Jekiseni Mvura Yekugadzira Sytem Ine Heat Exchanger

Chigadzirwa tsananguro

Mvura yejekiseni ndiyo inonyanya kushandiswa kugadzirira sterile mukugadzirwa kwemishonga isina utachiona.Hunhu hunodiwa hwemvura yejekiseni hwakanyatsogadziriswa mu pharmacopoeias.Pamusoro pezvakajairwa zvekuongorora zvinhu zvemvura yakasvibiswa, senge acidity, chloride, sulfate, calcium, ammonium, carbon dioxide, zvinhu zvinogoneka nyore oxidizable, zvinhu zvisingaite, uye simbi inorema, inodawo kupasa bvunzo yepyrogen.GMP inotaura zvakajeka kuti kugadzirira, kuchengetedza, uye kugovera mvura yakacheneswa uye jekiseni remvura kunofanirwa kudzivirira kuwanda uye kusvibiswa kwehutachiona.Zvishandiso zvinoshandiswa pakuchengetedza matangi nemapaipi zvinofanirwa kunge zvisina chepfu uye zvisingaite corrosion.

Zvinodiwa zvemhando yejekiseni mvura yekurapa michina ndeiyi inotevera:

Mvura yejekiseni inoshandiswa sechinhu chinonyungudutsa kugadzirira majekiseni ekugadzirisa uye isina kucheneswa rinsing agents, kana kugeza mbiya (kunyatso kugeza), kugeza kwekupedzisira kwezvivharo zverabha, kugadzirwa kwakachena kweupfu, uye mishonga yekiriniki inonyungudika mumvura inonyungudutsa majekiseni eupfu, infusions, majekiseni emvura, etc. Nokuti mishonga yakagadzirirwa inobaiwa zvakananga mumuviri kuburikidza nemhasuru kana intravenous administration, zvinodiwa zvehutano zvakanyanya kukwirira uye zvinofanirwa kusangana nezvinodiwa zvemajekiseni akasiyana-siyana maererano nekusabereka, kusavapo kwepyrogens, kujekesa, magetsi emagetsi anofanira kuva. > 1MΩ/cm, bacterial endotoxin <0.25EU/ml, uye microbial index <50CFU/ml.

Mamwe mazinga emhando yemvura anofanirwa kusangana nemakemikari anoratidza emvura yakacheneswa uye ane yakanyanya kuderera yakazara organic carbon concentration (ppb level).Izvi zvinogona kutariswa zvakananga nekushandisa yakasarudzika yakazara organic kabhoni analyzer, iyo inogona kuiswa mukati mejekiseni remvura rekupa kana pombi yekudzorera kuti utarise panguva imwe chete conductivity yemagetsi uye tembiricha.Pamusoro pekuzadzisa zvinodiwa nemvura yakacheneswa, mvura yejekiseni inofanirawo kuva nehuwandu hwehutachiona hwe<50CFU/ml uye kupasisa pyrogen test.

Zvinoenderana nemirairo yeGMP, iyo yakacheneswa mvura uye majekiseni emvura masisitimu anofanirwa kuita GMP kusimbiswa isati yatanga kushandiswa.Kana chigadzirwa chacho chichida kuendeswa kunze kwenyika, chinofanirawo kuenderana nezvinodiwa neUSP, FDA, cGMP, etc. Kuti zvive nyore kutaura uye nzira dzakasiyana-siyana dzekurapa kubvisa tsvina mumvura, Tafura 1 inonyora zvinodiwa zvehutano hwemvura yeUSP. GMP uye mhedzisiro yeakasiyana maitiro ekurapa ekubvisa tsvina mumvura sezvakasanganisirwa muChinese GMP nhungamiro yekushandisa.Kugadzirira, kuchengetedza, uye kugovera mvura yejekiseni kunofanirwa kudzivirira kuwanda nekusvibiswa kwehutachiona.Zvishandiso zvinoshandiswa pakuchengetedza matangi nemapaipi zvinofanirwa kunge zvisina chepfu uye zvisingaite corrosion.Kugadzirwa uye kuiswa kwepombi kunofanirwa kudzivirira magumo akafa uye mapofu mapaipi.Kucheneswa nekuita sterilization kutenderera kunofanirwa kuisirwa matangi ekuchengetedza uye mapaipi.Iyo yekufemesa chiteshi chejekiseni rekuchengetedza mvura tangi inofanirwa kuiswa ine hydrophobic bactericidal sefa isingadere fiber.Mvura yejekiseni inogona kuchengetwa nekushandisa tembiricha yekudzivirira pamusoro pe80 ℃, kutenderera kwetembiricha pamusoro pe65 ℃, kana kuchengetedza pasi pe4 ℃.

