Countstar BioTech

Mohlahlobi oa hau o nepahetseng le o tšepahalang oa tlhahlobo ea tlhahiso ea lisele

The Countstar BioTech e kopanya kh'amera ea mebala ea 5-megapixels ea CMOS le benche ea rona ea "Fixed Focus Technology" e nang le patente e felletseng ea tšepe ho lekanya ka nako e ts'oanang mahloriso a lisele, ho sebetsa, kabo ea bophara, ho pota-pota, le sekhahla sa ho kopanya potolohong e le 'ngoe ea liteko.Li-algorithms tsa rona tsa "software" li ntlafalitsoe bakeng sa temoho e tsoetseng pele le e felletseng ea lisele.

Sebaka sa Likopo

Countstar BioTech e ka sebelisoa ho sekaseka mefuta eohle ea litloaelo tsa lisele tsa mammalia, lisele tsa likokoanyana, lisele tse ngata tse fapaneng tsa mofetše, le lisebelisoa tsa mantlha tse emisitsoeng lipatlisisong, nts'etsopele ea ts'ebetso le tikoloho ea tlhahiso e laoloang ke cGMP.

Likarolo tsa Tekheniki / Melemo ea mosebelisi

Litlhahlobo tse ngata tsa Mehlala ho Slide e le 'Ngoe
Sekaseka disampole kgafetsa mme o tlohelle sistimi hore e bale karolelano ka bo eona ho lefa inhomogeneities
Sebaka se Seholo sa Pono
Ho ipapisitsoe le boholo ba lisele le sampole, lisele tse fihlang ho 2,000 li ka hlahlojoa setšoantšong se le seng.
Khamera ea Mmala ea 5-Megapixel
E fumana litšoantšo tse hlakileng, tse hlakileng le tse hlakileng
Analysis of Cell Aggregates
E lemoha le ho arola lisele tse le 'ngoe esita le ka har'a kakaretso
Netefatso e Hlakileng ea Liphetho
Fetolela ka hare ho pono ea sephetho lipakeng tsa setšoantšo se fumanweng, se tala le ho bona lisele tse ngotsweng
Ho Nepaha le ho Nepaha
Coefficient of variation (cv) lipakeng tsa liphetho tsa aliquots ka hare ho likamore tse 5 tsa slide ke <5%
Harmonization of Analyzers
Papiso ea analzer-to-analyzer ea lisebelisoa tsa Countstar BioTech e bonts'itse coefficient of variation (cv) <5%
Molumo o Fokotsoeng oa Mohlala
Ke 20 μL feela ea sampuli e hlokahalang bakeng sa ho tlatsa kamore e le 'ngoe.Sena se lumella ho etsa lisampole khafetsa, mohlala, ho tsoa litloaelong tsa lisele tsa mini-bioreactor
Nako e Khutšoane ea Teko
Ka nako e ka tlase ho metsotsoana e 20 esita le litšoantšo tse rarahaneng li hlahlojoa ke li-algorithms tsa rona tse ncha.
Theko e tlase, e Sebelisang Nako hantle, le Lintho tse ka tšoarellang
Sebopeho sa rona se ikhethileng sa Chamber Slide se thusa tlhahlobo e latellanang ea lisampole tse fihlang ho tse 5 ka tatellano e le 'ngoe, le ho fokotsa tlhahiso ea litšila haholo.

Lintlha
Litlhaloso tsa Tekheniki
Khoasolla

Lintlha

Ts'ebeletso ea rona ea netefatso ea IQ/OQ/PQ e ikhethileng

Re nts'etsapele, ho latela litokomane tsa rona tse tloaelehileng, bakeng sa bareki ba rona lifaele tsa IQ / OQ ka bomong mme re li tšehetsa ts'ebetsong ea netefatso, le lits'ebetso tsa PQ (ka meralo ea linyeoe tsa liteko)

Software ea Countstar BioTech

1. Ts'ebetso e sireletsehileng le e lumellanang

Taolo e felletseng ea phihlello ea basebelisi ba maemo a 4, li-signature tsa E-automatic, encryption ea litšoantšo le liphetho tsa data base e sirelelitsoeng, hammoho le lifaele tsa log tse sa fetoheng li lumella ts'ebetso ho latela litataiso tsa 'nete tsa cGxP.

2. Tlhahlobo ea Boitsebiso bo Tsoetseng Pele

The Countstar BioTech e fana ka likarolo tse tsoetseng pele tsa tlhahlobo ea data, e kopanyang Chate ea Nako ea Temo (CTCs), tlhahlobo e akaretsang, le tlhahlobo ea papiso e tobileng ea lisampole tse fapaneng.

3. Sephetho sa data

Ho na le lifomate tse fapaneng tsa tlhahiso ea data: li-spreadsheet tsa MS-Excel, litlaleho tsa PDF tseo u ka li khethang, lifaele tsa litšoantšo tsa JPEG tse kopaneng, kapa lithempleite tse hatisitsoeng ka kotloloho.

4. Tšireletso ea cGMP e lumellanang le tsamaiso ea data

Tsamaiso ea data ea Countstar BioTech e ikamahanya le likarolo tsohle le melaoana ea 'nete ea FDA's 21 CFR Karolo ea 11. ID ea mosebelisi, litempe tsa nako ea tlhahlobo, liparamente, le litšoantšo li bolokoa ka mokhoa oa data o patiloeng.

Litlhaloso tsa Tekheniki

Litlhaloso tsa Tekheniki
Sephetho sa Lintlha	Tsepamiso, Ts'ebetso, Diameter, Aggregation, Roundness (Ho tsamaellana)
Mekhahlelo ea Tekanyo	5.0 x 10 ⁴ – 5.0 x 10 ⁷ /ml
Boholo Range	4 - 180 μm
Molumo oa Phaposi	20 μl
Nako ea Tekanyo	<20s
Sephetho Format	JPEG/PDF/MS-Excel spreadsheet
Phello	5 lisampole / Countstar Chamber Slide

Litlhaloso tsa Slide
Lintho tse bonahalang	Poly(methyl) Methacrylate (PMMA)
Boholo:	75 mm (w) x 25 mm (d) x 1.8 mm (h)
Botebo ba Chamber:	190 ± 3 μm (feela 1.6% e kheloha bakeng sa ho nepahala ho phahameng)
Molumo oa Phaposi	20 μl

Khoasolla

Bukana ea Countstar BioTech.pdf Khoasolla