ISO Class vs. Qub Class 100, 10,000 thiab 100,000: Dab tsi Cleanroom Buyers Yuav Tsum Paub

Yog hais tias chav tsev yuav khoom specification tseem haisChav Kawm 100, Chav Kawm 10,000, lossis Chav Kawm 100,000, tsis txhob xav tias terminology nws tus kheej yog qhov yuav tsum tau tag nrho. Cov no yog cov ntsiab lus kev faib chav huv si qub uas cuam tshuam nrog Tsoom Fwv Teb Chaws Standard 209E. Tus qauv raug muab tso tseg los ntawm US General Services Administration nyob rau lub Kaum Ib Hlis 2001, thiab ISO 14644-1 thiab ISO 14644-2 tom qab ntawd tau dhau los ua cov txheej txheem thoob ntiaj teb siv rau kev faib cov huab cua huv. Hauv kev xyaum ua lag luam, Chav Kawm 100 yog txuam nrog ISO Class 5, Class 10,000 nrog ISO Class 7, thiab Class 100,000 nrog ISO Class 8.

Rau cov neeg yuav khoom, txawm li cas los xij, kev paub txog cov ntawv no tsuas yog qhov pib. Qhov kev sib tw tiag tiag yog nkag siab txog qhov kev faib tawm hais txog dab tsi, tus neeg muag khoom tau cog lus li cas, thiab cov pov thawj dab tsi yuav tsum tau thov ua ntej cov khoom raug pom zoo.

Vim li cas cov neeg yuav khoom tseem pom "Class 100" ntawm Cleanroom RFQs?

Qub cleanroom terminology tsis tau ploj mus tsuas yog vim tus qauv qub raug tshem tawm. Ntev -Khiav cov npe khoom muag, kev qhia tshwj xeeb sab hauv, cov neeg siv khoom kos duab, SOPs, thiab cov qauv kev yuav khoom yuav txuas ntxiv siv cov ntsiab lus uas tau tsim ntau xyoo dhau los.

Qhov ntawd tsis tuaj yeem ua rau qhov kev xav tau tsis raug.

Ib tus neeg siv khoom uas sau "Class 100 cleanroom" kuj tseem yuav muaj kev sib kis zoo kawg nkaus - tswj lub hom phiaj. Qhov teeb meem yog tias lo lus tuaj yeem tawm ntau chav rau kev txhais lus thaum nws raug xa los ntawm ib lub tuam txhab mus rau lwm qhov.

Piv txwv li, tus neeg yuav khoom tuaj yeem xa RFQ rau kev so haum rau Chav Kawm 100 ib puag ncig. Ib tus neeg xa khoom tuaj yeem txhais qhov no raws li qhov kev thov rau cov khoom tsim hauv thaj chaw ISO 5. Lwm tus tuaj yeem nkag siab tias nws yog qhov qis -lint so npaj rau siv hauv ISO 5. Ib feem peb tsuas yog siv "Class 100 tshaj" raws li kev piav qhia kev lag luam.

Tag nrho peb cov lus teb tuaj yeem zoo sib xws ntawm daim ntawv thaum sawv cev sib txawv.

Yog vim li cas cov lus qub yuav tsum tau muab txhais es tsis yog qhov muag dig.

Yuav ua li cas Class 100, 10,000 thiab 100,000 sib haum rau ISO Classes?

Feem ntau siv hla- siv yog:

FDA cov ntaub ntawv txuas ntxiv qhia cov kev sib koom ua ke hauv cov ntsiab lus tswj hwm, suav nrog Chav Kawm 100 (ISO 5), Chav Kawm 10,000 (ISO 7), thiab Chav Kawm 100,000 (ISO 8).

Tab sis qhov no yuav tsum tau kho raws li ib tughla -kev siv nruab nrab ntawm kev faib tawm, tsis yog ib qho yooj yim renaming ce.

TS EN ISO 14644-1 cais chav huv thiab huv huv- thaj chaw huab cua raws li qhov xav tau ntawm cov pa hauv huab cua ntawm qhov ntsuas particle loj. Tus qauv txiav txim siab txog cov neeg particle nrog qhov qis dua qhov loj ntawm 0.1 µm mus rau 5 µm thiab siv cov khoom siv hauv cov huab cua los txiav txim siab cov particle concentration ntawm qhov chaw kuaj.