Mapombi anoshandiswa pamidziyo yepretreatment yemvura yejekiseni anowanzo shandisa ABS engineering mapurasitiki kana PVC, PPR, kana zvimwe zvinhu zvakakodzera.Nekudaro, sisitimu yekugovera yemvura yakacheneswa uye jekiseni remvura inofanirwa kushandisa inoenderana pombi zvinhu zvemakemikari disinfection, pasteurization, kupisa sterilization, nezvimwewo, sePVDF, ABS, PPR, uye zviri nani simbi isina tsvina, kunyanya iyo 316L mhando.Stainless simbi ishoko rakajairika, kunyatsotaura, yakakamurwa kuita simbi isina tsvina uye acid-resistant simbi.Stainless steel imhando yesimbi inoshingirira mukuora nemidziyo isina simba yakaita semhepo, chiutsi, nemvura, asi isingadzivirirwe nekuora nevezvenhau vane makemikari anoita seasidhi, alkali, nemunyu, uye ine zvinhu zvisina tsvina.

(I) Hunhu hwejekiseni mvura Mukuwedzera, simba rekuyerera velocity pakukura kwe microorganisms mupombi inofanira kufungwa.Kana iyo Reynolds nhamba Re inosvika zviuru gumi uye ichigadzira kuyerera kwakadzikama, inogona kunyatso gadzira mamiriro asina kunaka ekukura kwema microorganisms.Mukupesana, kana iwo magadzirirwo emvura dhizaini nekugadzira asina kutariswa, zvichikonzera kuderera kwakanyanya kuyerera, hutsinye hwepombi madziro, kana pombi mapofu ari mupombi, kana kushandisa mavharuvhu asina kurongeka, nezvimwewo, hutachiona hunogona zvachose. vanovimba nezvinangwa zvakakonzerwa neizvi kuti vavake nzvimbo yavo yekuberekera - biofilm, iyo inounza njodzi nematambudziko mukushanda uye kutonga kwemazuva ese kwemvura yakacheneswa uye majekiseni emvura masisitimu.

(II) Zvinodiwa zvekutanga zvejekiseni remvura masisitimu

Iyo jekiseni yemvura system inoumbwa nemidziyo yekuchenesa mvura, midziyo yekuchengetera, pombi dzekugovera, uye mapaipi.Iyo nzira yekuchenesa mvura inogona kuve pasi pekusvibiswa kwekunze kubva mumvura yakasvibira uye kunze kwezvinhu.Kusvibiswa kwemvura yakasvibirira ndiyo huru yekubuda kunze kwekusvibiswa kwemaitiro ekuchenesa mvura.Iyo US Pharmacopeia, European Pharmacopeia, uye Chinese Pharmacopeia zvese zviri pachena zvinoda kuti mvura mbishi yemvura yemishonga inofanirwa kusangana nemhando yepamusoro yemvura yekunwa.Kana muyero wemvura yekunwa usina kuzadzikiswa, matanho ekutanga ekurapa anofanira kutorwa.Sezvo Escherichia coli chiri chiratidzo chekusvibiswa kukuru kwemvura, pane zvakajeka zvinodiwa zveEscherichia coli mumvura yekunwa pasi rose.Mamwe mabhakitiriya anosvibisa haana kupatsanurwa uye anomiririrwa mumiyero se "yakazara mabhakitiriya kuverenga".China inotara muganhu we100 mabhakitiriya / ml yehuwandu hwemabhakitiriya kuverenga, zvichiratidza kuti kune kusvibiswa kwehutachiona mumvura yakasvibirira inosangana nechiyero chemvura yekunwa, uye mabhakitiriya makuru anosvibisa anoisa pangozi nzira dzekugadzirisa mvura iGram-negative bacteria.Zvimwe zvinhu zvakaita senge zvisina kudzivirirwa vent ports pamatangi ekuchengetera kana kushandiswa kweakaderera gasi mafirita, kana kuyerera kwemvura kubva kune yakasvibiswa nzvimbo, zvinogona zvakare kukonzera kusvibiswa kwekunze.

