Smart Weigh tau cog lus los pab cov neeg siv khoom nce kev tsim khoom ntawm tus nqi txo.
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Smart Weigh tau cog lus los pab cov neeg siv khoom nce kev tsim khoom ntawm tus nqi txo.
Author: Smartweigh-Multihead Weighter
Plaub txoj kev ntim aseptic yuav tsum xav txog. Niaj hnub no, ntau yam thev naus laus zis tsom rau cov tuam txhab tshuaj thiab biopharmaceutical yog: (1) chav kawm tag nrho 100 chav huv, (2) kev cais tawm, (3) txwv tsis pub nkag mus rau cov kab ke (RABS), (4) siv ib zaug. Qhov twg yog qhov zoo tshaj rau koj? 1. Chav Kawm 100 Cleanroom: Cleanroom thev naus laus zis yog thawj zaug tsim nyob rau xyoo 1960 los siv rau hauv kev lag luam aerospace thiab hluav taws xob kom tsis txhob muaj cov kab mob me me.
Cov kab mob yog cov kab mob, thiab kev lag luam tshuaj sai sai pom tau hais tias qhov kev txawj no tuaj yeem lav tsis muaj cua. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Class 100 cleanrooms are the most common in aseptic manufacturing (ISO 5 and A/B Class performance) yog sib npaug), siv lub tshuab ua kom muaj huab cua zoo (HEPA) lim kom tshem tawm tag nrho cov khoom thiab cov kab mob. Loj ntim laminar lossis unidirectional cua ntws txo qhov kev hloov ntawm cov khoom ntawm ib qho chaw mus rau lwm qhov.
Hauv xyoo 1970, aseptic filling tau ua tiav ntawm cov tshuab spec hauv qab HEPA lim panels. Cov khoom siv lub tshuab saum lub thawv yog qhov muaj peev xwm ntawm kev sib kis, thiab dhau sijhawm lawv tau txav mus kom deb li deb tau hauv qab qib ua haujlwm. Txhawm rau kom mloog zoo dua cov cua lim ntawm lub tshuab, cov ntaub ntawv yas qhov rais kuj tau ntxiv.
Daim ntaub qhov rais kuj tseem ceeb rau tus neeg teb xov tooj kom tsis txhob kov lub tshuab lossis khoom. Cov neeg tsim khoom tau tig mus rau 100% HEPA ceilings los tswj tag nrho cov chav mus rau chav kawm 100. Qhov no txhim kho kev tswj, tab sis nce peev thiab cov nqi khiav lag luam, tshwj xeeb tshaj yog cov huab cua tuav.
2. Opto-Isolators: Nyob rau hauv lub 80s thiab 90s, kev cais tawm tau tsim los txhim kho kev thaiv ntawm tib neeg thiab cov khoom thaum txo cov nqi. Lub tshuab cais tawm tau piav qhia tias yog chav huv huv hauv ib lub thawv. Tag nrho cov txheej txheem raug kaw nyob rau hauv ib lub thawv kaw, pressurized nrog cua lim los ntawm HEPA lim.
Thaum lub sijhawm ua haujlwm, tsis muaj tus neeg teb xov tooj raug tso cai nkag mus tsuas yog los ntawm lub hnab looj tes interface. Image courtesy of chase-logeman anchaselogeman-isolator-web.jpg rau kev cais tawm (sab saum toj HEPA lim tsis pom). Duab courtesy ntawm chase-logeman anchase-logman-isolator-inside-web.jpg pub lub cais sab hauv uas qhia lub hnab looj tes chaw nres nkoj.
Tom qab kev khiav haujlwm ntau lawm, lub tshuab cais tawm yuav qhib, ntxuav, thiab npaj rau kev khiav haujlwm tom ntej. Thaum rov ua dua, lub tshuab cais tawm tau ntim nrog cov tshuaj tua kab mob, feem ntau yog vapor hydrogen peroxide (VHP), kom tsis muaj menyuam txhua yam hauv. Tsis zoo li cov tshuaj tsuag tshuaj los yog tshuaj tua kab mob, VHP nkag mus rau hauv qhov chaw me me.
