Sisteme ea Tlhahiso ea Metsi e Ente Ka Mocheso oa Mocheso

Tlhaloso ea Sehlahisoa

Metsi a enteng ke oona o sebelisoang ka ho fetisisa o hloekisitsoeng ka ho fetisisa tlhahisong ea litokisetso tse nyopa.Litlhoko tsa boleng ba metsi a ente li laoloa ka thata ho li-pharmacopoeias.Ho phaella linthong tse tloaelehileng tsa ho hlahloba metsi a distilled, tse kang acidity, chloride, sulfate, calcium, ammonium, carbon dioxide, lintho tse ka khonang ho oxidiza habonolo, lintho tse sa tsitsang, le litšepe tse boima, e boetse e hloka ho feta tlhahlobo ea pyrogen.GMP e bolela ka ho hlaka hore ho lokisoa, ho bolokoa le ho ajoa ha metsi a hloekisitsoeng le ente e lokela ho thibela ho ata le ho silafala ha likokoana-hloko.Lisebelisoa tse sebelisoang bakeng sa litanka tsa polokelo le liphaephe li lokela ho ba tse se nang chefo le tse thibelang ho bola.

Litlhoko tsa boleng ba lisebelisoa tsa ho hloekisa metsi ke tse latelang:

Metsi a ente a sebelisoa e le mokelikeli bakeng sa ho lokisa litharollo tsa ente le lisebelisoa tse hlatsuoang, kapa bakeng sa ho hlatsoa linkho (ho hlatsuoa hantle), ho hlatsuoa ha li-stoppers tsa rabara, ho hlahisa mouoane o hloekileng, le litlhare tsa bongaka tse qhibilihang ka metsing bakeng sa liente tse hloekisitsoeng, li-infusions. liente tsa metsi, joalo-joalo Hobane meriana e lokiselitsoeng e kenngoa ka ho toba 'meleng ka mesifa kapa tsamaiso ea methapo, litlhoko tsa boleng li phahame ka ho khetheha 'me li lokela ho finyella litlhoko tsa liente tse sa tšoaneng ho latela sterility, ho ba sieo ha pyrogens, ho hlaka, conductivity ea motlakase e lokela ho ba. > 1MΩ/cm, bacterial endotoxin <0.25EU/ml, le microbial index <50CFU/ml.

Maemo a mang a boleng ba metsi a tlameha ho kopana le matšoao a lik'hemik'hale a metsi a hloekisitsoeng 'me a be le "organic carbon concentration" e tlase haholo (ppb level).Sena se ka shejoa ka kotloloho ka ho sebelisa analyzer e ikhethileng ea organic carbon analyzer, e ka kengoang phepelong ea metsi ea ente kapa liphaephe tsa ho khutlisa ho lekola boleng ba motlakase le mocheso ka nako e le 'ngoe.Ntle le ho fihlela litlhoko tsa metsi a hloekisitsoeng, metsi a ente a boetse a lokela ho ba le palo ea baktheria ea <50CFU/ml le ho feta tlhahlobo ea pyrogen.

Ho latela melaoana ea GMP, lits'ebetso tsa metsi a hloekisitsoeng le liente li tlameha ho netefatsoa ka GMP pele li ka sebelisoa.Haeba sehlahisoa se hloka ho romelloa kantle ho naha, se tlameha hape ho latela litlhoko tse tsamaellanang tsa USP, FDA, cGMP, joalo-joalo. Bakeng sa ho nolofalloa ha litšupiso le mekhoa e fapaneng ea kalafo ea ho tlosa litšila metsing, Lethathamo la 1 le thathamisa litlhoko tsa boleng ba metsi tsa USP. GMP le litlamorao tsa mekhoa e fapaneng ea kalafo ea ho tlosa litšila ka metsing joalo ka ha e kenyelelitsoe ho litataiso tsa ts'ebetso tsa China GMP.Ho lokisoa, ho bolokoa le ho ajoa ha metsi a ente ho lokela ho thibela ho ata le ho silafala ha likokoana-hloko.Lisebelisoa tse sebelisoang bakeng sa litanka tsa polokelo le liphaephe li lokela ho ba tse se nang chefo le tse thibelang ho bola.Moralo le ho kenya liphaephe li lokela ho qoba liphaephe tse shoeleng le liphaephe tse foufetseng.Lipotoloho tsa ho hloekisa le ho thibela likokoana-hloko li lokela ho thehoa bakeng sa litanka tsa polokelo le liphaephe.Boema-kepe ba moea ba tanka ea polokelo ea metsi ea ente bo lokela ho kengoa ka sefene sa hydrophobic bactericidal se sa tšolleng likhoele.Metsi a ente a ka bolokoa ka ho sebelisa mohatsela oa mocheso o ka holimo ho 80 ℃, ho potoloha mocheso ka holimo ho 65℃, kapa ho boloka ka tlaase ho 4℃.

