa komoya.
Uvavanyo lwe-Static: uvavanyo olwenziwayo xa inkqubo yokucoca umoya yokucoca umoya isebenza ngokuqhelekileyo, izixhobo zenkqubo zifakwe, kwaye akukho basebenzi bokuvelisa kwindawo yokucoca.
Uvavanyo lweDynamic: uvavanyo olwenziwe xa igumbi lokucoca likwimveliso eqhelekileyo.
Ubuzali: Ukungabikho kwezinto eziphilayo.
Sterilization: Indlela yokufumana inzala. Umahluko phakathi kwegumbi elicocekileyo kunye negumbi eliqhelekileyo elinomoya. Amagumbi acocekileyo kunye namagumbi aqhelekileyo ane-air-conditioning ziindawo apho iindlela ezenziweyo zisetyenziselwa ukudala nokugcina indawo yomoya efikelela kubushushu obuthile, ukufuma, isantya sokuhamba komoya kunye nokucoca umoya. Umahluko phakathi kwezi zimbini umi ngolu hlobo lulandelayo:
Igumbi elicocekileyo elinomoya opholileyo
Amasuntswana amiswe ngaphakathi emoyeni kufuneka alawulwe. Ubushushu, umswakama, isantya sokuhamba komoya kunye nomthamo womoya kufuneka ufikelele kwi-frequency ethile ye-ventilation (igumbi elicocekileyo lokuhamba kwe-unidirectional 400-600 amaxesha / h, igumbi elingenalo i-unidirectional elicocekileyo 15-60 amaxesha / h).
Ngokuqhelekileyo, ukushisa kuncitshiswa ngamaxesha angama-8-10 / h. I-Ventilation iyindawo yokushisa eqhubekayo ngamaxesha angama-10-15 / h. Ukongeza ekujongeni amaqondo obushushu kunye nokufuma, ucoceko kufuneka luvavanywe rhoqo. Ubushushu kunye nokufuma kufuneka kuvavanywe rhoqo. Ukunikezelwa komoya kufuneka kudlule kwi-filtration yezigaba ezintathu, kwaye i-terminal kufuneka isebenzise izihluzo zomoya ze-hepa. Sebenzisa izixhobo zokuqala, eziphakathi kunye nobushushu kunye nokufuma. Igumbi elicocekileyo kufuneka libe noxinzelelo oluthile olulungileyo ≥10Pa kwindawo ejikelezileyo. Kukho uxinzelelo olulungileyo, kodwa akukho mfuneko yokulinganisa. Abasebenzi abangena kufuneka batshintshe izihlangu ezikhethekileyo kunye nempahla engcolileyo kwaye badlule kwishawa yomoya. Yahlula ukuhamba kwabantu kunye nolungiselelo.
Amasuntswana amisiweyo: ngokuqhelekileyo abhekisela kwiincinci eziqinileyo kunye nezilulwelo ezimisiwe emoyeni, kunye nobukhulu bayo besayizi malunga ne-0.1 ukuya kwi-5μm. Ucoceko: isetyenziselwa ukubonakalisa ubungakanani kunye nenani leengqungquthela eziqulethwe emoyeni kwiyunithi nganye umthamo wendawo, osemgangathweni wokuhlukanisa ukucoceka kwendawo.
I-Airlock: Igumbi lesithinteli elisekwe ekungeneni nasekuphumeni kwegumbi elicocekileyo ukuvala ukuhamba komoya ongcolileyo kunye nolawulo loxinzelelo loxinzelelo oluphuma ngaphandle okanye kumagumbi akufutshane.
Ishawari yomoya: Uhlobo lwesitshixo somoya esisebenzisa iifeni, izihluzi, kunye neenkqubo zokulawula ukuvuthela umoya ujikeleze abantu abangena egumbini. Yenye yeendlela ezisebenzayo zokunciphisa ungcoliseko lwangaphandle.
Impahla yokusebenza ecocekileyo: Iimpahla ezicocekileyo ezinemveliso yothuli oluphantsi esetyenziselwa ukunciphisa amasuntswana aveliswa ngabasebenzi.
