Process Development
Yakajairika mashandisirwo muProcess Development yeBiopharma indasitiri senge kusarudzwa kwesero, kugadzirwa kwesero bhengi, masero ekuchengetedza mamiriro-ing, chigadzirwa goho optimization inoda kutariswa zvachose kwesero mamiriro paramita.Iyo Countstar Altair ndiyo yakakwana chishandiso chekutevera izvi zvinhu nenzira yakangwara, inokurumidza, inodhura-inoshanda, yakanyanya kunaka uye inotendeseka nzira.Inogona kubatsira kukurumidza kusimudzira maindasitiri-scale maitiro zvakanyanya.
Pilot uye Makuru-Scale Manufacturing
Inopindirana, yakawanda-parameter yekutarisa kwemutyairi uye akakura-masero tsika chinhu chinodzivirirwa chekuvimbisa yakakwana mhando yezvigadzirwa zvekupedzisira, zvisinei nesero pacharo kana intracellular kana zvinhu zvakavanzwa zviri mukutarisa kwemaitiro ekugadzira.Iyo Countstar Altair yakanyatso kuenderana nekukasira kuyedza batch mumitsara yekugadzira, yakazvimirira kubva kune yega bioreactor mavhoriyamu.
Quality Control
Kurapa kwakavakirwa pamasero ipfungwa dzinovimbisa dzekurapa kwezvikonzero zvakasiyana-siyana zvezvirwere.Sezvo masero pachawo ari mukutarisisa kwekurapa, kudzora kwemhando yepamusoro kweparamita yavo ndiyo nzira inoshanda yekupinza maseru zvinoenderana nezvinodiwa zvakafanotsanangurwa.Kubva pakuzviparadzanisa uye kupatsanurwa kwemasero evanopa, kutariswa kwefiriji yavo uye matanho ekufambisa, kusvika pakupararira uye kupfuudza kwemhando dzemasero akakodzera, iyo Countstar Altair ndiyo yakanakira sisitimu yekuyedza maseru pane chero akanyorwa mabasa.Analyzer ine nzvimbo yayo muhutongi hwemhando yepamusoro uye pasi pemvura kugadzirisa.
Zvese-mu-imwe, Compact Dhizaini
Iyo diki tsoka inosanganiswa nehuremu hwayo hunogona kuita inoita kuti Countstar Altair ive yakanyanya mobile analyzer, inogona kuchinjika nyore kubva kune imwe lab kuenda kune imwe.Iine yakabatanidzwa yekupedzisira-sensitive touchscreen uye CPU iyo Countstar Altair inopa mukana wekuona uye kuongorora iyo yakawanikwa data nekukasira uye inochengeta kusvika ku150,000 zviyero pane yayo yakaoma yakabatanidzwa hard disk drive.
Smart Nekukurumidza uye Intuitively-kushandisa
Iyo intuitive software interface inosanganiswa neiyo pre-yakaiswa BioApps (assay template protocol) inoumba hwaro hwekugadzika uye nekukurumidza kushanda kweCountstar Altair mumatanho matatu chete.Pinda mumatanho matatu chete uye asingasviki masekonzi makumi matatu / sampu yemifananidzo yako nemhedzisiro:
Danho Rokutanga: Stain 20µL yesampuli yako yesero
Danho repiri: Isa iyo siraidhi yekamuri uye sarudza yako BioApp
Danho rechitatu: Tanga kuongorora uye kuwana mifananidzo nemigumisiro pakarepo
Zvakarurama Uye Zvakarurama
Mibairo inogona kudhindwa zvakanyanya.
Unique Patented Fixed Focus Technology (FFT)
Iyo Countstar Altair ine yakanyanya kusimba, yakazara-simbi yakagadzirwa, yekuona bhenji, ine yedu patented Fixed Focus Technology yakabatanidzwa.Iko hakuna kudikanwa chero nguva kuti mushandisi we Countstar Altair agadzirise tarisiro nemaoko pamberi pekuyera.
