1. Muaj feem cuam tshuam txog kev tsim tshuaj yeeb los ntawm cov neeg ua haujlwm
Raws li peb txhua tus paub, hauv kev tsim cov tshuaj tsis muaj menyuam hauv txhua lub caij, tib neeg yog qhov muaj kuab paug loj tshaj plaws. Raws li tib neeg yog qhov tseem ceeb tshaj plaws, thiab cov cuab yeej siv tshuaj tua kab mob thiab tshuaj tua kab mob tsis tuaj yeem siv. Yog li ntawd, kev tswj hwm ntawm tib neeg kev sib kis tau dhau los ua qhov teeb meem tseem ceeb rau kev lag luam tshuaj tsis muaj menyuam. Table 1 teev qee cov ntaub ntawv hais txog qhov muaj feem cuam tshuam los ntawm tib neeg rau kev tsim tshuaj.
Rooj 1 Cov ntaub ntawvntawm human related microorganisms | |
Lub cev | Cov ntaub ntawv ntawm microorganisms |
Plaub hau | 15million / cm² |
Qhov ncauj | 1-100million/ml |
Nose-throat (secretions) | 1million-10million/ml |
Cov tawv nqaij npog (dub) | 500-1000/cm² |
Thaj chaw ntawm hws qog (underarm) | 24million / cm² |
Tes | 100-6000/cm² |
Ntiv tes ntiv tes | 20-100/cm² |
Taw | 100-1000/cm² |
Cov ntsiab lus gastric | 1000-10000/g |
Cov kab mob me me | 1000-1million/g |
Cov hnyuv loj | 100million-10billion/g |
Rectum cov ntsiab lus | 100billion/g (=10 feem pua -20 feem pua ntawm excrement) |
2. Qhov yuav tsum tau muaj ntawm GMP Rau Kev Ua Haujlwm Rau Cov Neeg Ua Haujlwm hauv Aseptic Ntau Lawm Clean Area
Hais txog cov khoom tsis muaj menyuam, muaj ob txoj kev tsim khoom rau cov khoom tsis muaj menyuam, ib qho yog cov txheej txheem kom tsis muaj menyuam thiab lwm qhov yog cov txheej txheem aseptic. Txawm tias cov tuam txhab lag luam siv cov txheej txheem ua kom tsis muaj menyuam, lossis siv cov txheej txheem aseptic los tsim cov tshuaj, tib neeg yog qhov muaj kuab paug loj tshaj plaws ntawm cov tshuaj. Yog li ntawd, rau cov neeg ua haujlwm hnav khaub ncaws hloov cov txheej txheem, kuj yog qhov tseem ceeb ntawm GMP hauv ntau lub tebchaws.
Los ntawm cov qauv GMP ntawm ntau lub teb chaws ntawm kev hloov khaub ncaws rau cov neeg koom nrog hauv kev tsim tshuaj aseptic, cov koom haum tswj hwm tshuaj ntawm ntau lub teb chaws, yuav ua li cas kom tsis txhob muaj kuab paug rau cov neeg ua haujlwm, yuav ua li cas rau kev tshawb fawb txog kev hloov cov txheej txheem, yuav ua li cas txheeb xyuas qhov ua tau zoo ntawm cov txheej txheem, yuav ua li cas. los saib xyuas lub xeev tswj ntawm cov txheej txheem hloov, muaj kev txhawj xeeb heev.
3. Cov ntsiab lus tseem ceeb hauv kev tsim cov txheej txheem hloov pauv hauv thaj chaw huv ntawm aseptic ntau lawm
3.1 Kev xaiv cov khoom siv thiab kev ntsuam xyuas zoo ntawm cov khaub ncaws huv
Vim tib neeg tsis tuaj yeem tua kab mob thiab ua kom tsis muaj menyuam zoo li cov khoom siv thiab cov khoom siv. Yog li ntawd, hnav khaub ncaws huv si uas tsim nyog tau dhau los ua lub ntsiab lus tseem ceeb ntawm kev tswj cov pa phem coj los ntawm tib neeg. Rau cov khoom siv ntawm cov khaub ncaws huv si siv los ntawm cov chaw lag luam tshuaj, GMP (kho kho dua hauv xyoo 2010) xav kom cov khaub ncaws yuav tsum tau ua kom tsis muaj menyuam ib qho khaub ncaws, tsis muaj cov fibers lossis cov khoom, thiab tuaj yeem khaws cov khoom tawm ntawm lub cev.
