Cov kua tank siab- cov lim dej ua tau zoo tau dhau los ua qhov kev xaiv tseem ceeb rau qib siab - qib huv huv (xws li qib A / B) hauv kev lag luam tshuaj vim lawv qhov kev sib khi zoo heev. Raws li GMP kev ua raws cai, lub hauv paus tseem ceeb ntawm nws cov kev saib xyuas kev lag luam yog ua kom muaj kev ncaj ncees ntawm nws "kua tank foob" ib txwm nyob hauv online los ntawm kev saib xyuas meej thiab cov qauv kev coj ua, tshem tawm txhua yam kev pheej hmoo ntawm kev xau.
Raws li cov kev cai tshwj xeeb ntawm kev lag luam kws tshuaj, nws cov txheej txheem kev saib xyuas tuaj yeem muab faib ua plaub qhov txuas tseem ceeb: kev tshuaj xyuas txhua hnub, kev ntsuas kev tshaj lij, kev hloov pauv tus qauv, thiab kev ua haujlwm txawv txav.
1, Kev Kho Kom Zoo rau Kev Ua Haujlwm Zoo Ua Kua Tank Lim hauv Kev Lag Luam Pharmaceutical
1. Kev tshuaj xyuas thiab saib xyuas txhua hnub
- Kev saib xyuas qhov sib txawv: Txhua hnub lossis tiag - lub sijhawm saib xyuas ntawm cov lim dej sib txawv yog qhov qhia ncaj qha los txiav txim seb nws puas yog txhaws
- Kev tshuaj xyuas qhov tshwm sim: Txhua hli xyuas seb cov kua tank sealant (feem ntau hu ua "jelly kua nplaum") puas txaus, seb nws puas tau deteriorated, tawg los yog dented, thiab tib lub sij hawm xyuas seb tus ncej yog deformed los yog corroded.
- Hloov chaw pib: Thaum qhov kev tiv thaiv siab tshaj 1.5-2 npaug ntawm qhov kev tawm tsam thawj zaug (los yog ncav cuag tus nqi xws li 450Pa), kev hloov pauv yuav tsum tau npaj.
- GMP kev sib raug zoo: Cov ntaub ntawv sib txawv siab yog ib qho tseem ceeb ntawm kev saib xyuas ib puag ncig ntawm chav huv thiab yuav tsum tau sau tseg thiab khaws cia.
2. Kev xeem thiab kev kuaj xyuas
- Kev ntsuam xyuas kev ncaj ncees (PAO kev kuaj pom pom): Qhov no yog qhov kev sim tseem ceeb uas yuav tsum tau ua hauv kev lag luam tshuaj, tshwj xeeb tshaj yog tom qab kev teeb tsa cov lim dej tshiab thiab thaum lub sijhawm rov ua haujlwm tsis tu ncua.
- Txoj kev kuaj pom cov dej ntws: Siv lub aerosol photometer kom tso pa tawm (PAO) ntws ntws ntawm cov lim dej thiab tshuaj xyuas cov dej ntws. Kev txheeb xyuas yuav tsum npog cov khoom siv lim dej, qhov chaw sib khi ntawm cov khoom siv lim thiab cov thav duab, thiab thaj chaw tseem ceeb tshaj plaws - qhov chaw sib khi ntawm cov kua tank thav duab thiab cov hniav ntug.
- Cov txheej txheem txheej txheem: Upstream concentration ntawm 20-80 μ g / L, scanning ceev ntawm 3-5cm / s, piv txwv lub taub hau deb ntawm cov khoom lim ntawm 2-4cm.
- Cov qauv siv tau: Nws yog feem ntau yuav tsum tau ua kom pom kev ua haujlwm zoo dua lossis sib npaug rau 99.99% (H13 qib thiab siab dua) lossis qhov nkag mus yuav tsawg dua lossis sib npaug li 0.01%. Txhua qhov dej xau tshaj qhov txwv yuav tsum tau cim thiab ua rau.
