Aseptic Barrier Thiab Performance Assurance: Kev Ntsuam Xyuas Tag Nrho Cov Txheej Txheem Kev Tswj Xyuas Zoo Rau Cov Khoom Siv Khoom Siv Pov Tseg

Lo lus tseem ceeb: Ib - lub sij hawm tho khoom; Kev tswj kom zoo
Rau txhua yam khoom siv kho mob cog lossis muab tso rau hauv tib neeg lub cev, "kev nyab xeeb thiab kev ua tau zoo" yog kab liab kiag li. Cov cuab yeej siv pov tseg, uas yog ib qho cuab yeej tseem ceeb rau kev tsim cov channel phais, nws qhov zoo cuam tshuam ncaj qha seb qhov kev phais tuaj yeem ua tau zoo thiab seb cov neeg mob puas yuav raug kev txom nyem los ntawm cov teeb meem loj xws li kev kis kab mob. Yog li ntawd, los ntawm cov yeeb nkab steel raw mus rau cov khoom ntim khoom tsis muaj menyuam, kev tswj xyuas zoo thoob plaws hauv nws lub neej tag nrho yog qhov kawg tiv thaiv kab los xyuas kom cov neeg mob muaj kev nyab xeeb. Cov kab ke no mus deb dhau qhov kev tshuaj xyuas cov khoom kawg; Nws npog txhua yam xws li kev tsim qauv, kev tshuaj xyuas cov khoom tuaj, kev siv tau zoo, kev tswj ib puag ncig, kev ua kom tsis muaj menyuam, thiab kev taug qab.
Pib los ntawm kev tsim: Kev zoo yog tsim los ntawm kev tsim.
Lub hauv paus chiv keeb ntawm kev tswj kom zoo yog nyob rau hauv kev tswj kev tsim. Kev tsim cov cuab yeej puncture yuav tsum ua raws li cov kev xav tau ntawm kev kho mob txaus thiab kev soj ntsuam kev pheej hmoo. Pab neeg tsim khoom yuav tsum tau txheeb xyuas tag nrho cov yam ntxwv tseem ceeb ntawm kev ua haujlwm: lub siab tshaj plaws ntawm kev sib tsoo quab yuam (kom tsis txhob muaj teeb meem hauv kev nkag mus) thiab qis qis (kom tsis txhob muaj kev sib tsoo ntau dhau), qhov xau tus nqi ntawm lub foob, kev sib txhuam quab yuam thaum lub cuab yeej siv, kev sib txuas lub zog ntawm cov khoom siv, biocompatibility ntawm cov ntaub ntawv, thiab lwm yam. Los ntawm kev kuaj xyuas thiab kev tsim qauv, kev siv cov qauv kev soj ntsuam xyuas, siv cov qauv kuaj thiab cov qauv kuaj pom zoo. tias qhov tsim tawm tsim tau raws li qhov xav tau ntawm cov tswv yim. Piv txwv li, lub kaum sab xis ntawm lub taub hau ntawm lub khob hliav qab, qhov roughness ntawm sab hauv phab ntsa ntawm lub raj, cov qauv tsim me me no tau dhau los suav tsis txheeb thiab kev ua kom zoo tshaj plaws kom ua tiav qhov zoo tshaj plaws ntawm kev nkag mus thiab kev nyab xeeb.
Kev tswj nruj ntawm cov khoom siv raw: Cov ntaub ntawv raw txiav txim siab lub qab nthab ntawm cov khoom.
High- cov khoom zoo pib nrog siab - cov ntaub ntawv zoo. Cov neeg tsim khoom yuav tsum tsim kom muaj kev soj ntsuam nruj ntawm cov neeg muag khoom thiab cov qauv tshuaj xyuas tuaj rau txhua pawg ntawm kev kho mob stainless hlau tubing, cov khoom yas, cov khoom siv silicone, thiab lwm yam.
* Cov khoom siv stainless hlau: Daim ntawv pov thawj cov ntaub ntawv yuav tsum tau ua pov thawj, thiab kev soj ntsuam spectral yuav ua kom paub tseeb tias muaj pes tsawg leeg (xws li chromium, npib tsib xee, thiab molybdenum cov ntsiab lus), nrog rau kev sim hardness, intergranular corrosion test, thiab lwm yam.
* Cov khoom yas: tshwj xeeb tshaj yog rau cov khoom siv kho qhov muag -qib polycarbonate siv hauv pob tshab puncture taub hau, lub teeb xa tawm, qhov ntsuas daj, thiab qhov ntsuas yaj yuav tsum raug kuaj, thiab cov impurities yuav tsum tau xyuas kom tsis muaj. Cov ntaub ntawv ntawm cov khoom hais txog "tsis muaj caws pliav, voids, me ntsis, impurities, khawb los yog npuas", uas feem ntau yog nyob ntawm purity ntawm raw cov ntaub ntawv.