Isihluzi somoya we-Hepa: Isihluzo somoya esine-effective yokubamba engaphezulu kwe-99.9% yamasuntswana anobubanzi obungaphezulu okanye obulingana ne-0.3μm kunye nokumelana nokuhamba komoya okungaphantsi kwe-250Pa kumthamo womoya olinganisiweyo.
Isihluzi somoya se-Ultra-hepa: Isihluzo somoya esine-effective yokubamba engaphezulu kwe-99.999% yeengqungquthela ezinobubanzi be-0.1 ukuya kwi-0.2μm kunye nokumelana nokuhamba komoya okungaphantsi kwe-280Pa kumthamo womoya olinganisiweyo.
Iworkshop ecocekileyo: Iqulethwe yinkqubo yokucoca umoya ephakathi kunye nenkqubo yokucoca umoya, kwaye ikwayintliziyo yenkqubo yokucoca, isebenza kunye ukuqinisekisa ukuqheleka kweeparamitha ezahlukeneyo. Ulawulo lobushushu kunye nokufuma: Iworkshop ecocekileyo yimfuno yokusingqongileyo ye-GMP kumashishini axuba amayeza, kunye nenkqubo yokucoca umoya (HVAC) sisiqinisekiso esisisiseko sokufikelela kwindawo yokucoca. I-cleanroom central conditioning system inokwahlulwa ibe ngamacandelo amabini: I-DC air conditioning system: umoya wangaphandle oye waphathwa kwaye unokuhlangabezana neemfuno zendawo uthunyelwa kwigumbi, emva koko wonke umoya ukhululwe. Ikwabizwa ngokuba yinkqubo yokukhupha ngokupheleleyo, esetyenziselwa iindibano zocweyo ezineemfuno ezizodwa zenkqubo. Indawo yokuvelisa uthuli kumgangatho wesine wendawo yokusebenzela ekhoyo yolu hlobo, njengendawo yokomisa i-granulation, indawo yokuzalisa ithebhulethi, indawo yokwaleka, indawo yokutyumza kunye neyokulinganisa. Ngenxa yokuba iworkshop ivelisa uthuli oluninzi, kusetyenziswa inkqubo yomoya yeDC. I-recirculation air conditioning system: oko kukuthi, ukunikezelwa komoya wegumbi elicocekileyo ngumxube wenxalenye yonyango lwangaphandle lomoya ococekileyo kunye nenxalenye yomoya obuyayo ukusuka kwindawo ecocekileyo yegumbi. Umthamo womoya ococekileyo wangaphandle udla ngokubalwa njenge-30% yomthamo womoya opheleleyo kwigumbi elicocekileyo, kwaye kufuneka kwakhona ihlangabezane nesidingo sokuhlawulela ukukhupha umoya ophuma kwigumbi. Ukujikeleza kwakhona kwahlulwe kumoya wokuqala wokubuyela kunye nomoya wokubuyela okwesibini. Umahluko phakathi komoya wokuqala obuyayo kunye nomoya wesibini wokubuyela: Kwinkqubo yomoya yegumbi elicocekileyo, umoya obuyayo osisiseko ubhekisa kumoya obuyela ngaphakathi wangaphakathi kuqala uxutywe nomoya omtsha, emva koko uphathwe ngepholileyo engaphezulu (okanye igumbi lokutshiza ngamanzi) ukufikelela kwindawo yomatshini wombethe, kwaye emva koko ufudunyezwe sisifudumezi sokuqala ukufikelela kwimeko yonikezelo komoya (ukwenzela ubushushu obungaguqukiyo kunye nenkqubo yokufuma). Indlela yokubuya yomoya wesibini kukuba umoya wokubuya ophambili uxutywe nomoya omtsha kwaye uphathwe yi-cooler surface (okanye igumbi lokutshiza ngamanzi) ukufikelela kwindawo yomatshini wokubethelwa komatshini, kwaye emva koko uxutywe nomoya wokubuyisela wangaphakathi kanye, kwaye imeko yonikezelo lomoya wangaphakathi inokufezekiswa ngokulawula umlinganiselo wokuxuba (ubukhulu becala inkqubo yokususa umswakama).
