ISO Cleanroom Class yog dab tsi? (Thiab Yuav Siv Li Cas Thaum Qhia Cov Chav thiab Cov Khoom Siv)
ISO chav huv huv yog ib qho kev faib tawm raws li ISO 14644-1 uas qhia txog qhov siab tshaj plaws tso cai rau cov pa hauv huab cua ntawm qhov ntau thiab tsawg hauv chav huv lossis huv cheeb tsam raws li tau teev tseg. Cov nplai khiav los ntawm ISO Class 1 (qhov nruj tshaj plaws) mus rau ISO Class 9 (tsawg kawg nruj); tus lej qis dua ib txwm txhais tau hais tias kev tswj hwm nruj dua ntawm cov pa hauv huab cua, tsis yog chav "zoo dua" chav.
Kab lus no piav qhia tias chav kawm ISO cleanroom ua tau ntsuas li cas, nws txiav txim siab li cas, qhov twg Chav Kawm 5 thiab Chav Kawm 8 haum rau kev tsim khoom tiag tiag, thiab - tseem ceeb rau cov neeg yuav khoom - siv ISO cov ntaub ntawv hauv chav kawm li cas thaum xaiv cov ntaub so, hnab looj tes, khaub ncaws, thiab lwm yam khoom siv tsis tau poob rau hauv cov cuab yeej cuab tam.
Qhov no yog leej twg rau: chav tsev tsim qauv / validation engineers, ntau lawm thiab QA / QC managers, thiab procurement / specification buyers uas xav tau ib tug tswv yim, kev txiav txim siab - npaj nkag siab txog ISO 14644-1 chav kawm.

Kev ceev ceev
ISO Class naj npawb ↓=huab cua txwv particle txwv ↓ (Class 1 yog qhov huv tshaj plaws; Chav Kawm 9 yog qhov nruj tshaj plaws).
Kev faib tawm yog ua raws li ntsuas qhov ntsuas huab cua ntawm qhov loj me me (feem ntau yog 0.1-5 µm), tsis yog ntawm qhov tsos, tu zaus, lossis huab cua hloov ib teev.
Ntawm 0.5 µm, ISO Class 5 tso cai rau 3,520 particles / m³, thaum ISO Class 8 tso cai rau 3,520,000 particles / m³-ib 1,000 × qhov sib txawv ntawm qhov tso cai.
TS EN ISO 14644-1 Kev faib tawm tsuas yog cov khoom hauv huab cua; nws tsis yog los ntawm nws tus kheej tus yam ntxwv microorganisms, tshuaj, los yog deg kab mob.
Ib yam khoom tsim nyog rau chav ISO 5 lossis Chav Kawm 8 tsis tuaj yeem txiav txim siab los ntawm chav kawm ib leeg; koj tseem xav tau cov ntaub ntawv ntawm particle tiam, lint, extractables, ntim, thiab tuav.
Vim li cas ISO Cleanroom Class Matters
Ib chav huv huv tsis yog "chav kawm" los ntawm kev huv nws zoo li cas. Nws qhov kev huv huv yog txhais los ntawm kev ntsuas cov pa hauv huab cua uas muaj nyob rau hauv cov kev ntsuas ntsuas. ISO 14644-1 tsim kev txwv kev faib tawm raws li qhov sib npaug ntawm cov khoom sib npaug lossis loj dua qhov ntau thiab tsawg, feem ntau ntsuas nrog lub teeb-scattering airborne particle counters ntawm qhov chaw kuaj pom.
Qhov kev sib txawv no tseem ceeb vim hais tias cov khoom uas tsis pom ntawm qhov muag liab qab tuaj yeem cuam tshuam cov txheej txheem rhiab heev (xws li, sterile filling, semiconductor lithography, implantable device sib dhos). Ib chav tuaj yeem pom tsis muaj dab tsi tsis tau tshaj li qhov txwv qhov xav tau rau cov txheej txheem muab.
Kev faib tawm ISO yog li muab cov chaw sib txawv thiab cov neeg muab khoom siv ib hom lus siv. Es tsis txhob hais tias ib chav yog "ntxhiab" dua li lwm tus, cov chaw tsim khoom tuaj yeem teev cov chav kawm ISO thiab qhia meej meej txog qib uas yuav tsum tau muaj ntawm kev tswj hwm huab cua.
