Hauv kev lag luam tshuaj, txhua txoj kev tsim khoom muaj feem xyuam rau kev nyab xeeb ntawm cov neeg mob lub neej. Los ntawm kev xaiv cov khoom siv raw mus rau cov txheej txheem ntau lawm, los ntawm kev tu cov cuab yeej mus rau kev tswj ib puag ncig, ib qho kev ua qias tuaj me ntsis tuaj yeem ua rau muaj kev pheej hmoo ntawm cov tshuaj zoo. Ntawm cov txuas tseem ceeb no, covtshuaj ntshiab chav generatortau dhau los ua ib qho ntawm cov cuab yeej tseem ceeb los ua kom muaj kev nyab xeeb ntawm cov tshuaj vim nws lub luag haujlwm tsis tuaj yeem hloov pauv. Nws tsis tsuas yog muab kev lees paub txhim khu kev qha rau aseptic ntau lawm, tab sis kuj tseem yog lub hauv paus tseem ceeb rau kev lag luam tshuaj niaj hnub kom txav mus rau cov qauv siab thiab zoo.

Ntshiab steam: lub lifeline ntawm kev tsim tshuaj

Cov kev cai rau kev huv huv hauv kev tsim tshuaj yog yuav luag nruj. Txawm hais tias nws yog txhaj tshuaj, biologics, tshuaj tiv thaiv, lossis tshuaj gene, cov cuab yeej siv, cov kav dej, ntim, thiab txawm tias huab cua ib puag ncig koom nrog lawv cov txheej txheem tsim khoom yuav tsum tau ua kom tsis muaj menyuam. Ntshiab chav (tseem hu ua "pharmaceutical grade steam") tau dhau los ua qhov kev nyiam ua kom tsis muaj menyuam hauv kev lag luam kws tshuaj vim nws qhov kub thiab txias thiab tsis muaj tshuaj lom neeg.

Qhov tseem ceeb ntawm kev ua kom tsis muaj menyuam

Ntshiab huv tuaj yeem nkag mus rau hauv cov phab ntsa microbial sai sai thiab tua cov kab mob, cov kab mob, thiab cov spores los ntawm qhov kub thiab txias (feem ntau siab dua 121 ℃) thiab siab. Piv nrog rau cov tshuaj tua kab mob, cov tshuaj tua kab mob ntshiab tsis muaj qhov seem seem, tshwj xeeb tshaj yog tsim rau cov khoom siv thiab cov thawv uas tuaj rau hauv kev sib cuag nrog cov tshuaj. Piv txwv li, kev ua kom tsis muaj menyuam ntawm cov cuab yeej tseem ceeb xws li cov kab txhaj tshuaj, lub tshuab ziab khaub ncaws, thiab bioreactors cia siab rau kev nkag mus rau cov pa ntshiab huv.

Qhov nruj ntawm cov qauv zoo

Raws li GMP cov tseev kom muaj, cov tshuaj dawb huv yuav tsum ua kom tau raws li peb qhov tseem ceeb:

Tsis muaj cua sov: Qhov chaw tshav kub yog cov pa phem uas tuaj yeem ua rau kub taub hau hauv cov neeg mob thiab yuav tsum tau muab tshem tawm tag nrho.

Condensed dej ua tau raws li tus qauv: Cov dej zoo tom qab cov dej ntshiab huv yuav tsum tau ua kom tau raws li cov dej rau kev txhaj tshuaj (WFI) tus qauv, nrog rau kev ua haujlwm ntawm ≤ 1.3 μ S / cm.

Tsim nyog tus nqi dryness: Lub chav dryness yuav tsum yog ≥ 95% kom tsis txhob ua kua dej cuam tshuam cov nyhuv sterilization.

Daim ntawv thov txheej txheem tag nrho

Los ntawm kev ua kom tsis muaj menyuam hauv online (SIP) ntawm cov cuab yeej tsim khoom mus rau huab cua hauv chav huv, los ntawm kev ntxuav cov khaub ncaws tsis huv mus rau cov txheej txheem tshuaj tua kab mob, cov pa ntshiab khiav mus rau tag nrho lub neej ntawm kev tsim tshuaj. Tshwj xeeb tshaj yog nyob rau hauv lub rooj cob qhia aseptic, lub tshuab hluav taws xob ntshiab yog qhov "core power source" uas khiav yuav luag 24 teev hauv ib hnub yam tsis muaj kev cuam tshuam.

Technological Innovation ntawm Pharmaceutical Ntshiab Steam Generator

Nrog rau kev thov kom zoo, kev ua tau zoo, thiab kev tiv thaiv ib puag ncig hauv kev lag luam tshuaj, thev naus laus zis ntawm cov tshuab hluav taws xob ntshiab tseem tab tom tawg tas li. Cov khoom siv niaj hnub no tau ua tiav kev ruaj ntseg thiab kev siv hluav taws xob ntau dua los ntawm kev txawj ntse thiab kev tsim qauv.