* Cov ntaub ntawv biocompatible: Txhua yam ntaub ntawv sib cuag nrog cov neeg mob yuav tsum muaj daim ntawv qhia txog biocompatibility test uas ua raws li ISO 10993 cov qauv (lossis cov chaw tsim khoom ua qhov ntsuas ntawm cov ntaub ntawv).
Kev txawj ntse hauv cov txheej txheem: Kev lees paub thiab saib xyuas cov txheej txheem tshwj xeeb
Kev tsim khoom ntawm cov cuab yeej xuas nrig ntaus cuam tshuam nrog ntau "cov txheej txheem tshwj xeeb", thiab cov txiaj ntsig ntawm cov txheej txheem no tsis tuaj yeem lees paub tag nrho los ntawm kev tshuaj xyuas tom ntej. Yog li ntawd, kev tswj hwm nruj yuav tsum tau siv los ntawm cov txheej txheem lawv tus kheej.
* Precision machining: Siv cov cuab yeej xws li Citizen Cincom L12-1M7, qhov tseeb ntawm cov cuab yeej siv tshuab yuav tsum tau ntsuas thiab tswj xyuas tsis tu ncua. Cov txheej txheem validation ntawm kev ua tsis tau (kev sib hloov ceev, pub tus nqi, txiav qhov tob) yog qhov tsim nyog, thiab kev ruaj ntseg ntawm cov txheej txheem yog saib xyuas los ntawm kev ntsuas qhov ntev ntawm thawj daim thiab tshuaj xyuas daim (siv precision calipers thiab cov duab ntsuas ntsuas).
* Electrolytic polishing: Qhov no yog txheej txheem tshwj xeeb tseem ceeb. Cov muaj pes tsawg leeg, concentration, kub, tam sim no thiab voltage tsis, thiab lub sij hawm kho ntawm electrolyte yuav tsum nruj me ntsis teev thiab saib xyuas. Qhov kev ua tau zoo ntawm cov txheej txheem yuav tsum tau lees paub los ntawm kev ntsuam xyuas tsis tu ncua ntawm qhov chaw roughness (siv cov profileometers) thiab corrosion kuj ntawm cov qauv.
* Txhaj tshuaj molding: Cov tsis xws li pwm kub, yaj kub, txhaj tshuaj, thiab tuav lub sij hawm ncaj qha cuam tshuam qhov loj, zoo li, thiab txhua yam khoom ntawm cov khoom yas. Cov kev txwv no yuav tsum tau ua raws li cov txheej txheem nruj nruj thiab raug soj ntsuam tas li thaum tsim khoom.
* Kev tu cov txheej txheem: Cov kev ua haujlwm ntawm ultrasonic tu yuav tsum tau ua pov thawj, piv txwv li, los ntawm kev ntsuam xyuas cov qib ntawm cov khoom tsis huv thiab tsis yog - cov khoom tsis zoo ntawm cov khoom ua haujlwm tom qab ntxuav.
Ua tiav los ntawm kev sim: Ntau-theem thiab ntau-sib nqus nrhiav kom pom
Cov ntaub ntawv khoom lag luam hais tias "ntau dua 6 qhov kev tshuaj ntsuam xyuas", uas ua rau peb -kev tshuaj xyuas lub network:
1. Kev tshuaj xyuas online: Cov neeg ua haujlwm ua tus kheej - kev tshuaj xyuas thiab kev tshuaj xyuas kev sib raug zoo thaum lub sijhawm ua haujlwm. Lawv siv cov tsom iav tsom iav thiab ntsuas qhov ntsuas kom nrawm nrawm rau qhov pom thiab qhov loj me.
2. Kev soj ntsuam cov txheej txheem: Cov neeg soj ntsuam zoo ua qhov kev kuaj xyuas qhov chaw ua haujlwm- hauv - kev vam meej raws li txoj kev npaj ua piv txwv. Lawv siv cov cuab yeej meej dua (xws li ob-cov duab ntsuas qhov ntev) los ntsuas qhov ntev thiab sau cov ntaub ntawv rau kev txheeb xyuas cov txheej txheem.
3. Kev tshuaj xyuas zaum kawg: 100% lossis AQL sampling tshuaj xyuas yog ua tiav ntawm cov khoom tiav. Qhov no suav nrog:
* Dimension soj ntsuam: tag nrho ntev, sab nraud txoj kab uas hla, puab txoj kab uas hla, qhov ntev qhov tseem ceeb.