Advanced Statistical Accuracy uye Precision
Kusvika kumatunhu matatu ekufarira pane imwechete kamuri uye kuyerwa kunogona kusarudzwa uye kuongororwa.Izvi zvinobvumira kuwedzera kwekuwedzera mukunyatso uye nekururama.Pachitokisi che 1 x 10 6 maseru/mL, iyo Countstar Altair inocherekedza maseru 1,305 mumatunhu matatu anofarira.Kuenzaniswa nebhuku rehemocytometer kuverenga, kuyera 4 masikweya ekuverenga grid, mushandisi anongotora 400 zvinhu, 3.26 nguva yakaderera pane mu Countstar Altair.
Yakanakisa mifananidzo mhinduro
Iyo 5 Megapixel yeruvara kamera pamwe chete neiyo 2.5x chinangwa inovimbisa yemhando yepamusoro mifananidzo.Inobvumira mushandisi kutora isingaenzaniswi morphological ruzivo rwesero rimwe nerimwe.
Innovative Image Recognition Algorithms
Isu takagadzira hunyanzvi hweMufananidzo Kuzivikanwa Algorithms, iyo iri kuongorora makumi maviri nenhatu maparamita echinhu chimwe nechimwe.Ichi ndicho chikonzero chisingadzivisiki chekujekesa, kusiyanisa kupatsanurwa kwemasero anoshanda uye akafa.
Kugadziriswa kuri nyore, kugadzirisa kuri nyore nekuda kwekuchinjika kwesoftware dhizaini uye pfungwa yeBioApps
Iyo BioApps yakavakirwa assay bvunzo menyu ndeye yakagadzika uye iri nyore-kushanda-kudya chimiro kugadzirisa maitiro ezuva nezuva bvunzo pa Countstar Altair kune ega hunhu hwemitsara yesero uye tsika nemagariro avo.Masetirwo eRudzi rweSero anogona kuyedzwa uye kuchinjirwa muHadhi Mode, BioApps nyowani inogona kuwedzerwa kune analyzer software neiyo nyore USB kurodha, kana kukopwa kune mamwe ma analyzer.Kuti zvive nyore, nzvimbo yedu yepakati yekuzivikanwa kwemifananidzo inogona zvakare kugadzira BioApps nyowani pahwaro hwe data yemifananidzo yakawanikwa yemutengi mahara.
Pfupiso yeMifananidzo Yakatorwa, Dhata, uye Histograms paKutarisa
Maonero anokonzeresa eiyo Countstar Altair inopa kukurumidza kuwana kune ese mifananidzo yakawanikwa panguva yechiyero, inoratidza ese akaongororwa data uye akagadzirwa histograms.Nekureruka kwemunwe kubata, mushandisi anogona kushandura kubva pakuona kuenda pakuona, activate kana kumisa-activate iyo yekuisa mazita.
Kuongorora kwe data
Diameter Distribution Histogram
Data Management
Iyo Countstar Rigel system inoshandisa yakavakirwa-mukati dhatabhesi ine yakaomesesa uye ergonomic dhizaini.Inopa vashandisi kuchinjika kwakanyanya maererano nekuchengetedza data uku vachiona yakachengeteka uye inoteedzera kubata kwemhedzisiro nemifananidzo.
Data Storage
Iine 500GB yema hard disk drives, inochengeta kusvika ku160,000 yakazara seti yedata rekuyedza kusanganisira mifananidzo.
Data Export
Sarudzo dzekuburitsa data dzinosanganisira PDF, MS-Excel, uye JPEG mafaera.Zvese zvinotengeswa kunze zviri nyore uchishandisa inosanganisirwa USB2.0 & 3.0 ekunze madoko
BioApp/Project Based Data Management
Itsva data yekuyedza yakarongwa mudhatabhesi nezita ravo reBioApp Project.Kuedza kunotevedzana kwepurojekiti kuchabatanidzwa kune maforodha otomatiki, zvichibvumira kukurumidza uye kwakachengeteka kudzoreredza.
Kuwana Nyore
Dhata inogona kusarudzwa nekuyedza kana zita reprotocol, zuva rekuongorora, kana mazwi akakosha.Yese data yakawanikwa inogona kuongororwa, kuongororwazve, kudhindwa, uye kutumirwa kunze kwenyika mune akasiyana mafomati.