Yog li, thaum daim ntawv yuav khoom hloov "Class 100" rau "ISO 5," cov lus tau hloov kho tshiab, tab sis cov ntsiab lus tseem ceeb tseem yuav tsum nkag siab.

Cov lus nug tseem ceeb tshaj plaws: "ISO 5" txhais li cas tiag?

Qhov no yog qhov uas ntau qhov kev yuav khoom yuam kev pib.

TS EN ISO 14644-1 yog ib qho kev faib ua feem ntawmhuab cua huv los ntawm cov pa particle concentration. Nws tsis cia li cais qhov huv ntawm txhua yam khoom uas muab tso rau hauv chav ntawd. Nws kuj tsis txhais lub cev, tshuaj, hluav taws xob, hluav taws xob, lossis lwm yam xwm txheej ntawm huab cua.

Qhov kev sib txawv ntawd tseem ceeb rau cov khoom siv huv huv.

Xav txog cov lus tshaj tawm tus neeg muag khoom xws li:

"Zoo rau ISO 5 chav huv."

Cov nqe lus ntawd tsis, los ntawm nws tus kheej, qhia koj seb tus neeg muag khoom puas tau piav qhia:

chav tsev uas cov khoom raug tsim,

ib puag ncig uas nws tau ntim,

lub hom phiaj kev siv ntawm cov khoom,

particle kev ua tau zoo ntawm cov khoom,

los yog ib qho kev sib txuas ntawm cov xwm txheej no.

Cov no yog cov lus nug txawv.

Cov khoom lag luam tuaj yeem tsim nyob rau hauv ib puag ncig tswj, tab sis tus neeg yuav khoom tseem yuav xav tau cov khoom lag luam - cov ntaub ntawv tshwj xeeb txog kev tso tawm, lint, seem, ntim, lossis lwm yam kev sib kis.

Vim li cas "Class 100=ISO 5" Tsis txaus rau Kev Muag Khoom

Piv txwv tias tus neeg yuav khoom tau txais peb nqe lus rau cov ntaub so huv. Tag nrho peb tus neeg muag khoom hais tias "ISO 5" lossis "Class 100."

Nws yuav zoo li cov khoom sib npaug.

Lawv tsis tas yuav sib npaug.

Tus neeg yuav khoom yuav tsum nug seb qhov twg tau sim thiab qhov kev thov yog raws li. Kev txheeb xyuas cov khoom muaj txiaj ntsig zoo yuav suav nrog:

1. Cov khoom nws tus kheej
Cov khoom siv twg yog siv? Tus qauv yog dab tsi? Puas yog nws woven, knitted, microfiber, lossis nonwoven? Nws coj li cas thaum so?

2. Particle thiab lint kev ua tau zoo
Cov khoom puas tau raug kuaj rau cov khoom tso tawm lossis lwm yam kev huv huv uas cuam tshuam rau daim ntawv thov?

3. Kev tsim khoom ib puag ncig
Cov khoom hloov pauv, ntxuav, ntim, thiab kaw qhov twg?

4. Ntim
Puas yog ib qho -bagged, ob npaug -bagged, nqus tsev{2}}packed, los yog ntim rau hauv lwm hom kev tswj?

5. Cov ntaub ntawv
Tus neeg muag khoom puas muab cov ntaub ntawv xeem, cov ntaub ntawv batch, lossis lwm yam pov thawj uas cuam tshuam nrog cov khoom siv tiag tiag?

Lub ntsiab lus tseem ceeb yog qhov yooj yim:

"ISO 5" yuav tsum tsis txhob dhau los ua ib qho kev hloov pauv rau cov khoom lag luam tiav.

Chav Kawm Cleanroom piav qhia txog ib puag ncig, tsis yog cov khoom lag luam

Qhov kev sib txawv no dhau los ua qhov tseem ceeb tshwj xeeb thaum yuav cov khoom siv so.

Piv txwv li, tus neeg yuav khoom cov khoom siv rau kev tsim khoom yuav xav tau cov khoom xws liLCD Vaj Huam Sib Luag Ntxuav So, tab sis qhov tseeb tias cov ntaub so yuav siv rau hauv thaj chaw ISO 5 tsis, los ntawm nws tus kheej, txhais txhua qhov kev ua tau zoo ntawm cov ntaub so.