Liphaephe tse sebelisoang bakeng sa lisebelisoa tsa pele bakeng sa metsi a ente hangata li sebelisa polasetiki ea boenjiniere ea ABS kapa PVC, PPR, kapa lisebelisoa tse ling tse loketseng.Leha ho le joalo, tsamaiso ea kabo ea metsi a hloekisitsoeng le metsi a ente e lokela ho sebelisa lisebelisoa tse tsamaisanang tsa lipeipi bakeng sa ho bolaea likokoana-hloko tsa lik'hemik'hale, pasteurization, sterilization ea mocheso, joalo-joalo, joalo ka PVDF, ABS, PPR, 'me ka ho khetheha tšepe e sa hloekang, haholo mofuta oa 316L.Tšepe e sa hloekang ke lentsoe le akaretsang, ha re bua hantle, le arotsoe ka tšepe e sa hloekang le tšepe e sa keneleng acid.Stainless steel ke mofuta oa tšepe o hananang le ho bola ke mecha ea litaba e fokolang joalo ka moea, mouoane, le metsi, empa ha e hanele ho bola ke mecha ea litaba e nang le lik'hemik'hale e kang acid, alkalis le matsoai, 'me e na le thepa e sa hloekang.

(I) Litšobotsi tsa metsi a ente Ho phaella moo, tšusumetso ea lebelo la phallo ea ho hōla ha likokoana-hloko ka phala e lokela ho nkoa.Ha nomoro ea Reynolds Re fihla ho 10,000 'me e theha phallo e tsitsitseng, e ka hlahisa maemo a sa thabiseng ka katleho bakeng sa kholo ea likokoana-hloko.Ho fapana le hoo, haeba lintlha tsa moralo le tlhahiso ea tsamaiso ea metsi li sa hlokomeloe, ho fella ka lebelo le tlase haholo la phallo, mabota a liphaephe, kapa liphaephe tse foufetseng pompong, kapa ho sebelisa li-valve tse sa lokelang, joalo-joalo, likokoana-hloko li ka 'na tsa e-ba teng ka ho feletseng. itšetleha ka maemo a sepheo a bakoang ke sena ho ikahela sebaka sa bona sa ho ikahela - biofilm, e tlisang likotsi le mathata ts'ebetsong le taolong ea letsatsi le letsatsi ea metsi a hloekisitsoeng le lits'ebetso tsa metsi a ente.

(II) Litlhoko tsa mantlha tsa litsamaiso tsa metsi a ente

Sistimi ea metsi ea ente e entsoe ka lisebelisoa tsa ho hloekisa metsi, lisebelisoa tsa polokelo, lipompo tsa kabo, le liphaephe.Tsamaiso ea ho hloekisa metsi e ka 'na ea e-ba tlas'a tšilafalo e ka ntle ho metsi a tala le lintho tse ka ntle.Tšilafalo ea metsi a tala ke mohloli o ka ntle oa tšilafalo ea tsamaiso ea metsi.The US Pharmacopeia, European Pharmacopeia, le Chinese Pharmacopeia kaofela li hloka ka ho hlaka hore metsi a tala bakeng sa metsi a meriana a lokela ho finyella bonyane litekanyetso tsa boleng ba metsi a nooang.Haeba maemo a metsi a nooang a sa fihlellehe, mehato ea pele ho kalafo e lokela ho nkuoa.Kaha Escherichia coli ke letšoao la tšilafalo e kholo ea metsi, ho na le litlhoko tse hlakileng bakeng sa Escherichia coli metsing a nooang linaheng tse ling.Libaktheria tse ling tse silafatsang ha lia aroloa 'me li emeloa ke litekanyetso e le "palo ea libaktheria kaofela".China e beha moeli oa libaktheria tse 100 / ml bakeng sa palo eohle ea libaktheria, e bontšang hore ho na le tšoaetso ea likokoana-hloko metsing a tala a finyellang maemo a metsi a nooang, 'me likokoana-hloko tse ka sehloohong tse silafatsang tse behang kotsing ea tsamaiso ea metsi ke libaktheria tsa Gram-negative.Lintlha tse ling tse joalo ka likou tse sa sirelelitsoeng tse kenang ka har'a litanka tsa polokelo kapa tšebeliso ea lihloela tse tlase tsa khase, kapa ho khutla ha metsi a tsoang litsing tse silafetseng, le tsona li ka baka tšilafalo ea kantle.