Thaum ua kom tsis muaj menyuam, txhua qhov kev teeb tsa zaum kawg yog ua tiav los ntawm qhov chaw nres nkoj hnab looj tes. Hauv txoj kev xav, nws yuav tsum muaj peev xwm khiav tau lub tshuab cais tawm hauv qhov chaw tsis muaj kev tswj hwm, xws li lub tsev khaws khoom, los ntawm tus neeg teb xov tooj hnav lub tsho (lab). Theoretically nws yog.
Qhov tseeb, ntau lub tuam txhab tau teeb tsa kev cais tawm hauv chav kawm 100 chav huv. Qhov no muab ib txheej ntxiv ntawm kev tu, tab sis tus nqi yog tsim kom muaj kev sib cais kom tsis txhob muaj. 3. Kev txwv tsis pub nkag mus rau qhov system (RABS): RABS yog ib qho kev cuam tshuam ntawm lub kaw lus qhib thiab ib qho kev sib cais, RABS muaj cov txheej txheem nyob rau hauv ib lub kaw ntom nti.
Cov kev cuam tshuam kev ua haujlwm nkag los ntawm qhov chaw nres nkoj hnab looj tes. Syntegon Pharma technologies Syntegon-Pharma- products_filling and Closing_FXS_3100-web.jpg Qhov qhib RABS txuas mus rau lub qab nthab, cia siab rau chav tsev huab cua tuav thiab pom qhov system. Kaw RABS muaj nws tus kheej huab cua tuav thiab pom qhov system.
RABS muaj cov txiaj ntsig zoo ntawm cov khoom sib cais vim nws qhov yooj yim. Qhov no yog qhov tseeb tshwj xeeb yog tias lawv tuaj yeem nyob hauv chav huv huv uas twb muaj lawm thiab tom qab ntawd txo cov nqi tsim kho. Qhov xav tau los tsim kom muaj chav huv huv offsets qee qhov kev txuag nqi piv rau cov neeg sib cais.
4. Cov khoom siv pov tseg: Cov khoom siv pov tseg pov tseg tau dhau los ua neeg nyiam hauv kev siv aseptic. Cov tshuab no muaj lub hnab yas los hloov cov tsoos hlau tuaj yeem. Lub hnab tuaj ntim ua ntej nrog txhua yam lim, tubing, chaw nres nkoj, filling nozzles, thiab lwm yam khoom siv uas xav tau.
Nws yog kaw rau hauv ib lub hnab tiv thaiv thiab sterilized. Cov cuab yeej tsim khoom ua kom tiav qhov system tsis muaj menyuam thiab npaj rau kev ua haujlwm. Image courtesy of sartorioussaritus Img_OctoPlus-_4154-web.jpg Qee lub tuam txhab muab kev cai siv ib zaug, suav nrog Sartorius (nws PreVAS - pre-validated, pre-assembled, pre-sterilized - Project Syntegon), Pall Corporation (nws Biotech ib zaug siv deev System) thiab lwm yam.
Raws li Marion Monstier, Sartorius Freeze-Thaw Products Manager, qhov zoo ntawm kev siv ib leeg muaj xws li: • Cov kaw lus kaw txo cov khoom xa mus thiab tuav, txo qhov kev pheej hmoo ntawm kev sib kis. • Hloov cov tshuab siv ib zaug ntawm cov khoom lag luam tshem tawm qhov muaj peev xwm ntawm kev sib kis kab mob vim kev tu tsis tiav lossis tsis tsim nyog. • Muab piv rau cov tshuab uas siv tau rov qab, cov txheej txheem no txo qis kev hloov pauv thiab teeb tsa lub sijhawm.
• Lawv tshem tawm cov kev cai huv huv. • Lawv ntws zoo dua, yog li ua kom cov khoom rov qab los.
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