Cov kev xaiv aseptic rau kev ntim tshuaj

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Plaub txoj kev xaiv ntim khoom aseptic uas yuav tsum xav txog. Niaj hnub no, ntau yam thev naus laus zis tsom mus rau cov chaw tsim tshuaj thiab biopharmaceutical yog: (1) chav huv chav kawm puv 100, (2) cov khoom cais, (3) cov kab ke txwv tsis pub nkag mus (RABS), (4) cov kab ke siv ib zaug xwb. Qhov twg zoo tshaj plaws rau koj?​1. Chav Kawm 100 Chav Huv: Cov thev naus laus zis chav huv tau tsim thawj zaug hauv xyoo 1960 rau kev siv hauv kev lag luam aerospace thiab electronics kom tsis txhob muaj kev sib kis ntawm cov khoom me me.

Cov kab mob yog cov khoom me me, thiab kev lag luam tshuaj sai sai no tau paub tias qhov kev txawj no tuaj yeem lav qhov cua huv. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Chav kawm 100 chav huv yog qhov feem ntau hauv kev tsim khoom aseptic (ISO 5 thiab A/B Chav kawm kev ua tau zoo sib npaug), siv lub lim dej ua haujlwm siab (HEPA) kom tshem tawm txhua yam khoom me me thiab cov kab mob. Cov cua laminar lossis unidirectional loj heev txo qhov kev hloov pauv ntawm cov khoom me me los ntawm ib qho chaw mus rau lwm qhov.

Xyoo 1970, kev sau cov pa phem aseptic tau ua tiav rau ntawm cov tshuab tshwj xeeb hauv qab HEPA lim vaj huam sib luag. Cov khoom siv tshuab saum lub thawv yog qhov ua rau muaj kuab paug, thiab dhau sijhawm lawv raug tsiv mus deb li deb tau hauv qab theem ua haujlwm. Txhawm rau kom cov huab cua lim tau zoo dua rau ntawm lub tshuab, cov yas npog qhov rais kuj tau ntxiv.

Daim ntaub qhov rai kuj ceeb toom tus neeg teb xov tooj kom tsis txhob kov lub tshuab lossis cov khoom. Cov chaw tsim khoom tig mus rau 100% HEPA qab nthab los tswj tag nrho cov chav mus rau chav kawm 100. Qhov no txhim kho kev tswj hwm, tab sis ua rau cov peev txheej thiab cov nqi khiav lag luam nce ntxiv, tshwj xeeb tshaj yog lub kaw lus tswj huab cua.

2. Cov Opto-Isolators: Xyoo 80s thiab 90s, cov khoom cais tau tsim los txhim kho qhov kev sib cais ntawm tib neeg thiab cov khoom thaum txo cov nqi. Lub isolator yog piav qhia tias yog chav huv hauv lub thawv. Tag nrho cov txheej txheem raug kaw hauv lub txee kaw, muaj cua lim los ntawm HEPA lim dej.

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. Duab los ntawm chase-logeman anchaselogeman-isolator-web.jpg rau lub kaw lus cais (tsis tau pom lub lim dej HEPA sab saum toj). Duab los ntawm chase-logeman anchase-logman-isolator-inside-web.jpg pub rau sab hauv ntawm lub tshuab cais uas qhia txog qhov chaw ntsaws hnab looj tes.

Tom qab ua tiav ib qho kev tsim khoom, lub isolator yuav raug qhib, ntxuav, thiab npaj txhij rau kev ua haujlwm tom ntej. Thaum rov kaw dua, lub isolator yuav muaj cov tshuaj tua kab mob, feem ntau yog vapor hydrogen peroxide (VHP), los tua kab mob txhua yam sab hauv. Tsis zoo li kev siv tshuaj tsuag lossis tshuaj txhuam tua kab mob ib txwm muaj, VHP nkag mus rau hauv qhov me me ntawm cov qhov tawg.

