"Peb ua tiav qhov chaw - Kev tshuaj xyuas tsis txaus?"
"Peb tau luam tawm cov khoom, ntxuav lawv, thiab tshuaj xyuas qhov ntev. Txhua yam zoo li qub. Peb puas tseem yuav tsum tau lees paub cov ntawv tshaj tawm - ua haujlwm?"
Yog tias koj ua haujlwm nrogHlau 3D Printing, tshwj xeeb tshaj yog siv cov txheej txheem SLM 3D Printing lossis Laser Printing hauv Hlau, cov lus nug no tuaj txog txhua lub sijhawm.
Los ntawm cov tswv yim pom, nws xav tias tsim nyog:
Ntu yog tiav lawm
Qhov loj me yog qhov tseeb
Cov khoom yog ua raws
Yog li vim li cas ntxiv lwm txheej ntawm validation?
Nov yog qhov tseeb - thiab qhov no yog qhov uas ntau qhov haujlwm tsis raug:
Hauv kev tsim kho mob, kev tshuaj xyuas ib leeg tsis txaus. Yog tias kev tshaj tawm - kev ua haujlwm tsis raug lees paub, cov txheej txheem raug suav tias tsis muaj kev tswj hwm.
Thiab cov txheej txheem tswj tsis tau tsis dhau txoj cai tswj hwm.
Cia peb rhuav qhov no kom meej meej - tsis muaj lus nyuaj, tsuas yog yuav ua li cas nws ua haujlwm tiag tiag hauv cov haujlwm.
Qhov "Validation" txhais tau li cas hauv Post-Kev ua tiav?
Cia nws yooj yim.
Kev lees paub txhais tau tias ua pov thawj tias koj cov txheej txheem ua ntu zus ua tau raws li qhov yuav tsum tau ua - tsis yog ib zaug xwb, tab sis txhua zaus.
Raws li US Food and Drug Administration cov lus qhia:
Cov neeg tsim khoom yuav tsum lees paub cov txheej txheem thaum cov txiaj ntsig tsis tuaj yeem lees paub los ntawm kev tshuaj xyuas ib leeg
Vim li cas qhov no tseem ceeb hauv kev tshaj tawm - ua:
Qee cov yam ntxwv tseem ceeb tsis tuaj yeem kuaj xyuas ntawm txhua qhov, xws li:
Kev ntxhov siab sab hauv
Kev ua haujlwm qaug zog
Ntev - lub sij hawm durability
Tias yog vim li cas cov neeg tswj hwm xav tau kev lees paub - tsis yog kev tshuaj xyuas xwb.
Yog vim li cas Post-Kev ua haujlwm yuav tsum muaj tseeb hauv Kev Kho Mob 3D Printing
1. Tshaj tawm-Kev ua haujlwm ncaj qha cuam tshuam rau kev ua tau zoo kawg
Tom qab Hlau 3D Printing, qhov chaw tsis "npaj-rau- siv."
Lawv feem ntau xav tau:
Kev kho cua sov
Nto xov
Ntxuav
Sterilization
Cov kauj ruam no tsis yog tshuaj pleev ib ce - lawv ncaj qha cuam tshuam:
Lub zog
nto zoo
biocompatibility
Raws li FDA cov lus qhia kev qhia:
Tshaj tawm - cov kauj ruam ua tiav yuav tsum tau sau tseg, thiab lawv cov teebmeem ntawm cov khoom siv thiab kev ua haujlwm ntawm cov cuab yeej yuav tsum raug ntsuas
Hauv cov ntsiab lus yooj yim:
Yog tias koj tsis lees paub tus ncej- ua tiav, koj tsis paub tias koj cov khoom kawg yog dab tsi.
2. Qee qhov txiaj ntsig tsis tuaj yeem txheeb xyuas yam tsis muaj kev sim ua kom puas tsuaj
Nov yog qhov teeb meem tseem ceeb:
Koj tuaj yeem ntsuas:
qhov ntev
nto roughness
Tab sis koj tsis tuaj yeem sim txhua ntu rau:
qaug zog lub neej
kev puas tsuaj sab hauv
long -kev coj cwj pwm
Raws li FDA cov txheej txheem qhia:
Thaum kev ntsuam xyuas tsis zoo los yog kev puas tsuaj, cov txheej txheem validation yuav tsum tau hloov
Qhov ntawd yog qhov tseeb rau ntau tusSLM 3D Printing Txheej txheemntu.
