Gel Foob Technology: Vim Li Cas Nws Tseem Ceeb rau GMP Kev Ua Raws Cai Hauv Chav Tshuaj

Pharmaceutical cleanrooms tsis nyob ntawm lim efficiency ib leeg. Lawv nyob ntawm kev ua tau zoo.

Ib qhov zoo -CCS sau tau yuav tsum xav txog kev tsim, khoom siv, kev saib xyuas, kev saib xyuas, kev tswj cov neeg muag khoom, thiab kev tshuaj xyuas tsis tu ncua ntawm kev pheej hmoo kis kab mob. Hauv lwm lo lus, lub foob ntawm lub lim thiab lub vaj tsev tsis yog qhov nthuav dav me me. Nws nyob ncaj qha rau hauv cov kab mob sib kis- tswj saw.

Peb cov engineers feem ntau pom ob qhov yuam kev uas yuav zam tau:

pawg tsuas yog tsom rau qib HEPA thiab tsis quav ntsej txog kev sib khi

pab pawg rov qab siv cov vaj tsev uas paub zoo hauv chav tsev - sab hloov lub qab nthab qhov twg gel channel thiab riam ntug yuav yog qhov kev xaiv zoo dua

Qhov ntawd yog qhov uas leakage pib. Tsis nyob hauv daim ntawv qhia. Hauv teb.

Ib txwm gasket- hom kev teeb tsa ua tiav lub foob los ntawm compressing lub gasket ntawm lub lim thav duab thiab cov mating nto. Lub gasket foob tau piav qhia raws li hauv qab no: lub foob pob hluav taws yog compressed tiv thaiv flange ntawm cov hniav nyiaj hniav kub, vaj tse, lossis khoom siv. Cov neeg yuav khoom feem ntau kuj siv tib lub hauv paus ntsiab lus hauv lawv cov gasket- hom kev teeb tsa: siv cov fasteners lossis cov khoom siv xauv kom ruaj ntseg rau hauv qhov chaw thiab tuav lub kaw ntom nti los ntawm compression.

Qhov twg gasketed systems tawm tsam

• Compression nyob ntawm lub zog sib xws. Yog tias qhov clamping tsis sib npaug, lub foob tsis sib xws.

• Nto flatness tseem ceeb. Kev sib txawv me me hauv lub ntsej muag vaj tse tuaj yeem dhau los ua txoj hauv kev xau.

•Txoj kev kam rau siab- nce ntxiv kev pheej hmoo. Lim thav duab, vaj tse ncej, fasteners, thiab cov txheej txheem installer tag nrho cuam tshuam qhov tshwm sim.

• Cov xwm txheej pabcuam tuaj yeem hloov lub foob. Txhua lub voj voog hloov tshiab qhia txog lub caij nyoog rau qhov tsis zoo.

• Hauv qab -loading thiab chav- sab hloov yog tsawg zam txim. Cov layouts feem ntau tau txais txiaj ntsig los ntawm kev sib khi uas yooj yim rau kev coj mus rau hauv qhov chaw. Camfil tshwj xeeb sau cov gel foob raws li qhov kev xaiv muaj zog rau cov ntxaij lim dej uas nyuaj rau nruab lossis nquag hloov, tshwj xeeb tshaj yog nyob rau hauv qab - thauj khoom lossis chav - sab hloov daim ntawv thov.

Qhov no yog vim li cas tus qauv EVA gasket uas zoo nkaus li zoo thaum lub sijhawm teeb tsa tuaj yeem dhau los ua qhov tsis muaj zog tom qab. me ntsis misalignment. Me ntsis warpage. Me ntsis torque tsis sib xws. Cov dej xau tsis tas yuav ua kom nrov. Nws tsuas yog yuav tsum muaj nyob.

Rau cov neeg siv tshuaj, qhov ntawd dhau los ua teeb meem tsim nyog, teeb meem txij nkawm, thiab thaum kawg yog teeb meem ua raws cai.

Gel- kaw HEPA cov ntxaij lim dej hloov pauv lub tshuab sealing.

Tsis zoo li cov ntsaws ruaj ruaj qhuav, cov thav duab lim no suav nrog cov khoom siv peripheral uas muaj gel. Lub vaj tsev lossis sab saum toj-mounted module siv riam- ntug lim thav duab interface- riam hlau- ntug uas ntxig rau hauv cov gel channel thiab tsim cov foob. Qee qhov piav qhia txog gel-cov ntxaij lim dej kaw raws li muaj kev sib xyaw ua ke ntawm cov gel channel uas muaj qhov qis-volatility gel, thaum lwm tus piav txog nws li riam-ntug flange raus hauv cov gel channel, tsim kom muaj kev sib txuas ntawm cov lim thiab cov cuab yeej.