Uxinzelelo oluhle: Ngokuqhelekileyo, amagumbi acocekileyo kufuneka agcine uxinzelelo oluhle lokuthintela ukungcoliseka kwangaphandle ukuba kungene ngaphakathi, kwaye kukulungele ukukhupha uthuli lwangaphakathi. Ixabiso elilungileyo loxinzelelo ngokuqhelekileyo lilandela iindlela ezimbini zokuyila: 1) Ukwahlukana koxinzelelo phakathi kwamagumbi acocekileyo amanqanaba ahlukeneyo naphakathi kweendawo ezicocekileyo kunye neendawo ezingacocekanga akufanele zibe ngaphantsi kwe-5Pa; 2) Umahluko woxinzelelo phakathi kweeworkshops ezicocekileyo zangaphakathi nangaphandle akufanele zibe ngaphantsi kwe-10Pa, ngokubanzi i-10 ~ 20Pa. (1Pa = 1N / m2) Ngokutsho kwe "Cleanroom Design Specification", ukukhethwa kwezinto eziphathekayo kwisakhiwo sokugcinwa kwegumbi lokucoca kufuneka kuhlangabezane neemfuno ze-thermal insulation, ukushisa ukushisa, ukuthintela umlilo, ukuxhathisa umswakama, kunye nothuli oluncinci. Ukongezelela, iimfuno zeqondo lokushisa kunye nomswakama, ukulawulwa kokwahlukana koxinzelelo, ukuhamba komoya kunye nomthamo wokunikezelwa komoya, ukungena kunye nokuphuma kwabantu, kunye nonyango lokucoca umoya lulungelelaniswe kwaye lubambisene ukwenza inkqubo yokucoca igumbi.
- Iimfuno zobushushu kunye nokufuma
Ubushushu kunye nokufuma okuhambelanayo kwegumbi lokucoca kufuneka kuhambelane neemfuno zemveliso yemveliso, kwaye indawo yemveliso yemveliso kunye nokuthuthuzela komsebenzi kufuneka kuqinisekiswe. Xa kungekho mfuneko zikhethekileyo zokuvelisa imveliso, uluhlu lweqondo lokushisa lwegumbi lokucoca lunokulawulwa kwi-18-26 ℃ kunye nomswakama ohambelanayo unokulawulwa kwi-45-65%. Ukuqwalasela ulawulo olungqongqo lwe-microbial contamination kwindawo engundoqo yokusebenza kwe-aseptic, kukho iimfuno ezikhethekileyo zempahla yabaqhubi kule ndawo. Ngoko ke, iqondo lokushisa kunye nomswakama ohambelanayo wendawo ecocekileyo unokumiselwa ngokweemfuno ezikhethekileyo zenkqubo kunye nemveliso.
- Ulawulo umahluko woxinzelelo
Ukuze ugweme ukucoceka kwegumbi elicocekileyo ekungcolisweni yigumbi elikufutshane, ukuhamba komoya kunye nezithuba zesakhiwo (izikhewu zocango, ukungena eludongeni, i-ducts, njl. Indlela yokulawula indlela yokuhamba komoya kukulawula uxinzelelo lwendawo ekufutshane. I-GMP idinga ukulinganiswa koxinzelelo olulinganisiweyo (DP) ukuba lugcinwe phakathi kwegumbi elicocekileyo kunye nendawo ekufutshane kunye nokucoceka okuphantsi. Ixabiso le-DP phakathi kwamanqanaba omoya ahlukeneyo kwi-GMP yaseTshayina ichazwe ukuba ingabikho ngaphantsi kwe-10Pa, kwaye umahluko ofanelekileyo okanye ongalunganga woxinzelelo kufuneka ugcinwe ngokweemfuno zenkqubo.
