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Countstar Altair

Yenzelwe ukusetyenziswa kwemihla ngemihla kwiindawo ezilawulwayo ze-cGMP

I-Countstar Altair ngumhlalutyi wemifanekiso eqaqambileyo esekwe kwintsimi, eyenzelwe ukujonga ngokuzenzekelayo iiseli ezincancisayo, iifungi kunye nokunqunyanyiswa kwamasuntswana.Ngokusekelwe kwi-metal-designed optical bench equlethe isisombululo esiphezulu sekhamera ye-5 (5) ye-Mega ye-CMOS yombala we-Mega Pixel ngokudibanisa ne-lens yokukhulisa i-2.5 ephezulu, kunye ne-Fixed Focus Technology edibeneyo ye-Fixed Focus Technology rhoqo eneenkcukacha kunye nemifanekiso ebukhali.Indlela yesilayidi yegumbi elizenzekelayo ivumela uhlalutyo olulandelelanayo ukuya kuthi ga kwiisampulu ezintlanu ngokulandelelana kunye nomboniso wayo ophilayo.Ii-algorithms zemifanekiso yethu yobunini ziyilwe ngezona ndlela ziphezulu zokuqaphela iiseli.I-Countstar Altair iya kwenza ukuba umsebenzisi amisele ngokuchanekileyo ugxininiso lweseli, ukusebenza kweseli, idiameter yeseli, inqanaba lokudityaniswa kwezinto, kunye nokungqukuva kwazo, ngokusekwe kwiindlela ezimisiweyo zokungcolisa ezifana ne-Trypan Blue.

 

Ubungakanani bezicelo

  • Uphuhliso lweNkqubo
  • I-Pilot kunye neMveliso eNkulu
  • Ulawulo lwemeko

 

Ukuthotyelwa kokusetyenziswa kwimo engqongileyo ye-cGxP

  • Imisayino ye-E kunye neefayile zelog yenkqubo ngokuthobela i-FDA's 21 CFR iSigaba 11
  • Inqanaba lesine, ulawulo lomsebenzisi olukhuselweyo
  • Isiseko sedatha esifihliweyo seziphumo kunye nemifanekiso
  • Ukuphuma okulungisekayo kunye nesici sokuvala
  • Isishwankathelo
  • Iimpawu zeTekhnoloji
  • Khuphela
Isishwankathelo

Uphuhliso lweNkqubo

Izicelo eziqhelekileyo kuPhuhliso lweNkqubo yoshishino lwe-Biopharma olufana nokukhethwa komgca weeseli, ukuveliswa kwebhanki yeeseli, ukugcinwa kwemeko yokugcinwa kweeseli, ukulungiswa kwemveliso yemveliso kufuna ukubeka iliso ngokusisigxina kwiiparamitha zesimo seseli.I-Countstar Altair sesona sixhobo sifanelekileyo sokulandela ezi nkalo ngendlela ekrelekrele, ekhawulezayo, eyonga iindleko, ichaneke kakhulu kwaye inokuqinisekiswa.Inganceda ukukhawulezisa uphuhliso lweenkqubo zesikali semizi-mveliso kakhulu.

 

 

I-Pilot kunye neMveliso eNkulu

Ukujongwa okuhambelanayo, i-multi-parameter monitoring ye-pilot kunye ne-cell-scale-scale cultures yinto efunekayo yokuqinisekisa umgangatho ophezulu weemveliso zokugqibela, ezizimeleyo kwiseli ngokwazo okanye izinto zabo ze-intracellular okanye ezifihliweyo ekugxininiseni inkqubo yokuvelisa.I-Countstar Altair ifaneleke ngokugqibeleleyo ukuvavanya ibhetshi rhoqo kwimigca yemveliso, ezimeleyo kwimiqulu ye-bioreactor nganye.

 

 

Ulawulo lwemeko

Unyango olusekwe kwiiseli ziingqikelelo ezithembisayo kunyango lwezizathu ezahlukeneyo zezigulo.Njengoko iiseli ngokwazo zigxile kunyango, ulawulo oluphezulu lwemigangatho yeparameters yeyona ndlela isebenzayo yokufaka iiseli ngokweemfuno ezichazwe kwangaphambili.Ukususela ekuzihlukaniseni kunye nokuhlelwa kweeseli zabaxhasi, ukubeka iliso kwiifriji zabo kunye namanyathelo okuthutha, ukuya ekwandeni kunye nokugqithiswa kweentlobo zeeseli ezifanelekileyo, i-Countstar Altair yinkqubo efanelekileyo yokuvavanya iiseli kuyo nayiphi na imisebenzi edwelisiweyo.I-analyzer enendawo yayo kulawulo lomgangatho wokusetyenzwa okuphezulu kunye nokwehla.

