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.