- Ipateni yokuhamba komoya kunye nomthamo wokunikezelwa komoya umbutho ofanelekileyo wokuhamba komoya yenye yeziqinisekiso ezibalulekileyo zokuthintela ungcoliseko kunye nokungcoliseka komnqamlezo kwindawo ecocekileyo. Umbutho ofanelekileyo wokuhamba komoya kukwenza umoya ococekileyo wegumbi uthunyelwe ngokukhawuleza kwaye usasazwe ngokulinganayo okanye usasazeke kuyo yonke indawo ecocekileyo, unciphise imisinga yeeddy kunye neekona ezifileyo, ukungcungcuthekisa uthuli kunye neebhaktheriya ezikhutshwa lungcoliseko lwangaphakathi, kwaye uzikhuphe ngokukhawuleza nangempumelelo, ukunciphisa ukubakho kothuli kunye neebhaktheriya ezingcolisa imveliso, kwaye ugcine ucoceko olufunekayo kwigumbi. Ekubeni iteknoloji ecocekileyo ilawula ukuxinwa kweengqungquthela ezimisiweyo emoyeni, kunye nomthamo womoya ohanjiswe kwigumbi elicocekileyo likhulu kakhulu kunokuba lifunwa ngamagumbi aqhelekileyo omoya, ifom yombutho wayo we-airflow ihluke kakhulu kubo. Ipateni yokuqukuqela komoya yahlulwe ikakhulu yangamacandelo amathathu:
- I-unidirectional flow: ukuhamba komoya kunye nemigca ehambelanayo kwicala elinye kunye nesantya somoya esingaguqukiyo kwicandelo elinqamlezayo; (Kukho iindidi ezimbini: ukuhamba ngokuthe nkqo kwe-unidirectional kunye ne-horizontal unidirectional flow.)
- I-non-unidirectional flow: ibhekisa kwi-airflow engahambelani nenkcazo ye-unidirectional flow.
3. I-Mixed flow flow: i-airflow eyenziwe nge-unidirectional flow kunye ne-non-unidirectional flow. Ngokuqhelekileyo, ukuhamba kwe-unidirectional kuhamba kakuhle ukusuka kwicala lokubonelela komoya wangaphakathi ukuya kwicala elihambelanayo lokubuyisela umoya, kwaye ukucoceka kunokufikelela kwiklasi ye-100. Ukucoceka kwamagumbi ahlambulukileyo angenawo unidirectional kuphakathi kweklasi ye-1,000 kunye neklasi ye-100,000, kwaye ukucoceka kwamagumbi ahlambulukileyo adibeneyo angafikelela kwiklasi ye-100 kwezinye iindawo. Kwinkqubo yokuqukuqela ethe tyaba, ukuhamba komoya kuhamba ukusuka kolunye udonga ukuya kolunye. Kwinkqubo yokuhamba ngokuthe nkqo, ukuhamba komoya kuhamba ukusuka kwisilingi ukuya emhlabeni. Imeko yokungena komoya yegumbi elicocekileyo ngokuqhelekileyo inokubonakaliswa ngendlela enembileyo ngokuthi "i-air change frequency": "inguqu yomoya" ngumthamo womoya ongena kwindawo ngeyure eyahlulwe ngumthamo wendawo. Ngenxa yemithamo eyahlukeneyo yokuhambisa umoya ococekileyo othunyelwe kwigumbi elicocekileyo, ukucoceka kwegumbi kukwahluke. Ngokwezibalo zethiyori kunye namava asebenzayo, amava aqhelekileyo ngamaxesha okungena komoya alandelayo, njengoqikelelo lokuqala lomthamo wokuhambisa umoya wegumbi elicocekileyo: 1) Kwiklasi ye-100,000, amaxesha okuphefumula ngokuqhelekileyo angaphezulu kwe-15 amaxesha / iyure; 2) Kwiklasi ye-10,000, amaxesha okuphefumula ngokuqhelekileyo angaphezulu kwamaxesha angama-25 / iyure; 3) Kwiklasi ye-1000, amaxesha okuphefumula ngokuqhelekileyo angaphezulu kwamaxesha angama-50 / iyure; 4) Kwiklasi ye-100, umthamo wokunikezelwa komoya ubalwa ngokusekelwe kwi-air supply cross-sectional wind speed of 0.2-0.45m / s. Uyilo olufanelekileyo lomthamo womoya luyinxalenye ebalulekileyo yokuqinisekisa ukucoceka kwendawo ecocekileyo. Nangona ukwandisa inani lokungenisa umoya wegumbi kunenzuzo ekuqinisekiseni ukucoceka, umthamo womoya ogqithisileyo uya kubangela ukuchithwa kwamandla. Inqanaba lococeko lomoya ubuninzi benani elivumelekileyo lamasuntswana othuli (static) ubuninzi benani elivumelekileyo lemicroorganisms (static) yomoya rhoqo (ngeyure)
4. Ukungena nokuphuma kwabantu kunye nezinto
Kumagumbi adibeneyo acocekileyo, abekwe ngokubanzi ekungeneni nasekuphumeni kwegumbi elicocekileyo ukuthintela ukuphuma komoya ongcolileyo wangaphandle kunye nokulawula umahluko woxinzelelo. Igumbi lokukhusela lilungisiwe. La magumbi esixhobo esinxibelelanayo alawula indawo yokungena kunye nokuphuma ngeengcango ezininzi, kwaye abonelela ngeendawo zokunxiba/zokukhulula iimpahla ezicocekileyo, ukubulala iintsholongwane, ukucocwa kunye neminye imisebenzi. Izitshixo zombane eziqhelekileyo kunye nezitshixo zomoya.
