ADAM™ CellT Plus is an automated cell counter that is available in cGMP production environment which provides a comprehensive solution to comply with the requirements of 21 CFR Part 11.
Basic principle of counting – Total cell number and cell viability (AO/DAPI staining)
ADAM™ CellT Plus is an automated fluorescence cell counter that utilises Acridine Orange (AO) and DAPI (4′,6-diamidino-2-phenylindole) to stain total and dead cells, respectively.
AO/DAPI stain nucleated cells only, effectively excluding interferences such as debris and red blood cells in samples with complex backgrounds, thus providing accurate cell counts and viability analysis. Moreover, ADAM™ CellT Plus is equipped with bright field imaging capabilities, expanding its utility across a wide range of applications in both industrial and academic settings.
Cell Size Measurement & Cell Aggregation Rate
ADAM™ CellT Plus not only measures the number of total cells, viable cells, non-viable cells, and viability results. In addition, they analyses the cell size and cell aggregation ratio as well.
Accuracy & Repeatability
Correlation of PBMCs total counting between flow cytometry, manual count and ADAM™ CellT Plus.
Cell Therapeutic Applications
ADAM™ CellT Plus is ideal cell counter for the monitoring and QC of the cell numbers and viability in the process of manufacturing a variety of cells (CAR-T cells, stem cells, etc.) for Cell Therapy under cGMP production environment.
21 CFR Part 11 Compliance – User Management & Access Control
There are three designated user groups: Admin, Supervisor, and User.
Admin have the highest level of privileges that can set account level to the users or release the accessibility to the data.
Record & Audit Trail
Every action of users is recorded in an audit trail which includes the date, time, and specific details of the action. All action logs are recorded to ensure data integrity and traceability of data management.
Electronic Signature
All reports may be digitally signed. The electronic signature information includes the name and user ID of the signer, the date and time of signature execution and meaning (e.g. review or approval) of the signature.
Validation of ADAM™ CellT Plus
ADAM™ calibration bead and QC slide (optional) 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.
Specifications:
- Focus: Auto-focusing
- Objective lens: 4 X
- Measuring range: 5 X 10E4~2 X 10E7 cells/mL (Detectable); 4 X 10E5~1X 10E7 cells/mL (Optimal)
- Size and weight: 277 x 276 x 270mm, 7kg
- Loading volume: 15 uL / test
- Channel: Bright field / 2 Fluorescence (AO & DAPI)
- Staining method: Acridine orange / DAPI solution
- Measuring volume: 3.2 µL / test
- Measuring time: Accuracy mode (AO/DP, Default): 17 sec/test
- Fast mode (AO/DP): 10 sec/test
