Precision Txhaj Moulded Cheebtsam Rau Cov Khoom Siv Kho Mob
Txheej txheem cej luam
Kev cai txhaj tshuaj molded yas Cheebtsam engineered rau kev kuaj mob, phais, thiab tshuaj xa tshuab. Tsim nyob rau hauv nruj ISO 13485 cov txheej txheem zoo, peb cov khoom tsim tau tsom mus rau qhov ruaj khov ntawm qhov ruaj khov, kev xaiv cov khoom siv biocompatible, thiab kev npaj ua kom huv huv. Peb koom tes nrog cov cuab yeej kho mob OEMs los ntawm cov cuab yeej qauv mus rau siab - ntim cov ntaub ntawv pov thawj, ua kom cov nplais seamless - nce thiab ua raws li FDA cov qauv kev cai.
Specifications
|
Parameter |
Txuj peev xwm |
Precision muaj peev xwm |
|
Dimensional kam rau ua |
+/- 0.05 mm |
Txog li +/- 0.01 mm (cov yam ntxwv tseem ceeb) |
|
Clamp Tonnage |
50t rau 350t |
Hluav taws xob & hybrid servo- tsav presses |
|
Phom hnyav |
0.1g txog 500g |
Micro- molding thiab nyias- phab ntsa muaj peev xwm |
|
Chav tsev huv |
ISO Class 8 (Class 100,000) |
ISO Class 7 (Class 10,000) ib puag ncig muaj |
|
Sterilization Compatibility |
EtO, Gamma Irradiation, E-Beam, Autoclave (121 ° C / 134 ° C) |
Nta
Tight Tolerance Replication:Servo- cov tshuab hluav taws xob txhaj tshuaj xa cov kaw- voj kab noj hniav kom tswj tau qhov ruaj khov qhov ntev hla ntau- cov cuab yeej kab noj hniav.
Traceability Integration:Laser-etched cov ntaub ntawv matrices los yog kab noj hniav- tus lej cim molded ncaj qha mus rau hauv cov khoom rau ntau ntau - mus rau -resin batch traceability.
Cleanroom Post-Kev ua haujlwm:Kev tshem tawm qhov tsis siv neeg, qhov rooj trimming, thiab sab hauv - ntim tau ua ncaj qha rau hauv ib puag ncig tswj kom tshem tawm cov kab mob sib kis.
Validation Readiness:Cov ntaub ntawv IQ / OQ / PQ muaj kev txhawb nqa los ntawm cov ntaub ntawv tshawb xyuas qhov muag pom thiab CMM cov ntaub ntawv.
Khoom siv & Kev tsim khoom
Kev kho mob -Qib Resins Processed
Amorphous Polymers:PC (Polycarbonate), PSU (Polysulfone), PES, COP / COC (Cyclic Olefin Polymer / Copolymer rau optical clarity thiab tsawg birefringence).
Ib nrab -Crystalline Polymers:PP (Polypropylene), HDPE / LDPE, PEEK, POM (Delrin), PA (Nylon).
Elastomers:TPE, TPU, LSR (Liquid Silicone Rubber) rau cov mos- kov cov ntsaws ruaj ruaj thiab diaphragms.
Manufacturing Infrastructure
Tooling Tsim:Hauv -tsev precision cuab tam chav nruab nrog siab - CNC ceev, hlau EDM, thiab iav EDM kom tswj pwm lub neej tshaj 1,000,000 cycles.
Moulding tshuab:Fanuc thiab Arburg cov tshuab hluav taws xob txhaj tshuaj uas muaj cov tshuab ziab khaub ncaws qhuav- cua tshuab ziab khaub ncaws thiab kaw- lub voj dej kub tswj kom tiv thaiv thermal degradation.
Daim ntawv thov
Diagnostic Consumables:Microfluidic chips, reagent cartridges, thiab cov qauv sau vials xav tau qhov pom kev pom tseeb thiab xoom rho tawm.
Surgical Instruments:Ergonomic reusable thiab pov tseg cov cuab yeej vaj tse, trocars, thiab endoscope Cheebtsam.
Kev tswj cov kua dej:Manifolds, connector li qub, luer fittings, thiab drip chambers yuav tsum tau xau -dawb sealing nyob rau hauv siab.
Kev xa tshuaj Devices:Cwj mem injector lub cev, inhaler inhaler actuators, thiab nws pib -injector structural shells.