Ibhokisi yokupasa: Ukungena kunye nokuphuma kwemathiriyeli kwigumbi elicocekileyo kubandakanya ibhokisi yokupasa, njl. Iingcango zabo ezimbini azikwazi ukuvulwa ngexesha elifanayo, eliqinisekisa ukuba umoya wangaphandle awukwazi ukungena kwaye uphume kwi-workshop xa izinto zihanjiswa. Ukongeza, ibhokisi yokupasa exhotyiswe ngesixhobo sesibane se-ultraviolet ayikwazi nje ukugcina uxinzelelo oluhle kwigumbi elizinzile, ukuthintela ukungcola, ukuhlangabezana neemfuno ze-GMP, kodwa idlala indima ekuzaleni kunye nokubulala iintsholongwane.
Ishawa yomoya: Igumbi leshawari yomoya yindawo yokungena nokuphuma kwempahla kwigumbi elicocekileyo kwaye ikwadlala indima yegumbi elivaliweyo elivaliweyo kwigumbi elicocekileyo. Ukuze kuncitshiswe inani elikhulu leengqungquthela zothuli eziziswa yimpahla ngaphakathi nangaphandle, ukuhamba komoya ococekileyo ocociweyo yi-hepa filters ifafazwe ukusuka kuzo zonke iindlela nge-nozzle ejikelezayo kwimpahla, ngokufanelekileyo kwaye ngokukhawuleza isuse amaqhekeza othuli. Ukuba kukho ishawa yomoya, kufuneka ivuthelwe kwaye ihlanjwe ngokwemigaqo phambi kokungena kwindawo yokusebenzela ecocekileyo engenathuli. Kwangaxeshanye, landela ngokungqongqo iinkcukacha kunye neemfuno zokusetyenziswa kweshawari yomoya.
