Ib qhov dej - npajtshuaj ntsuam kuaj layoutNws yog ib qho tseem ceeb rau kev tswj cov tshuaj zoo, kev ua raws li GMP, thiab kev ua haujlwm txhua hnub. Cov lus qhia tshwj xeeb xav kom chav kuaj tshuaj yuav tsum muaj chaw txaus kom tau raws li qhov xav tau ntawm txhua qhov kev sim. Txawm hais tias koj tab tom tsim lub chaw kuaj tshuaj QC, chav kuaj microbiology, lossis chav kuaj tshuaj tag nrho, txhua hom kev ua haujlwm tshuaj ntsuam xyuas yuav tsum muaj qhov sib cais, tsim nyog thaj chaw - zoo dua thaj chaw uas muaj kev faib tawm ntawm lub cev: qhov chaw txais thiab chaw khaws cia rau kev kuaj xyuas; reagent thiab standard txais thiab chaw cia khoom; ntxuav qhov chaw; thaj chaw ua haujlwm tshwj xeeb; Cov cheeb tsam kev soj ntsuam dav dav; kev ua cov ntaub ntawv thiab cov chaw khaws ntaub ntawv; chaw ua haujlwm; thiab cov neeg ua haujlwm chav xws li chav xauv khoom lossis lounges. Hauv peb qhov kev paub dhau los ua haujlwm nrog lub chaw soj nstuam haum-tawm cov haujlwm, tau txais qhov zoning txoj cai los ntawm qhov pib txuag cov nqi rov ua haujlwm tseem ceeb tom qab. Yog li ntawd, nyob rau hauv tus tsim, peb feem ntau pom zoo cov nram qab no functional cheeb tsam:
Central Laboratory;
Chav ntsuas, suav nrog chav ntsuas dav dav, chav ntsuas ntsuas qhov tseeb, thiab chav sib npaug;
Chav kuaj kab mob microbiological, suav nrog tsis muaj menyuam lossis ib nrab- chav tsis muaj menyuam, chav kab lis kev cai, thiab chav npaj kev tu cev;
Cov haujlwm pabcuam xws li chav ziab khaub ncaws, chav tshuaj tua kab mob, chav reagent cia, chav iav cia, chav roj, chav tshwj xeeb roj, thiab chav soj ntsuam kuaj;
Kev tswj hwm kev ua haujlwm xws li chaw ua haujlwm soj ntsuam zoo thiab chav tsev khaws ntaub ntawv.
Tsis tas li ntawd, qhov chaw yuav tsum tau nruab nrog cov chav pabcuam xws li cua- chav cua txias, chav faib hluav taws xob, chav txee, thiab chav dej, uas tuaj yeem npaj ua ke nrog thaj chaw tswj hwm lossis teeb tsa sib cais. Yog tias chav kuaj tshuaj yog ib lub tsev nyob ib leeg, chaw ua haujlwm, hloov, faib, thiab kev soj ntsuam cov qauv tuaj yeem nyob hauv pem teb. Yog tias nws yog ib qho chaw ua haujlwm sib koom ua ke thiab kev tshuaj xyuas zoo, ntu kev tshuaj xyuas zoo yuav tsum muab tso rau saum lub chaw ua haujlwm. Cov cheeb tsam no yuav tsum tsis txhob ua qias tuaj lossis cuam tshuam rau ib leeg - ib qho tseem ceeb ntawm GMP kev txiav txim siab uas cov kws tshuaj xyuas niaj hnub tshuaj xyuas thaum kuaj xyuas.
Central Laboratory Layout rau Pharmaceutical QC
Lub chaw soj nstuam hauv nruab nrab yog qhov chaw ua haujlwm zoo rau kev ua qauv, kev npaj reagent, tsom xam titration, ntxuav cov cuab yeej, thiab sau ntawv tshaj tawm thaum muaj ntau hom kev sim tshuaj. Nws yog qhov chaw tsom xam thiab ntsuas qhov tseem ceeb, feem ntau nrog tus hneev taw loj. Txhawm rau kom yooj yim ntawm kev ua haujlwm, nws yuav tsum nyob ib sab ntawm chav ziab khaub ncaws, sib npaug chamber, thiab chav ntsuas. Los ntawm qhov kev pom zoo ntawm kev yuav khoom, qhov sib thooj no txo cov sij hawm coj mus kuaj thiab hla - kev pheej hmoo kis kab mob ntawm cov theem ua haujlwm.