Dab tsi yog ISO Cleanroom Class Tiag tiag
Cov chav kawm ISO cleanroom piav qhia txog qhov tso cai ntawm cov pa hauv huab cua ntawm cov khoom tshwj xeeb - qhov loj me. TS EN ISO 14644-1 Kev txiav txim siab qhov loj me ntawm 0.1 µm txog 5 µm rau kev faib tawm.
Lub hauv paus ntsiab lus yog yooj yim:
Qhov qis dua tus lej ISO, qhov tsawg dua qhov tso cai ntawm cov pa hauv huab cua.
ISO Class 1 sawv cev rau ib puag ncig huv heev; ISO Class 9 tso cai kom muaj ntau qhov ntau dua ntawm cov khoom.
Qhov no yog vim li cas ISO Class 5 thiab ISO Class 8 tsis yog cov ntawv sib hloov tau; lawv sawv cev rau cov khoom sib txawv loj heev - tswj cov kev cai uas cuam tshuam rau cov txheej txheem tsim, kev coj ua ntawm cov neeg ua haujlwm, kev sib kis- cov txheej txheem tswj, thiab kev xaiv cov khoom siv.
Yog tias koj tab tom qhia txog chav huv huv rau kev ua kom tsis muaj menyuam, kev sib dhos semiconductor, lossis kev tsim cov khoom siv cog qoob loo, cov kauj ruam tom ntej yog los xyuas qhov tseeb qhov txwv thiab tsim qhov cuam tshuam rau cov chav kawm ntawd -saib peb qhov tob tob:ISO Class 5 txhais li cas?
Yuav ua li cas ISO Cleanroom Class raug txiav txim
ISO cleanroom classification yog ua raws li ntsuas cov pa particle concentration, tsis yog nyob ntawm kev tu zaus, huab cua - hloov pauv tus nqi, lossis qhov pom kev pom.
Lub teeb -scattering airborne particle counter yog siv los txiav txim siab qhov sib npaug ntawm cov khoom sib npaug los yog loj dua qhov ntau thiab tsawg ntawm qhov chaw kuaj pom. Tom qab ntawd cov txiaj ntsig tau muab piv nrog cov kev txwv tsis pub muaj feem cuam tshuam nrog kev faib tawm ISO.
Peb yam yuav tsum tau txiav txim siab thaum txhais cov kev faib ISO:
Particle loj
Tus lej ntawm ib leeg tsis txaus. Qhov loj me me yog qhov tseem ceeb vim tias kev faib chav huv huv yog txhais raws li cov lus qhia tshwj xeeb - qhov loj me.
Piv txwv li, ib chav tsev tej zaum yuav muaj ib tug tej yam concentration ntawm particles ntawm 0.5 µm tab sis ib tug txawv concentration ntawm particle loj. Qhov no yog vim li cas cov rooj sib cais chav huv qhia pom cov ntsiab lus sib piv nrog rau cov kab uas hla.
Particle concentration
Qhov kev faib tawm tsom mus rau seb muaj pes tsawg cov khoom muaj nyob hauv cov huab cua uas tau hais tseg. Raws li ISO chav kawm tus lej txo qis, qhov tso cai rau cov pa hauv huab cua ua kom nruj dua.
Sampling qhov chaw thiab txheeb cais
Kev faib chav huv huv tsis yog tsim los ntawm ib qho kev ntsuas xws li coj mus rau qhov twg hauv chav. Particle concentration raug soj ntsuam ntawm qhov chaw kuaj pom raws li cov txheej txheem kev faib tawm thiab cov cai tswj hwm hauv ISO 14644-1.
Cov kev ntsuas ntsuas yog li tseem ceeb npaum li tus lej kawg.
ISO Cleanroom Chav Table (ISO 14644-1: 2015)
TS EN ISO 14644-1 muab cuaj chav huv huv, txij li ISO Class 1 txog ISO Class 9. Cov lus hauv qab no qhia txog qhov siab tshaj plaws particle concentrations (particles / m³) rau cov khoom loj. Cov txiaj ntsig tau sib npaug raws li feem ntau nthuav tawm hauv cov ntaub ntawv kev lag luam.
