Isitofu seNkqubo yeMveliso yaManzi kunye neTshintsho lobushushu

Ingcaciso yeMveliso

Amanzi okutofa ngawona malungiselelo asetyenziswa kakhulu angenazintsholongwane kwimveliso yamalungiselelo angenazintsholongwane.Iimfuno ezisemgangathweni zamanzi enaliti zilawulwa ngokungqongqo kwi-pharmacopoeias.Ukongeza kwizinto eziqhelekileyo zokuhlola amanzi adibeneyo, njenge-acidity, i-chloride, i-sulfate, i-calcium, i-ammonium, i-carbon dioxide, izinto ezixutywe lula, izinto ezingenakuguquka, kunye nesinyithi esinzima, kufuneka kwakhona iphumelele uvavanyo lwe-pyrogen.I-GMP icacisa ngokucacileyo ukuba ukulungiswa, ukugcinwa, kunye nokuhanjiswa kwamanzi ahlambulukileyo kunye namanzi enaliti kufuneka kuthintele ukwanda kunye nokungcoliswa kwee-microorganisms.Izinto ezisetyenziselwa iitanki zokugcina kunye nemibhobho kufuneka ingabi netyhefu kwaye inganyangeki.

Iimfuno zomgangatho wezixhobo zokucoca amanzi zimi ngolu hlobo lulandelayo:

Amanzi okutofa asetyenziswa njengesinyibilikisi ekulungiseni izisombululo zenaliti kunye ne-agent ecocekileyo yokuhlanjwa, okanye ukuhlamba i-vials (ukuhlamba ngokuchanekileyo), ukuhlanjwa kokugqibela kwezithinteli zerabha, ukuveliswa komphunga ococekileyo, kunye nezinyibilikisi zeklinikhi zeklinikhi ezinyibilikayo zomgubo wokutofa ngomgubo oyinyumba, ukufakwa. iinaliti zamanzi, njl. Ngenxa yokuba amayeza alungisiweyo atofwa ngokuthe ngqo emzimbeni ngolawulo lwesihlunu okanye nge-intravenous, iimfuno zomgangatho ziphezulu kakhulu kwaye kufuneka zihlangabezane neemfuno zeenaliti ezahlukeneyo ngokwemiqathango yobunyumba, ukungabikho kwepyrogens, ukucaca, ukuqhutyelwa kombane kufuneka kube. > 1MΩ/cm, i-endotoxin yebhaktheriya <0.25EU/ml, kunye ne-microbial index <50CFU/ml.

Eminye imigangatho yomgangatho wamanzi kufuneka ihlangabezane nezalathi zekhemikhali zamanzi acociweyo kwaye ibe neconcentration ye-organic carbon ephantsi kakhulu (inqanaba le-ppb).Oku kunokujongwa ngokuthe ngqo ngokusebenzisa isihlalutyi esikhethekileyo se-organic carbon analyzer, enokufakwa kwi-naliti yonikezelo lwamanzi okanye ukubuyisela umbhobho ukujonga ngaxeshanye ukuhanjiswa kombane kunye namaxabiso obushushu.Ukongeza kokuhlangabezana neemfuno zamanzi ahlanjululweyo, i-injection yamanzi kufuneka ibe nenani lebhaktheriya <50CFU / ml kwaye iphumelele uvavanyo lwe-pyrogen.

Ngokwemigaqo ye-GMP, amanzi acociweyo kunye neenkqubo zamanzi zokutofa kufuneka zingene kuqinisekiso lwe-GMP ngaphambi kokuba zisetyenziswe.Ukuba imveliso idinga ukuthunyelwa ngaphandle, kufuneka ihambelane neemfuno ezihambelanayo ze-USP, i-FDA, i-cGMP, njl. Ukuze kube lula ukubhekisela kunye neendlela ezahlukeneyo zonyango zokususa ukungcola emanzini, iThebhile 1 idwelisa iimfuno zomgangatho wamanzi we-USP. I-GMP kunye nemiphumo yeendlela ezahlukeneyo zonyango zokususa ukungcola emanzini njengoko kufakwe kwizikhokelo zokuphunyezwa kwe-GMP yaseTshayina.Ukulungiswa, ukugcinwa, kunye nokusasazwa kwamanzi okutofwa kufanele kuthintele ukwanda kunye nokungcoliswa kwee-microorganisms.Izinto ezisetyenziselwa iitanki zokugcina kunye nemibhobho kufuneka zingabi netyhefu kwaye zikwazi ukumelana nokuhlwa.Uyilo kunye nokufakwa kwemibhobho kufuneka kuphephe iziphelo ezifileyo kunye nemibhobho eyimfama.Imijikelo yokucoca kunye nokuvala inzala kufuneka isekwe kwiitanki zokugcina kunye nemibhobho.Indawo yokungena umoya yetanki yokugcina amanzi yokutofa kufuneka ifakwe kunye ne-hydrophobic bactericidal filter engachithi imicu.Amanzi atofwayo anokugcinwa ngokusebenzisa ukugqunywa kobushushu obungaphezulu kwe 80℃, ukujikeleziswa kobushushu obungaphezulu kwe 65℃, okanye ugcino olungaphantsi kwe 4℃.