Kev kho kom haum
Tooling Options:Prototype aluminium pwm (ceev-tig, 1 mus rau 5 kab noj hniav) thiab ntau lawm-qib hardened steel pwm (ntau-kab noj nrog kub khiav tshuab).
Kev Ua Haujlwm Thib Ob:Ultrasonic welding, ncoo luam ntawv, laser npav, thiab sub- kev sib koom ua ke.
Ntim Solutions:Cleanroom ob -baging, kev cai thermoformed tais ntim, thiab kev cai daim ntawv lo rau cov neeg siv khoom tshwj xeeb.
QC & Quality Assurance
Cov cuab yeej tshuaj xyuas:Keyence optical comparators, 3D CMM, automated multi-axis vision ntsuas tshuab, thiab laser roughness testers.
Txheej txheem tswj:Tiag -lub sij hawm kab noj hniav saib xyuas thiab automated rejection sorting tawm - ntawm -spec txhaj.
Cov ntawv pov thawj:ISO 13485: 2016 certified chaw; Ib puag ncig huv huv tau tshawb xyuas tsis tu ncua los ntawm cov khoom txee thiab kev saib xyuas microbial.
Cov ntaub ntawv:Cov ntaub ntawv ntsuam xyuas cov ntaub ntawv (MTR), Daim Ntawv Pov Thawj Kev Ntsuam Xyuas (CoA), thiab cov ntaub ntawv soj ntsuam tag nrho uas muab rau txhua qhov ntau lawm.
FAQ
Q: Koj lub sij hawm ua cov txheej txheem yog dab tsi rau kev kho pwm pwm thiab kuaj thawj zaug?
A: Tooling fabrication feem ntau yuav siv sij hawm 4 mus rau 6 lub lis piam nyob ntawm qhov nyuaj. T1 cov qauv thiab cov ntawv ceeb toom thawj zaug tau xa tuaj hauv 7 hnub ua haujlwm tom qab ua tiav pwm.
Q: Koj puas muab tag nrho IQ / OQ / PQ validation txhawb?
A: Yog. Peb muab cov qauv kev cai ua tiav thiab cov ntaub ntawv ua tiav, suav nrog Kev Txhim Kho Kev Tsim Nyog (IQ), Kev Tsim Nyog Ua Haujlwm (OQ), thiab Kev Ua Haujlwm Zoo (PQ) txhawb nqa rau cov khoom siv tswj hwm.
Q: Koj ua li cas txog kev kho mob - qib resin cia thiab tswj ntau ntau?
A: Tag nrho cov ntaub ntawv kho mob tau muab cia rau hauv qhov kub thiab txias - thiab cov av noo - tswj lub tsev khaws khoom. Cov ntaub ntawv ntau tus lej raug kaw rau ntawm lub hopper resin thiab taug qab los ntawm cov ntawv ntim khoom kom paub meej FIFO nruj thiab traceability.
Q: Koj puas tuaj yeem ua raws li ntau- khoom lossis ntxig molding?
A: Yog. Peb siv ntau- txhaj tshuaj presses thiab ntsug rotary rooj rau yas- rau- hlau inserts thiab dual- hardness (lub cev nruj + mos foob TPE) configurations.
RFQ
Txhawm rau muab qhov kev ntsuam xyuas raug thiab kev lag luam, thov xa koj qhov project yuav tsum tau rau peb pab pawg engineering ntawm [Insert Email / RFQ Portal Link].
Daim ntawv teev cov ntaub ntawv xav tau
CAD cov ntaub ntawv:3D qauv (STEP, IGES, lossis Parasolid) thiab 2D kev kos duab nrog rau cov lus qhia tseem ceeb.
Khoom Specification:Cov qib cob qhia lossis cov kev cai ua haujlwm (xws li, txoj kev ua kom tsis muaj menyuam, qhov pom kev pom tseeb, tshuaj tiv thaiv).
Volume Projections:Kwv yees txhua xyoo ntim (EAU), batch loj, thiab lub hom phiaj pib lub sijhawm.
Regulatory Requirements:Cov kev xav tau ntawm kev ntim khoom huv, FDA xa mus rau theem, thiab cov ntaub ntawv xav tau zoo (IQ / OQ / PQ, CoA).
Cim npe nrov: Tuam Tshoj precision txhaj tshuaj molded Cheebtsam rau kev kho mob, Tuam Tshoj precision txhaj molded Cheebtsam rau kev kho mob pab kiag li lawm manufacturers, lwm tus neeg, Hoobkas
Xa kev nug