|
ISO Class |
Ntau dua lossis sib npaug li 0.1 µm |
Ntau dua lossis sib npaug li 0.2 µm |
Ntau dua lossis sib npaug li 0.3 µm |
Ntau tshaj lossis sib npaug li 0.5 µm |
Ntau dua lossis sib npaug li 1 µm |
Ntau dua lossis sib npaug li 5 µm |
|
ISO 1 |
10 |
- |
- |
- |
- |
- |
|
ISO 2 |
100 |
24 |
10 |
- |
- |
- |
|
ISO 3 |
1,000 |
237 |
102 |
35 |
- |
- |
|
ISO 4 |
10,000 |
2,370 |
1,020 |
352 |
83 |
- |
|
ISO 5 |
100,000 |
23,700 |
10,200 |
3,520 |
832 |
29 |
|
ISO 6 |
1,000,000 |
237,000 |
102,000 |
35,200 |
8,320 |
293 |
|
ISO 7 |
- |
- |
- |
352,000 |
83,200 |
2,930 |
|
ISO 8 |
- |
- |
- |
3,520,000 |
832,000 |
29,300 |
|
ISO 9 |
- |
- |
- |
35,200,000 |
8,320,000 |
293,000 |
Nco tseg:
"-" qhia tias qhov loj me tsis siv los txhais cov chav kawm ntawd hauv cov lus tshaj tawm.
Daim ntawv pov thawj tiag tiag yuav tsum ua raws li ISO 14644-1 qhov chaw kuaj, suav, thiab cov txheej txheem txheeb cais; Cov lus no yog kom nkag siab qhov loj thiab qhov sib txawv ntawm cov chav kawm.
Qhov no ua rau lub ntsiab lus ntawm tus lej hauv chav kawm yooj yim nkag siab:
|
ISO Class |
General theem ntawm huab cua particle tswj |
|
ISO 1 |
Kev nruj nruj heev |
|
ISO 2 |
Kev nruj nruj heev |
|
ISO 3 |
nruj heev |
|
ISO 4 |
Kev huv huv heev |
|
ISO 5 |
Kev huv huv siab |
|
ISO 6 |
Tswj kev huv |
|
ISO 7 |
Tswj chav huv huv ib puag ncig |
|
ISO 8 |
Ib puag ncig huv huv |
|
ISO 9 |
Tsawg tshaj plaws nyob rau hauv lub ISO cleanroom ntau yam |
Cov lus piav qhia no tsuas yog ib txoj hauv kev kom pom qhov ntsuas. Qhov kev faib tawm yog nyob ntawm ntsuas particle concentrations es tsis yog cov ntawv piav qhia.
Vim li cas ISO Class 5 thiab ISO Class 8 feem ntau tham txog
ISO Class 5 thiab ISO Class 8 feem ntau ntsib nyob rau hauv kev tsim khoom thiab kev tswj ib puag ncig vim tias lawv sawv cev rau ntau qib sib txawv ntawm kev tswj hwm huab cua thiab daim ntawv qhia rau cov txheej txheem kev xav tau.
Ib puag ncig ISO Class 5 muaj ntau qhov kev txwv nruj dua li qhov ISO Class 8 ib puag ncig. Ntawm 0.5 µm, Chav Kawm 5 tso cai rau 3,520 particles / m³, thaum Chav Kawm 8 tso cai rau 3,520,000 particles / m³. Qhov sib txawv no tuaj yeem cuam tshuam:
Cov txheej txheem tsim (xws li laminar flow hoods, cais tawm, RABS rau aseptic processing)
Cov neeg ua haujlwm (qib hnav khaub ncaws, txwv kev txav mus los, kev cob qhia)
Kev sib kis -cov txheej txheem tswj (ntau zaus, cov ntaub ntawv ntws, cais tawm)
Kev xaiv cov khoom siv hauv chav tsev (cov ntaub so, hnab looj tes, khaub ncaws, mop taub hau)
Rau ib qho kev piav qhia ntawm lwm chav kawm siv dav, saibISO Class 8 yog dab tsi thiab nws huv npaum li cas?
Lub ntsiab lus tseem ceeb yog qhov qis dua ISO chav kawm yuav tsum tsis txhob muab txhais ua "zoo dua" rau txhua txoj kev tsim khoom. Ib chav huv huv yuav tsum raug cais raws li kev sib kis - tswj cov txheej txheem nws tsim los txhawb.