Imibhobho esetyenziselwa ukucocwa kwezixhobo zokutofa amanzi idla ngokusetyenziswa iiplastiki zobunjineli ze-ABS okanye iPVC, iPPR, okanye ezinye izinto ezifanelekileyo.Nangona kunjalo, inkqubo yokuhambisa amanzi ahlambulukileyo kunye namanzi enaliti kufuneka isebenzise izixhobo zemibhobho ehambelanayo yokubulala iintsholongwane, i-pasteurization, inzalo yobushushu, njl.Insimbi engenasici ligama eliqhelekileyo, ngokungqongqo, lahlulwe libe yintsimbi engatyiwayo kunye nentsimbi enganyangekiyo kwiasidi.Insimbi engagqwali luhlobo lwentsimbi ekwaziyo ukumelana nokudleka ngamajelo eendaba abuthathaka njengomoya, umphunga, namanzi, kodwa ayixhathisi ukubola ngamajelo osasazo ayingozi ngokwemichiza afana neeasidi, iialkali, neetyuwa, kwaye ineempawu ezingenasici.

(I) Iimpawu ze-injection yamanzi Ukongeza, impembelelo yesantya sokuhamba ekukhuleni kwe-microorganisms kumbhobho kufuneka ithathelwe ingqalelo.Xa inombolo yeReynolds Reynolds ifikelela kwi-10,000 kwaye yenza ukuhamba okuzinzile, inokudala ngokufanelekileyo iimeko ezingathandekiyo zokukhula kwe-microorganisms.Ngokuchasene noko, ukuba iinkcukacha zoyilo lwenkqubo yamanzi kunye nokuveliswa azinikwa ngqalelo, okukhokelela kwisantya esisezantsi kakhulu, iindonga zemibhobho erhabaxa, okanye imibhobho engaboniyo kumbhobho, okanye ukusebenzisa iivalvu ezingafanelekanga ngokwesakhiwo, njl. njl., ii-microorganisms zinokuthi ngokupheleleyo. bathembele kwiinjongo zenjongo ebangelwa koku ukwakha indawo yabo yokuzalela - i-biofilm, ezisa imingcipheko kunye neengxaki ekusebenzeni kunye nolawulo lwemihla ngemihla lwamanzi ahlambulukileyo kunye neenkqubo zamanzi zokutofa.

(II) Iimfuno ezisisiseko kwiinkqubo zamanzi zokutofa

Inkqubo yamanzi yokutofa yenziwe ngezixhobo zokunyanga amanzi, izixhobo zokugcina, iimpompo zokuhambisa, kunye nemibhobho.Inkqubo yokucoca amanzi inokuba phantsi kongcoliseko lwangaphandle kumanzi akrwada kunye nezinto zangaphandle.Ungcoliseko lwamanzi akrwada ngowona mthombo wangaphandle wongcoliseko lweenkqubo zokucocwa kwamanzi.I-US Pharmacopeia, i-European Pharmacopeia, kunye ne-Chinese Pharmacopeia zonke zifuna ngokucacileyo ukuba amanzi akrwada kumanzi oxubo mayeza kufuneka ahlangabezane ubuncinane nemigangatho yomgangatho wamanzi okusela.Ukuba umgangatho wamanzi okusela awufezekiswanga, amanyathelo onyango lwangaphambili kufuneka athathwe.Ekubeni i-Escherichia coli iluphawu lokungcoliseka okukhulu kwamanzi, kukho iimfuno ezicacileyo ze-Escherichia coli emanzini okusela kumazwe ngamazwe.Ezinye iibhaktheriya ezingcolisayo azohlulwanga kwaye zimelwe kwimigangatho “njengobalo lwebhaktheriya iyonke”.I-China ibeka umda we-100 ibhaktheriya / ml kwinani elipheleleyo leebhaktheriya, ebonisa ukuba kukho ungcoliseko lwe-microbial kumanzi akrwada ahlangabezana nomgangatho wamanzi okusela, kunye neebhaktheriya ezingcolisayo ezibeka ingozi kwiinkqubo zokunyanga amanzi yi-Gram-negative bacteria.Ezinye izinto ezinje ngeendawo zokungena umoya ezingakhuselekanga kwiitanki zokugcina okanye ukusetyenziswa kwezihluzo zegesi ezikumgangatho ophantsi, okanye ukubuya umva kwamanzi aphuma kwiindawo ezingcolisekileyo, nako kunokubangela ungcoliseko lwangaphandle.

