Nrog rau kev nthuav dav ntawm kev cuam tshuam hauv tsev ntawm FDA thiab EU GMP thiab kev tshaj tawm GMP tshiab thoob plaws tebchaws, kev saib xyuas zoo ntawm thaj chaw huv huv hauv cov tuam txhab tshuaj, tshwj xeeb tshaj yog cov khoom raug tshem tawm, tau dhau los ua qhov pib uas cov tuam txhab yuav tsum hla.
Lub cheeb tsam huv si hauv online saib xyuas qhov system paub txog kev saib xyuas cov khoom raug tshem tawm los ntawm kev txhim kho ntau lub chaw taws teeb particle sensors ntawm txhua qhov tseem ceeb sampling point hauv kev cob qhia, saib xyuas thiab kaw cov huab cua hauv cheeb tsam saib xyuas los ntawm cov sensors hauv lub sijhawm, xa cov txiaj ntsig soj ntsuam mus rau kev tswj hwm. khoos phis tawj thiab los ntawm kev ua tiav cov txiaj ntsig nrog kev soj ntsuam software uas tshwj xeeb rau kev lag luam tshuaj thiab raws li 21CFR PART11.
System Function
(1) Kev tswj chaw taws teeb: Kev ua haujlwm zoo li cov chaw taws teeb tiag- lub sijhawm saib xyuas thiab teeb tsa lub tswb, khaws cov ntaub ntawv, qhia kho thiab luam tawm tuaj yeem nqa tawm los ntawm lub computer hauv chav tswj;
(2) Lub suab- lub tswb nrov: Ntau lub tswb suav nrog cov qauv ntsuas ntsuas ntsuas, kev sib txuas lus tsis ua haujlwm lub tswb, cov xov tooj ntau dhau lub tswb thiab lub tswb teeb meem kho vajtse tuaj yeem lav lub sijhawm ntev - haujlwm ruaj khov ntawm lub kaw lus;
(3) Nws tau teeb tsa nrog lub tshuab nqus tsev sab nraud uas muaj peev xwm ntawm isokinetic sampling ntawm tus nqi ntws ntawm 28.3L / min;
(4) Ob-channel simultaneous particle suav, ib txhij saib xyuas ntawm cov khoom tshem tawm nrog qhov loj me ntawm 0.5 thiab 5.0 microns;
(5) Nws tuaj yeem saib xyuas tus nqi khiav hauj lwm ntawm txhua qhov particle sensor thiab tso saib cov xwm txheej ua haujlwm;
(6) Cov khoom txee ua haujlwm nyob rau hauv ib puag ncig tsis muaj menyuam tuaj yeem ua qhov kev soj ntsuam tas li ntev li 24 teev thiab tau teeb tsa nrog ua - hauv kev saib xyuas ntws.
Yam ntxwv
(1) Nws tuaj yeem saib xyuas cov khoom (0.5/5.0 microns) synchronically los ntawm ntau txoj hauv kev raws li kev saib xyuas hauv kev lag luam tshuaj;
(2) Nws tus nqi ntws yog 28.3L / min;
(3) Lub sensor yog muab tso rau hauv ib lub stainless hlau (316L) vaj tse, corrosion{2}}resistant
(4) Nws tuaj yeem tiv thaiv -VHP (vaporized hydrogen peroxide) qauv uas tsim nyog rau fumigation tshuaj tua kab mob ib puag ncig hauv chav huv;
(5) Nws tau nruab nrog lub taub hau isokinetic sampling uas yuav tsis cuam tshuam rau hauv huab cua;
(6) Nws tuaj yeem cache 250 pawg ntawm cov ntaub ntawv rau lub hom phiaj ntawm kev teb rau qhov tsis ua haujlwm tam sim ntawd;
(7) Daim ntawv tshaj tawm ua raws li cov qauv muaj feem xyuam ntawm FS-209E, ISO14644-1 thiab EU GMP.
(8) Nws calibration yog ua raws li cov cai ntawm NIST (National Institute of Standards thiab Technology);
Cim npe nrov: online particle xyuas system, Tuam Tshoj, lwm tus neeg, manufacturers, hoobkas, ua nyob rau hauv Suav teb