ISO Class 5 vs Class 8: Cov ntawv thov raug thiab cuam tshuam
ISO Class 5feem ntau yog txuam nrog:
Aseptic ua zones (piv txwv li, sau cov kab hauv qab laminar airflow)
Cov kauj ruam tseem ceeb ntawm semiconductor lossis microelectronics
Implantable ntaus ntawv los ua ke qhov twg particle-vim tsis xws luag yog tsis tsim nyog
ISO Class 8feem ntau yog txuam nrog:
Cov chaw ntim khoom, chav hnav khaub ncaws, thiab thaj chaw hloov khoom siv
Tsawg dua cov cuab yeej tseem ceeb sib dhos lossis sub- cov kauj ruam sib dhos
Hauv qab ib puag ncig txhawb siab dua - cov cheeb tsam hauv chav kawm
Cov chav kawm nruj dua feem ntau hais txog HVAC / pom qhov xav tau siab dua, cov txheej txheem ua haujlwm nruj dua, thiab cov nqi khiav ntau dua. Tias yog vim li cas "ua kom huv si" tsis tshua muaj qhov pom kev zoo; lub hom phiaj yog "ua kom huv si raws li tus txheej txheem xav tau."
Lub Xeev Cov Neeg Nyob: Vim li cas "Raws li-Ua", "Thaum- So" thiab "Ua Haujlwm" Hloov daim ntawv thov ISO
TS EN ISO 14644-1 txhais tau hais tias peb lub xeev muaj neeg nyob vim tias qib particle nyob ntawm seb cov khoom siv thiab cov neeg ua haujlwm puas muaj.
Raws li - ua: Kev tsim kho thiab kev pabcuam tiav; tsis muaj cov cuab yeej tsim khoom, khoom siv, lossis cov neeg ua haujlwm tam sim no. Siv los txheeb xyuas qhov yooj yim pom thiab lub hnab ntawv ua haujlwm.
Thaum - so: Cov txheej txheem cov cuab yeej raug teeb tsa thiab ua haujlwm raws li kev pom zoo; tsis muaj neeg ua haujlwm nyob. Siv los ntsuas particle load los ntawm cov khoom ua ntej qhia cov neeg.
Kev ua haujlwm: Cov cuab yeej siv ua haujlwm nrog tus lej teev cov neeg ua haujlwm ua haujlwm. Qhov no yog qhov ze tshaj plaws rau kev tsim khoom tiag tiag thiab feem ntau qhia tau hais tias muaj ntau tshaj particle suav.
|
Lub xeev nyob |
Cov cuab yeej ntsia & ua haujlwm? |
Cov neeg ua haujlwm tam sim no? |
Hom hom phiaj |
Vim li cas nws tseem ceeb rau cov chav kawm ISO |
|
Raws li - ua |
Tsis muaj cov khoom siv ntau lawm |
Tsis muaj |
Tshawb xyuas kev tsim kho, pom, sealing |
Qhia qhov kev ua tau zoo hauv paus tsis muaj txheej txheem lossis cov neeg thauj khoom |
|
Thaum - so |
Yog lawm |
Tsis muaj |
Ntsuas cov cuab yeej- tsim cov khoom |
Isolates cov cuab yeej pab txhawb rau particle suav |
|
Kev ua haujlwm |
Yog lawm |
Yog lawm |
Paub meej tias kev ua tau zoo raws li kev tsim khoom tiag |
Reflects muaj tseeb nyob rau hauv -siv particle theem |
Cov lus qhia tswv yim: thaum tus neeg muag khoom hais tias "chav no yog ISO Class 5", nug "nyob rau hauv lub xeev twg?" Tib chav tuaj yeem dhau Chav Kawm 5 ntawm - so tab sis drift mus rau Chav Kawm 6/7 hauv kev ua haujlwm yog tias hnav ris tsho lossis kev ua haujlwm tsis tswj hwm.
Yog li ntawd, kev faib chav huv huv yuav raug txiav txim siab raws li cov neeg nyob sib txawv, thiab qhov sib txawv ntawm cov khoom tuaj yeem hloov pauv nyob ntawm seb cov khoom siv thiab cov neeg ua haujlwm puas muaj thiab ua haujlwm. Tias yog vim li cas kev faib chav huv yuav tsum tsis txhob txo qis rau ib tus lej yam tsis nkag siab txog cov xwm txheej hauv qab qhov ntsuas tau ua.