Daim ntawv thov tej zaum yuav xav tau tsawg particle tiam, tswj lint, haum absorbency, tsawg residue, los yog compatibility nrog ib tug tshwj xeeb tu txheej txheem. Cov yam ntxwv zoo li no yuav tsum tau hais cais los ntawm kev faib chav.

Hauv lwm lo lus:

Kev faib chav huv huv teb cov lus nug ib puag ncig. Cov khoom specification teb cov lus nug ntawm cov khoom.

Ob qho tib si cuam tshuam, tab sis lawv tsis sib hloov.

Cov neeg yuav khoom yuav nug dab tsi thaum tus neeg muag khoom hais tias "ISO 5 Compatible"?

Kev sib tham muaj txiaj ntsig zoo pib nrog peb lo lus nug.

Puas yog "ISO 5" xa mus rau qhov chaw tsim khoom lossis cov khoom lag luam?

Nug seb qhov kev faib ISO siv qhov twg. Ib nqe lus hais txog lub Hoobkas ib puag ncig tsis tas yuav yog nqe lus hais txog kev ua haujlwm ntawm cov khoom.

Cov yam ntxwv huv huv twg tau raug kuaj?

Es tsis txhob nug tsuas yog seb cov khoom puas yog "ISO 5 sib xws," nug seb qhov twg tau ntsuas, los ntawm txoj kev twg, thiab nyob rau hauv cov xwm txheej twg.

Cov khoom kuaj puas phim cov khoom siv?

Qhov no feem ntau yog overlooked. Daim ntawv tshaj tawm kev sim yog qhov tseem ceeb tshaj plaws thaum cov khoom siv, kev tsim kho, qhov loj me, kev ua, ntim, thiab kev teeb tsa sib haum rau cov khoom tiag tiag.

Txoj hauv kev no pab cov neeg yuav khoom sib piv cov khoom lag luam ntawm cov pov thawj ntau dua li cov lus siv.

Yuav Ua Li Cas Ib Tug Qub "Class 100" RFQ Yuav Sau Li Cas?

Ib qho kev qhia qub yuav hais tias:

Cleanroom wipes rau Chav Kawm 100.

Ib qho kev qhia meej niaj hnub no tuaj yeem txheeb xyuas:

• Daim ntawv thov:Siv hauv chav huv ISO Class 5
• Yuav tsum muaj cov khoom:Tsawg particle thiab qis -lint kev ua tau zoo
• Khoom siv:Txhais raws li cov txheej txheem ntxuav
• Loj:Specified so qhov ntev
• Ntim:Yuav tsum bagging configuration
• Sterility:Sterile los yog tsis yog -sterile, qhov muaj feem xyuam
• Kev sim:Kev kuaj huv tshwj xeeb lossis cov khoom seem thaum xav tau
• Cov ntaub ntawv:Yuav tsum tau xeem ntawv los yog batch records

Qhov no tsis txhais hais tias txhua RFQ xav tau txhua qhov ntsuas. Lub ntsiab lus yog los hloov ib daim ntawv tsis meej nrog cov kev cai uas tseem ceeb rau daim ntawv thov.

Rau daim ntawv thov tswj tau zoo, tus neeg yuav khoom kuj xav tausterile cleanroom wipes rau ISO 5nrog rau kev ua kom tsis muaj menyuam, ntim khoom, thiab cov ntaub ntawv xav tau. Cov kab lus "ISO 5" ib leeg yuav tsis txhais cov cai.

Yuav ua li cas yog tus neeg siv khoom tseem siv "Class 100"?

Tsis tas yuav tsum sib cav nrog tus neeg siv khoom lub ntsiab lus.

Ib txoj hauv kev zoo yog khaws cov lus qub thiab ntxiv cov ntaub ntawv ISO tam sim no:

Class 100 (feem ntau yog raws li ISO Class 5)

Tom qab ntawd lees paub qhov kev lees paub tiag tiag nrog cov neeg siv khoom lossis pab pawg tsim khoom.

Qhov no yog qhov tshwj xeeb tshaj yog thaum cov neeg siv khoom qub specification tau siv ntau xyoo. Khaws cov ntsiab lus keeb kwm raws li kev siv yuav txo qhov kev pheej hmoo ntawm kev hloov pauv ntawm cov neeg siv khoom xav tau thaum lub sijhawm hloov tshiab.