Sterile Room thiab Semi-Sterile Room Design
Ib chav tsis muaj menyuam (lossis ib nrab- chav tsis muaj menyuam) yog qhov chaw ua haujlwm rau kev kuaj xyuas microbiological zoo. Cov kev xav tau ntawm microbiological zoo rau kev npaj tshuaj poob rau hauv ob pawg: kev xav kom tsis muaj menyuam thiab cov qauv kev nyiam huv. Rau kev ua kom tsis muaj menyuam - xws li kev txhaj tshuaj thiab tshuaj kho qhov muag - kev sim yuav tsum tau ua nyob rau hauv chav tsis muaj menyuam, feem ntau ua tiav los ntawm kev txhim kho lub rooj zaum huv hauv chav kawm 10,000 qhov chaw huv. Rau kev npaj uas tsis tas yuav ua kom tsis muaj menyuam tab sis yuav tsum txwv tsis pub muaj microbial colony suav (cov qauv kev nyiam huv) - xws li cov khoom siv hauv qhov ncauj, kev npaj ua kua sab hauv, thiab kev npaj sab nraud - tuaj yeem ua rau hauv ib nrab- chav tsis muaj menyuam, siv lub rooj zaum huv si hauv Chav Kawm 100,000 huv si.
Chav tsev tsis muaj menyuam (lossis ib nrab- chav tsis muaj menyuam) yog thaj chaw huv thiab yuav tsum tau tsim raws li GMP cov cai rau thaj chaw huv. Cov neeg ua haujlwm yuav tsum nkag mus rau hauv chav hnav khaub ncaws thiab tsis khoom, thiab cov khoom siv lossis cov khoom yuav tsum dhau los ntawm chav tsis muaj lossis hloov qhov rais, nrog rau kev ua kom tsis muaj menyuam ua ntej nkag. Chav tsev tsis muaj menyuam yuav tsum muaj lub qhov rais saib xyuas kom cov haujlwm tuaj yeem saib xyuas los ntawm sab nraud, ua kom cov neeg siv kev nyab xeeb. Lub tshuab cua- yuav tsum nyob ze ntawm lub tshuab cua txias kom luv cov pa xa rov qab. Kev txhawb nqa qhov chaw - xws li chav kab lis kev cai, chav npaj kev tu cev, chav ntxuav, thiab chav ua kom tsis muaj menyuam - kuj tseem yuav suav nrog hauv qhov teeb tsa.
Instrument Room Planning for Analytical Test
Chav ntsuas feem ntau suav nrog chav ntsuas qhov sib npaug, spectrum chamber, microscope chamber, thiab chav ntsuas dav dav. Qhov sib npaug chamber feem ntau yuav tsum tau teeb tsa sib cais, nrog rau chav nyob rau txhua qhov chaw uas xav tau; lwm chav tuaj yeem teeb tsa raws li cov kev xav tau tshwj xeeb. Cov chaw no yuav tsum tau muab tso rau kom deb li deb tau los ntawm qhov chaw vibration thiab qhov chaw cua sov, thaum tseem nyob ze rau lub hauv paus chaw kuaj mob. Cov hauv paus ntsiab lus tseem ceeb suav nrog: cais qhov chaw ntub thiab qhuav rau kev tswj cov dej noo; cais cov cua sov- tsim thiab txias- cov cuab yeej siv rau kev siv hluav taws xob zoo; pab pawg tsis tu ncua- cov cuab yeej ntsuas kub kom tswj tau yooj yim dua; thiab centralizing tshuav nyiaj li cas rau streamlined hnyav thiab sampling.
Siab -Tub Tsev Tsev Kho Mob (Kub qhuav thiab tshuaj tua kab mob)
Qhov siab - tsev cog khoom kub yog hais txog chav ziab khaub ncaws thiab chav ntxuav tais diav - qhov chaw rau ziab qhov cub, muffle furnaces, los yog sterilizing txee. Cov no feem ntau yuav tsum nyob deb ntawm chav reagent thiab chav freezer. Chav tsev yuav tsum tau nruab nrog qhov kub thiab txias - hnov cov pa taws ceeb toom thiab lub tshuab ua pa tawm kom ua raws li kev nyab xeeb.
Sample Observation Room Requirements
Cov chav soj ntsuam kuaj hauv tsev muaj cov khoom siv raw, cov ntaub ntawv ntim khoom, thiab cov qauv khoom tiav. Nws tuaj yeem yog chav tsev nyob ib leeg lossis ib cheeb tsam uas tau muab faib. Qhov cua thiab noo noo- pov thawj yuav tsum tau ua tib zoo xav hauv kev tsim. Yog xav tau kev cia txias, yuav tsum muaj qhov ntxoov ntxoo lossis qhov kub thiab txias -chaw tswj yuav tsum tau muab. Yog hais tias nyob rau hauv pem teb thib ob los yog siab dua, cov txheej txheem load xam yuav tsum tau xyuas kom muaj kev ruaj ntseg.