- Lub voj voog: Feem ntau ua txhua 6-12 lub hlis lossis raws li GMP validation voj voog.
3. Txuj kev hloov pauv
- Kev npaj ua haujlwm: Qhia rau lub tuam tsev tsim khoom ua ntej thiab npaj cov kua tank lim ntawm tib tus qauv. Ua ntej hloov, nco ntsoov xyuas qhov tseeb ntawm cov lim dej tshiab.
- Disassembly thiab Tu: Kaw lub kaw lus thiab ua tib zoo tshem tawm cov lim qub kom tsis txhob muaj kab mob sib kis. Ua tib zoo ntxuav lub thawv siab zoo li qub thiab kev teeb tsa kom ntseeg tau tias tsis muaj plua plav lossis impurities.
- Txhim kho lub lim dej tshiab: Tshem tawm cov yeeb yaj kiab tiv thaiv los ntawm cov hniav ntawm cov lim tshiab, xyuas tias cov sealant zoo li qub, ua kom haum rau cov kua tank, thiab nruab nws ntsug thiab tsis tu ncua nyob rau hauv qhov chaw ib zaug. Nws yog nruj me ntsis txwv tsis pub ua kom rov kho dua kom tsis txhob ua puas lub sealant los yog distorting lub gel, uas yuav ua rau to.
- Lub hauv paus ntsiab lus tseem ceeb: Cov txheej txheem kev teeb tsa yuav tsum xyuas kom meej tias cov hniav ntawm lub lim yog ua tiav thiab ua haujlwm zoo nyob rau hauv cov kua nplaum sib khi ntawm cov kua tank, tsim kom muaj kev ruaj ntseg airtight seal.
4. Kev daws teeb meem txawv txav
- Cov kua dej ntws tawm: Tshawb xyuas seb lub tank puas puas lawm, seb lub sealing gasket puas muaj hnub nyoog, seb txoj haujlwm puas yog, thiab hloov nws yog tias tsim nyog.
- Filter efficiency poob: Ua ntej, ua PAO leak detection kom paub meej seb nws puas yog cov khoom lim tawm los yog foob tsis ua haujlwm, thiab ua qhov ntsuas ntsuas.
- Qhov txawv txav txawv txav: Tshawb xyuas qhov thaiv qhov sib txawv (qhov siab qhov sib txawv) lossis kev puas tsuaj (tsis tshua muaj siab sib txawv), thiab ua qhov kev txiav txim siab raws li kev ntsuas huab cua.
- Kev lees paub qhov yuav tsum tau ua: Txhua qhov kev kho lossis hloov pauv yuav tsum tau rov kuaj dua rau kev ncaj ncees ua ntej nws tuaj yeem siv tau. |
2, Kev ceev faj tshwj xeeb rau kev kho tshuaj
- Kev ua raws cai: Txhua yam kev saib xyuas, suav nrog kev tshuaj xyuas, hloov, thiab kev sim, yuav tsum muaj cov ntaub ntawv ntxaws ntxaws thiab cov ntawv teev tseg, thiab suav nrog hauv tuam txhab GMP cov ntaub ntawv zoo. Daim ntawv pov thawj ntawm kev ua raws cai thiab lwm yam ntaub ntawv ntawm lub lim yuav tsum tau muab khaws cia kom zoo.
- Cov neeg ua haujlwm thiab kev nyab xeeb: Cov neeg saib xyuas yuav tsum tau txais kev cob qhia kev cob qhia thiab hnav cov khoom tiv thaiv thaum ua haujlwm. Cov lim qub hloov pauv yog cov pa phem thiab yuav tsum tau muab pov tseg raws li kev cai kho mob / kev lag luam pov tseg.
- Kev tswj ib puag ncig: Thaum lub sij hawm hloov lub lim, cov pa phem rau thaj chaw huv si yuav tsum raug txo kom tsawg mus rau qhov loj tshaj plaws, xws li txo cov neeg ua haujlwm txav thiab qhib qhov rooj.