 

 

 

Yonke-kwinye, uyilo oluQinisekileyo

Unyawo oluncinci ludityaniswe nobunzima obunokwenzeka benza i-Countstar Altair ibe sihlalutyi esihamba kakhulu, esinokutshintshwa ngokulula ukusuka kwenye ilebhu ukuya kwenye.Ngescreen sayo esidityanisiweyo se-ultra-sensitive touchscreen kunye ne-CPU i-Countstar Altair inika ithuba lokujonga kwaye uhlalutye idatha efunyenweyo ngokukhawuleza kwaye igcine ukuya kuthi ga kwi-150,000 yemilinganiselo kwi-hard disk edityanisiweyo ye-hard drive.

 

 

I-Smart ekhawulezayo kunye ne-Intuitive-to-ukusebenzisa

Ujongano lwesoftware esebenzayo ludityaniswe neBioApps efakwe ngaphambili (iiprothokholi zetemplate zovavanyo) zenza isiseko sokusebenza ngokukhululeka nangokukhawuleza kwe-Countstar Altair ngamanyathelo amathathu kuphela.Ngena ngamanyathelo ama-3 kuphela kwaye ngaphantsi kwemizuzwana engama-30 / isampula yemifanekiso yakho kunye neziphumo:

Inyathelo lokuQala: Stain 20µL yesampulu yeseli yakho

Inyathelo lesiBini: Faka isilayidi segumbi kwaye ukhethe i-BioApp yakho

Inyathelo lesiThathu: Qala uhlalutyo kwaye ufumane imifanekiso kunye neziphumo ngokukhawuleza

 

 

Iziphumo ezichanekileyo nezichanekileyo

Iziphumo ziyakwazi ukuveliswa kwakhona.

 

 

ITekhnoloji yoJoliso eGxilwe kwilungelo elilodwa lomenzi wechiza (FFT)

I-Countstar Altair iqulethe ibhentshi eyomeleleyo, eyenziwe ngesinyithi epheleleyo, enelungelo elilodwa lomenzi wechiza iFixed Focus Technology edityanisiweyo.Akukho mfuneko nangaliphi na ixesha ukuba umqhubi we-Countstar Altair alungelelanise ugxininiso ngesandla phambi kokulinganisa.

 

Ukuchaneka koBalo oluPhezulu kunye nokuchaneka

Ukuya kuthi ga kwimimandla emithathu yomdla ngegumbi elinye kunye nokulinganisa kunokukhethwa kwaye kuhlalutywe.Oku kuvumela ukwanda okongeziweyo kokuchaneka nokuchaneka.Kugxininiso lweseli ye-1 x 10 6 iiseli/mL, i-Countstar Altair ibeka iliso kwiiseli eziyi-1,305 kwimimandla emi-3 enomdla.Xa kuthelekiswa nezibalo ze-hemocytometer ye-manual, ukulinganisa izikwere ezi-4 zegridi yokubala, umqhubi uya kubamba kuphela izinto ezingama-400, amaxesha angama-3.26 ngaphantsi kwe-Countstar Altair.

 

 

Iziphumo ezigqwesileyo zemifanekiso

Ikhamera ye-5 ye-Megapixel yombala ngokudibanisa kunye nenjongo ye-2.5x iqinisekisa imifanekiso ephezulu.Ivumela umsebenzisi ukuba abambe iinkcukacha zemorphological ezingalinganiyo zeseli nganye.

 

 

Ii-algorithms zoKuqatshelwa koMfanekiso

Siye saphuhlisa ii-Algorithms zokuQatshelwa koMfanekiso, ezihlalutya iiparamitha ezingama-23 zento nganye.Esi sisiseko esingenakuthintelwa sohlelo olucacileyo, olwahlukileyo lweeseli ezisebenzayo nezifileyo.

 

 

Ukuziqhelanisa ngokulula, ukwenza lula ngenxa yoyilo lwesoftware ebhetyebhetye kunye nomxholo weBioApps

Imenyu yovavanyo olusekwe kwi-BioApps yinto ekhululekileyo kwaye kulula ukuyitya ukwenza ngokwezifiso iimvavanyo zemihla ngemihla kwi-Countstar Altair kwiimpawu zomntu ngamnye wemigca yeeseli kunye neemeko zabo zenkcubeko.Izicwangciso zoHlobo lweSeli zinokuvavanywa kwaye zilungelelaniswe kwiModi yokuHlela, i-BioApps entsha inokongezwa kwi-software ye-analyzer ngokulayishwa kwe-USB elula, okanye ikopishwe kwabanye abahlalutyi.Ukulungiselela okuphezulu, indawo yethu ephambili yokuqondwa kwemifanekiso inokuyila ii-BioApps ezintsha kwisiseko sedatha yemifanekiso efunyenweyo yomthengi simahla.

