Feem ntau yuam kev hauv kev ntsuas kev ua kom tsis muaj menyuam muaj xws li cov qauv tsis sib xws, tsis yog - cov txheej txheem kev ntsuas tus qauv, kev tswj ib puag ncig tsis txaus, cov khoom siv tsis raug ntsuas, thiab cov ntaub ntawv tsis tiav. Cov kev ua yuam kev no tuaj yeem cuam tshuam loj rau kev ntseeg tau thiab ua raws cov txiaj ntsig kev xeem.
1. Tej yam yuam kev hauv kev npaj ua qauv
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Yam yuam kev |
Kev tshwm sim tshwj xeeb |
Qhov tshwm sim |
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Siv cov khoom sib txawv ntawm cov khoom siv raw |
Kev sib xyaw cov ntaub ntawv los ntawm ntau pawg tsim khoom |
Qhov sib txawv ntawm qhov hnyav molecular thiab additives ua rau kev ua haujlwm hloov pauv, ua rau cov ntaub ntawv sib piv. |
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Cov txheej txheem molding tsis sib xws |
Kev hloov pauv hauv qhov tsis xws li yaj kub thiab lub sijhawm txias> ± 5 degree |
qhov sib txawv loj hauv kev ntxhov siab, cuam tshuam rau qhov nyiam tawg tom qab ua kom tsis muaj menyuam. |
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Tsis txaus ua ntej-Kev kho kom qhuav |
Cov khoom nyoos tsis qhuav ntawm 120℃rau 4-6 teev |
noo noo ua rau hydrolysis thaum ua kom tsis muaj menyuam, ua rau muaj zog poob qis. |
2. Feem ntau yuam kev hauv kev xeem ua tiav
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Yam yuam kev |
Kev tshwm sim tshwj xeeb |
Qhov tshwm sim |
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Inaccurate Sterilization Dosage Control |
Qhov tseeb absorbed gamma irradiation koob tshuaj deviates los ntawm lub hom phiaj tus nqi los ntawm ntau tshaj ± 5% |
underestimating lossis overestimating cov khoom kam rau ua. |
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Tsis tsim nyog Cycling Sequence |
Sterilization tsis tau ua raws li kev siv tiag tiag (piv txwv li, chav ua raws li EO) |
ua tsis raug raws li qhov kev siv tshuaj kho mob. |
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Kev sim qeeb |
Cov tsos mob, kho tshuab, thiab tshuaj ntsuam xyuas tsis tau ua tib yam |
ncua lub voj voog ntsuas qhov ncauj qhov ntswg ua haujlwm thaum ntxov degradation. |
Cov Lus Qhia Tseem Ceeb: Cov txheej txheem irradiation yuav tsum tau saib xyuas hauv lub sijhawm tiag tiag - siv lub dosimeter, thiab tsawg kawg peb lub voj voog ua kom tsis muaj menyuam (gamma → EO → steam) yuav tsum tau ua haujlwm los simulate tiag - ntiaj teb siv.
3. Kev saib xyuas ib puag ncig thiab khoom siv
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Yam yuam kev |
Tej yam tshwm sim |
Qhov tshwm sim |
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Lub Sijhawm Thauj Ntau dhau |
Qauv ua kom tsis muaj menyuam rau qhov kev sim ncua> 2 teev |
Wuhan qhov kub thiab av noo ib puag ncig nrawm nrawm nrawm |
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Uncalibrated Khoom |
Universal kuaj tshuab thiab colorimeter tsis calibrated rau ntau tshaj 30 hnub |
Cov ntaub ntawv sib txawv ntawm cov khoom sib txawv cuam tshuam qhov tseeb |
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Tsis muaj Standard Reference Materials |
Tsis muaj NIST- ntawv pov thawj PC swb lossis lwm yam SRM tswj tau tso |
Tsis muaj peev xwm txheeb xyuas qhov system stability |
4. Kev Tswj Xyuas Cov Ntaub Ntawv thiab Traceability Deficiencies
Phau Ntawv Teev Tseg yuam kev: Kev cia siab rau ntawm daim ntawv foos, muaj feem cuam tshuam rau kev luam qhov yuam kev lossis kev tso tseg.
Confused Coding: Tsis siv ob -dimensional coding system ("Material_Batch_Round_Project") ua rau cov qauv tsis meej pem.
Tsis Muaj Kev Tshawb Fawb Txoj Kev: Tsis siv ELN system, ua rau nws tsis tuaj yeem taug qab hloov kho keeb kwm, ua tsis tau raws li GMP cov cai.
Kev Txhim Kho Kev Txhim Kho: Tsis siv neeg sau cov kev txhaj tshuaj molding tsis siv neeg los ntawm MES system thiab muab lawv nrog Cov Ntaub Ntawv Siv Hluav Taws Xob (ELN) kom ua tiav tag nrho - txheej txheem digital traceability.