Common Procurement yuam kev

Ib qho yuam kev feem ntau yog kho cov txheej txheem qub thiab tshiab zoo li lawv tsuas yog ob lub npe rau tib daim ntawv. Lawv muaj feem cuam tshuam, tab sis cov txheej txheem kev faib tawm txawv.

Ib qho ntxiv yog xav tias cov khoom lag luam tsim hauv ISO 5 qhov chaw tau txais txiaj ntsig zoo ib yam li cov khoom lag luam nrog kev ua haujlwm huv.

Ib feem peb yog pom zoo cov khoom vim "ISO 5" tshwm nyob rau hauv cov khoom npe.

Qhov thib plaub yog muab piv rau cov neeg muab khoom siv tsuas yog los ntawm chav huv huv xwb tsis yog muab piv rau lawv cov ntaub ntawv tiag tiag, kev sim, ntim khoom, thiab cov ntaub ntawv.

Txoj kev nyab xeeb dua yog siv qhov kev faib ua ib feem ntawm kev yuav khoom tshwj xeeb es tsis yog tag nrho cov lus qhia.

Dab tsi yuav tsum yog tus neeg yuav khoom Cleanroom tso rau ntawm RFQ?

Ib qhov dej- qauv RFQ feem ntau yuav tsum cais qhov yuav tsum tau ua rau ntau txheej.

Environmental xav tau:
Qhia rau cov chav kawm ISO lossis chav kawm qub txeeg qub teg siv los ntawm cov neeg siv khoom.

Yam khoom xav tau:
Qhia cov khoom siv, kev tsim kho, qhov loj me, absorbency, lint los yog particle yuav tsum tau, thiab npaj daim ntawv thov.

Qhov yuav tsum tau muaj kev sib kis:
Ntxiv cov tshuaj residue, ionic contamination, microbial, los yog lwm yam yuav tsum tau thaum muaj feem xyuam rau cov txheej txheem.

Ntim xav tau:
Txhais lub hnab ntim khoom, lub tshuab nqus tsev, lub hnab ntim tsis muaj menyuam, lossis lwm yam kev tuav pov hwm yog tias tsim nyog.

Cov ntaub ntawv xav tau:
Qhia seb cov ntawv xeem, daim ntawv pov thawj ntawm kev txheeb xyuas, kev txheeb xyuas ntau npaum li cas, lossis lwm yam ntaub ntawv zoo yuav tsum tau ua.

Cov qauv no ua rau cov lus sib piv tau yooj yim dua vim tias cov neeg muag khoom tau teb rau cov kev xav tau ntsuas tsis yog txhais ib kab lus dav dav.

Cov lus nug zoo dua tsis yog "Class 100 lossis ISO 5?"

Rau kev ua kom huv huv, cov lus nug tseem ceeb dua tsis yog qhov yooj yimClass 100 sib npaug ISO 5.

Cov lus nug zoo dua yog:

Cov txheej txheem yuav tsum muaj kev huv npaum li cas, thiab cov khoom siv ntsuas tau npaum li cas yuav tsum tau ua kom pom?

Cov lus qub qub tseem muaj txiaj ntsig zoo thaum sib txuas lus nrog cov neeg siv khoom uas muaj keeb kwm tshwj xeeb. ISO terminology tseem ceeb rau cov ntaub ntawv niaj hnub no. Tab sis tsis muaj leej twg yuav tsum hloov cov kev cai tiag tiag ntawm daim ntawv thov.

Thaum cov neeg yuav khoom txav los ntawmqub terminology → ISO siv → daim ntawv thov yuav tsum tau → khoom pov thawj → tus neeg muag khoom pov thawj, lawv tau txais lub hauv paus kom meej meej rau kev ntsuam xyuas cov khoom siv huv huv.

Qhov ntawd yog lub hom phiaj tiag tiag ntawm kev hloov pauv Chav Kawm 100, Chav Kawm 10,000, thiab Chav Kawm 100,000 mus rau niaj hnub ISO terminology: tsis yog tsuas yog hloov daim ntawv lo, tab sis kom tshem tawm qhov tsis meej pem ntawm kev yuav khoom.