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Qib ntawm Cov Lus Qhia Hauv Tebchaws Meskas, GMP cov hauv paus ntsiab lus tau suav nrog hauv ntu 210 thiab ntu 211 ntawm txoj cai ntawm tsoomfwv cov cai.Vim tias cov kev cai no nyuaj los hloov kho lossis ntxiv, FDA tau tshaj tawm cov ntaub ntawv sib txawv ntawm GMP cov cai thiab cov lus qhia ua haujlwm rau cov kws tshuaj, xws li Kev Qhia rau ...Nyeem ntxiv»
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GMP (Good Manufacturing Practice) yog cov txheej txheem tswj xyuas thiab saib xyuas cov tshuaj tsim khoom thoob ntiaj teb.Nws tseem yog qhov tsim nyog tso cai rau cov chaw tsim tshuaj lag luam kom nkag mus rau hauv kev lag luam thoob ntiaj teb.GMP muaj xws li: chaw, neeg, chaw, huv si, validation, ua ...Nyeem ntxiv»
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Tuam Tshoj yeej ib txwm yog lub lag luam loj loj ntawm kev lag luam tshuaj, tsis ntev los no qhia txog qhov muaj peev xwm ntawm kev tswj hwm hauv ntiaj teb.Ntawm cov uas, cov khoom siv tshuaj ua kom loj hlob thiab ua raws li cov kws tsim tshuaj.Hauv qhov no, yuav ua li cas rau yav tom ntej?1. Auto...Nyeem ntxiv»
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1. Xaiv cov khoom noj kom zoo Tom qab ntxiv qee cov hydrated magnesium silicate rau hauv cov tshuaj ntsuab granules, lub kaum sab xis ntawm repose tau txo qis, fluidity tau nce thiab sau qhov hnyav sib txawv tau nqaim.Hauv lwm qhov xwm txheej, Avicel PH302 ua ib qho diluent kuj txo qis qhov hnyav ntawm qhov sib txawv ntawm ...Nyeem ntxiv»
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Peb qhov ua tau ua rau yuav tsum tau nyob: lub plhaub capsule, cov yam ntxwv ntawm cov khoom siv thiab cov khoom siv.Capsule plhaub Nws yog ib qho tseem ceeb los xyuas kom meej qhov zoo ntawm koj cov khoom siv capsule khoob.Txhua lub plhaub tsis yooj yim los yog deformed capsule yuav ua rau muaj kev puas tsuaj loj.Test lub plhaub capsule chemically thiab lub cev ...Nyeem ntxiv»
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Lub tshuab nqus tsev Decapsulator yog ib hom tsis tshua muaj nyob rau hauv khw muag tshuaj, feem ntau vim hais tias encapsulation yog yooj yim los tswj.Txawm li cas los xij, lub tshuab txawv txawv no tseem tau txais kev nyiam ntawm cov kws tsim tshuaj raws li qhov tsim nyog ceev faj rau qhov tsis raug kaw.Nov yog qee qhov zoo o ...Nyeem ntxiv»
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Vim li cas ho xaiv Halo Pharmatech ua ib qho ntawm koj cov neeg muag khoom hauv kev lag luam tshuaj?Nov yog qee qhov laj thawj rau koj kom paub: Cov Khoom Tsim Kho Tshiab thiab kev txhim kho yog lub hauv paus ntawm kev tsim khoom.Hauv Halo Pharmatech, txhua lub tshuab yog tsim los ntawm kev xav tau cov khoom siv tshuaj ...Nyeem ntxiv»
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Nyob rau hauv cov txheej txheem ntawm cov tshuaj capsule kaw, ntim capsule defects tshwm sim yog qhov teeb meem tshaj plaws.Splits, telescoped capsules, folds thiab cap tucks tshwm sim thaum lub capsule kaw, ua rau muaj peev xwm ntawm cov khoom xau.Thaum cov tshuaj ntsiav tsis zoo yuav luag tsis pom, muab pov tseg lossis ...Nyeem ntxiv»
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Cov tshuaj ntsiav khoob yog tsim los ntawm gelatin, uas yog muab los ntawm cov tsiaj protein (nqaij nqaij npuas, tsiaj pob txha & tawv nqaij thiab ntses pob txha) thiab cog polysaccharides los yog lawv cov derivatives (HPMC, starch, pullulan thiab lwm yam).Cov khoob khoob khoob khoob no yog ua hauv ob ntu: qhov qis dua "lub cev" uas ...Nyeem ntxiv»
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Rov qab rau xyoo 2012, Halo Pharmatech tau pib tsim cov tshuaj ntsiav tshuaj tshiab, uas tau txawv los ntawm feem ntau ntawm lwm lub tshuab hnyav hauv khw.Tsis zoo li lwm hom tshuaj ntsiav tshuaj hnyav, kev ua haujlwm ceev ntawm lub tshuab no tsis raug kho, tag nrho rau nws cov neeg siv.Nws lub tsev-block-liked stru...Nyeem ntxiv»