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Kab Granulation Hom Ntub Dej Uas Muaj Kev Ntim Siab

Nws yog qhov tsim nyog rau kev tsim cov tshuaj lom neeg heev, muaj zog heev, thiab ua xua heev, thiab yuav tsum ncav cuag OEB4 & OEB5 kom txo qis qhov txaus ntshai ntawm cov neeg ua haujlwm thaum lub sijhawm tsim khoom thiab qhov cuam tshuam rau ib puag ncig.

Cov khoom siv ua raws li Tuam Tshoj xyoo 2010 ntawm GMP, European GMP, thiab FDA cov cai, thiab ua tau raws li OEB cov kev cai airtight, kom txo qhov kev puas tsuaj ntawm cov khoom rau cov khoom siv sib cuag;

Cov Lus Qhia Txog Tus Qauv EHS rau Kev Lag Luam Tshuaj Suav Teb (2020); Kev Txwv Kev Ua Haujlwm rau Cov Yam Txaus Ntshai hauv Chaw Ua Haujlwm

    Cov Kab Granulation Uas Muaj Kev Ntim Siab Thiab Ntub Dej Fo8

    Cov yam ntxwv

    1. Txais yuav lub hnab cua foob, kev tswj hwm kev nyab xeeb;
    2. Txais yuav lub hnab PE lossis lub qhov (ab valve) rau kev thauj khoom thiab tshem tawm;
    3. Txais yuav BIBO system rau cov pa tso pa tawm, nrog rau F9/H13 lim dej;
    4. Kev ntxuav WIP / Kev ntxuav CIP / Kev ntxuav tes.
    Kev txhais lus ntawm kev tswj hwm OEB
    APIs nrog cytotoxicity thiab kev ua haujlwm siab yog ib chav kawm ntawm cov khoom xyaw tshuaj uas muaj kev ua haujlwm pharmacological siab, nrog rau cov tshuaj kho mob qis dua thiab tsawg dua cov kev mob tshwm sim, thiab tau nyiam ntau lub siab los ntawm kev ua lag luam hauv xyoo tas los no. Txawm hais tias kev ua lag luam rau cov tshuaj nquag heev yog dav, lawv kuj ntsib teeb meem loj dua. Ntxiv nrog rau kev tua cov hlwb qog noj ntshav, cov tshuaj tiv thaiv qog kuj tseem tuaj yeem tua cov hlwb ib txwm muaj. Lawv qhov kev ua xua tuaj yeem ua rau muaj kev tsis haum tshuaj hauv tib neeg, thiab lawv muaj kev phom sij rau kev noj qab haus huv ntawm cov neeg noj qab haus huv. Yog li ntawd, qhov kev pheej hmoo tseem ceeb uas tau xav txog hauv cov txheej txheem tsim khoom ntawm cytotoxic thiab cov APIs nquag heev yog kev raug plua plav. Qhov kev daws teeb meem zoo tshaj plaws yog siv cov thev naus laus zis airtight isolation los tswj cov hmoov av xau hauv cov txheej txheem tsim khoom. Vim yog qhov cwj pwm no, qhov project no feem ntau kawm txog OEL (Occupational Exposure Limit) tus nqi nyob rau hauv cov khoom siv sib txawv ntawm cov khoom siv lom, nrog rau cov khoom siv sib xws OEB airtight qib thiab airtight tswv yim. Raws li cov yam ntxwv ntawm cytotoxic thiab cov khoom siv raw nquag heev, raws li cov thev naus laus zis labyrinth sealing uas twb muaj lawm, cov thev naus laus zis tsis zoo sealing thiab cov thev naus laus zis airtight isolation, ntau yam kev sib xyaw ua ke sealing uas haum rau cov ntaub ntawv zoo li no tau raug kawm. Cov thev naus laus zis micro-leakage sealing tuaj yeem thaiv lossis thaiv nrog cov cytotoxicity siab. Cov channel xau ntawm cov APIs nquag los tswj tus nqi xau
    Cov kev cai ntawm cov khoom siv OEB
    1. OEB 1~2 yuav tsum tau teeb tsa cov chaw uas cua nkag los, xws li kev ua kom cua nkag tau zoo ntawm cov chaw uas raug cua nkag.
    2. OEB 3 Thaum muaj kev sib cuag nrog cov neeg ua haujlwm, cov khoom siv thiab cov chaw kaw cua yuav tsum tau siv ntau li ntau tau, thiab cov kev ntsuas tswj xws li cua nkag, lub tshuab cua laminar, chav ua haujlwm ywj pheej nrog lub tshuab cua hauv zos, lub tshuab pa taws, thiab lwm yam yuav tsum tau siv rau hauv cov qhov chaw uas raug cov hmoov tshuaj.
    3. Qib OEB 4-5 Yuav tsum muab qhov tseem ceeb rau kev siv cov khoom siv thiab cov chaw kaw tag nrho, thiab kev tsim cov kev tsim khoom siv thev naus laus zis kaw. Cov kab khoom yuav tsum siv tag nrho cov khoom siv thiab cov chaw kaw. Kev cuam tshuam nrog kev sib cuag ua haujlwm, kev tswj hwm xws li kev cais tawm, kev ua haujlwm kaw lub thawv hnab looj tes, α-β valve, hnab nkag thiab hnab tawm, thiab lwm yam yuav tsum tau siv. Cov khoom siv tsim khoom yuav tsum siv nws tus kheej qhov cua nruj heev, xws li lub tshuab ziab peb-hauv-ib.