Qhov no coj ob qho txiaj ntsig tseem ceeb.

• Ua ntej, nws txo qhov kev cia siab ntawm qhov zoo meej compression ntawm lub tiaj tus gasket nto.

• Thib ob, nws muab cov kua dej- kaw qhov sib txuas rau kev teeb tsa. Gel sealing muaj "kua dej- nruj nruj," uas yog ib qho laj thawj rau nws siv dav hauv kev tshawb fawb txog lub neej thiab hauv - lub tsev hloov pauv tau.

Ntau tus engineers piav txog gel seals ua tus kheej - kho. Qhov no tsis yog qee lub sij hawm tej yam yees siv, tab sis yog ib txoj hauv kev zoo tshaj plaws los muab nws.

Thaum cov hniav ntxig rau hauv cov gel, cov gel ntws raws cov hniav. Txawm tias muaj kev ua siab ntev me ntsis, kev txav me ntsis thaum lub sijhawm teeb tsa, lossis kev cuam tshuam hauv cheeb tsam, cov gel ua raws li cov ntug hlau thiab tswj kev sib cuag. Nws yog cov cuab yeej no uas ua rau cov kua gel cuam tshuam ntau dua kev zam txim ntau dua li cov gasket qhuav compression nyob rau hauv complex installation ib puag ncig. Qhov no yog ib qho engineering inference los ntawm Camfil thiab American Aerospace Manufacturing (AAF) cov lus piav qhia ntawm gel / hniav interface, qhov chaw uas lawv raus cov hniav nyob rau hauv lub gel channel los ua ib tug kua, leak- pov thawj foob.

Qhov no yog tus nqi tiag tiag, tsis yog kev lag luam gimmick. Nws txo qhov kev nkag siab ntawm installation.

Nov yog txoj hauv kev yooj yim tshaj plaws rau duab lub installation.

Simplified installation daim duab

Tsev / qab nthab module
↓
Hlau riam ntug
↓ nkag
[Gel- puv perimeter channel]
[HEPA lim lub cev]

Lub riam ntug belongs rau lub vaj tse, qab nthab daim phiaj, los yog module.
Lub gel channel belongs rau lub lim thav duab.

Thaum lub lim tau nqa los yog thawb rau hauv txoj hauj lwm:

tusriam ntug dlhos nrog gel channel

tusriam ntug nkag mus rau hauv gel

cov gel ntws ncig ntawm ntug

retainers los yog locking hardware tuav lub lim nyob rau hauv qhov chaw

AAF cov ntaub ntawv kev teeb tsa tau hais tias cov gel foob channel yuav tsum tau ua raws li cov riam ntug ntawm lub tsev, thiab ib zaug zaum thiab kaw kom zoo, lub lim foob tawm tsam riam ntug. Camfil cov ntawv txheeb tau piav qhia txog tib qho kev sib raug zoo nyob rau hauv ob qho tib si vaj tse thiab gel-cov ntxaij lim dej.

Yog vim li cas qhov no tseem ceeb nyob rau hauv cov tshuaj ceilings

A riam ntug lim ncejtshwj xeeb tshaj yog pab tau qhov twg:

• lim yoghauv qab -loaded

• nkag mus yogntawm chav sab

• Hloov zaus ntau dua

• qhov project xav tau ibtxheej txheem rooj zaum ntau dua

•Txoj kev pheej hmoo los ntawm gasket compression variability yog qhov txais tsis tau

Qhov no yog vim li cas gel- cov ntxaij lim dej channel tshwm sim ntau zaus hauv cov tshuaj plenum modules, qab nthab systems, thiab chav tsev - sab hloov vaj tse. Camfil qhia meej txog cov ntawv thov no.

Cov neeg yuav khoom tsis tas yuav cim txhua kab lus ntawm Cov Ntawv Ntxiv 1 kom nkag siab txog qhov txaus ntshai.

Cov ntaub ntawv siv tau meej meej:

•Koj xav tau ib daim ntawv pov thawj CCS (Cleanroom Certification System).

•Koj yuav tsum tau rov ua kom koj chav huv huv thiab cov cuab yeej siv huab cua huv si.

•Recertification suav nrog kev ntsuam xyuas kev ncaj ncees ntawm cov lim zaum kawg.

