Ukuthuthukiswa Kwenqubo
Izicelo ezijwayelekile Ekuthuthukisweni Kwenqubo yemboni ye-Biopharma njengokukhethwa kwelayini yeselula, ukukhiqizwa kwebhange lamaselula, ukubeka isimo sokugcinwa kwamaseli, ukuthuthukiswa komkhiqizo womkhiqizo kudinga ukuqapha unomphela kwemingcele yesimo seseli.I-Countstar Altair iyithuluzi elikahle kakhulu lokulandelela lezi zici ngendlela ehlakaniphile, esheshayo, eyongayo, enembe kakhulu nesemthethweni.Kungasiza ukusheshisa ukuthuthukiswa kwezinqubo zesikali sezimboni kakhulu.
I-Pilot kanye Nokukhiqiza Okukhulu
Ukuqapha okungaguquguquki, okunamapharamitha amaningi kokuhlola kanye namasiko amaseli amakhulu kuyimfuneko engenakugwemeka ukuze kuqinisekiswe ikhwalithi ephezulu yemikhiqizo yokugcina, ngaphandle kweseli ngokwalo noma izinto ezingaphakathi kwamaseli noma ezifihliwe ekugxileni kwenqubo yokukhiqiza.I-Countstar Altair ifaneleka ngokuphelele ukuhlolwa kwenqwaba emigqeni yokukhiqiza, ngaphandle kwevolumu ngayinye ye-bioreactor.
Ikhwalithi yokulawula
Izindlela zokwelapha ezisekelwe kumaseli ziyimiqondo ethembisayo yokwelapha izimbangela ezihlukahlukene zezifo.Njengoba amaseli ngokwawo egxile ekwelashweni, ukulawulwa kwekhwalithi okuthuthukisiwe kwemingcele yawo kuyindlela ephumelela kakhulu yokufaka amaseli ngokwezidingo ezichazwe ngaphambilini.Kusukela ekuhlukaniseni nasekuhlukaniseni amaseli abanikeli, ukugadwa kwesiqandisi kanye nezinyathelo zokuthutha, kuze kufike ekwandeni nokudlula kwezinhlobo zamaseli afanelekile, i-Countstar Altair iwuhlelo olufanele lokuhlola amaseli kunoma yimiphi imisebenzi esohlwini.I-analyzer enendawo yayo ekulawuleni ikhwalithi yokucubungula okukhuphuka nomfula.
Konke-kokukodwa, Idizayini Ehlangene
Unyawo oluncane luhlanganiswe nesisindo esingenzeka lwenza i-Countstar Altair ibe isihlaziyi esihamba phambili, esingagudluzwa kalula sisuka kwenye ilebhu siye kwenye.Ngesikrini sayo sokuthinta esizwela kakhulu esihlangene kanye ne-CPU i-Countstar Altair inikeza ithuba lokubuka nokuhlaziya idatha etholiwe ngokushesha futhi igcine izilinganiso ezifika ku-150,000 ku-hard disk drive yayo ehlanganisiwe.
I-Smart Fast and Intuitively-to-use
Ukusebenzelana kwesofthiwe enembile ngokuhlanganiswa ne-BioApps efakwe ngaphambili (amaphrothokholi esifanekiso sokuhlola) kwakha isisekelo sokusebenza ngokunethezeka nokushesha kwe-Countstar Altair ngezinyathelo ezintathu kuphela.Ngena ngezinyathelo ezi-3 kuphela nangaphansi kwamasekhondi angu-30/isampula yezithombe zakho nemiphumela:
Isinyathelo sokuqala: Gcoba u-20µL wesampula yeseli yakho
Isinyathelo sesibili: Faka isilayidi segumbi bese ukhetha i-BioApp yakho
Isinyathelo Sesithathu: Qala ukuhlaziya futhi uthole izithombe nemiphumela ngokushesha
Imiphumela Enembile Nenembe
Imiphumela ikhiqizeka kabusha kakhulu.
I-Unique Patented Fixed Focus Technology (FFT)
I-Countstar Altair iqukethe ibhentshi eliqine ngokwedlulele, elenziwe ngensimbi egcwele, elibonakalayo, elihlanganiswe nobunikazi bethu be-Fixed Focus Technology.Asikho isidingo noma kunini sokuthi u-opharetha we-Countstar Altair alungise ukugxila mathupha ngaphambi kokulinganisa.