Txoj kev loj hlob nyob rau hauv core technology

Multi-function distillation thev naus laus zis: Los ntawm ntau theem zog rov qab, cov dej nyoos (feem ntau yog cov dej huv) hloov mus rau hauv chav dej ntshiab, txo kev siv hluav taws xob ntau dua 30% piv rau cov khoom siv niaj hnub.

Kev txawj ntse tswj: nruab nrog lub kaw lus tsis siv neeg saib xyuas, tshawb pom lub sijhawm tiag tiag ntawm chav dryness, kub, thiab siab, tsis siv neeg lub tswb thiab hloov kho rau cov xwm txheej txawv txav, kom tsis txhob muaj kev ua haujlwm ntawm tib neeg.

Tsawg carbon tsim: siv cov khoom siv hluav taws xob rov qab los txo cov khoom pov tseg hluav taws xob, nyob rau hauv txoj kab nrog kev hloov pauv ntsuab ntawm kev lag luam tshuaj.

Qhov 'dual insurance' ntawm kev ruaj ntseg zoo

Niaj hnub nimno ntshiab chav generators feem ntau nruab nrog dual zoo kev ruaj ntseg mechanisms:

Kev saib xyuas online: Kev saib xyuas lub sijhawm tiag tiag ntawm chav purity los ntawm cov khoom siv xws li ntsuas ntsuas ntsuas thiab TOC ntsuas ntsuas.
Rov qab tsim: dual lub twj tso kua mis thaub qab, ntau theem pom thiab lwm yam tsim kom muaj kev ruaj ntseg ntawm cov cuab yeej siv thaum muaj xwm txheej ceev.

Flexibility nyob rau hauv teb rau complex thov

Cov tshuab hluav taws xob ntshiab huv tuaj yeem kho tau rau thaj chaw tshiab xws li biopharmaceuticals thiab kev kho ntawm tes. Piv txwv li, cov cuab yeej siv rau cov tshuaj tiv thaiv mRNA yuav tsum tau ua kom tau raws li qhov yuav tsum tau ua kom tsis muaj menyuam, thiab qee lub tuam txhab tau qhia "ultra pure steam" thev naus laus zis los tswj cov qib endotoxin hauv cov dej condensed hauv qab 0.001 EU / mL.
Nrog rau kev loj hlob sai ntawm biopharmaceuticals, cov kev xav tau siab dua tau muab tso rau pem hauv ntej rau qhov zoo ntawm cov pa ntshiab. Kev tsim cov tshuaj tshiab xws li cov tshuaj noob thiab cov tshuaj tiv thaiv kab mob monoclonal yuav tsum muaj qhov chaw huv huv. Qhov no nthuav tawm qhov kev sib tw thev naus laus zis tshiab rau cov tshuab hluav taws xob ntshiab.

Lub tswv yim ntawm kev tsim ntsuab yog hloov qhov kev xav ntawm cov tshuab hluav taws xob ntshiab. Kev siv cov khoom siv txuag hluav taws xob, cov ntaub ntawv zoo ib puag ncig, thiab kev txhim kho cov kev tswj xyuas ntse yog txhua yam tsav kev lag luam mus rau kev coj ua kom ruaj khov.

Daim ntawv thov ntawm cov cuab yeej ntse yog hloov kho hom kev ua haujlwm ntawm cov tshuab hluav taws xob ntshiab. Kev siv cov chaw taws teeb saib xyuas, kev saib xyuas kev kwv yees, kev hloov kho ntse thiab lwm yam haujlwm tsis yog tsuas yog txhim kho kev ua haujlwm ntawm cov cuab yeej siv, tab sis kuj muab kev ruaj ntseg zoo dua rau kev tsim tshuaj.

Niaj hnub no, raws li kev nyab xeeb tshuaj yog nce nqi, qhov tseem ceeb ntawmtshuaj ntshiab chav generatorstab tom ua qhov tseem ceeb. Nws tsis yog tsuas yog cov cuab yeej tseem ceeb rau kev tsim tshuaj, tab sis kuj yog ib qho tseem ceeb ntawm kev tiv thaiv kev nyab xeeb ntawm pej xeem tshuaj. Nrog rau kev nce qib ntawm kev siv thev naus laus zis tas li, cov tshuab hluav taws xob ntshiab huv yuav tsis ntseeg tau ua lub luag haujlwm ntau dua hauv kev lag luam tshuaj thiab ua kom muaj txiaj ntsig zoo rau tib neeg kev noj qab haus huv.