Chav huv yog dab tsi?
Cov chav huv huv, tseem hu ua chav tsis muaj plua plav, feem ntau yog siv los ua ib feem ntawm kev lag luam kev lag luam lossis kev tshawb fawb tshawb fawb, suav nrog kev tsim tshuaj, khoom noj, CRTs, LCDs, OLEDs, thiab microLED zaub.Cov chav huv huv yog tsim los tswj kom muaj cov khoom tsis tshua muaj qis, xws li plua plav, cov kab mob hauv huab cua, lossis cov khoom vaporized.
Yuav kom meej meej, chav huv huv muaj kev tswj cov pa phem, uas tau teev tseg los ntawm tus lej ntawm cov khoom ib lub cubic meter / ib cubic feet ntawm qhov loj me me.Ib chav huv huv kuj tseem tuaj yeem xa mus rau txhua qhov chaw nyob hauv qhov chaw uas cov pa phem tau txo qis thiab lwm yam kev ntsuas ib puag ncig xws li ntsuas kub, av noo, thiab siab tswj.
GMP huv chav tsev yog dab tsi?
Hauv kev txiav txim siab tshuaj, chav huv yog hais txog chav tsev uas ua tau raws li GMP cov lus qhia tshwj xeeb hauv GMP sterility specifications (piv txwv li, Annex 1 ntawm EU thiab PIC/S GMP Guidelines, nrog rau lwm cov qauv thiab cov lus qhia uas yuav tsum tau ua los ntawm cov neeg saib xyuas kev noj qab haus huv hauv zos. ).Nws yog kev sib xyaw ua ke ntawm engineering, kev tsim khoom, kev ua tiav, thiab kev tswj xyuas kev ua haujlwm (tswj cov tswv yim) yuav tsum tau hloov chav ib txwm rau hauv chav huv.
Raws li cov qauv tsim nyog ntawm FDA cov koom haum, lawv tau tsim cov kev cai nruj thiab meej rau cov chaw tsim tshuaj hauv kev lag luam tshuaj.Kev Ua Zoo Zoo (GMP) rau kev tsim cov khoom siv tshuaj tsis muaj menyuam yog tsim los xyuas kom meej tias cov tshuaj muaj kev nyab xeeb thiab muaj lawv cov khoom siv thiab ntau npaum li cas.Cov qauv no txhawm rau txo qhov kev pheej hmoo ntawm microbial, feem ntau, thiab pyrogen paug.Txoj cai no, tseem hu ua cov kev coj ua zoo tam sim no (cGMP), suav nrog cov txheej txheem tsim khoom, kev tswj kom zoo, ntim khoom, cov neeg ua haujlwm, thiab GMP cov chaw.
Hauv kev tsim cov tshuaj tsis muaj menyuam yaus thiab cov cuab yeej siv kho mob, feem ntau tsis tas yuav muaj chav huv huv siab, thaum tsim cov tshuaj tsis muaj menyuam, xws li cov tshuaj molecular thiab cov tshuaj hluavtaws, muaj inevitably xav tau cov chav huv huv siab. - GMP huv chav.Peb tuaj yeem txheeb xyuas ib puag ncig rau kev tsim cov tshuaj tsis muaj menyuam thiab cov khoom siv roj ntsha raws li GMP cov huab cua huv thiab kev faib tawm.
Raws li cov kev cai ntawm GMP cov cai, kev tsim cov tshuaj tsis muaj menyuam lossis cov khoom siv roj ntsha feem ntau muab faib ua plaub theem: A, B, C, thiab D.