Puas yog ISO Cleanroom Class piav qhia txhua yam txog kev huv?
Tsis yog. Ib chav kawm ISO cleanroom tshwj xeeb hais txog kev huv ntawm huab cua. Nws tsis, los ntawm nws tus kheej, piav qhia txhua yam kev sib kis tau.
TS EN ISO 14644-1 Kev faib tawm tsis tuaj yeem siv los ua tus yam ntxwv ntawm lub cev, tshuaj, hluav taws xob, hluav taws xob (microbial), lossis lwm yam xwm txheej ntawm huab cua. Lwm yam kev huv huv tej zaum yuav tsum tau muab cais cais thiab tswj, suav nrog tshuaj lom neeg, siv tau, nanoscale, lossis qhov chaw paug.
Qhov no yog qhov sib txawv tseem ceeb thaum yuav cov khoom siv huv huv.
Kev so yuav siv tau rau hauv ib puag ncig ISO Class 5, piv txwv li, tab sis nws qhov kev tsim nyog tsis tuaj yeem txiav txim siab los ntawm chav kawm ISO ntawm chav. Lwm cov yam ntxwv yuav muaj feem xyuam, xws li particle tiam, lint tso tawm, extractable residues, absorbency, khoom compatibility, ntim, thiab yuav ua li cas cov khoom yog ua ntej siv.
Hauv lwm lo lus:
ISO chav kawm piav qhia txog kev huv ntawm huab cua tswj ib puag ncig; nws tsis tuaj yeem lees paub txhua yam khoom siv hauv ib puag ncig ntawd.
Cov khoom lag luam- theem tus yam ntxwv thiab kev sib kis- kev tswj hwm tseem yuav tsum tau txiav txim siab.
Daim Ntawv Teev Npe: Xaiv cov ntaub so thiab khoom siv rau koj chav ISO
ISO chav kawm qhia koj txog huab cua, tsis yog cov khoom. Siv daim ntawv txheeb xyuas no kom tsis txhob muaj qhov tsis sib xws thaum qhia cov ntaub so, hnab looj tes, khaub ncaws, lossis lwm yam khoom siv:
Paub meej tias chav kawm ISO thiab lub xeev nyobsiv rau kev faib (raws li -built / at-so / operational).
Sau cov txheej txheem txaus ntshai: particle generation, lint, extractables, chemical compatibility, absorbency, deg-kev pheej hmoo khawb.
Thov cov ntaub ntawv xeem: particle tiam, lint qhab nia, extractables/residues, compatibility nrog koj cov kuab tshuaj los yog actives.
Tshawb xyuas ntim thiab tuav: muab ob npaug rau- ntim ntim hauv chav huv, ua ntej- ntxuav/sterilization, thiab koj SOP rau kev qhib thiab siv.
Khiav ib qho kev sim me menyob rau hauv lub hom phiaj nyob rau hauv lub xeev thiab saib xyuas hais ua ntej scaling.
Xauv hauv batch tswj thiab hloov kev tswjnrog koj tus neeg muag khoom kom tsis txhob muaj kev hloov pauv ntawm cov khoom siv uas xav tau.
Yog tias koj xav tau qhov chaw pib, saib pebCleanroom so xaiv phau ntawv qhiathiab cov ntaub ntawv cov khoom (txuas mus rau koj cov nplooj ntawv tshwj xeeb).
Thaum ntsuam xyuas cov ntaub so huv huv, hnab looj tes, khaub ncaws, lossis lwm yam khoom siv, nws yog qhov tsim nyog los nug ob peb nqe lus nug:
Dab tsi ISO chav kawm yog cov khoom tsim los siv rau hauv, thiab nyob rau hauv lub xeev twg?
- Dab tsi ntawm particle thiab lint tswj yuav tsum tau ua rau cov txheej txheem no?
- Cov khoom puas tau raug kuaj xyuas cov yam ntxwv ntawm kev huv?
- Puas yog cov khoom ntim thiab ua haujlwm zoo rau qhov chaw npaj?
- Cov khoom puas haum rau kev tu lossis kev tsim khoom?
Txoj hauv kev no zam kev ua yuam kev ntau: xav tias cov khoom tsim nyog tsuas yog vim nws cov lus piav qhia muaj tib tus lej ISO raws li chav huv.