Mukuwedzera, kune kusvibiswa kwemukati panguva yekugadzirira uye kushanda kwegadziriro yekurapa mvura.Kusvibiswa kwemukati kunoenderana zvakanyanya nedhizaini, kusarudzwa kwezvinhu, kushanda, kuchengetedza, kuchengetedza, uye kushandiswa kwemvura yekurapa masisitimu.Midziyo yakasiyana-siyana yekuchenesa mvura inogona kuve matsime emukati ekusvibiswa kwehutachiona, senge ma microorganisms ari mumvura yakasvibira ari adsorbed pamusoro peiyo activated kabhoni, ion exchange resin, ultrafiltration membranes, uye zvimwe zvishandiso, kugadzira biofilms.Microorganisms inogara mubiofilms inodzivirirwa ne biofilms uye kazhinji haibatirwe nemishonga inouraya utachiona.Imwe bviro yekusvibiswa iripo muhurongwa hwekugovera.Microorganisms inogona kuumba makoroni panzvimbo yepombi, mavharuvhu, uye dzimwe nzvimbo uye kuwanda ipapo, achigadzira biofilms, zvichibva zvave zvisingaperi zvinosvibisa.Naizvozvo, mamwe makambani ekunze ane zvimiro zvakaomesesa zvekugadzira masisitimu ekurapa mvura.

(III) Maitiro ekushanda emajekiseni emvura masisitimu

Tichifunga nezve kucheneswa nguva dzose uye kuuraya utachiona kwepombi yekugovera sisitimu, pane kazhinji nzira mbiri dzekushandisa dzemvura yakacheneswa uye majekiseni emvura masisitimu.Imwe ndeye batch operation, apo mvura inogadzirwa mumabheti, akafanana nezvigadzirwa.Basa re "batch" rinonyanya kufunga nezvekuchengetedza, sezvo nzira iyi inogona kuparadzanisa imwe huwandu hwemvura panguva yekuedzwa kusvikira kuedza kwapera.Imwe yacho inoramba ichigadzirwa, inozivikanwa se "inoenderera" kushanda, uko mvura inogona kugadzirwa ichishandiswa.

IV) Kutarisira kwezuva nezuva kwejekiseni remvura system Kutarisira kwezuva nezuva kwemvura system, kusanganisira kushanda nekugadzirisa, kwakakosha zvikuru kusimbiswa uye kushandiswa kwakajairwa.Nokudaro, chirongwa chekutarisa uye chekudzivirira chekuchengetedza chinofanira kusimbiswa kuti chive nechokwadi chokuti hurongwa hwemvura hunogara huri mumamiriro ekutonga.Izvi zvinosanganisira:

Kushanda uye kugadzirisa maitiro ehurongwa hwemvura;
Kutarisisa chirongwa cheakakosha emhando yemvura paramita uye anoshanda paramita, kusanganisira calibration yezviridzwa zvakakosha;
Nguva dzose disinfection / sterilization chirongwa;
Chirongwa chekuchengetedza chekudzivirira chemidziyo yekurapa mvura;
Nzira dzekutarisira dzemidziyo yakakosha yekurapa mvura (kusanganisira zvikamu zvikuru), masisitimu ekuparadzira mapaipi, uye mamiriro ekushanda.