 

 

Isishwankathelo seMifanekiso eFundiweyo, iDatha, kunye neeHistograms ngokuJonga nje

Umbono obangelwayo we-Countstar Altair unika ukufikelela ngokukhawuleza kuyo yonke imifanekiso efunyenwe ngexesha lokulinganisa, ibonisa yonke idatha ehlalutyiweyo kunye ne-histograms eyenziwe.Ngokuchukumisa umnwe olula, umsebenzisi unokutshintsha ukusuka kwimboniselo ukuya kwimboniselo, avule okanye avale imo yokuleyibhile.

 

Isishwankathelo sedatha

 

 

I-Histogram yokusasazwa kweDiameter

 

Ulawulo lwedatha

Inkqubo ye-Countstar Rigel isebenzisa i-database eyakhelwe-ngaphakathi kunye noyilo oluyinkimbinkimbi kunye ne-ergonomic.Inika abaqhubi ukuguquguquka okukhulu malunga nokugcinwa kwedatha ngelixa uqinisekisa ukuphathwa ngokukhuselekileyo kunye nokulandeleka kweziphumo kunye nemifanekiso.

 

 

Ugcino lwedatha

Nge-500GB ye-hard disk drives, igcina ukuya kuthi ga kwi-160,000 yeeseti ezipheleleyo zovavanyo oluquka imifanekiso.

 

Ukuthunyelwa ngaphandle kwedatha

Ukhetho lwemveliso yedatha lubandakanya iPDF, iMS-Excel, kunye neefayile zeJPEG.Zonke ezithunyelwa ngaphandle ngokulula usebenzisa i-USB2.0 kunye ne-3.0 yamazibuko angaphandle

 

 

Ulawulo lweDatha eSekwe kwiProjekthi yeBioApp/

Idatha yovavanyo olutsha luhlelwe kwisiseko sedatha ngegama labo leProjekthi ye-BioApp.Imifuniselo elandelelanayo yeprojekthi iya kudityaniswa kwiifolda zabo ngokuzenzekelayo, ivumela ukufunyanwa ngokukhawuleza nokukhuselekileyo.

 

 

Ukubuyiswa okulula

Idatha inokukhethwa ngokulinga okanye igama leprotocol, umhla wokuhlalutya, okanye amagama angundoqo.Yonke idatha efunyenweyo inokuphononongwa, ihlalutywe kwakhona, iprintwe, kwaye ithunyelwe ngaphandle kwiifomathi ezahlukeneyo.

 

 

I-FDA 21 CFR Icandelo11

Ukuhlangabezana neemfuno zale mihla zamayeza kunye ne-cGMP yokuvelisa

I-Countstar Altair yenzelwe ukuhlangabezana neemfuno zale mihla zamayeza kunye nemveliso ye-cGMP.I-software ihambelana ne-21 CFR inxalenye ye-11. Iimpawu eziphambili ziquka i-software ekwazi ukumelana ne-tamper, ulawulo lokufikelela komsebenzisi, kunye neerekhodi ze-elektroniki kunye neesignesha ezibonelela ngomkhondo wophicotho okhuselekileyo.Inkonzo ye-IQ/OQ kunye nenkxaso ye-PQ evela kwiingcali zobugcisa be-Countstar nazo ziyafumaneka ukubonelela.

 

 

Ngena komsebenzisi

 

 

Amanqanaba amane olawulo lokufikelela komsebenzisi

 

 

I-E-Signatures kunye neeFayile zeLog

 

 

Inkonzo yokuqinisekisa ephuculweyo (IQ/OQ) kunye nokuMiswa kweNqaku eliMgangatho

Xa kuphunyezwa i-Altair kwindawo elawulwayo, inkxaso yethu ye-IQ / OQ / PQ iqala ngokukhawuleza - siya kudibana nawe xa kuyimfuneko ngaphambi kokuphunyezwa kwesiqinisekiso.

I-Countstar ibonelela ngamaxwebhu okuqinisekisa ayimfuneko ukuze ifanelekele i-CountstarAltair ukwenza inkqubo yophuhliso kunye nemisebenzi yokuvelisa kwiindawo ezinxulumene ne-cGMP.