- Unyango lokucoca umoya kunye neempawu zalo
Ubuchwephesha bokucoca umoya bubuchwephesha obubanzi bokudala indawo yomoya ecocekileyo kunye nokuqinisekisa nokuphucula umgangatho wemveliso. Ikakhulu ukucoca amasuntswana emoyeni ukufumana umoya ococekileyo, kwaye emva koko uqukuqele kwicala elinye kwisantya esifanayo ngokuhambelanayo okanye ngokuthe nkqo, kwaye uhlambe umoya ngamasuntswana ajikeleze kuwo, ukuze ufezekise injongo yokucoca umoya. Inkqubo ye-air conditioning yegumbi elicocekileyo kufuneka ibe yinkqubo yokucoca umoya ococekileyo kunye nemigangatho emithathu yokucoca: isihluzo sokuqala, isihluzo esiphakathi kunye ne-hepa filter. Qinisekisa ukuba umoya othunyelwe kwigumbi ungumoya ococekileyo kwaye unokunciphisa umoya ongcolileyo egumbini. Isihluzi esiphambili sifanelekile kakhulu kwi-filtration ephambili ye-air conditioning kunye ne-ventilation systems kunye nokubuyisela ukuhluzwa komoya kumagumbi acocekileyo. Isihluzo senziwe ngeentsinga ezenziweyo kunye nentsimbi. Inokuthintela ngokufanelekileyo amasuntswana othuli ngaphandle kokwenza ukuchasana kakhulu nokuhamba komoya. Iifiber ezidibeneyo ngokungenamkhethe zenza izithintelo ezingenakubalwa kwiinqununu, kwaye indawo ebanzi phakathi kweefayili ivumela ukuhamba komoya ukuba kudlule kakuhle ukukhusela inqanaba elilandelayo lokucoca kwinkqubo kunye nenkqubo ngokwayo. Kukho iimeko ezimbini zokuhamba komoya wangaphakathi oyinyumba: enye i-laminar (oko kukuthi, zonke iinqununu ezimisiweyo kwigumbi zigcinwe kwi-laminar layer); enye i-non-laminar (oko kukuthi, ukuhamba komoya wangaphakathi kunesiphithiphithi). Kwiindawo ezininzi zamagumbi acocekileyo, ukuhamba komoya wangaphakathi akusiyo i-laminar (i-turbulent), engakwazi nje ukuxuba ngokukhawuleza amaqhekeza amisiweyo afakwe emoyeni, kodwa kwakhona enze amasuntswana amileyo kwigumbi aphinde abaleke, kwaye umoya othile unokudodobala.
6. Uthintelo lomlilo kunye nokufuduswa kweendibano zocweyo ezicocekileyo
1) Inqanaba lokumelana nomlilo weeworkshops ezicocekileyo aziyi kuba ngaphantsi kwenqanaba lesi-2;
2) Ingozi yomlilo yeeworkshops zokuvelisa kwiindibano zocweyo ezicocekileyo ziya kuhlulwa kwaye ziphunyezwe ngokuhambelana nomgangatho wangoku wesizwe "Ikhowudi yoKhuselo loMlilo loYilo lweZakhiwo".
3) Isilingi kunye neepaneli zodonga zegumbi elicocekileyo aziyi kutsha, kwaye izinto ezixubileyo aziyi kusetyenziswa. Umda wokumelana nomlilo wesilingi awuyi kuba ngaphantsi kwe-0.4h, kwaye umda wokumelana nomlilo wesilingi ye-corridor yokukhupha awuyi kuba ngaphantsi kwe-1.0h.
4) Kwisakhiwo somzi-mveliso esibanzi ngaphakathi kwendawo yomlilo, imilinganiselo yokwahlulwa kwemizimba engatshiyo iya kumiselwa phakathi kwemveliso ecocekileyo kunye neendawo zokuvelisa ngokubanzi. Umda wokumelana nomlilo wodonga lokwahlula kunye nesilingi ehambelana nayo ayiyi kuba ngaphantsi kwe-1h. Izinto ezingatshiyo okanye ezichasene nomlilo ziya kusetyenziselwa ukugcwalisa ngokuqinileyo imibhobho edlula eludongeni okanye kwisilingi;
5) Iindawo zokuphuma zokhuseleko ziya kusasazwa, kwaye akufuneki kubekho iindlela ezigwenxa ukusuka kwindawo yokuvelisa ukuya kwindawo yokuphuma yokhuseleko, kwaye iimpawu ezicacileyo zokuphuma ziya kumiselwa.
6) Umnyango wokukhusela ukhuseleko oludibanisa indawo ecocekileyo kunye nendawo engacocekanga kunye nendawo ecocekileyo ngaphandle iya kuvulwa kwindlela yokuphuma. Umnyango wokuphuma okhuselekileyo akufanele ube ngumnyango omisiweyo, umnyango okhethekileyo, ucango olusecaleni okanye umnyango ozenzekelayo wombane. Udonga lwangaphandle lweworkshop ecocekileyo kunye nommandla ococekileyo kumgangatho ofanayo kufuneka luxhotyiswe ngeengcango kunye neefestile ukuze abacimi bomlilo bangene kwindawo ecocekileyo yokusebenzela, kunye nokuphuma okukhethekileyo komlilo kufuneka kubekwe kwindawo efanelekileyo yodonga lwangaphandle.