Zvinodiwa zvekushandisa pre-kurapa:

Midziyo yepamberi yekurapa yemvura yakacheneswa inofanirwa kuve yakashongedzerwa zvinoenderana nemhando yemvura yemvura yakasvibira, uye chinodiwa ndechekutanga kusangana nechiyero chemvura yekunwa.
Multi-media mafirita uye zvinyoro-nyoro zvemvura zvinofanirwa kukwanisa kuita otomatiki backwashing, kuberekwa patsva, uye kuburitsa.
Activated carbon filters inzvimbo idzo organic matter inoungana.Kuti udzivise kusvibiswa kwebhakitiriya uye bhakitiriya endotoxin, mukuwedzera kune chinodiwa chekuwachira otomatiki, kuuraya hutachiona hwemhepo kunogona kushandiswa zvakare.
Sezvo kusimba kwe255 nm wavelength yeUV mwenje inokonzereswa neUV inopesana nenguva, zviridzwa zvine nguva yekurekodha uye kusimba kwemamita zvinodiwa.Chikamu chakanyudzwa chinofanira kushandisa 316L simbi isina tsvina, uye chivharo chemwenje chequartz chinofanira kubviswa.
Mvura yakacheneswa mushure mekupfuura nemusanganiswa-bed deionizer inofanira kutenderedzwa kuti igadzikane kunaka kwemvura.Zvisinei, iyo yakasanganiswa-bed deionizer inogona chete kubvisa cations uye anions kubva mumvura, uye haibatsiri pakubvisa endotoxins.

Zvinodiwa pakugadzirwa kwemvura yejekiseni (tsvina yakachena) kubva mumidziyo yekuchenesa mvura: Mvura yejekiseni inogona kuwanikwa kuburikidza nedistillation, reverse osmosis, ultrafiltration, etc. Nyika dzakasiyana dzakatsanangura nzira dzakajeka dzekugadzira mvura yejekiseni, dzakadai se:

The United States Pharmacopeia (24th edition) inotaura kuti "mvura yejekiseni inofanira kuwanikwa ne distillation kana kuti reverse osmosis kucheneswa kwemvura inosangana nezvinodiwa neAmerican Water and Environmental Protection Association, European Union, kana Japanese zvinodiwa nemutemo."
The European Pharmacopeia (chinyorwa cha1997) inotaura kuti “mvura yejekiseni inowanwa kupfurikidza nokunyudzwa kwakafanira kwemvura inosvitsa mipimo yepamutemo yemvura yokunwa kana kuti mvura yakacheneswa.
The Chinese Pharmacopeia (2000 edition) inotsanangura kuti "chigadzirwa ichi (mvura yejekiseni) imvura inowanikwa nekunyungudutswa kwemvura yakacheneswa."Zvinogona kuonekwa kuti mvura yakacheneswa inowanikwa ne distillation ndiyo nzira inofarirwa pasi rose yekugadzira mvura yejekiseni, nepo chipfunga chakachena chichigona kuwanikwa pachishandiswa muchina mumwe chete wemvura wedistillation kana imwe jenareta yakachena yakachena.

Distillation ine yakanaka yekubvisa mhedzisiro pazvinhu zvisingaite organic uye inorganic zvinhu, zvinosanganisira zvakamiswa zvakaomesesa, colloids, mabhakitiriya, mavhairasi, endotoxins, uye humwe hutsvina mumvura mbishi.Chimiro, kuita, simbi zvinhu, nzira dzekushanda, uye mbishi mvura mhando yemuchina wemvura we distillation zvese zvinokanganisa kunaka kwemvura yejekiseni.Iyo "multi-effect" yemuchina wemvura yakawanda-effect distillation inonyanya kureva kuchengetedza simba, uko simba rekupisa rinogona kushandiswa kakawanda.Chinhu chakakosha pakubvisa endotoxins mumushini wemvura we distillation ndiyo inoparadzanisa mvura-mvura.