Cov kauj ruam ntxaws ntxaws rau kev ntsuas kev ua kom tsis muaj menyuam muaj xws li tsib theem tseem ceeb: kev npaj ua qauv, pretreatment, cyclic sterilization, kev ntsuas kev ua tau zoo, thiab kev txheeb xyuas cov ntaub ntawv. Txhua kauj ruam yuav tsum muaj kev tswj hwm nruj ntawm qhov sib txawv kom ntseeg tau tias cov txiaj ntsig tau zoo.
1. Kev npaj ua qauv
Raw Material Requirements: Siv cov ntaub ntawv los ntawm tib batch (xws li Tritan ™ 12000, batch tooj LOT # 202603XXXX) kom tsis txhob muaj kev hloov pauv los ntawm qhov sib txawv ntawm qhov hnyav molecular lossis additives.
Moulding Txheej Txheem: Npaj cov qauv raws li kev txhaj tshuaj molding tsis zoo. Cov ntsiab lus tseem ceeb tswj:
Qhov kub thiab txias: ± 5℃fluctuation
Kev txhaj tshuaj siab: tas li
Lub Sijhawm Txias: Ua raws
Pwm Number: Sau npe (piv txwv li, Pwm-PC-03)
Pawg Tswj Xyuas: Siv dual -dim coding (piv txwv li, TR12000_202603_G1_ME). Npaj 10 cov qauv sib npaug rau ib pawg, nrog 2 ua thaub qab.
2. Kev kho mob ua ntej
Kev ziab: Tag nrho cov qauv tau qhuav ntawm 120℃rau 4-6 teev kom tshem tawm cov dej noo thiab tiv thaiv hydrolysis thaum tsis muaj menyuam.
Kev sib npaug: Tom qab ziab, cov qauv tau muab tso rau hauv qhov kub thiab txias chamber (25 degree, 50% RH) rau 24 teev kom sib npaug.
Optional Enhanced Pretreatment: Txhawm rau simulate cov huab cua hauv zos ntawm Wuhan, cov qauv tuaj yeem raug 75% RH rau 24 teev ua ntej ziab los txhim kho qhov ntsuas qhov tseeb.
Lub Hom Phiaj: Txhawm rau tshem tawm qhov cuam tshuam ntawm qhov sib txawv ntawm qhov sib txawv ntawm qhov sib txawv ntawm qhov ntsuas qhov ntsuas.
3. Cyclic Sterilization Execution
Sterilization Method Combination: Hloov ua kom tsis muaj menyuam raws li kev siv tiag tiag, 3-5 cycles pom zoo:
Gamma Rays: 25-50 kGy (Tsev Tshuaj Qib Standard)
Ethylene Oxide (EO): 450-600 mg / L, 37-55 degree, 1-6 teev
Siab -Tsuas Kub, Siab -Npaum Chav: 121 degree, 15 psi, 30 feeb
Dose Monitoring: Sau cov gamma irradiation absorbed koob tshuaj nyob rau hauv lub sij hawm siv lub dosimeter, xyuas kom meej tias nws yog tswj nyob rau hauv ± 5% ntawm lub hom phiaj tus nqi.
Lub Sijhawm Sijhawm Sijhawm: 1-3 hnub ntawm txhua lub voj voog kom tsis muaj menyuam txhawm rau pab txhawm rau kuaj kev ua haujlwm thiab rov ua haujlwm.
Piv txwv: Ib lub voj voog ib txwm muaj yog G1 → EO1 → S1 → G2 → EO2 → S2, simulating tiag- ntiaj teb ntau-scenario siv.
4. Kev Ntsuas Kev Ua Haujlwm
Cov kev ntsuam xyuas hauv qab no yuav raug ua tam sim tom qab txhua qhov kev ua kom tsis muaj menyuam kom tsis txhob cuam tshuam los ntawm ib puag ncig:
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Cov khoom kuaj |
Txais Tus Qauv |
Txoj Kev Xeem |
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Qhov tshwm sim hloov |
Tsis muaj xim (ΔE <3), tsis muaj pos huab, tsis muaj kab nrib pleb |
Kev kuaj pom pom + colorimeter |
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Mechanical Properties |
Tensile / cuam tshuam lub zog txo <15% |
Universal xeem tshuab (ISO 527/179) |
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Transparency Retention |
Kev xa tawm> 85% (pom qhov chaw) |
Spectrophotometer |
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Kev nyab xeeb tshuaj |
Tsis muaj bisphenol A nag lossis daus, EO residue <10 ppm |
HPLC, GC-MS |
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Biocompatibility |
Ua tau raws li ISO 10993 cov cai |
Cytotoxicity, kuaj rhiab heev |
Pom zoo kev ntsuam xyuas tib lub sijhawm: Pib qhov tsos thiab kuaj kev xa mus tom qab thawj puag ncig, ua qhov kev sim tshuab ib txhij nyob rau hauv qhov thib ob, thiab muab tshuaj ntsuam xyuas hauv qhov thib peb los txhawm rau lub voj voog.
5. Kev txheeb xyuas cov ntaub ntawv thiab tshaj tawm
Cov ntaub ntawv Summary: Cov ntsiab lus ntawm qhov kev hloov pauv hloov pauv ntawm txhua qhov puag ncig thiab teeb tsa qhov nkhaus nkhaus.
Compliance Criteria: All indicators meet the qualification standards; there is no sudden performance degradation (e.g., a sudden drop in impact strength >15%); chemical residues tsis pub dhau qhov txwv.
Kev Tshaj Tawm Tshaj Tawm: suav nrog cov ntaub ntawv nyoos, kev sib piv COA, cov ntaub ntawv ntsuas cov khoom siv, thiab kev tshawb xyuas txoj kev, ua raws li GMP cov cai.