FDA 21 CFR Chikamu11
Sangana neazvino mishonga uye kugadzira cGMP zvinodiwa
Iyo Countstar Altair yakagadzirirwa kusangana nemazuva ano emishonga uye yekugadzira cGMP zvinodiwa.Iyo software inowirirana ne21 CFR chikamu 11. Zvinhu zvakakosha zvinosanganisira tamper-resistant software, user access management, uye zvinyorwa zvemagetsi uye masiginecha anopa nzira yakachengeteka yekuongorora.IQ/OQ sevhisi uye PQ rutsigiro kubva kuCountstar tekinoroji nyanzvi dziripowo kupa.
Mushandisi Login
Mana-level mushandisi kuwana manejimendi
E-Siginecha uye Log Mafaira
Inokwidziridzwa yekusimbisa sevhisi (IQ/OQ) uye Yakajairwa Particle Kumiswa
Paunenge uchiita iyo Altair munzvimbo yakadzorwa, yedu IQ/OQ/PQ tsigiro inotanga nekukurumidza - tichasangana newe kana zvichidikanwa tisati taitwa.
Countstar inopa anodiwa magwaro ekusimbisa kuti akwanise iyo CountstarAltair yekuita hurongwa hwekuvandudza uye mabasa ekugadzira munzvimbo dzine hukama neCGMP.
Dhipatimendi redu reQA rakagadzira hurongwa hwakazara mukati-mumba kuti vatevedze cGAMP (Yakanaka Automation Manufacturing Practice) nhungamiro yekugadzira analyzer, kutanga kubva pachiridzwa uye software dhizaini maitiro kuburikidza neyekupedzisira fekitori yekugamuchira bvunzo dzemasisitimu uye zvinodyiwa.Isu tinovimbisa kubudirira kwechokwadi (IQ, OQ) pa-saiti, uye isu tichabatsira mukuita kwePQ.
Chiridzwa Kusimba Muedzo(IST)
Countstar yakagadzira hurongwa hwakazara hwekusimbisa yekuyedza kugadzikana uye huchokwadi hwezviyero zveAltair kuitira kuti ive nechokwadi cheiyo chaiyo uye inodhinda data yekuyera inotorwa zuva nezuva.
Yedu proprietary IST yekutarisa chirongwa (Instrument Stability Test) ndiyo vimbiso yako yekuti zviridzwa zvedu zvinosangana nemazinga anodiwa munzvimbo dzakadzorwa necGMP.Iyo IST icharatidza uye, kana zvichidikanwa, gadzirisa zvakare chiridzwa mukutenderera kwakatsanangurwa kwenguva kuvimbisa mhedzisiro yakayerwa neCountstar. Altair inoramba yakarurama uye yakagadzikana mukati mehupenyu hwese kutenderera kwekushandisa.
Density Standard Beads
- Inoshandiswa kugadzirisa zvakare huchokwadi uye huchokwadi hwezviyero zvekusimbisa kuona kunaka kwezviyero zvemazuva ese.
- Icho zvakare chishandiso chinosungirwa chekubatanidza uye kuenzanisa pakati akati wandei Countstar Altair zviridzwa uye samples.
- 3 chiyero chakasiyana cheDensity Standard Beads chiripo: 5 x 10 5 /ml, 2 x 10 6 /ml, 4 x 10 6 /ml.
Viability Standard Beads
- Inoshandiswa kutevedzera mazinga akasiyana-siyana ane maseru-ane samples.
- Inosimbisa huchokwadi uye kuberekazve kwehupenyu / kufa kunyora.Inoratidza kuenzaniswa pakati peakasiyana Countstar Altair zviridzwa uye samples.
- 3 chiyero chakasiyana cheViability Standard Beads chiripo: 50%, 75%,100%.
Diameter Standard Beads
- Inoshandiswa kugadzirisa zvakare dhayamita yekuongorora zvinhu.
- Inoratidza huchokwadi uye kugadzikana kwechinhu chekuongorora ichi.Inoratidza kuenzaniswa kwemhedzisiro pakati peakasiyana Countstar Altair zviridzwa uye samples.
- 2 chiyero chakasiyana cheDiameter Standard Beads chiripo: 8 μm uye 20 μm.