Ukongezelela, kukho ukungcola kwangaphakathi ngexesha lokulungiselela kunye nokusebenza kwenkqubo yokucoca amanzi.Ungcoliseko lwangaphakathi lunxulumene ngokusondeleyo noyilo, ukukhethwa kwezinto, ukusebenza, ukugcinwa, ukugcinwa, kunye nokusetyenziswa kweenkqubo zokunyanga amanzi.Izixhobo ezahlukeneyo zokucocwa kwamanzi zinokuba yimithombo yangaphakathi yongcoliseko lwemicrobial, ezinje ngemicroorganisms kumanzi akrwada abhengezwa kumphezulu wekhabhoni esebenzayo, iireyini zokutshintshiselana ngeion, iinwebu zeultrafiltration, kunye nezinye izixhobo, zenza iibhayofilm.Ii-Microorganisms ezihlala kwii-biofilms zikhuselwe yi-biofilms kwaye azichatshazelwa ngokubanzi ngamayeza okubulala iintsholongwane.Omnye umthombo wongcoliseko ukhona kwinkqubo yokuhambisa.Ii-Microorganisms zinokwenza iikholoni kumphezulu wemibhobho, iivalvu, kunye nezinye iindawo kwaye ziphindaphindeka apho, zenze iifilimu zebhayoloji, ngaloo ndlela zibe yimithombo eqhubekayo yokungcoliseka.Ngoko ke, ezinye iinkampani zangaphandle zinemigangatho engqongqo yoyilo lweenkqubo zokunyanga amanzi.

(III) Iindlela zokusebenza zeenkqubo zokutofa kwamanzi

Ukuqwalasela ukucocwa rhoqo kunye nokubulawa kweentsholongwane kwindlela yokusasazwa kwemibhobho, ngokuqhelekileyo kukho iindlela ezimbini zokusebenza zamanzi ahlambulukileyo kunye neenkqubo zamanzi zokutofa.Enye i-batch operation, apho amanzi aveliswa kwiibhetshi, ezifana neemveliso.Umsebenzi "webhetshi" ubukhulu becala kuqwalaselo lokhuseleko, njengoko le ndlela inokwahlula umlinganiselo othile wamanzi ngexesha lovavanyo de uvavanyo lugqitywe.Enye imveliso eqhubekayo, eyaziwa ngokuba "umsebenzi oqhubekayo", apho amanzi anokuveliswa ngelixa esetyenziswa.

IV) Ulawulo lwemihla ngemihla lwesixokelelwano samanzi sokutofa Ulawulo lwemihla ngemihla lwesixokelelwano samanzi, kubandakanywa ukusebenza kunye nokugcinwa, kubaluleke kakhulu ekuqinisekiseni kunye nokusetyenziswa okuqhelekileyo.Ngoko ke, isicwangciso sokubeka iliso kunye nokukhusela ukugcinwa kufuneka kusekwe ukuqinisekisa ukuba inkqubo yamanzi ihlala ikwimeko elawulwayo.Le mixholo ibandakanya:

Iinkqubo zokusebenza kunye nokugcinwa kwenkqubo yamanzi;
Isicwangciso sokubeka iliso kwiiparamitha eziphambili zomgangatho wamanzi kunye neerameters zokusebenza, kubandakanywa ukulinganisa izixhobo eziphambili;
Isicwangciso sarhoqo sokubulala iintsholongwane/sokubulala iintsholongwane;
Isicwangciso solondolozo sothintelo lwezixhobo zokucoca amanzi;
Iindlela zokulawula izixhobo ezibalulekileyo zokunyanga amanzi (kubandakanywa amacandelo amakhulu), iinkqubo zokuhambisa imibhobho, kunye neemeko zokusebenza.

