Countstar Mira FL Plus Automated Fluorescent Cell Analyzer
| Brand | Countstar |
|---|---|
| Origin | Shanghai, China |
| Model | Mira FL Plus |
| Measurement Time | 20–50 s |
| Cell Concentration Range | 1×10⁴ – 3×10⁷ cells/mL |
| Sample Volume | 20 µL |
| Throughput | 5 samples per run |
| Detectable Cell Size Range | 1–180 µm |
| Imaging Sensor | 8.3 MP CMOS |
| Optical Resolution | Enhanced via fixed-focus optical architecture |
| Fluorescence Channels | AO/PI, GFP, RFP |
| Compliance | FDA 21 CFR Part 11, GMP-aligned data integrity framework |
Overview
The Countstar Mira FL Plus Automated Fluorescent Cell Analyzer is an engineered solution for high-precision, fluorescence-enabled cell quantification and viability assessment in research and quality-controlled bioprocessing environments. Built upon a dual-modal imaging principle—combining brightfield morphology analysis with multi-channel fluorescence detection—the instrument delivers quantitative metrics including total cell count, viable/non-viable discrimination (via trypan blue, acridine orange/propidium iodide), and transfection efficiency (GFP/RFP expression). Its fixed-focus optical architecture eliminates manual focusing variability, ensuring consistent depth-of-field across all sample runs. Coupled with an 8.3-megapixel CMOS sensor and high-transmission optical lens assembly, the system captures >2× the effective analysis area of a standard hemocytometer, enabling statistically robust sampling from minimal volumes (20 µL). The platform is purpose-built for reproducibility in routine QC workflows and early-stage cell therapy development.
Key Features
- Fixed-focus optical design ensures repeatable image acquisition without user intervention or calibration drift.
- Dual-mode imaging engine supports simultaneous brightfield and up to three fluorescence channels (AO/PI, GFP, RFP) on a single field-of-view.
- AI-powered image segmentation and classification algorithm trained on diverse mammalian, insect, and suspension-adapted cell lines—optimized for morphological heterogeneity and low-contrast fluorescence signals.
- Validated measurement range: 1×10⁴ to 3×10⁷ cells/mL; detectable particle size: 1–180 µm—enabling accurate enumeration of primary T-cells, hybridomas, CHO, HEK293, and organoid-derived aggregates.
- Integrated thermal management maintains stable sensor performance during sequential runs, minimizing dark-current noise in low-signal fluorescence acquisitions.
- Compact footprint (W×D×H: 280 × 320 × 340 mm) and intuitive touchscreen interface support benchtop deployment in biosafety cabinets or cleanroom-adjacent labs.
Sample Compatibility & Compliance
The Mira FL Plus accommodates standard 20 µL capillary slides compatible with manual pipetting or optional auto-loader integration. It supports common viability dyes—including trypan blue (0.4%), AO/PI (1:1 v/v), and commercial GFP/RFP staining kits—without requiring hardware modification. All data handling, user access control, audit trail generation, and electronic signature functions conform to FDA 21 CFR Part 11 requirements. The software architecture includes role-based permissions, immutable timestamped logs, and configurable retention policies. A full 3Q validation package (IQ/OQ/PQ protocols, test scripts, and summary reports) is provided to support GLP/GMP-regulated environments. Instrument qualification documentation aligns with ISO/IEC 17025 and ICH Q5D expectations for cell-based assay instrumentation.
Software & Data Management
The embedded Countstar Analysis Suite v4.x provides a validated, standalone Windows-based application with encrypted local database storage. It features pre-configured templates for common assays (e.g., “CHO Viability Post-Thaw”, “CAR-T Expansion Monitoring”, “HEK293 Transfection Efficiency”), each enforcing standardized gating logic and statistical reporting (CV%, % viability, fold-change vs. control). Raw image files (.tiff) and processed metadata (.csv/.xlsx) are exportable with embedded audit trail references. Server synchronization (SMB/CIFS), network printer integration, and scheduled backup to NAS or cloud storage (AWS S3-compatible endpoints) are natively supported. All user actions—including parameter edits, result approvals, and report exports—are logged with operator ID, timestamp, and contextual hash verification.
Applications
- Bioprocess monitoring: Real-time tracking of suspension culture density and viability across upstream bioreactor campaigns.
- Cell therapy QC: Release testing of autologous/allogeneic products per USP and ASTM E3151-18 guidelines.
- Transfection optimization: Quantitative comparison of promoter strength, vector design, or electroporation parameters using GFP/RFP intensity distribution metrics.
- Primary cell banking: Stability-indicating assays for cryopreserved PBMCs, NK cells, or dendritic cells under controlled thawing conditions.
- Academic screening: High-content phenotypic analysis in CRISPR-edited clones where morphological deviation correlates with functional impairment.
FAQ
Does the Mira FL Plus require daily calibration?
No. The fixed-focus optical path and factory-characterized sensor response eliminate routine recalibration. Annual performance verification using NIST-traceable microsphere standards is recommended.
Can the system be integrated into a LIMS environment?
Yes. HL7 and ASTM E1384-compliant API endpoints enable bidirectional data exchange with major LIMS platforms (e.g., LabVantage, Thermo Fisher SampleManager).
Is remote software update supported?
Firmware and application updates are delivered via signed USB media or authenticated HTTPS download; all updates undergo SHA-256 integrity verification prior to installation.
What level of training is required for first-time users?
Operators complete competency verification after ≤2 hours of guided workflow training; no prior image analysis expertise is required.
How is data integrity maintained during power interruption?
The system employs journaling file system (NTFS) with atomic write operations and automatic recovery checkpoints—ensuring zero data loss even during unexpected shutdowns.
