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I-Countstar Altair

Idizayinelwe ukusetshenziswa nsuku zonke ezindaweni ezilawulwa yi-cGMP

I-Countstar Altair iyisihlaziyi sesithombe esisekelwe enkambini esikhanyayo, esidizayinelwe ukuqapha okuzenzakalelayo kwamaseli ezincelisayo, ukhunta nokumiswa kwezinhlayiyana.Kusekelwe ebhentshini eligcwele lensimbi elakhiwe ngensimbi eliqukethe ikhamera yombala we-CMOS enokulungiswa okuphezulu kweMega Pixel emihlanu (5) ihlanganiswe nelensi yokukhulisa engu-2.5 enesilinganiso esiphezulu, kanye nobuchwepheshe obuhlanganisiwe be-Fixed Focus ukuze uthole izithombe eziningiliziwe nezibukhali.Indlela yesilayidi yegumbi elizenzakalelayo ivumela ukuhlaziya okulandelanayo kwamasampuli afika kwamahlanu ngokulandelana okukodwa kanye nesici sawo sokubuka bukhoma.Ama-algorithms ethu ezithombe zobunikazi aklanywe ngamasu athuthuke kakhulu okuqaphela amaseli.I-Countstar Altair izovumela umsebenzisi ukuthi anqume ngokunembile ukugxiliswa kweseli, ukusebenza kweseli, ububanzi beseli, ileveli yokuhlanganisa yezinto, kanye nokuba yindilinga kwazo, ngokusekelwe ezindleleni zamabala ezimisiwe ezifana nokukhishwa kwe-Trypan Blue.

 

Ububanzi Bezicelo

  • Ukuthuthukiswa Kwenqubo
  • I-Pilot kanye Nokukhiqiza Okukhulu
  • Ikhwalithi yokulawula

 

Ukuvumelana ukuze kusetshenziswe ezindaweni ze-cGxP

  • Ama-E-siginesha namafayela okungena esistimu ngokuthobelana ne-FDA's 21 CFR Ingxenye 11
  • Izinga lesine, ukuphathwa komsebenzisi okuvikelwe ngephasiwedi
  • Isizinda sedatha esibethelwe semiphumela nezithombe
  • Isici esilungisekayo sokuphuma nokuvala shaqa
  • Uhlolojikelele
  • I-Tech Specs
  • Landa
Uhlolojikelele

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.

 

I-Tech Specs

 

 

Imininingwane Yezobuchwepheshe
Imodeli I-Countstar Altair
Ibanga lobubanzi 3μm ~ 180μm
Ibanga lokugxila 1 × 10 4 ~ 3 × 10 7 /mL
Ukukhulisa inhloso 2.5x
Isici sokufanekisa

Ikhamera ye-CMOS engu-5-megapixel

I-USB 1×USB 3.0 1×USB 2.0
Isitoreji 500GB
RAM 4GB
Ukunikezwa kwamandla kagesi 110 ~ 230 V/AC, 50/60Hz
Isikrini 10.4 intshi isikrini esithintwayo
Isisindo 13kg (28lb)
Usayizi (W×D×H) Umshini: 254mm×303mm×453mm

Usayizi wephakheji: 430mm×370mm×610mm

Izinga lokushisa lokusebenza 10°C ~ 40°C
Umswakama osebenzayo 20% ~ 80%

 

 

Imininingwane Yesilayidi
Okubalulekile I-Polymethyl Methacrylate (PMMA)
Ubukhulu: 75 mm (w) x 25 mm (d) x 1.8 mm (h)
Ukujula Kwegumbi: 190 ± 3 μm (ukuchezuka okungu-1.6% kuphela ngokunemba okuphezulu)
Ivolumu yeChamber 20 ml

 

 

Landa
  • I-Countstar Altair Brochure.pdf Landa
  • Ukulanda ifayela

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