Ukunemba Okuthuthukisiwe Kwezibalo Nokunemba
Kungakhethwa futhi kuhlaziywe izifunda ezintathu ezithakaselayo ngegumbi elilodwa kanye nesilinganiso.Lokhu kuvumela ukwanda okwengeziwe kokunemba nokunemba.Ekuhlanganiseni kweseli okungu-1 x 10 6 amaseli/mL, i-Countstar Altair iqapha amaseli angu-1,305 ezifundeni ezingu-3 zentshisekelo.Uma kuqhathaniswa nezibalo ze-hemocytometer ezimanuwali, zikala izikwele ezi-4 zegridi yokubala, opharetha uzothwebula izinto ezingama-400 kuphela, izikhathi ezi-3.26 ngaphansi kune-Countstar Altair.
Imiphumela yezithombe ezivelele
Ikhamera enemibala engu-5 Megapixel ihlanganiswe neziqinisekiso zenhloso engu-2.5x zezithombe zokucaca okuphezulu.Ivumela umsebenzisi ukuthi athwebule imininingwane ye-morphological engenakuqhathaniswa yeseli ngalinye.
Ama-algorithms amasha Wokuqaphela Isithombe
Senze ama-algorithms amasha okuqaphela isithombe, ahlaziya amapharamitha angama-23 ento eyodwa.Lesi isisekelo esingenakugwenywa sokuhlukaniswa okucacile, okuhlukile kwamaseli asebenzayo nafile.
Ukuzivumelanisa nezimo okulula, ukwenza ngokwezifiso okulula ngenxa yesakhiwo sesofthiwe esivumelana nezimo nomqondo we-BioApps
Imenyu yokuhlola esekelwe ku-BioApps iyisici esinethezekile nesidleka kalula sokwenza ukuhlola kwesimiso sansuku zonke kube ngezifiso ku-Countstar Altair kuya kuzici ngazinye zemigqa yeseli nezimo zabo zesiko.Izilungiselelo zohlobo lweseli zingahlolwa futhi zishintshwe kumodi yokuhlela, i-BioApps entsha ingangezwa kusofthiwe yokuhlaziya ngokulayisha okulula kwe-USB, noma ikopishelwe kwabanye abahlaziyi.Ukuze kube lula kakhulu, indawo yethu eyinhloko yokuqashelwa kwesithombe ingaphinda idizayine i-BioApps entsha ngesisekelo sedatha yesithombe esitholiwe yekhasimende mahhala.
Uhlolojikelele Lwezithombe Ezitholiwe, Idatha, nama-Histograms Ngokushesha
Umphumela wokubuka kwe-Countstar Altair unikeza ukufinyelela ngokushesha kuzo zonke izithombe ezitholwe ngesikhathi sokulinganisa, ubonisa yonke idatha ehlaziyiwe nama-histogram akhiqiziwe.Ngokuthinta umunwe nje, u-opharetha angashintsha asuke ekubukeni aye kwelinye, avule noma avale imodi yokulebula.
Uhlolojikelele lwedatha
I-Histogram Yokusabalalisa Ububanzi
Ukuphathwa Kwedatha
Uhlelo lwe-Countstar Rigel lusebenzisa isizindalwazi esakhelwe ngaphakathi esinomklamo oyinkimbinkimbi kanye ne-ergonomic.Inikeza ama-opharetha ukuguquguquka okukhulu ngokuphathelene nokugcinwa kwedatha kuyilapho iqinisekisa ukuphathwa okuphephile nokulandelekayo kwemiphumela nezithombe.
Isitoreji Sedatha
Ngo-500GB wamadrayivu e-hard disk, igcina kufika ku-160,000 amasethi aphelele edatha yokuhlola okuhlanganisa nezithombe.
Ukuthunyelwa Kwedatha
Izinketho zokukhipha idatha zihlanganisa amafayela e-PDF, i-MS-Excel, namafayela e-JPEG.Zonke zithunyelwa kalula kusetshenziswa izimbobo zangaphandle ze-USB2.0 nezingu-3.0
I-BioApp/Project Based Data Management
Idatha yokuhlola entsha ihlelwa kusizindalwazi ngegama labo lephrojekthi ye-BioApp.Ukuhlolwa okulandelanayo kwephrojekthi kuzoxhunywa kumafolda awo ngokuzenzakalelayo, okuvumela ukubuyiswa okusheshayo nokuvikelekile.
Ukubuyisa Okulula
Idatha ingakhethwa ngegama lokuhlola noma lephrothokholi, idethi yokuhlaziya, noma amagama angukhiye.Yonke idatha etholiwe ingabuyekezwa, ihlaziywe kabusha, iphrintwe, futhi ithekeliswe ngamafomethi ahlukahlukene.