Cov ntaub siv hauv cov khaub ncaws ua haujlwm feem ntau yog ua los ntawm cov ntaub ntawv rov ua dua thiab cov ntaub ntawv pov tseg. Reusable textile fabrics yog tsim los ntawm fibers woven los ntawm spinning. Cov ntaub ntawv siv ib leeg feem ntau yog ua los ntawm nonwovens. Kev ua cov nonwovens yog ib-kauj ruam txheej txheem uas tsis tas yuav spinning thiab weaving.
Txij li thaum xyoo 1970s, cov tuam txhab tsim khoom tau siv cov kev kho mob triple-resistant rau cov ntaub nto kom txo tau cov ntshav thiab kua dej. Xav txog tias kev ntxhua khaub ncaws yuav maj mam rhuav tshem cov txheej txheem kev kho mob ntawm qhov chaw ntawm cov ntaub, cov txheej txheem ntxuav thiab zaus tau teev tseg los xyuas kom meej tias qhov kev ua tau zoo ntawm cov ntaub ua tau raws li qhov yuav tsum tau ua tom qab ntxuav txhua.
Hauv Tuam Tshoj txoj kev lag luam tshuaj, feem ntau ntawm cov khaub ncaws huv si thaum ntxov yog polyamide filament. Tam sim no polyester filaments yog siv nyob rau hauv tsev thiab txawv teb chaws. Nrog rau kev txhim kho txuas ntxiv ntawm kev lag luam cov kev xav tau rau kev ua haujlwm zoo ntawm cov khaub ncaws huv si, cov khaub ncaws huv huv tau tshwm sim ntawm lub sijhawm keeb kwm, uas yuav tsum muaj kev sib txhuam voltage tsawg dua 300V, thiab muaj kev ntxuav zoo. Tam sim no, kev tswj kom zoo ntawm cov khaub ncaws huv hauv kev lag luam tshuaj hauv Suav teb feem ntau yog raws li YYT0506.1-8 los tswj cov khoom zoo.
3.2 Tsim cov txheej txheem hloov
Tam sim no, Suav aseptic kws tshuaj lag luam muaj cov qauv tsim sib txawv rau cov neeg ua haujlwm hauv cheeb tsam A / B nkag mus. Txawm li cas los xij, cov hauv paus ntsiab lus hauv qab no yuav tsum ua raws li:
◆ Qhov chaw thiab qhov chaw ntawm qhov hloov pauv tuaj yeem ua tau raws li qhov siab tshaj plaws ntawm cov neeg los ntawm tib lub sijhawm, tsis tuaj yeem nqaim dhau.
◆ Lub tsho tiv no tus kheej yuav tsum tsis txhob muab coj mus rau hauv chav xauv khoom uas ua rau theem B lossis C huv. Ib chav hnav khaub ncaws dav thiab nyab xeeb yuav tsum tau teem rau ntawm qhov nkag ntawm cov neeg ua haujlwm thiab nruab nrog lub xauv.
◆ Txhua tus neeg ua haujlwm yuav tsum hloov nws cov khaub ncaws ua haujlwm tsis muaj menyuam txhua lub sijhawm thaum nws nkag mus rau qhov chaw huv huv A/B; los yog hloov nws tsawg kawg ib zaug. Tab sis kev soj ntsuam cov txiaj ntsig yuav tsum tau siv los ua kom pom qhov ua tau ntawm txoj kev no. Qhov no yuav tsum muaj aseptic rhiav cov khoom ntxhua khaub ncaws, tag nrho cov khaub ncaws qhov chaw thiab cov khoom siv huv huv kom tsis muaj menyuam tuaj yeem ua tau raws li qhov yuav tsum tau ua ntawm cov khoom siv ntau tshaj plaws. Tsis tas li ntawd, yog tias cov chaw lag luam kws tshuaj muab cov khaub ncaws huv aseptic rau txhua qhov kev hloov pauv ib zaug, thiab tuaj yeem rov qab siv tau hauv kev hloov pauv, nws yog ib qho tsim nyog yuav tsum teeb tsa lub hanger hauv cov neeg ua haujlwm tawm channel, kom ntseeg tau tias cov khaub ncaws huv si tau khaws cia ib ntus hauv txoj kev. ntawm kev ncua tom qab cov neeg ua haujlwm tawm, kom tsis txhob muaj kev sib kis ntawm qhov chaw ntawm cov khaub ncaws huv hauv cov txheej txheem ntawm stripping.