Ho phaella moo, ho na le tšilafalo ea ka hare nakong ea ho lokisetsa le ho sebetsa ha mokhoa oa ho hloekisa metsi.Tšilafalo ea ka hare e amana haufi-ufi le moralo, khetho ea thepa, ts'ebetso, tlhokomelo, polokelo, le ts'ebeliso ea litsamaiso tsa kalafo ea metsi.Lisebelisoa tse fapaneng tsa ho hloekisa metsi li ka fetoha mehloli e ka hare ea tšilafalo ea likokoana-hloko, joalo ka likokoana-hloko tse ka metsing a tala tse adsorbed holim'a carbon e entsoeng, li-resin tsa li-ion, li-membrane tsa ultrafiltration, le lisebelisoa tse ling, tse etsang biofilm.Likokoana-hloko tse phelang ka har'a biofilm li sirelelitsoe ke biofilms 'me ka kakaretso ha li angoe ke likokoana-hloko.Mohloli o mong oa tšilafalo o teng tsamaisong ea kabo.Likokoana-hloko li ka etsa likolone holim'a liphaephe, li-valve, le libaka tse ling 'me tsa ikatisa moo, li etsa li-biofilms, kahoo li fetoha mehloli e tsitsitseng ea tšilafalo.Ka hona, lik'hamphani tse ling tsa linaha tse ling li na le litekanyetso tse thata tsa moralo oa mekhoa ea ho hloekisa metsi.

(III) Mekhoa ea ho sebetsa ea tsamaiso ea metsi a ente

Ha ho nahanoa ka tlhoekiso ea kamehla le ho bolaea likokoana-hloko tsamaisong ea kabo ea lipeipi, hangata ho na le mekhoa e 'meli ea ts'ebetso bakeng sa lits'ebetso tsa metsi a hloekisitsoeng le metsi a ente.E 'ngoe ke ts'ebetso ea batch, moo metsi a hlahisoang ka lihlopha, tse tšoanang le lihlahisoa.Ts'ebetso ea "batch" ke haholo-holo bakeng sa ho nahana ka polokeho, kaha mokhoa ona o ka arola palo e itseng ea metsi nakong ea teko ho fihlela tlhahlobo e phethoa.E 'ngoe ke tlhahiso e tsoelang pele, e tsejoang e le ts'ebetso "e tsoelang pele", moo metsi a ka hlahisoang ha a ntse a sebelisoa.

IV) Tsamaiso ea letsatsi le letsatsi ea tsamaiso ea metsi a ente Tsamaiso ea letsatsi le letsatsi ea tsamaiso ea metsi, ho kenyeletsa ts'ebetso le tlhokomelo, e bohlokoa haholo bakeng sa ho netefatsa le ho sebelisoa ka tloaelo.Ka hona, moralo oa tlhokomelo le thibelo o lokela ho thehoa ho netefatsa hore tsamaiso ea metsi e lula e le boemong bo laoloang.Litaba tsena li kenyelletsa:

Mekhoa ea ts'ebetso le tlhokomelo ea tsamaiso ea metsi;
Moralo oa ho beha leihlo bakeng sa litekanyetso tsa bohlokoa tsa boleng ba metsi le mekhoa ea ts'ebetso, ho kenyeletsoa le ho lekanya lisebelisoa tsa bohlokoa;
Moralo oa kamehla oa ho bolaea likokoana-hloko/ho hloekisa;
Morero o thibelang oa tlhokomelo ea lisebelisoa tsa ho hloekisa metsi;
Mekhoa ea tsamaiso ea lisebelisoa tsa bohlokoa tsa ho hloekisa metsi (ho kenyeletsoa le likarolo tse kholo), litsamaiso tsa kabo ea lipeipi, le maemo a ts'ebetso.