Cov lus nug nquag
Dab tsi yog qhov kev teeb tsa zoo tshaj plaws rau chav kuaj tshuaj?
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Lub chaw kuaj tshuaj zoo tshaj plaws hauv chav kuaj kev sib cais ua haujlwm rau hauv ib cheeb tsam sib txawv - chav kuaj nruab nrab, chav ntsuas ntsuas, chav kuaj kab mob microbiological, cov qauv cia, thiab chaw ua haujlwm tswj hwm - txhawm rau tiv thaiv kev sib kis -kev sib kis thiab txhim kho kev ua haujlwm zoo.
Dab tsi yog qhov txawv ntawm chav tsis muaj menyuam thiab ib nrab- chav tsis muaj menyuam?
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Chav tsev tsis muaj menyuam siv Chav Kawm 10,000 qhov chaw huv huv rau cov khoom uas xav tau kom tsis muaj menyuam tag nrho (xws li kev txhaj tshuaj), thaum ib nrab- chav tsis muaj menyuam siv Chav Kawm 100,000 ib puag ncig rau cov khoom uas muaj cov qauv kev nyiam huv es tsis yog kom tsis muaj menyuam (piv txwv li, cov khoom hauv qhov ncauj).
Lub chav ntsuas yuav tsum nyob qhov twg hauv chav kuaj tshuaj?
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Chav ntsuas yuav tsum nyob ze rau lub hauv paus chaw kuaj mob tab sis nyob deb ntawm kev co thiab cua sov qhov chaw, nrog rau qhov chaw ntub / qhuav thiab kub / txias sib cais kom raug thiab lub zog efficiency.
Vim li cas GMP huv cheeb tsam tsim tsim tseem ceeb hauv chav tsis muaj menyuam?
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GMP huv cheeb tsam tsim tiv thaiv kev kis kab mob los ntawm kev tswj cov neeg ua haujlwm thiab cov khoom ntws, cov chav tsis muaj kab mob, cov txheej txheem kom tsis muaj menyuam, thiab kev soj ntsuam qhov rais - txhua qhov tseem ceeb rau kev soj ntsuam kev tswj hwm.
Leej twg feem ntau xav tau lub chaw kuaj tshuaj kuaj kev tsim qauv kev pabcuam?
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Cov tuam txhab tshuaj, thib peb- cov chaw kuaj sim thib peb, biotech QC departments, thiab cov tsev muag tshuaj hauv tsev kho mob feem ntau xav tau cov kws tshuaj ntsuam xyuas cov qauv tsim qauv thiab haum- tawm cov kev pabcuam.
Xaiv qhov layout zoo rau koj qhov chaw
Thaum xaiv qhov chaw kuaj tshuaj, cov neeg yuav khoom yuav tsum xav txog cov qauv dhau los, kuaj pawg (chemical vs. microbiological), kev xav tau nthuav dav yav tom ntej, thiab hauv zos GMP / cov cai tswj hwm. Hom kev kuaj sim no feem ntau siv thoob plaws cov chaw tsim tshuaj, thib peb- cov chaw kuaj sim, cov tsev muag tshuaj hauv tsev kho mob, thiab chaw tswj xyuas biotech zoo. Rau cov chaw tuav ob qho tib si kev kuaj tsis muaj menyuam thiab kev tshuaj ntsuam xyuas tshuaj lom neeg, cov qauv tsim qauv uas muaj kev sib cais ntawm lub cev huv si thiab thaj chaw ua haujlwm feem ntau yog tus nqi tshaj plaws - siv tau ntev - lub sijhawm xaiv.
Guangzhou BOKA Laboratory System Technology Co., Ltd. yog lub tuam txhab lag luam tshwj xeeb hauv kev tsim, kev npaj, kev tsim kho, thiab haum- tawm ntawm lub chaw soj nstuam hauv Suav teb. Peb cov khoom lag luam suav nrogLaboratory cov rooj zaum, fume hoods, nruab nrab chaw nres tsheb, sab rooj,gas cylinder txee, qab nthab platforms, kuaj rooj tog, thiab kuaj tshuab engineering xws li cua tshuab, pneumatic systems, thiab purification systems.
Xav tau kev pab npaj koj lub chaw kuaj tshuaj lossis tshuaj kuaj tshuaj? Tiv tauj pebrau qhov kev daws teeb meem, lossis thov ib daim ntawv tsocai hnub no kom tau txais cov lus qhia kws tshaj lij raws li koj qhov chaw xav tau.