JIMBIO CL II Flow-Based Coulter Counter

Overview

The JIMBIO CL II Flow-Based Coulter Counter is an engineered solution for high-fidelity, impedance-based cell and biological particle quantification using the principle of resistive pulse sensing (RPS), commonly known as the Coulter principle. Unlike optical or fluorescence-based methods, this instrument measures changes in electrical resistance as individual particles—such as mammalian cells, yeast, algal protoplasts, fungal spores, pollen grains, or spermatozoa—pass through a microfluidic aperture under controlled hydrodynamic flow. This physical measurement provides intrinsic size-dependent resolution without reliance on staining, labeling, or optical calibration. The CL II implements a proprietary microfluidic architecture that eliminates disposable chips or cartridges, enabling true consumable-free operation while maintaining metrological traceability across repeated measurements. Designed for routine QC/QA labs, academic core facilities, and bioprocess development environments, it delivers robust performance under GLP- and GMP-aligned workflows.

Key Features

• Chip-Free Microfluidic Design: Eliminates recurring cartridge costs and cross-contamination risk; all fluidic pathways are permanently integrated and cleaned via programmable internal rinse cycles.
• Full-Sample Analysis: Processes only 10 µL of undiluted sample—ideal for precious or low-yield biological preparations such as primary isolates or microalgal cultures.
• High-Resolution Sizing: Achieves 0.5 µm diameter resolution within the 5–30 µm range, enabling discrimination between morphologically similar populations (e.g., budding vs. mature yeast, intact vs. lysed protoplasts).
• Automated Dilution Algorithm: When sample concentration exceeds the upper detection limit, the system calculates optimal dilution factors and logs them with full audit trail for regulatory review.
• Real-Time Histogram Generation: Instantly displays particle size distribution histograms with user-definable gate boundaries, supporting population subsetting and comparative analysis across runs.
• Regulatory-Ready Architecture: Firmware supports time-stamped, user-locked data logging with immutable metadata—including operator ID, timestamp, instrument serial number, and environmental parameters (if sensor-equipped).

Sample Compatibility & Compliance

The CL II is validated for heterogeneous, non-standardized biological suspensions including unstained eukaryotic cells, microbial spores, plant-derived micro-particles, and gametes. It does not require centrifugation, fixation, or viability dyes. Its impedance-based detection remains insensitive to optical turbidity, pigmentation, or autofluorescence—making it especially suitable for chlorophyll-rich algae or melanized fungal conidia. All firmware and data handling protocols conform to FDA 21 CFR Part 11 requirements for electronic records and signatures. Full 3Q validation packages (Installation Qualification, Operational Qualification, Performance Qualification) are provided upon request and include IQ/OQ test scripts, calibration certificates traceable to NIST standards, and risk assessment documentation aligned with ISO 13485 and ICH Q5C guidelines.

Software & Data Management

The CL II operates with embedded firmware and a Windows-compatible desktop application delivering full local control and offline analysis. Data export is supported via USB 2.0 to CSV, PDF, or XML formats compliant with LIMS integration standards. Each dataset includes raw pulse amplitude/time series, gated event counts, statistical summaries (mean, SD, CV%), and histogram binning metadata. Audit trails record every user action—including parameter modification, gate adjustment, or manual reanalysis—with SHA-256 hashing for integrity verification. Software versioning follows semantic versioning (SemVer) and is maintained under change control per ISO/IEC 17025 Annex A.3.3.

Applications

• Yeast viability and batch consistency monitoring in brewing and biofermentation
• Microalgal biomass quantification in photobioreactor optimization studies
• Fungal spore enumeration for agricultural biocontrol product release testing
• Pollen grain concentration analysis in plant reproductive biology research
• Sperm motility-independent concentration assessment in andrology labs
• Protoplast yield validation following enzymatic digestion in plant genetic transformation workflows

FAQ

Does the CL II require calibration standards or reference beads?
No. The system uses factory-calibrated aperture geometry and stable current sources; periodic verification with NIST-traceable polystyrene standards is optional but not mandatory for daily use.
Can the instrument differentiate live from dead cells?
No. As an impedance-based counter, it reports physical particle count and size—not membrane integrity or metabolic activity. Viability must be assessed separately via dye exclusion or functional assays.
Is remote monitoring or network connectivity supported?
Not natively. Data transfer occurs exclusively via USB 2.0; however, exported files are compatible with enterprise data aggregation platforms via scripted ingestion pipelines.
What maintenance is required beyond daily rinsing?
Annual verification of aperture integrity and electronic baseline stability is recommended. No consumables, pumps, or optical components require replacement during normal operation.
How is data integrity ensured during power interruption?
All measurements are written to non-volatile memory before display; incomplete runs are flagged and recoverable upon reboot with full metadata retention.