    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab Tshaj Plaws

    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab Tshaj Plaws (1) rg3
    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab Tshaj Plaws (2)fq4
    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab (3) tz3
    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab (4) 0re
    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab (5)abo
    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab (6) 7ve

    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab Tshaj Plaws

    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab (1)xrb
    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab (2) 0hx
    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab Tshaj Plaws (3)3u7
    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab (4)f9k
    Kev Tsim Khoom - Cov Khoom Siv Ua Haujlwm Siab (5)zt6

    Kev Tsim Khoom - Kev Tswj Xyuas Lean (Qhov Chaw Sib Dhos)

    Kev Tsim Khoom - Kev Tswj Xyuas Lean (Qhov Chaw Sib Dhos) (1)jv0
    Kev Tsim Khoom - Kev Tswj Xyuas Lean (Qhov Chaw Sib Dhos) (2)xdz
    Kev Tsim Khoom - Kev Tswj Xyuas Lean (Qhov Chaw Sib Dhos) (3)usk
    Kev Tsim Khoom - Kev Tswj Xyuas Lean (Qhov Chaw Sib Dhos) (4)9jj

    Kev Tsim Khoom - Kev Tswj Xyuas Zoo

    Txoj cai zoo:
    cov neeg siv khoom ua ntej, zoo ua ntej, kev txhim kho tas mus li thiab kev ua tau zoo.
    Kev Tsim Khoom - Kev Tswj Xyuas Zoo (1)fp5
    Kev Tsim Khoom - Kev Tswj Xyuas Zoo (2)f7t
    Kev Tsim Khoom - Kev Tswj Xyuas Zoo (3)b40
    Kev Tsim Khoom - Kev Tswj Xyuas Zoo (4)x6y
    Cov khoom siv ua tiav siab heev + cov cuab yeej ntsuas kev ntsuas meej + cov txheej txheem ntws nruj + kev tshuaj xyuas cov khoom tiav + cov neeg siv khoom FAT
    = Tsis muaj qhov tsis zoo ntawm cov khoom lag luam hauv Hoobkas

    Kev Tswj Xyuas Zoo ntawm Kev Tsim Khoom (Cov Cuab Yeej Ntsuas Kev Ntsuas Tseeb)

    Kev Tswj Xyuas Zoo ntawm Kev Tsim Khoom (Cov Cuab Yeej Ntsuas Kev Ntsuas Tseeb) mgf

    Ntim & Xa Khoom

    Ntim & Xa Khoomd15

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