Isebe lethu le-QA liseke isiseko esibanzi ngaphakathi kwindlu ukuthobela i-cGAMP (i-Good Automation Manufacturing Practice) izikhokelo zokuvelisa abahlalutyi, ukususela kwisixhobo kunye nenkqubo yoyilo lwesoftware ngovavanyo lokugqibela lokwamkelwa kwefektri kwiinkqubo kunye nezinto ezisetyenziswayo.Siqinisekisa ukuqinisekiswa okuyimpumelelo (IQ, OQ) kwisayithi, kwaye siya kunceda kwinkqubo ye-PQ.

 

Uvavanyo loZinzo lwesixhobo (IST)

I-Countstar iseke isicwangciso sokuqinisekisa esibanzi sokuvavanya ukuzinza kunye nokuchaneka kwemilinganiselo ye-Altair ukwenzela ukuba kuqinisekiswe ukuba idatha yomlinganiselo ochanekileyo kunye nokuveliswa kwakhona iyabanjwa yonke imihla.

Inkqubo yethu yokubeka iliso ye-IST (uVavanyo loZinzo lwe-Instrument) sisiqinisekiso sakho sokuba izixhobo zethu ziya kuhlangabezana nemigangatho efunekayo kwimimandla elawulwa yi-cGMP.I-IST iya kungqina kwaye, ukuba kuyimfuneko, iphinde ilungelelanise isixhobo kumjikelo wexesha ochaziweyo ukuqinisekisa iziphumo ezilinganiswe yi-Countstar.   I-Altair ihlala ichanile kwaye izinzile ngexesha lomjikelo wobomi wokusetyenziswa.

 

 

Amaso aMigangatho yoXinaniso

  • Isetyenziselwa ukulinganisa kwakhona ukuchaneka kunye nokuchaneka kwemilinganiselo yoxinaniso ukuqinisekisa umgangatho wemilinganiselo yemihla ngemihla.
  • Ikwasisixhobo esisisinyanzelo sokudibanisa kunye nokuthelekisa phakathi kwe-Countstar ezininzi   Izixhobo zeAltair kunye neesampuli.
  • Imigangatho emi-3 eyahlukeneyo ye-Density Standard Beads iyafumaneka: 5 x 10 5 /ml, 2 x 10 6 /ml, 4 x 10 6 /ml.

 

 

Viability Standard Beads

  • Isetyenziselwa ukulinganisa amanqanaba ahlukeneyo eisampulu ezineseli.
  • Iqinisekisa ukuchaneka kunye nokuveliswa kwakhona kwelebhile ephilayo / efileyo.Ingqina ukuthelekisa phakathi kwe-Countstar eyahlukileyo   Izixhobo zeAltair kunye neesampuli.
  • Imigangatho emi-3 eyahlukeneyo ye-Viability Standard Beads iyafumaneka: 50%,75%,100%.

 

 

I-Dimeter Standard Beads

  • Isetyenziselwa ukulinganisa kwakhona uhlalutyo lwedayamitha yezinto.
  • Ingqina ukuchaneka kunye nokuzinza kolu phawu lohlalutyo.Ibonisa ukuthelekiseka kweziphumo phakathi kwe-Countstar eyahlukileyo   Izixhobo zeAltair kunye neesampuli.
  • Imigangatho emi-2 eyahlukeneyo ye-Diameter Standard Beads iyafumaneka: 8 μm kunye ne-20 μm.

 

Iimpawu zeTekhnoloji

 

 

Iinkcukacha zobuGcisa
Umzekelo Countstar Altair
Uluhlu lwe-diameter 3μm ~ 180μm
Uluhlu lokugxila 1 × 10 4 ~ 3 × 10 7 /mL
Ukwandiswa kwenjongo 2.5x
Isiqalelo somfanekiso

Ikhamera ye-CMOS ene-5-megapixel

i-USB 1×USB 3.0 1×USB 2.0
Ugcino 500GB
i-ram I4GB
Ukunikezwa Amandla 110 ~ 230 V/AC, 50/60Hz
Ikhusi 10.4 intshi yesikrini esichukumisayo
Ubunzima 13kg (28lb)
Ubungakanani (W×D×H) Umatshini: 254mm×303mm×453mm

Ubungakanani bephakheji: 430mm×370mm×610mm

Ubushushu bokusebenza 10°C ~ 40°C
Ukufuma okusebenzayo 20% ~ 80%

 

 

IiNgcaciso zesilayidi
Izinto eziphathekayo I-Polymethyl Methacrylate (PMMA)
Imilinganiselo: 75 mm (w) x 25 mm (d) x 1.8 mm (h)
Ubunzulu beGumbi: 190 ± 3 μm (kuphela yi-1.6% ukutenxa ukuchaneka okuphezulu)
Umthamo wegumbi 20 μl

 

 

Khuphela
  • Incwadana ye-Countstar Altair.pdf Khuphela
  • Khuphela iFayile

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