Litlhoko tsa lisebelisoa tsa pele ho kalafo:

Lisebelisoa tsa pele ho kalafo bakeng sa metsi a hloekisitsoeng li lokela ho hlomelloa ho latela boleng ba metsi a metsi a tala, 'me tlhokahalo ke ho qala ho fihlela maemo a metsi a nooang.
Li-filters tsa multimedia le li-softeners tsa metsi li lokela ho khona ho hlatsoa li-backwashing, ho tsosolosa le ho ntša metsi.
Li-filters tsa carbon tse sebetsang ke libaka tseo lintho tse phelang li bokellanang ho tsona.Bakeng sa ho thibela tšilafalo ea endotoxin ea baktheria le ea baktheria, ntle le tlhokahalo ea ho hlatsuoa ka boiketsetso, ho ka sebelisoa ho bolaea likokoana-hloko tsa mouoane.
Kaha matla a 255 nm wavelength a khanya ea UV a susumetsoang ke UV a lekana le nako, lisebelisoa tse nang le nako ea ho rekota le limithara tse matla lia hlokahala.Karolo e qoelitsoeng e lokela ho sebelisa tšepe e sa hloekang ea 316L, 'me sekoaelo sa lebone sa quartz se lokela ho tlosoa.
Metsi a hloekisitsoeng ka mor'a hore a fete ka har'a bethe e tsoakiloeng ea deionizer a tlameha ho potoloha ho tsitsisa boleng ba metsi.Leha ho le joalo, deionizer ea bethe e tsoakiloeng e ka tlosa li-cations le anions feela metsing, 'me ha e sebetse ho tlosa li-endotoxins.

Litlhoko tsa tlhahiso ea metsi a ente (mouoane o hloekileng) ho tsoa lisebelisoa tsa ho hloekisa metsi: Metsi a enteng a ka fumanoa ka distillation, reverse osmosis, ultrafiltration, joalo-joalo Linaha tse fapaneng li hlalositse mekhoa e hlakileng ea ho hlahisa metsi a ente, joalo ka:

United States Pharmacopeia (khatiso ea bo24) e re "metsi a enteng a tlameha ho fumanoa ka ho hloekisoa kapa ho khutlisa osmosis ho hloekisa metsi a fihlelang litlhoko tsa American Water and Environmental Protection Association, European Union, kapa litlhoko tsa molao tsa Japane."
The European Pharmacopeia (khatiso ea 1997) e bolela hore “metsi a enteng a fumanoa ka ho hloekisoa ho loketseng ha metsi a finyellang litekanyetso tsa molao tsa metsi a nooang kapa metsi a hloekisitsoeng.”
Chinese Pharmacopeia (khatiso ea 2000) e bolela hore "sehlahisoa sena (metsi a enteng) ke metsi a fumanoang ka ho tšeloa ka metsi a hloekisitsoeng."Ho ka bonoa hore metsi a hloekisitsoeng a fumanoang ka ho hloekisoa ke mokhoa o ratoang ke machaba oa ho hlahisa metsi a ente, ha mouoane o hloekileng o ka fumanoa ka mochine o tšoanang oa metsi a hloekisitsoeng kapa jenereithara e arohaneng e hloekileng ea mouoane.

Distillation e na le phello e ntle ea ho tlosa linthong tse sa fetoheng tsa manyolo le lintho tse sa tsitsang, ho kenyelletsa le lintho tse tiileng tse emisitsoeng, li-colloid, libaktheria, livaerase, li-endotoxins le litšila tse ling metsing a tala.Sebopeho, ts'ebetso, lisebelisoa tsa tšepe, mekhoa ea ts'ebetso, le boleng ba metsi a tala a mochini oa metsi a distillation kaofela li tla ama boleng ba metsi a ente."Mekhoa e mengata" ea mochine oa metsi a nang le mefuta e mengata haholo-holo e bolela ho boloka matla, moo matla a mocheso a ka sebelisoang ka makhetlo a mangata.Karolo e ka sehloohong ea ho tlosa li-endotoxins mochineng oa metsi a distillation ke karohano ea metsi a mouoane.