* Kev tshuaj xyuas qhov tshwm sim: xyuas qhov smoothness ntawm cov hlau qhov chaw nyob rau hauv cov teeb pom kev zoo, lub pob tshab ntawm cov khoom yas, khawb, stains, burrs.
* Kev sim ua haujlwm: sim qhov kev ua tau zoo ntawm cov ntsaws ruaj ruaj (kev ntsuas roj nruj), qhov ntse ntawm lub khob hliav qab (raug quab yuam kuaj), qhib thiab kaw kev ua haujlwm ntawm li qub, kev sib txuas lub zog ntawm txhua feem.
* Kev tshuaj xyuas tshwj xeeb: xws li kev tshuaj ntsuam xyuas ntawm cov kab noj hniav sab hauv ntawm cov hlau tsis muaj hlau. Qhov no yog ib kauj ruam tseem ceeb los xyuas kom meej tias tsis muaj cov khoom seem, thiab cov khoom me me thaum lub sijhawm ua haujlwm tuaj yeem ua rau qhov chaw embolic.
4. Kev kuaj sim: Cov qauv raug coj los ntawm cov kab ntau lawm rau kev sim ua kom puas tsuaj ntau dua, xws li kev ntsuas lub zog tensile, kev sim qaug zog, thiab simulated siv kev sim, los xyuas qhov kev ua tau zoo ntawm cov khoom.
Thaum kawg, ua kom tsis muaj menyuam thiab tso tawm: Tsim kom muaj kev tsis muaj menyuam
Cov khoom siv tho qhov pov tseg yuav tsum muab xa mus rau hauv lub xeev tsis muaj menyuam. Txoj kev ua kom tsis muaj menyuam feem ntau yog ethylene oxide sterilization. Tag nrho cov txheej txheem ua kom tsis muaj menyuam yuav tsum tau ua pov thawj nruj, suav nrog kev teeb tsa kev lees paub, kev lees paub kev ua haujlwm thiab kev lees paub kev ua haujlwm, kom ntseeg tau tias cov tshuaj tua kab mob tuaj yeem nkag mus rau hauv cov khoom siv tsis zoo tshaj plaws thiab tua tag nrho cov kab mob. Tom qab txhua batch ntawm cov khoom yog sterilized, aseptic tshuaj ntsuam thiab ethylene oxide residue xeem yuav tsum tau ua. Tsuas yog thaum lawv tsim nyog thiaj li raug tso tawm.
Kev lees paub qhov system: ISO 13485 thiab Traceability
Tag nrho cov haujlwm no tau ua nyob rau hauv lub moj khaum ntawm ISO 13485 kev tswj hwm cov cuab yeej kho mob zoo. Cov txheej txheem no yuav tsum tau tsim kom muaj cov ntaub ntawv ua tiav los xyuas kom meej tag nrho traceability los ntawm cov batch naj npawb ntawm raw cov ntaub ntawv mus rau ntau lawm cov khoom, tus neeg teb xov tooj, cov txheej txheem tsis, soj ntsuam xyuas, thiab thaum kawg rau cov neeg siv kawg. Thaum muaj teeb meem, nws tuaj yeem txheeb xyuas sai thiab tswj tau qhov txaus ntshai.
Xaus
Ib qho yooj yim zoo li cov cuab yeej tho siv pov tseg yog txhawb nqa los ntawm kev ua haujlwm tsis tshua muaj, nruj thiab sib cuam tshuam kev tswj hwm zoo. Los ntawm cov qauv molecular ntawm cov khoom siv raw mus rau lub xeev tsis muaj menyuam ntawm cov khoom kawg, txhua qhov kev nthuav dav yog tswj hwm. Rau cov chaw tsim khoom xws li Manners Technology, nws cov txiaj ntsig tsis yog tsuas yog muaj cov cuab yeej siv Citizen siab heev lossis cov tshuab txhaj tshuaj molding, tab sis kuj tseem nyob hauv lub tsev thiab ua haujlwm zoo xws li cov txheej txheem zoo uas tuaj yeem tsim cov khoom muaj kev nyab xeeb, ua tau zoo thiab zoo ib yam. Qhov no tsis yog tsuas yog tsim nyog ua raws li cov cai, tab sis kuj yog lub luag haujlwm hnyav rau lub neej thiab kev noj qab haus huv ntawm cov neeg mob. Hauv kev lag luam khoom siv kho mob, "zoo yog lub neej" tsis yog ib lo lus tsis muaj qab hau xwb; nws yog ib qho kev nqis tes ua uas permeates txhua txheej txheem thiab txhua qhov kev tshuaj xyuas.