Inkcazo yendibano yocweyo ye-GMP: I-GMP sisishunqulelo seZenzo zoMveliso eziLungileyo. Umxholo wayo ophambili kukubeka phambili iimfuno ezisisinyanzelo kwingqiqo yenkqubo yemveliso yeshishini, ukusetyenziswa kwezixhobo zokuvelisa, kunye nokuchaneka kunye nokulinganisa imisebenzi yemveliso. Ukuqinisekiswa kwe-GMP kubhekiselele kwinkqubo apho urhulumente kunye namasebe afanelekileyo aququzelela ukuhlolwa kwayo yonke imiba yeshishini, njengabasebenzi, uqeqesho, izibonelelo zezityalo, indawo yokuvelisa, iimeko zococeko, ulawulo lwezinto eziphathekayo, ulawulo lwemveliso, ulawulo lomgangatho, kunye nolawulo lokuthengisa, ukuvavanya ukuba bahlangabezana neemfuno zokulawula. I-GMP ifuna ukuba abavelisi beemveliso kufuneka babe nezixhobo ezifanelekileyo zokuvelisa, iinkqubo ezifanelekileyo zokuvelisa, ulawulo olugqibeleleyo lomgangatho kunye neenkqubo ezingqongqo zokuvavanya ukuqinisekisa ukuba umgangatho wemveliso yokugqibela uyahlangabezana neemfuno zemimiselo. Ukuveliswa kwezinye iimveliso kufuneka kuqhutywe kwiindibano zocweyo eziqinisekisiweyo ze-GMP. Ukuphumeza i-GMP, ukuphucula umgangatho wemveliso, kunye nokwandiswa kweekhonsepthi zenkonzo sisiseko kunye nomthombo wophuhliso lwamashishini amancinci naphakathi phantsi kweemeko zoqoqosho lwemarike. Ungcoliseko lwegumbi elicocekileyo kunye nolawulo lwalo: Inkcazo yongcoliseko: Ungcoliseko lubhekisa kuzo zonke izinto ezingeyomfuneko. Kungakhathaliseki ukuba yizinto eziphathekayo okanye amandla, ngokude nje kungeyona inxalenye yemveliso, akuyimfuneko ukuba ibe khona kwaye ichaphazele ukusebenza kwemveliso. Kukho imithombo emine esisiseko yongcoliseko: 1. Izibonelelo (isilingi, umgangatho, udonga); 2. Izixhobo, izixhobo; 3. Abasebenzi; 4. Iimveliso. Qaphela: Ungcoliseko oluncinci lunokulinganiswa ngeemicrons, oko kukuthi: 1000μm=1mm. Ngokuqhelekileyo sinokubona kuphela amaqhekeza othuli kunye nobukhulu be-particle enkulu kune-50μm, kunye nothuli olungaphantsi kwe-50μm lunokubonwa kuphela nge-microscope. Ungcoliseko lwemicrobial yegumbi olucocekileyo luvela ikakhulu kwimiba emibini: ukungcoliseka komzimba womntu kunye nokungcoliseka kwesixhobo seworkshop. Ngaphantsi kweemeko eziqhelekileyo ze-physiological, umzimba womntu uya kuhlala uchitha izikali zeeseli, ezininzi zazo zithwala ibhaktheriya. Ekubeni umoya ubuyisela inani elikhulu leengqungquthela zothuli, libonelela abathwali kunye neemeko zokuphila kwiibhaktheriya, ngoko ke i-atmospheric ngumthombo oyintloko webhaktheriya. Abantu ngowona mthombo mkhulu wongcoliseko. Xa abantu bethetha kwaye behamba, bakhulula inani elikhulu leengqungquthela zothuli, ezibambelela kumphezulu wemveliso kwaye zingcolise imveliso. Nangona abasebenzi abasebenza kwigumbi elicocekileyo benxiba iimpahla ezicocekileyo, iimpahla ezicocekileyo azinakukuthintela ngokupheleleyo ukusasazeka kwamasuntswana. Uninzi lweengqungquthela ezinkulu ziza kuhlala ngokukhawuleza phezu