ISO Cleanroom Class vs Other Cleanroom Parameters
Ib chav kawm ISO cleanroom yuav tsum tsis txhob totaub nrog rau lwm qhov chaw ib puag ncig.
Kev hloov pauv huab cua ib teev, huab cua nrawm, qhov kub thiab txias, cov av noo, qhov sib txawv ntawm qhov sib txawv, thiab lub sijhawm rov qab tuaj yeem yog qhov tseem ceeb hauv kev tsim chav huv thiab kev ua haujlwm, tab sis lawv tsis hloov pauv nrog kev faib tawm ISO.
Piv txwv li, huab cua tau teev tseg - hloov pauv tsis tau txhais cov chav kawm ISO. Ib yam li ntawd, kev ua tiav ib qho kev faib tawm ISO tsis txhais tau tias txhua qhov kev ntsuas ib puag ncig tau txais mus txog qhov yuav tsum tau muaj.
Qhov kev sib txawv no yog qhov tshwj xeeb tshaj yog rau cov neeg yuav khoom nyeem cov lus qhia tshwj xeeb. Ib tus lej yuav tsum tsis txhob raug kho raws li kev piav qhia tag nrho ntawm chav huv.
ISO 14644-1 thiab Pharmaceutical / GMP Cov ntsiab lus (Annex 1, EM)
Ntau cov chaw muag tshuaj thiab biotech siv ob qho tib si ISO 14644-1 thiab cov cai / cov lus qhia xws li EU GMP Annex 1 lossis FDA kev cia siab.
TS EN ISO 14644-1 Feem ntau faib cov pa particle concentration.
GMP cov txheej txheem (xws li EU GMP Annex 1) tseem hais txog kev saib xyuas microbial, kev saib xyuas ib puag ncig (EM) cov tswv yim, thiab cov kev txwv tsis pub muaj zog / zoo li qub rau thaj chaw tseem ceeb (Qib A / B / C / D).
Yog li ntawd, cov chav tsev tshuaj feem ntau tau teev tseg siv ob chav kawm ISO (rau cov khoom) thiab GMP qib / EM cov phiaj xwm (kom muaj kev sib kis thiab kev saib xyuas tsis tu ncua).
Yog tias koj ua haujlwm hauv pharma lossis biotech, nws tsim nyog nyeem yuav ua li cas ISO cov chav kawm qhia rau GMP qib thiab EM kev cia siab hauv pebPharmaceutical Cleanroom Classificationqhia (txuas mus rau koj nplooj ntawv).
Kev tsis nkag siab ntau txog ISO Cleanroom Classes
"ISO Class 5 txhais tau hais tias chav tsev tsis muaj cov khoom."
Tsis yog. ISO kev faib tawm tsim qhov siab tshaj plaws uas tso cai rau huab cua los ntawm particle concentration rau qhov loj me me. Txawm tias cov chav huv huv heev tseem muaj cov khoom siv; Lub hom phiaj yog kom lawv nyob rau hauv cov kev txwv.
"Ib tus lej ISO qis dua txhais tau tias txhua tus txheej txheem yuav tsum siv nws."
Tsis tas li. Qhov kev faib chav huv yuav tsum yog nyob ntawm qhov kev sib kis rhiab heev ntawm cov txheej txheem thiab theem ntawm kev tswj ib puag ncig xav tau. Tshaj -kev qhia tshwj xeeb tuaj yeem ntxiv tus nqi thiab kev ua haujlwm tsis muaj txiaj ntsig.
"ISO chav kawm ntsuas cov kab mob."
Tsis ncaj. TS EN ISO 14644-1 Kev faib tawm cov pa particle concentration thiab tsis yog nws tus kheej qhia qhov ua tau zoo ntawm cov khoom hauv huab cua. Yuav tsum muaj kev tswj hwm lossis cov qauv ntxiv thaum muaj kab mob microbial muaj kev txhawj xeeb.
"Cov chav kawm ISO qhia kuv seb puas yog chav huv huv huv huv."
Tsis yog los ntawm nws tus kheej. Cov khoom lag luam - theem tus yam ntxwv thiab kev sib kis - kev tswj hwm tseem yuav tsum tau txiav txim siab.
"ISO Class 8 yog ' qias neeg' thiab yuav tsum zam."