◆ Cov hnab looj tes yuav tsum tau tshuaj tua kab mob ntau zaus thaum ua haujlwm, thiab yuav tsum tau hloov lub qhov ncauj qhov ntswg thiab hnab looj tes thaum tsim nyog. Raws li nws tsis yog qhov ua tau zoo los hloov lub qhov ncauj qhov ntswg hauv chav kawm B, nws raug nquahu kom muab lub npog ntsej muag thiab hnab looj tes hloov chaw nyob hauv chav hloov pauv kawg ntawm kev hloov pauv nkag. Lub rooj zaum stainless hlau tuaj yeem siv los hloov.
◆ Cov chav hloov pauv yuav tsum tau tsim raws li qhov ntsuas cua ntsuas cua kom cais cov theem sib txawv ntawm kev hloov khaub ncaws thiab tsis txhob muaj cov kab mob microbial thiab cov kab mob sib kis kom deb li deb tau.
◆ Yuav tsum muaj qhov cua txaus hauv chav hnav khaub ncaws. Cov qib zoo li qub ntawm sab nraub qaum ntawm chav hnav khaub ncaws yuav tsum zoo ib yam li ntawm thaj chaw huv huv. Rau qhov kev xav tau no, feem ntau yuav tsum tau ua kom qhov kev huv huv ntawm chav hloov khaub ncaws tsis muaj menyuam yuav tsum ncav cuag qib B.
◆ Yog tias tsim nyog, chav hloov pauv nkag mus thiab tawm hauv thaj chaw huv tuaj yeem teeb tsa nyias. Yog tias lub tuam txhab kws kho mob tau cais cov kev nkag mus thiab tawm ntawm kev hnav khaub ncaws tsis muaj menyuam, kev faib cov channel thiab cov txheej txheem rov qab los tom qab siv cov khaub ncaws huv yuav tsum tau txiav txim siab. Hauv qhov no, cov khaub ncaws huv huv nkag mus rau thaj tsam A / B tsuas yog siv tau ib zaug xwb.
◆ Feem ntau, cov chaw ntxhua khaub ncaws tsuas yog ntsia tau rau hauv thawj theem ntawm kev hloov khaub ncaws.
◆ Nws raug nquahu kom hloov cov channel raug cais raws li poj niam txiv neej. Txawm hais tias qee lub tuam txhab yuav muaj tib yam poj niam txiv neej ntawm cov neeg ua haujlwm nkag mus rau thaj tsam A / B, nws yog qhov zoo dua los cais lawv los ntawm poj niam txiv neej vim tias muaj peev xwm muaj cov poj niam txiv neej sib txawv hauv cov neeg soj ntsuam sab nraud, cov neeg saib xyuas ib ntus thiab cov neeg ua pov thawj.
Raws li cov hauv paus ntsiab lus saum toj no, nws tau hais tias kev lag luam kws tshuaj yuav tsum tsim cov kev hloov pauv rau cov neeg ua haujlwm nkag mus rau thaj tsam A / B raws li daim ntawv qhia nram qab no.
3.3 Kev cob qhia neeg ua haujlwm thiab kev ntsuam xyuas
Vim yog qhov nyuaj ntawm cov neeg ua haujlwm hnav khaub ncaws hloov cov txheej txheem rau nkag mus rau theem A / B cheeb tsam ntawm aseptic kws tshuaj nroj tsuag, cov neeg ua haujlwm hnav khaub ncaws hloov pauv kev cob qhia kuj yog lub hauv paus rau kev ua kom muaj kev pov thawj tiav ntawm cov txheej txheem. Cov tuam txhab lag luam yuav tsum tsim cov txheej txheem kev hloov pauv tshwj xeeb, nthuav dav thiab qhia meej thiab qhia cov neeg ua haujlwm cuam tshuam (nrog rau cov neeg ua haujlwm aseptic, QA cov neeg saib xyuas, QC cov neeg ua haujlwm kuaj, cov neeg ua haujlwm tu thiab cov neeg saib xyuas cuam tshuam). Txhawm rau kom ua tiav cov txiaj ntsig kev cob qhia zoo, cov tuam txhab tshuaj tuaj yeem siv ntau yam kev cob qhia hloov pauv xws li kev ua qauv qhia tib neeg, cov tub ntxhais kawm xyaum, video hloov khaub ncaws, kev kawm hauv nruab nrab thiab lwm yam. Hauv luv luv, kev cob qhia hnav khaub ncaws zoo thiab ua tau zoo yog lub hauv paus rau kev ua tiav cov txheej txheem kev hnav khaub ncaws.