Xunshu iCount 60 / iCount 60Pro Automated Colony Counter

Overview

The Xunshu iCount 60 and iCount 60Pro are fully automated colony counters engineered for precision, reproducibility, and regulatory compliance in pharmaceutical, food safety, clinical, and environmental microbiology laboratories. Based on high-resolution digital imaging and advanced image segmentation algorithms, these instruments quantify microbial colonies on standard agar-based solid media—including pour plates, spread plates, membrane filters, spiral plates, and commercial test films (e.g., 3M Petrifilm™)—using objective, operator-independent analysis. The core measurement principle relies on multi-spectral optical imaging combined with adaptive thresholding, active contour modeling (including fast active contours and multi-phase level-set methods), and morphological feature extraction to distinguish true colonies from background heterogeneity, debris, or condensation artifacts. Unlike manual counting or basic threshold-based systems, the iCount platform implements context-aware segmentation that adapts dynamically to variations in colony size, contrast, color, texture, and spatial distribution—enabling reliable enumeration across diverse microorganisms (bacteria, yeasts, molds, actinomycetes) and complex backgrounds.

Key Features

• Tri-modal illumination architecture: Five-color tunable trans-illumination (cold white, daylight white, dream blue, rose red, forest green) preserves natural colony pigmentation while optimizing contrast against variable agar backgrounds; suspended dual-LED dark-field illumination delivers uniform cosmic-blue background illumination ideal for low-contrast bacterial colonies; fog-diffused reflectance illumination (3100–5800 K, 50–7000 lux) eliminates glare and halo artifacts from glass Petri dishes while enhancing surface texture and chromatic fidelity.
• High-fidelity imaging subsystems: iCount 60 employs a 12 mm, 6 MP, 170 lp/mm lens paired with a Sony 1/1.7″ CMOS sensor (12 MP, 1.85 µm pixels); iCount 60Pro upgrades to a 16 mm, 10 MP, 200 lp/mm lens and Sony 1″ CMOS sensor (20 MP, 2.4 µm pixels), delivering superior signal-to-noise ratio and sub-10 µm spatial resolution for detecting microcolonies as small as 0.01 mm.
• Regulatory-grade software architecture: Implements four-tier user role separation (System Administrator, Data Manager, Operator, Reviewer) with granular permission controls, electronic signatures, auto-generated timestamps, immutable audit logs, and full workflow reconstruction capability—fully aligned with FDA 21 CFR Part 11, EU Annex 11, and GLP/GMP data integrity requirements.
• Intelligent colony recognition engine: Supports rapid parameter tuning via mouse-wheel interaction; includes dedicated modules for homogeneous plates, uneven backgrounds, microcolonies, colored media, mold morphology, inverse contrast, and multi-color classification based on hue, saturation, size, circularity, and edge gradient profiles.
• Comprehensive contamination mitigation: Automatic grid-line removal for membrane filters; background text elimination (e.g., marker pen annotations); user-defined exclusion zones; manual split of clustered or chain-forming colonies; and AI-assisted impurity rejection using shape, intensity, and spatial dispersion criteria.

Sample Compatibility & Compliance

The iCount series accommodates all standard microbiological sample formats: pour plates (agar depth ≥ 3 mm), spread plates, membrane filtration assemblies (nitrocellulose, mixed cellulose ester), spiral plating patterns (Spiral BioSampler® compatible), and commercially available test films including 3M Petrifilm™ Aerobic Count, Staphylococcus aureus, Coliform, and E. coli/Coliform Count products. Petri dish diameters range from 35 mm to 150 mm. The system is validated for use in environments requiring adherence to ISO 4833-1:2013 (microbiology of food and animal feeding stuffs), USP and , EP 2.6.12, and Chinese Pharmacopoeia IV (2020 Edition) microbial limits testing. Its electronic record architecture satisfies ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and supports full traceability during regulatory inspections.

Software & Data Management

The iCount Colony Analysis Suite operates on Windows 10 and integrates tightly with the hardware’s imaging and illumination subsystems. All operations—including image acquisition, parameter selection, statistical processing, manual corrections, and report generation—are logged automatically in an encrypted relational database. Each entry records operator ID, timestamp, image hash, dilution factor, plate dimensions, selected algorithm, raw and corrected counts, and revision history. Reports export natively to PDF (with embedded digital watermarks and dual electronic signatures) or Excel (CSV-compatible). Audit trail data is non-erasable and cannot be modified post-generation—even by administrators—ensuring evidentiary integrity. Optional backup protocols support scheduled database archiving to network drives or external SSDs, with version-controlled snapshot retention.

Applications

The iCount platform serves critical functions across regulated and research-intensive workflows: quantitative microbial limit testing per pharmacopeial monographs; environmental monitoring in cleanrooms (ISO 14644-1); sterility assurance validation; bioburden assessment in medical device manufacturing; shelf-life and challenge studies in food R&D; antimicrobial efficacy testing (ISO 22196, ASTM E2149); antifungal performance evaluation (ASTM D3273); and QC/QA release testing in biopharmaceutical upstream and downstream processes. Its ability to differentiate colony types by spectral signature enables semi-quantitative identification workflows when coupled with selective/differential media—supporting early-stage strain screening without requiring additional culturing steps.

FAQ

Does the iCount system comply with FDA 21 CFR Part 11 requirements?
Yes. It implements role-based access control, electronic signatures, immutable audit trails, automatic timestamping, and full workflow reconstruction—meeting all technical and procedural criteria for electronic records and signatures.
Can the system process 3M Petrifilm™ test films without manual pre-processing?
Yes. Dedicated one-click modules support automatic grid detection and colony enumeration on 3M Aerobic Count, Staphylococcus aureus, Coliform, and E. coli/Coliform Count films—including optional manual verification for ambiguous colonies.
What is the smallest detectable colony size?
The system resolves features down to 0.01 mm under optimal imaging conditions (iCount 60Pro, dark-field mode), enabling reliable detection of microcolonies formed by slow-growing or stressed organisms.
Is calibration traceable to national standards?
Yes. The instrument includes built-in calibration routines using NIST-traceable stage micrometers, with optional user-performed verification and documentation per ISO/IEC 17025.
How is data security enforced across user roles?
Four-tier privilege isolation prevents unauthorized access: System Administrators manage accounts only; Data Managers handle archival but cannot alter live results; Operators perform analyses but cannot delete logs; Reviewers validate outputs and apply final sign-off—no role permits retroactive editing.