kwendawo ngenxa yobunzima, kwaye ezinye iincinci ezincinci ziya kuwela phezu kwento kunye nokuhamba komoya. Kuphela xa amasuntswana amancinci afikelela kugxininiso oluthile aze adityaniswe kunye anokubonakala ngeso lenyama. Ukuze kuncitshiswe ukungcoliseka kwamagumbi acocekileyo ngabasebenzi, abasebenzi mabalandele ngokungqongqo imimiselo xa bengena naxa bephuma. Inyathelo lokuqala phambi kokungena kwigumbi elicocekileyo kukukhulula idyasi yakho kwigumbi lokuqala lokutshintsha, unxibe iislippers eziqhelekileyo, uze ungene kwigumbi lesibini lokutshintsha izihlangu. Ngaphambi kokungena kwishifti yesibini, hlamba kwaye womise izandla zakho kwigumbi le-buffer. Yomisa izandla zakho ngaphambili nangasemva kwezandla zakho de izandla zakho zingafumi. Emva kokungena kwigumbi lesibini leshifti, tshintsha iislippers zokuqala zokutshintsha, nxiba iimpahla zokusebenza ezinyumba, kwaye ufake izihlangu zokuhlanjululwa kweshifti yesibini. Kukho iingongoma ezintathu ezingundoqo xa unxibe iimpahla zokusebenza ezicocekileyo: A. Nxiba kakuhle kwaye ungazivezi iinwele zakho; B. Imaski kufuneka igqume impumlo; C. Coca uthuli kwiimpahla zokusebenza ezicocekileyo phambi kokuba ungene kwindawo yokusebenzela ecocekileyo. Kulawulo lwemveliso, ukongeza kwinjongo ethile, kusekho abasebenzi abaninzi abangangeni kwindawo ecocekileyo njengoko kufuneka kwaye izixhobo aziphathwa ngokungqongqo. Ke ngoko, abavelisi beemveliso kufuneka bafune ngokungqongqo abaqhubi bemveliso kwaye bahlakulele ukuqaphela ukucoceka kwabasebenzi bemveliso. Ungcoliseko lwabantu-iintsholongwane:
1. Ungcoliso oluveliswa ngabantu: (1) Ulusu: Abantu badla ngokulukhupha ulusu lwabo ngokupheleleyo rhoqo emva kweentsuku ezine, yaye abantu baphalaza malunga namaqhekeza ali-1,000 eluswini ngomzuzu (ubukhulu obuqhelekileyo bungama-30*60*3 eemicron) (2) Iinwele: Iinwele zomntu (ububanzi bumalunga neemicrons ezingama-50–100) zihlala ziwa. (3) I-saliva: iqulethe i-sodium, i-enzymes, ityuwa, i-potassium, i-chloride kunye namasuntswana okutya. (4) Impahla yemihla ngemihla: amasuntswana, iifibers, silica, cellulose, iikhemikhali ezahlukahlukeneyo kunye neebhaktheriya. (5) Abantu baya kuvelisa amasuntswana angama-10,000 amakhulu kune-0.3 microns ngomzuzu xa behleli okanye behleli.
2. Uhlalutyo lwedatha yovavanyo lwangaphandle lubonisa ukuba: (1) Kwigumbi elicocekileyo, xa abasebenzi bembethe impahla engcolileyo: inani lebhaktheriya elikhutshwayo xa lisekho ngokubanzi 10 ~ 300 / min. Ubungakanani beebhaktheriya ezikhutshwayo xa umzimba womntu usebenza ngokubanzi yi-150 ~ 1000 / min. Ubungakanani beebhaktheriya ezikhutshwayo xa umntu ehamba ngokukhawuleza i-900 ~ 2500 / min.person. (2) Ukhohlokhohlo luyi-70 ~ 700/min.person. (3) Ukuthimla ngokuqhelekileyo yi-4000 ~ 62000/min.person. (4) Ubungakanani bebhaktheriya ekhutshwayo xa unxibe iimpahla eziqhelekileyo ngu-3300 ~ 62000 / min.person. 5
Ixesha lokuposa: Mar-05-2025