3. Additive Manufacturing muaj ntau qhov sib txawv
Piv nrog rau kev ua haujlwm ib txwm muaj, Laser Printing hauv Hlau qhia:
thermal stress
microstructure variation
nto irregularities
Kev tshawb fawb kev lag luam pom zoo:
Post{0}}kev ua tiav yog qhov tseem ceeb los txhim kho cov khoom siv kho tshuab thiab qhov zoo ntawm qhov chaw
Tab sis ntawm no yog qhov catch:
Yog tias tom qab- hloov pauv, cov khoom kawg hloov pauv ib yam nkaus.
4. Kev tso cai pom zoo nyob ntawm tus txheej txheem validation
Regulators tsis tsuas yog pom zoo rau tus tsim.
Lawv ntsuas:
khoom
kev tsim khoom
tshaj tawm -kev ua haujlwm + validation
Raws li FDA:
Cov cuab yeej siv yuav tsum ua kom pom kev ua tau zoo ib yam los ntawm cov txheej txheem siv tau
Tsis muaj kev lees paub=tsis muaj pov thawj ntawm qhov sib xws=kev pheej hmoo ntawm kev tsis lees paub.
Yuav ua li cas yog tias koj hla Post-Kev Ua Haujlwm Zoo?
Wb tham tiag -lub ntiaj teb yuav tshwm sim.
Kev cai ncua sij hawm lossis tsis lees paub
Tsis muaj ntaub ntawv pov thawj
Yuav tsum tau kuaj ntxiv
Cov khoom tsis sib xws
Batch-rau-batch variation
kev ua tsis tau zoo
Muaj kev pheej hmoo siab dua
tsis pom qhov tsis xws luag
txo lub neej
Them Nyiaj Rework
rov xeem dua
redesigning txheej txheem
Hauv luv luv: hla validation ib txwm raug nqi ntau dua tom qab.
Lub Ncej twg -Cov kauj ruam ua haujlwm feem ntau yuav tsum muaj kev lees paub?
Yog tias koj ua haujlwm nrog lub tuam txhab hlau 3D luam ntawv, cov no yog cov kauj ruam tseem ceeb uas yuav tsum tau lees paub:
1. Kev kho cua sov / kev ntxhov siab
Tswj kev ntxhov siab sab hauv
cuam tshuam lub zog thiab durability
2. Nto tiav
cuam tshuam lub neej qaug zog
cuam tshuam rau kev ntxuav thiab kom tsis muaj menyuam
3. Cov txheej txheem ntxuav
tshem cov hmoov thiab cov kab mob
tseem ceeb rau kev nyab xeeb kev kho mob
4. Sterilization Compatibility
yuav tsum tsis txhob degrade cov khoom
yuav tsum rov ua dua
5. Machining / kawg ua tiav
xyuas kom meej qhov tseeb
cuam tshuam kev sib dhos
Txhua yam ntawm cov kauj ruam no yuav tsum yog:
txhais
tswj
ua pov thawj
Validation vs Inspection - Qhov txawv tseem ceeb
Qhov no yog qhov uas ntau tus neeg yuav khoom tsis meej pem.
Kev tshuaj xyuas=Kev Tshawb Fawb
ntsuas qhov loj
kos nto
txheeb xyuas qhov tshwm sim
Kev lees paub=Ua pov thawj ntawm txheej txheem
txhais cov parameter
kuaj qhov sib xws
ntaub ntawv repeatability
Koj xav tau ob qho tib si - tab sis kev lees paub los ua ntej.
Case tiag: Thaum validation twb ploj lawm
Ib tus neeg siv khoom tuaj rau Sunhingstones tom qab ua tsis tiav.
Qhov xwm txheej:
Tsim kev pom zoo
cov khoom ua raws
luam ntawv ruaj khov
Teeb meem:
Tshaj tawm - kev ua haujlwm tsis raug cai
Kev kho cua sov sib txawv ntawm cov khoom siv
Cov txheej txheem ntxuav tsis yog tus qauv
Qhov tshwm sim:
Cov txiaj ntsig kuaj tsis sib xws
Txoj cai tswjfwm tau thov cov ntaub ntawv ntxiv
Qhov project ncua sij hawm los ntawm lub hlis
Peb ua dab tsi:
Txhais tag nrho cov ntawv tshaj tawm - txheej txheem validation
standardized tag nrho cov parameter
tau sau tseg txhua kauj ruam
Qhov tshwm sim:
Dhau rov-kev sim
ua tiav cov txiaj ntsig zoo ib yam
tau mus rau pem hauv ntej kom pom zoo
Sunhingstones kuj tau lees paub hauv ESTA-Txoj kev sib tham txog kev lag luam rau kev tswj xyuas cov txheej txheem kev siv tau zoo hauv cov hlau 3D luam ntawv cov chaw tsim khoom ua haujlwm.
