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ADAM CellT – automatyczny licznik komórek zgodny z cGMP/CFR21

ADAM-CellT is an automated cell counter that is available in cGMP production environment. It has an easy-to-use built-in tablet and complies with 21 CFR part 11. When 21 CFR part 11 mode is activated, data cannot be modified by any user.

Numer katalogowy Model Zasilanie
ADAM-CellT ADAM CellT 230V 50/60Hz
Dodaj do Koszyka Zapytań (możesz wybrać kilka produktów) lub napisz na alab@alab.com.pl
Wymiary 227 x 276 x 270 mm
Waga 7 kg
Czas pomiaru 25 sek.
Zakres pomiarowy 5x10^4 – 4x10^6 komórek/ml
Wyświetlacz Tak
Inne Technika oznaczenia oparta na barwieniu jodkiem propidyny
Urządzenie automatycznie zlicza wszystkie komórki oraz komórki martwe
Urządzenie pozwala na ustalenie żywotności próby- liczone automatycznie przez aparat
Możliwość implementacji zewnętrznego wyświetlacza na którym można obserwować zliczane jądra komórkowe oraz martwe komórki
Numeracja prób
Uzyskiwane wyniki zapisywane w pamięci urządzenia (200 zapamiętanych pomiarów)
Możliwość podłączenia komputera do urządzenia oraz eksportu danych do programu Excel
Możliwości oprogramowania Podgląd zliczanych jąder komórkowych
Podgląd zliczanych martwych komórek
Oprogramowanie zgodne z CFR21 / cGMP
Pełna rejestracja działań Użytkownika
Analiza wykresów tworzonych przez oprogramowanie

OPIS

Key features and benefits

  • Cell Therapeutic Applications – ideal device for monitoring and QC of the cell numbers and viability in the process of manufacturing cells (CAR-T cells, stem cells, etc.) for Cell Therapy.
  • Automatic image analysis – Designed to measure cell count and viability accurately and precisely
  • Very fast – the ADAM™MC2 takes less than 25 seconds
  • Accuracy & Repeatability – High accuracy with unique image cytometer technique
  • Counting aggregated and irregular-shaped cells – ADAM-MC2 provides accurate and reliable results because it counts aggregated and irregular-shaped cells
  • Broad range – Measures cell concentrations ranging from 5 x 10^4 to 4 x 10^6 cells/ml and cells with sizes rangingbfrom 3 µm to 50 µm
  • CFR21 compliance – Also available in cGMP production environment that needs to be monitored during the manufacturing of cell therapy products.
  • Data Management – Every action of users is recorded in an audit trail which includes the date, time, and specific details of the action

 

Accurate Automated Cell Counter for cGMP

ADAM-CellT complies with 21 CFR part 11. When 21 CFR part 11 mode is activated, data cannot be modified by any user. Every action is recorded in an audit trail including the date, time and specific details of the action.

ADAM calibration beads allow quick diagnosis when problems occur, which ensures accuracy of the instrument.

  • Accurate results for cell counting and viability
  • 21 CFR part 11 compliance
  • Cell therapy quality control
  • Various applications: stem cell/ CAR-T cell/ CAR-NK cell/ Adipose-derived stem cell

 

Data Management

ADAM-CellT complies 21 CFR part 11 which is a regulation about electronic records and signatures for use in cGMP facilities.
When 21 CFR Part 11 mode is activated, data cannot be modified by any user.
Every action of users is recorded in an audit trail which includes the date, time, and specific details of the action.

 

Application

  • Stem cells
  • CAR-NK cells
  • Whole blood cells
  • Adipose-derived stem cells
  • CAR-T cells
  • PBMCs
  • Aggregated cells
  • and much more..

 

Validation of ADAM-CellT

ADAM calibration beads allow quick diagnosis when problems occur, which ensures accuracy of the instrument. Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are designed to validate performance of the instrument.

 

The ADAM-MC2 utilizes sensitive fluorescence dye staining (PI), LED optics and CCD detection technologies to make the cell analysis more accurate and reliable.
It complies with 21 CFR part 11 which is a regulation about electronic records and signatures for use in cGMP facilities.

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