ADAM-CellT Automated Cell Counter for cGMP - Labor İldam
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.

Key Features & Benefits
• Less than 25 sec to get results
• Cell therapy quality control
• 21 CFR part 11 compliance
• Stem cell, CAR-T cell, CAR-NK cell, Adipose-derived stem cell
• Accurate cell counting and viability
• Automated image analysis


Product name / Cat. No.

ADAM CellT / ADAM-CellT

Loading Volume

23 μL (2ch), 13 μL (4ch)

Measuring Volume

8.6 μL/test (2ch), 3.4 μL/test (4ch)

Measure range

5 X 10E4 ~ 4 X 10E6 cells/mL

Focus

Auto-focusing

LED

4W Green LED

Weight

7.0 Kg

Size

277 X 276 X 270 mm

Analysis time

< 50 sec / test (2ch), < 25 sec / test (4ch)

Dyes

PI (Propidium Iodide)

Connectivity

WiFi (USB Dongle)

Cell type

Cell line (clumpy cell, single cell), PMBCs, Adipose Stem cell, Total white blood cell, Primary cells



Various Applications 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

Viability Measurement -PI-Staining Method

  • After the samples are stained with fluorescent dye, propidium iodide, which intercalates DNA to stain the nucleus of target cells, ADAM-MC2 takes fluorescent images automatically.
  • The obtained images are processed by image analysis software integrated inside the system

Data Management- 21 CFR Part 11 Compliance

  • 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. Electronic signatures based upon biometrics are designed to ensure that they cannot be reused by, or assigned to, anyone else.

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.

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