Thaum twg ua kom huv lawm, txhua qhov kev teeb tsa zaum kawg yuav ua tiav los ntawm qhov chaw ntsaws hnab looj tes. Hauv kev xav, nws yuav tsum ua tau kom siv lub tshuab cais tawm hauv qhov chaw tsis muaj kev tswj hwm, xws li lub tsev rau khoom, los ntawm tus neeg teb xov tooj hnav lub tsho tiv no kuaj mob. Hauv kev xav nws yog.

Qhov tseeb, ntau lub tuam txhab tau teeb tsa cov khoom cais tawm hauv chav kawm 100 chav huv. Qhov no muab ib txheej ntxiv ntawm kev ntxuav, tab sis qhov tseem ceeb yog tsim kom muaj cov khoom cais tawm kom tsis txhob muaj. 3. Lub Tshuab Txwv Tsis Pub Nkag Mus (RABS): RABS yog kev sib haum xeeb ntawm lub kaw lus qhib thiab lub kaw lus cais tawm, RABS muaj cov txheej txheem hauv lub thawv nruj.

Cov kev cuam tshuam ua haujlwm nkag mus los ntawm qhov chaw ntsaws hnab looj tes. Syntegon Pharma technologies Syntegon-Pharma- products_filling and Closing_FXS_3100-web.jpg Lub RABS qhib nthuav dav mus rau lub qab nthab, vam khom rau chav tsev lub tshuab tswj cua thiab lim dej. Lub RABS kaw muaj nws tus kheej lub tshuab tswj cua thiab lim dej.

RABS muaj qhov zoo dua li cov khoom cais vim nws yooj yim. Qhov no yog qhov tseeb tshwj xeeb yog tias lawv tuaj yeem nyob hauv cov chav huv uas twb muaj lawm thiab tom qab ntawd txo cov nqi tsim kho. Qhov xav tau los tsim chav huv pab them qee qhov kev txuag nyiaj piv rau cov khoom cais.

4. Cov tshuab siv ib zaug xwb: Cov tshuab siv ib zaug xwb tab tom nrov zuj zus hauv cov ntawv thov aseptic. Cov tshuab no muaj lub hnab yas los hloov lub thoob hlau ib txwm muaj. Lub hnab no tau ntim ua ntej nrog txhua yam lim dej, raj, qhov chaw, cov taub ntim khoom, thiab lwm yam khoom siv uas xav tau.

Nws tau kaw rau hauv lub hnab tiv thaiv thiab sterilized. Lub cuab yeej tsim khoom ua tiav lub kaw lus sterile thiab npaj txhij rau kev ua haujlwm. Duab los ntawm sartorioussaritus Img_OctoPlus-_4154-web.jpg Qee cov chaw tsim khoom muab cov txheej txheem siv ib zaug xwb, suav nrog Sartorius (nws PreVAS - pre-validated, pre-assembled, pre-sterilized - Project Syntegon), Pall Corporation (nws Biotech ib zaug Sexual Use System) thiab lwm yam.

Raws li Marion Monstier, Sartorius Freeze-Thaw Products Manager, cov txiaj ntsig ntawm cov tshuab siv ib zaug xwb suav nrog: • Cov tshuab kaw txo cov khoom xa thiab tuav, txo qhov kev pheej hmoo ntawm kev ua qias tuaj. • Hloov cov tshuab siv ib zaug xwb ntawm cov khoom khiav tawm tshem tawm qhov muaj peev xwm ntawm kev ua qias tuaj vim tsis tiav lossis tsis raug ntxuav. • Piv rau cov tshuab siv tau dua, cov tshuab hloov pauv no txo ​​​​​​lub sijhawm hloov pauv thiab teeb tsa.

• Lawv tshem tawm cov kev cai pov thawj tu. • Lawv ntws dej zoo dua, yog li ua rau cov khoom rov qab zoo dua.

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