RWD C200FL Intelligent Fluorescence Cell Counter

Overview

The RWD C200FL Intelligent Fluorescence Cell Counter is a fully integrated, benchtop cell analysis system engineered for high-precision, rapid quantification and viability assessment of mammalian, primary, stem, and immune cells. It employs dual-mode optical imaging—simultaneous brightfield and fluorescence microscopy—combined with proprietary deep-learning-based image segmentation algorithms to distinguish morphologically intact viable cells from non-viable or membrane-compromised cells. Unlike conventional manual hemocytometer counting or flow cytometry-based methods, the C200FL operates on a fixed-focus, chamber-based platform eliminating user-dependent focusing variability and reducing inter-operator bias. Its measurement principle relies on high-contrast digital image capture at 10× magnification, followed by pixel-level classification using AO/PI or Trypan Blue staining patterns—enabling quantitative determination of concentration, viability, clumping rate, and growth kinetics in a single 5-second acquisition.

Key Features

• Fixed-focus optical architecture ensures consistent image plane alignment across all samples—no manual focusing required, enhancing measurement reproducibility and operator independence.
• Integrated six-channel disposable counting chamber with automated fluidic loading—enables parallel processing of up to six independent samples without cross-contamination.
• Configurable field-of-view selection: users may choose 1, 2, or 3 adjacent fields per chamber for statistical robustness—each full acquisition completed within 5 seconds under brightfield mode.
• Dual-channel fluorescence excitation/emission optics optimized for Acridine Orange (Ex/Em: 488/525 nm) and Propidium Iodide (Ex/Em: 535/617 nm), supporting standardized AO/PI dual-stain viability assays per ISO 20391-1 and ASTM E2810 guidelines.
• On-device 500 GB SSD storage with encrypted data partitioning—supports long-term retention of raw images, processed results, audit trails, and user-defined protocols.
• FDA 21 CFR Part 11-compliant software architecture featuring electronic signatures, role-based access control, immutable audit logs, and full traceability of all analytical events—including parameter changes, result exports, and user logins.

Sample Compatibility & Compliance

The C200FL accommodates a broad spectrum of suspension-based biological samples, including peripheral blood mononuclear cells (PBMCs), hybridomas, CHO and HEK293 suspension cultures, dissociated primary neurons, tumor spheroid single-cell suspensions, and mesenchymal stem cells (MSCs). It supports standard viability dyes—Trypan Blue (for membrane integrity assessment), AO/PI (for nucleic acid–based discrimination), and GFP/RFP-expressing transfected populations. All hardware and firmware comply with IEC 61010-1 safety standards for laboratory equipment. The embedded operating system and application software are validated per GAMP 5 principles and support GLP/GMP-aligned workflows, including instrument qualification (IQ/OQ/PQ), change control documentation, and electronic record retention aligned with 21 CFR Part 11 Subpart B requirements.

Software & Data Management

The C200FL runs a purpose-built, Android-based embedded OS with a touchscreen-optimized UI designed for minimal training overhead. Its app-style workflow engine allows users to save, name, and recall preconfigured assay templates—including dye type, exposure time, gain settings, and gating thresholds. All counting results—including total concentration (cells/mL), viability (%), clump index (%), and population growth curves—are auto-generated and exportable in CSV, PDF, or Excel-compatible XLSX formats. Audit trail metadata includes timestamped entries for every user action, image capture event, and calibration verification. Data encryption at rest (AES-256) and secure export via USB-C or network share ensure compliance with institutional data governance policies and GDPR/HIPAA-aligned handling of human-derived sample information.

Applications

• Cell Therapy Manufacturing: Release testing of CAR-T and NK cell products per USP and Ph. Eur. 5.2.12, including viability confirmation prior to cryopreservation and post-thaw recovery assessment.
• Biopharmaceutical Process Development: Monitoring of upstream bioreactor harvests, clone selection, and passage optimization through real-time concentration and viability trending.
• Vaccinology & Immunology Research: Quantitative analysis of dendritic cell maturation, T-cell expansion, and antigen-presenting cell viability following stimulation protocols.
• Oncology & Stem Cell Studies: Enumeration of tumor organoid-derived single-cell suspensions and MSC differentiation batches where size heterogeneity and aggregation behavior impact functional readouts.
• Transfection Efficiency Validation: Dual-fluorescence quantification of GFP+/PI− populations in transiently or stably transfected lines—supporting CRISPR editing validation and reporter gene expression profiling.
• Non-cellular Particle Analysis: Enumeration of calibration microspheres (e.g., 10 µm polystyrene standards), pollen grains, and environmental particulates in quality control and environmental monitoring contexts.

FAQ

Does the C200FL require external computer connectivity for operation?
No—the instrument is a fully self-contained system with an integrated display, processor, and storage; no PC or laptop is needed for routine counting or data review.
Can the device store historical counting data with user attribution and timestamps?
Yes—every result file includes embedded metadata: operator ID, date/time stamp, chamber ID, staining protocol, and software version, all preserved in an immutable audit log.
Is AO/PI staining compatible with primary human T cells without fixation?
Yes—the C200FL’s low-light fluorescence optics and short exposure times minimize phototoxicity, enabling live-cell AO/PI analysis of unfixed PBMCs and activated T-cell cultures per ISO 20391-2 Annex B recommendations.
What is the effective sample volume analyzed per field of view?
Each 1.72 mm × 1.3 mm counting chamber has a defined depth of 0.1 mm, yielding a nominal volume of 0.2236 µL per field; total analyzed volume scales linearly with selected FOV count (1–3).
How is regulatory compliance verified during installation and routine use?
RWD provides IQ/OQ documentation templates, built-in system suitability tests (e.g., focus stability check, fluorescence intensity uniformity grid), and optional third-party validation support aligned with FDA and EMA expectations for automated cell counting systems.