Cov koom haum tswj hwm tam sim no suav nrog: ISO, USP 800, thiab US Federal Standard 209E (yav tas los, tseem siv).Txoj Cai Tshuaj Zoo thiab Kev Nyab Xeeb (DQSA) tau tsim tawm thaum lub Kaum Ib Hlis 2013 los hais txog kev tuag txog tshuaj yeeb thiab cov xwm txheej tsis zoo.Tsoom Fwv Teb Chaws Zaub Mov, Tshuaj, thiab Cosmetic Act (FD&C Act) tsim cov txheej txheem tshwj xeeb thiab cov cai rau tib neeg cov qauv.503A yog tsim los ntawm lub xeev lossis tseemfwv lub chaw tso cai nyob rau hauv kev saib xyuas ntawm cov neeg ua haujlwm raug tso cai (tshuaj kws kho mob / kws kho mob) 503B muaj feem xyuam nrog cov chaw tawm sab nraud thiab yuav tsum muaj kev saib xyuas ncaj qha los ntawm cov kws muag tshuaj, tsis muaj chaw muag tshuaj.Lub Hoobkas tau ntawv tso cai los ntawm Food and Drug Administration (FDA).
DERSION Modular Clean Room
1. QHOV TSEEM CEEB THIAB INSTALLATION
Qhov zoo tshaj plaws kom pom tseeb ntawm chav tsev modular yog tias lawv yooj yim thiab ceev rau nruab.Lawv tsis tas yuav tsim los ntawm kos thiab yuav tsis cuam tshuam koj txoj haujlwm nrog lub lis piam lossis ntau lub sijhawm ntawm kev tsim kho.Lawv yog tsim los ntawm prefabricated panels thiab framing, yog li lawv tuaj yeem teeb tsa tsis pub dhau hnub lossis lub lis piam.Los ntawm kev xaiv DERSION modular chav huv, koj lub koom haum tuaj yeem zam kev qeeb thiab pib siv koj chav huv yuav luag tam sim ntawd.
Dab tsi ntxiv, DERSION patent tsim ua rau nws yooj yim rau kev sib sau lossis disassemble peb cov chav huv si modular thiab pheej yig ntxiv rau lawv.Qhov no txhais tau hais tias peb cov neeg siv khoom muaj qhov yooj yim ntxiv rau, lossis rho tawm, lawv chav huv tau teeb tsa raws li qhov xav tau ntawm lawv lub koom haum hloov pauv.Vim tias peb cov chav huv huv modular tsis yog cov qauv ruaj khov, lawv raug nqi tsawg dua rau kev yuav khoom thiab nrog tus nqi saib xyuas qis dua.
2. Kev ua tau zoo
Modular cleanrooms siv HEPA thiab ULPA kiv cua lim kom tshem tawm cov teeb meem ntawm huab cua thiab khaws cov kab mob kom tsawg kawg nkaus.DERSION muaj ntau chav huv huv thiab chav huv huv uas tuaj yeem pab koj lub koom haum ua raws li ISO, FDA, lossis EU cov qauv.Ob peb lub softwall thiab rigidwall cleanrooms ua tau raws li ISO 8 rau ISO 3 los yog Qib A rau Qib D kev ntsuas huab cua huv.Peb rigidwall cleanrooms yog cov nqi qis dua rau kev ua tau raws li USP797 cov cai.
Cov txiaj ntsig ntawm cov chav huv huv modular tshaj cov chav huv huv yog ntau yam.Lawv cov nqi pheej yig, kev teeb tsa yooj yim thiab kev saib xyuas, thiab kev ua haujlwm dhau sijhawm ua rau lawv xaiv zoo rau cov tuam txhab lossis cov koom haum uas xav tau ib puag ncig huv si los ua haujlwm tam sim ntawd.Ntawm DERSION peb ntseeg hais tias nyob rau hauv qhov zoo ntawm peb cov khoom cleanroom thiab qhov yooj yim lawv muab rau peb cov neeg muas zaub.Yog xav paub ntxiv txog yuav ua li cas cov khoom no yuav pab tau koj lub koom haum ua tau raws li nws cov kev xav tau, mus saib peb softwall thiab rigidwall modular huv chav nplooj ntawv.