Txoj kev sib khi koj xaiv yuav cuam tshuam seb lub kaw lus uas tau teeb tsa tuaj yeem rov ua dua cov tshev no nyob rau lub sijhawm ntev.

Yog li ntawd, lub ntsiab lus no yuav tsum tau tham thaum lub sij hawm tsim qauv, tsis yog tom qab commissioning.

Hauv qee lub tshuab, cov pa roj carbon monoxide tseem yog qhov kev xaiv tsim nyog. Txawm li cas los xij, nyob rau hauv cov tshuaj qab nthab modules, tshwj xeeb tshaj yog thaum hloov lim los ntawm chav tsev, gel / riam- ntug sealing txoj kev feem ntau muab cov pab pawg neeg muaj kev nyab xeeb ntau dua thaum nruab thiab tu. Ntawm Zoslong, peb muab gel sealing khoom tshwj xeeb rau cov ntawv thov uas nyuaj rau nruab thiab yuav tsum tau hloov ntau zaus.

Cov neeg yuav khoom qee zaum tsis meej pem cov hauv qab no:

ISO 16890 / EN 779 Cov Cuab Yeej Cuab Yeej Cuab Yeej

EN 1822 / ISO 29463 (HEPA thiab ULPA Lim cais thiab kuaj)

Kev teeb tsa foob kev ua haujlwm hauv GMP chav huv

Cov no tsis yog tib lub tswvyim.

Ntau cov lus qhia tam sim no hais tias ISO 16890 tau hloov EN 779 rau cov cua lim dav dav, thaum HEPA thiab ULPA cov khoom raug kuaj thiab tau lees paub raws li EN 1822 thiab ISO 29463. Qhov no yog qhov tseem ceeb vim tias kev xaiv cov lim dej dav hlau hauv chav ua tshuaj huv sib txawv ntawm cov qauv {{} HVAC. Hauv qhov no, cov neeg yuav khoom yuav tsum xav txog ob qho tib si HEPA kev faib tawm thiab kev ntseeg siab ntawm lub foob pob.

Qhov no yog ib qho ntawm cov laj thawj vim li cas peb feem ntau qhia cov neeg siv khoom los txiav txim siab xaiv cov ntsiab lus - ntawm - siv lim raws li peb qhov kev txiav txim siab - ib feem:

• Lim xov xwm thiab kev ntsuas kev ua tau zoo

• Txoj kev hloov tsev thiab hloov

•Sealing interface, tshwj xeeb tshaj yog xaiv cov gel channel thiab gasket

Yog hais tias ib qho ntawm cov no mus tsis ncaj ncees lawm, nws tuaj yeem ua rau muaj kev cuam tshuam tom qab ntawm chav tsev.

Thaum peb tshuaj xyuas lub sijhawm tshuaj lim dej, peb tsis saib kev ua haujlwm ua ntej. Peb xyuas lub tswv yim installation.

Peb feem ntau nug:

• Qhov no puas yog achav- sab hloov tauqhov system?

•Lub vaj tsev puas siv ariam ntug lim ncejinterface?

• Puas yuav hloov cov lim dej ntau txaus uas gasket repeatability ua ib qho kev txhawj xeeb?

•Puas yog qhov kev sim ua kom dhau qhov kev tsim nyog nruj thaum siv lub qab nthab kom zoo dua rau kev nplij siab HVAC?

• Puas yog tus neeg siv khoom sib piv cov lim rau lub tsev, lossis tsuas yog qhov ntev?

Tsis ntev los no peb tau pab tus neeg ua haujlwm huv chav kuaj xyuas chav - sab plenum layout rau thaj tsam GMP. Thawj lub sij hawm hu rau gasketed davhlau ya nyob twg cov ntxaij lim dej vim hais tias yog lawv cov qauv kev coj ua nyob rau hauv kev lag luam tej yaam num. Qhov teeb meem tsis yog qib HEPA. Qhov teeb meem yog installation repeatability tom qab hloov yav tom ntej. Pab pawg tau hloov mus rau gel-channel tsim nrog rab riam- ntug vaj tse lub tswv yim, uas tau muab lawv txoj hauv kev tswj tau ntau dua rau kev ua haujlwm thiab tom qab kho.

Qhov kev hloov ntawd tsis yog qhov txaus ntshai. Tab sis feem ntau nws yog qhov sib txawv ntawm lub kaw lus uas yooj yim kom tsim nyog thiab ib qho uas ua rau mob taub hau.