Iimfuno zezixhobo zonyango lwangaphambili:

Izixhobo zonyango zangaphambili zamanzi ahlambulukileyo kufuneka zixhotyiswe ngokomgangatho wamanzi wamanzi akrwada, kwaye imfuneko kukuqala ukuhlangabezana nomgangatho wamanzi okusela.
Izihluzi zemulti-media kunye nezithambiso zamanzi kufuneka zikwazi ukwenza i-backwashing ezenzekelayo, ukuvuselela, kunye nokukhupha.
Izihluzi zekhabhoni ezisebenzayo ziindawo apho i-organic matter iqokelelana khona.Ukuze kuthintelwe ukungcoliseka kwe-endotoxin yebhaktiriya kunye nebhaktiriya, ukongeza kwimfuno yokuhlambela umva ngokuzenzekelayo, ukubulawa kweentsholongwane ngomphunga kungasetyenziswa.
Kuba ubunzulu be-255 nm bevelength yokukhanya kwe-UV ebangelwa yi-UV ihambelana ngokungafaniyo nexesha, izixhobo ezinexesha lokurekhoda kunye nobukhulu beemitha ziyafuneka.Icandelo elintywilisiweyo kufuneka lisebenzise i-316L yensimbi engenasici, kunye nesibane sesibane se-quartz kufuneka sikhutshwe.
Amanzi ahlambulukileyo emva kokudlula kwi-mixed-bed deionizer kufuneka ajikelezwe ukuzinzisa umgangatho wamanzi.Nangona kunjalo, i-deionizer yebhedi edibeneyo inokususa kuphela i-cations kunye ne-anion emanzini, kwaye ayisebenzi ekususeni i-endotoxins.

Iimfuneko zokuveliswa kwamanzi okutofa (umphunga ococekileyo) kwizixhobo zokucocwa kwamanzi: Amanzi atofwayo angafunyanwa ngokuxutywa kwe-distillation, i-osmosis ye-reverse, i-ultrafiltration, njl.

I-United States Pharmacopeia (uhlelo lwama-24) ithi “amanzi atofwayo kufuneka afunyanwe ngokucocwa okanye ukuhlanjululwa kwe-osmosis yamanzi ahlangabezana neemfuno zeAmerican Water and Environmental Protection Association, iEuropean Union, okanye iimfuno ezisemthethweni zaseJapan.”
IThe European Pharmacopeia (uhlelo lowe-1997) ithi “amanzi atofwayo afunyanwa ngokuxutywa kwamanzi afanelekileyo afikelela imilinganiselo emiselweyo yamanzi okusela okanye amanzi acociweyo.”
I-Chinese Pharmacopeia (uhlelo luka-2000) icacisa ukuba "le mveliso (amanzi okutofa) ngamanzi afunyenwe ngokuxutywa kwamanzi acociweyo."Kuyabonakala ukuba amanzi acociweyo afunyenwe ngokuhluzwa ayindlela ekhethwayo kwihlabathi jikelele yokuvelisa amanzi okuhlamba, ngelixa umphunga ococekileyo unokufunyanwa kusetyenziswa umatshini wamanzi wokuhluzwa okufanayo okanye ijenereyitha ecocekileyo ecocekileyo yomphunga.

I-Distillation inesiphumo esihle sokususa kwizinto ezingaguquguqukiyo ze-organic kunye ne-inorganic, kubandakanywa izinto eziqinileyo, i-colloids, ibhaktheriya, iintsholongwane, i-endotoxins, kunye nezinye izinto ezingcolileyo emanzini akrwada.Ulwakhiwo, ukusebenza, izinto zetsimbi, iindlela zokusebenza, kunye nomgangatho wamanzi akrwada omatshini wamanzi we-distillation uya kuchaphazela umgangatho wamanzi wokutofa."I-multi-effect" yomatshini wamanzi we-distillation we-multi-effect ibhekisela ikakhulu ekugcinweni kwamandla, apho amandla ashushu angasetyenziswa amaxesha amaninzi.Inxalenye ephambili yokususa i-endotoxins kumatshini wamanzi adityanisiweyo ngumahluli wamanzi omphunga.