I-FDA 21 CFR Ingxenye11
Hlangana nezidingo zesimanje ze-cGMP zemithi nezokukhiqiza
I-Countstar Altair yakhelwe ukuhlangabezana nezidingo zesimanje ze-cGMP zezemithi nezokukhiqiza.Isofthiwe ithobela 21 CFR ingxenye ye-11. Izici ezibalulekile zifaka isofthiwe ekwazi ukumelana nokuphazamiseka, ukuphathwa kokufinyelela komsebenzisi, namarekhodi e-elekthronikhi namasignesha ahlinzeka ngomkhondo wokucwaninga ovikelekile.Isevisi ye-IQ/OQ kanye nokwesekwa kwe-PQ okuvela kochwepheshe bezobuchwepheshe be-Countstar nakho kuyatholakala ukuze kuhlinzekwe.
Ukungena komsebenzisi
Ukuphathwa kokufinyelela komsebenzisi okunezinga eliphezulu
Ama-E-Signatures kanye Namafayela Okungena
Isevisi yokuqinisekisa ethuthukiswayo (IQ/OQ) kanye Nokumiswa Kwezinhlayiya Okujwayelekile
Lapho sisebenzisa i-Altair endaweni elawulwayo, ukwesekwa kwethu kwe-IQ/OQ/PQ kuqala ngaphambi kwesikhathi - sizohlangana nawe uma kudingeka ngaphambi kokwenza ukufaneleka.
I-Countstar inikeza imibhalo yokuqinisekisa edingekayo ukuze ifanelekele i-CountstarAltair ekwenzeni ukuthuthukiswa kwenqubo nemisebenzi yokukhiqiza ezindaweni ezihlobene ne-cGMP.
Umnyango wethu we-QA ususungule ingqalasizinda egcwele ngaphakathi endlini ukuze ihambisane ne-cGAMP (Good Automation Manufacturing Practice) imihlahlandlela yabahlaziyi bokukhiqiza, kusukela enqubweni yokuklama ithuluzi nesofthiwe ngokuhlolwa kokugcina kokwamukelwa kwefekthri kwezinhlelo nezinto ezisetshenziswayo.Siqinisekisa ukuqinisekiswa okuyimpumelelo (IQ, OQ) esizeni, futhi sizosiza enqubweni ye-PQ.
Ukuhlolwa Kokuqina Kwensimbi(IST)
I-Countstar isungule uhlelo lokuqinisekisa oluphelele lokuhlola ukuzinza nokunemba kwezilinganiso ze-Altair ukuze kuqinisekiswe ukuthi idatha yokulinganisa enembile nengaphinde ikhiqizeke ithwetshulwa nsuku zonke.
Uhlelo lwethu lobunikazi lokuqapha i-IST (Instrument Stability Test) isiqinisekiso sakho sokuthi amathuluzi ethu azohlangabezana namazinga adingekayo ezindaweni ezilawulwa yi-cGMP.I-IST izofakazela futhi, uma kunesidingo, ilinganise kabusha ithuluzi emjikelezweni wesikhathi ochaziwe ukuze kuqinisekiswe imiphumela elinganiswa i-Countstar. I-Altair ihlala inembile futhi izinzile phakathi nawo wonke umjikelezo wokuphila wokusetshenziswa.
Ubuhlalu obujwayelekile bokuminyana
- Isetshenziselwa ukulinganisa kabusha ukunemba nokunemba kwezilinganiso zokugxila ukuze kuqinisekiswe ikhwalithi yezilinganiso zansuku zonke.
- Futhi iyithuluzi eliyisibopho lokuvumelanisa nokuqhathanisa phakathi kwe-Countstar eminingana Amathuluzi e-Altair namasampuli.
- Izinga eli-3 elihlukene le-Density Standard Beads liyatholakala: 5 x 10 5 /ml, 2 x 10 6 /ml, 4 x 10 6 /ml.
Ubuhlalu obujwayelekile bokusebenza
- Isetshenziselwa ukulingisa amaleveli ahlukahlukene amasampuli aqukethe amaseli.
- Iqinisekisa ukunemba nokukhiqizwa kabusha kokulebula okubukhoma / okufile.Ifakazela ukuqhathanisa phakathi kwe-Countstar ehlukene Amathuluzi e-Altair namasampuli.
- Izinga eli-3 elihlukene le-Viability Standard Beads liyatholakala: 50%,75%,100%.
Ubuhlalu obujwayelekile be-Diameter
- Isetshenziselwa ukulinganisa kabusha ukuhlaziywa kobubanzi bezinto.
- Ifakazela ukunemba nokuzinza kwalesi sici sokuhlaziya.Ibonisa ukuqhathaniswa kwemiphumela phakathi kwe-Countstar ehlukene Amathuluzi e-Altair namasampuli.
- Izinga eli-2 elihlukene le-Diameter Standard Beads liyatholakala: 8 μm no-20 μm.