Tsis yog. ISO Class 8 yog qhov tsim nyog rau ntau qhov chaw txhawb nqa ( ntim, hnav khaub ncaws, hloov pauv) thiab tuaj yeem ua tiav txaus rau cov txheej txheem nrog cov khoom qis dua. Qhov tseem ceeb yog txuam cov chav kawm rau cov txheej txheem kev pheej hmoo.
FAQ Txog ISO Cleanroom Class
Cov chav kawm ISO cleanroom yog dab tsi?
ISO 14644-1 chav huv huv chav huv yog cov qauv kev faib tawm ntawm kev huv huv hauv huab cua raws li cov ntsiab lus ntawm qhov ntau thiab tsawg hauv chav huv lossis huv cheeb tsam, raws li tau hais tseg hauv ISO 14644-1.
Dab tsi yog chav kawm huv ISO cleanroom?
ISO Class 1 yog qhov kev faib tawm huv tshaj plaws nyob rau hauv ISO Class 1-9 nplai vim tias nws tso cai rau cov huab cua qis tshaj plaws.
Puas yog tus lej ISO siab dua txhais tau tias chav huv huv?
Tsis yog. Qhov txawv yog qhov tseeb. Tus lej ISO qis dua qhia tau tias kev tswj hwm nruj dua ntawm cov pa hauv huab cua.
Puas yog ISO Class 5 huv dua li ISO Class 8?
Yog lawm. ISO Class 5 muaj qhov tso cai rau huab cua tsawg tsawg dua li ISO Class 8 rau qhov ntau thiab tsawg siv hauv kev faib (xws li 3,520 vs 3,520,000 particles / m³ ntawm 0.5 µm).
Puas yog ISO chav huv huv chav ntsuas ntsuas txhua hom kev sib kis?
Tsis yog. Nws feem ntau hais txog huab cua los ntawm cov particle concentration. Lwm yam kev kis kab mob (microbial, chemical, deg) yuav xav tau kev tswj hwm, ntsuas, lossis cov qauv.
Vim li cas ISO 14644-1 tseem ceeb?
TS EN ISO 14644-1 Cov txheej txheem rau kev faib cov huab cua huv los ntawm cov pa hauv huab cua, muab cov neeg siv chav huv thiab cov tuam txhab tsim cov qauv txheej txheem los piav qhia thiab ntsuas kev huv hauv huab cua.
Dab tsi ISO chav kawm sib raug rau FED-STD-209E Class 100?
ISO Class 5 feem ntau suav hais tias yog sib npaug rau FED-STD-209E Class 100 hais txog qhov txwv tsis pub dhau 0.5 µm, txawm tias cov qauv sib txawv hauv cov txheej txheem thiab cov txheej txheem.
Lub chav huv yuav tsum tau rov- kuaj ISO ntau npaum li cas?
Re- xeem zaus nyob ntawm koj qhov kev ua tau zoo, kev tswj hwm kev cia siab, thiab cov txheej txheem kev pheej hmoo; ntau qhov chaw ua haujlwm ib ntus re-kev tsim nyog (xws li, txhua xyoo) ntxiv rau kev saib xyuas ib puag ncig tsis tu ncua. Tshawb xyuas koj cov SOPs sab hauv thiab cov kev taw qhia txog kev tswj hwm.
Kev xav zaum kawg: Los ntawm "paub tus lej" mus rau "Siv Nws Wisely"
Kev nkag siab txog chav kawm ISO yog qhov tsawg dua ntawm kev nco txog tus lej thiab ntau ntxiv txog kev nkag siab txog tus lej ntawd qhov tseeb ntsuas: huab cua los ntawm qhov nruab nrab ntawm qhov ntau thiab tsawg thiab cov xwm txheej.
Thaum qhov kev sib raug zoo ntawm chav kawm ISO, qhov loj me, particle concentration, thiab cov neeg nyob hauv lub xeev yog qhov tseeb, nws yuav yooj yim dua rau:
Txhais kev huv chav huv huv kom raug
Xaiv cov chav kawm zoo rau koj cov txheej txheem (tsis yog "qhov huv tshaj plaws")
Xaiv cov khoom siv uas haum rau koj qhov kev kis kab mob tiag tiag - tswj kev xav tau
Yog tias koj xav pab txhais koj cov txheej txheem yuav tsum ua rau hauv chav kawm ISO thiab cov khoom siv tshwj xeeb, saib pebkev sib tham huv chav / kev xaiv khoompage (link to your page).

