LUNA-FX7™ Automated Cell Counter by Aligned Genetics

Overview

The LUNA-FX7™ Automated Cell Counter is a benchtop digital imaging cytometer engineered for precision, reproducibility, and regulatory readiness in demanding life science and bioprocessing environments. Utilizing high-resolution brightfield and dual-channel fluorescence microscopy combined with motorized precision autofocus, the system captures consistent, high-fidelity images of unstained or fluorescently labeled cells across a broad size range (1–90 µm). Its core measurement principle relies on pixel-based morphometric segmentation and intensity-thresholded object detection—optimized for heterogeneous populations including aggregated cells, primary isolates, and fragile suspension cultures. Designed to meet the operational rigor of GMP-aligned workflows, the LUNA-FX7™ supports daily instrument qualification through integrated QC protocols and traceable validation slides, making it suitable for cell therapy manufacturing, upstream bioprocess monitoring, and regulated QC labs.

Key Features

• Motorized autofocus system delivering sub-micron Z-axis repeatability for consistent focal plane acquisition across all sample types and chamber configurations.
• Multi-chamber slide compatibility—including 1-, 3-, and 8-well counting chambers—enabling flexible throughput scaling from single-sample verification to parallel batch analysis.
• Advanced de-clustering algorithm trained on diverse cell morphologies (e.g., PBMCs, CHO, HEK293, yeast, algae), enabling accurate enumeration of individual cells within aggregates without manual intervention.
• Dual-fluorescence excitation/emission optics with narrow-band LED sources and optimized emission filters ensure minimal spectral crosstalk and high signal-to-noise ratio for viability assays (e.g., AO/PI, Calcein-AM/EthD-1).
• Built-in QC dashboard with pass/fail criteria based on user-defined thresholds for image quality, focus score, and cell morphology uniformity—supporting GLP-compliant documentation practices.
• Optional CountWire™ software module providing full 21 CFR Part 11 compliance: electronic signatures, audit trails, role-based access control, and immutable data archiving.

Sample Compatibility & Compliance

The LUNA-FX7™ accommodates a wide spectrum of biological samples relevant to translational and industrial applications: peripheral blood mononuclear cells (PBMCs), primary tissue-derived cells, adherent cell line suspensions (post-trypsinization), microbial cells (yeast, bacteria, microalgae), and nucleated erythrocytes. It meets ISO 13485-aligned design controls and supports IQ/OQ documentation packages upon request. When configured with CountWire™, the system satisfies FDA 21 CFR Part 11 requirements for electronic records and signatures—including secure user authentication, time-stamped audit logs, and data integrity safeguards for raw image files, metadata, and exported reports (PDF, CSV, TIFF). All firmware and software updates are version-controlled and documented per change management SOPs.

Software & Data Management

The embedded operating system runs a deterministic real-time imaging pipeline with onboard image processing acceleration. Standard software includes automated cell identification, viability calculation, concentration derivation, and statistical reporting (CV%, % viability, total count, average diameter). Data export supports USB mass storage, encrypted Wi-Fi transfer to local network drives, and direct Ethernet integration with LIMS or ELN systems. CountWire™ extends functionality with bioprocess-specific modules: time-series tracking of growth kinetics, trend visualization of viability/concentration over passages or bioreactor runs, and configurable alert thresholds for out-of-specification events. All exported datasets retain embedded metadata—including instrument ID, operator ID, timestamp, slide lot number, and calibration status—for full traceability.

Applications

• Cell therapy manufacturing: Release testing of CAR-T, NK, and MSC products per USP & ISCT guidelines.
• Upstream bioprocess monitoring: Daily sampling of mammalian and insect cell cultures in bioreactors and shake flasks.
• CRO and core facility support: High-volume sample triage for flow cytometry prep, transfection optimization, and cryopreservation QC.
• Primary cell research: Enumeration of low-yield isolates (e.g., tumor-infiltrating lymphocytes, hepatocytes) with minimal handling-induced stress.
• Microbial QC in fermentation: Yeast and algal biomass quantification with simultaneous viability assessment.
• Educational and training labs: Intuitive interface and visual feedback support rapid user onboarding without specialized microscopy training.

FAQ

Does the LUNA-FX7™ require external calibration standards?

No—each unit ships with NIST-traceable validation slides and an onboard calibration routine that verifies optical alignment, illumination uniformity, and autofocus accuracy prior to first use and after firmware updates.
Can the system distinguish between live/dead cells without fluorescent dyes?

Brightfield-only mode provides morphological discrimination (e.g., membrane integrity, granularity), but quantitative viability assessment requires compatible fluorescent stains (e.g., acridine orange/propidium iodide) and dual-channel detection.
Is remote monitoring supported?

Yes—via Ethernet or Wi-Fi, users can initiate counts, view real-time thumbnails, download reports, and receive email/SNMP alerts through enterprise IT infrastructure.
What slide types are compatible with the LUNA-FX7™?

Officially validated consumables include LUNA™ 1-well, 3-well, and 8-well disposable counting slides (Cat. No. LUNA-FX7-SLIDE-1, -3, -8), manufactured under ISO 13485-certified conditions.
How is data integrity ensured during long-term deployment?

CountWire™ enforces write-once-read-many (WORM) archival policies, cryptographic hash verification of stored images, and synchronized timestamping across all subsystems—meeting ALCOA+ principles for regulated environments.