Common Buyer Misunderstandings
Cia peb tshem ob peb yam ntxiv:
"Yog tias kev tshuaj xyuas dhau, tsis xav tau kev lees paub"
Kev tshuaj xyuas tsis raug - tsis tuaj yeem npog txhua yam
"Validation tsuas yog rau luam ntawv xwb"
Post{0}} kev ua haujlwm tseem ceeb sib npaug
"Peb tuaj yeem lees paub tom qab"
Kev lees paub yuav tsum ua raws li kev tsim khoom
"Prototyping cov txiaj ntsig tau txaus"
Kev tsim khoom yuav tsum muaj kev lees paub cais
Yuav Ua Li Cas Kom Pom Zoo Tshaj Tawm -Kev Ua Haujlwm Zoo
Yog tias koj tab tom nrhiav Metal 3D Printing, ntawm no yog qhov koj yuav tsum ua:
1. Txhais tag nrho cov hauj lwm ua ntej
Ua ntej kuaj los yog xa
2. Ua haujlwm nrog tus kws tsim khoom uas muaj kev paub dhau los
Nrhiav:
kev kho mob qhov project
meej validation txheej txheem
3. Txheem txhua kauj ruam
ruaj tsis
tswj cov cuab yeej
4. Sau txhua yam
cov ntaub ntawv txheej txheem
xeem tau
batch cov ntaub ntawv
5. Ua qauv tsim thiab ntau lawm
Tsis txhob hloov cov txheej txheem loj tom qab
FAQ
Puas yog kev kho mob 3D luam tawm qhov yuav tsum tau ua tom qab- ua qhov tseeb?
Yog - tshwj xeeb tshaj yog thaum cov txiaj ntsig tsis tuaj yeem txheeb xyuas tag nrho los ntawm kev tshuaj xyuas.
Vim li cas ho tsis tshuaj xyuas txaus?
Vim tias qee yam khoom (xws li qaug zog thiab kev ntxhov siab sab hauv) tsis tuaj yeem sim rau txhua qhov.
Cov txheej txheem twg yuav tsum raug lees paub?
Kev kho cua sov, tu, nto tiav, thiab kom tsis muaj menyuam.
Puas yog SLM 3D Printing xav tau kev lees paub?
Yog - vim muaj kev hloov pauv ntau dua thiab nyuaj.
Kuv puas tuaj yeem hla validation rau prototypes?
Tau - tab sis tsis yog rau kev tsim kho mob.
Yuav ua li cas yog tias validation ploj lawm?
Koj muaj feem cuam tshuam txog kev ncua sij hawm, kev ua tsis zoo, thiab kev tsis lees paub.
Kev xav zaum kawg - Kev lees paub yog dab tsi hloov cov txheej txheem rau hauv ib yam khoom
Yog tias muaj ib yam uas yuav tsum nco ntsoov, nws yog qhov no:
Hauv kev kho mob Hlau 3D Printing, koj cov khoom tsis yog ib feem - nws yog cov txheej txheem validated qab nws.
Tsis muaj validation:
koj tsis tuaj yeem ua pov thawj tsis sib xws
koj tsis tuaj yeem ua kom muaj kev nyab xeeb
koj tsis tuaj yeem hla kev tshuaj xyuas
Pib Nrog Cov Txheej Txheem Ua Tau Zoo - Tsis yog ib feem luam tawm xwb
Yog tias koj tab tom npaj ib txoj haujlwm kho mob siv SLM 3D Printing Process los yogLaser Printing nyob rau hauv Hlau, tsis txhob tso validation raws li ib tug afterthought.
Xa koj cov duab kos thiab cov ntaub ntawv thov rau peb.
Peb yuav pab koj:
txhais ib tug validated workflow
align prototyping nrog ntau lawm
npaj kom muaj kev pom zoo raws li txoj cai
Tsis muaj kwv yees. Tsis muaj kev ncua. Tsuas yog cov txheej txheem koj tuaj yeem ntseeg tau.
Cov ntaub ntawv
FDA - Cov txheej txheem ntawm 3D Printed Medical Devices
FDA - Kev txiav txim siab rau cov khoom siv kho mob Additive Manufactured
FDA - Lub luag haujlwm ntawm 3D Printing hauv Kev Tswj Xyuas Kev Kho Mob
Protolabs – Hlau 3D Printing Post-Kev Qhia Txog Kev Ua Haujlwm
Kev lag luam tshaj tawm txog kev tsim khoom ntxiv validation thiab kev tswj cov txheej txheem