COMECAUSE IN-YJ300 Automated Colony Counter and Inhibition Zone Analyzer

Overview

The COMECAUSE IN-YJ300 Automated Colony Counter and Inhibition Zone Analyzer is an integrated digital imaging platform engineered for precise, reproducible microbiological quantification in regulated and research laboratory environments. It operates on the principle of high-resolution digital image acquisition coupled with algorithm-driven morphometric analysis—leveraging calibrated pixel-to-millimeter conversion to translate optical data into quantitative colony-forming unit (CFU) counts and inhibition zone diameters. The system is designed to meet the metrological demands of ISO 4833-1:2013 (microbiological methods—horizontal method for enumeration of microorganisms), USP <61> and <62>, CLSI M07–ED11, and EU Pharmacopoeia 2.6.12. Its dual-purpose architecture supports both routine microbial enumeration and antibiotic susceptibility testing (AST), making it suitable for QC/QA workflows in pharmaceutical manufacturing, food safety laboratories, clinical microbiology, and academic research.

Key Features

• Sealed dark chamber with stray-light suppression and programmable dual illumination: top-mounted 360° quad-color LED visible light source (white, red, green, blue) and bottom-mounted UV-C (254 nm) sterilization lamp
• 12 MP color CMOS sensor with 12 mm fixed-focus lens; minimum detectable colony diameter: 0.1 mm; counting accuracy ≥98% (per ISO 4833-1 validation protocols)
• Adaptive illumination control: independent software-based on/off switching and 1–100% brightness adjustment for upper and lower light sources; user-defined lighting profiles are storable and recallable
• Multi-mode colony segmentation: automatic detection and splitting of clustered, overlapping, or irregular colonies using edge-aware watershed and texture-based classification algorithms
• Comprehensive morphometric output per colony: diameter, area, perimeter, circularity, grayscale intensity, and RGB channel distribution
• Three-tier inhibition zone detection: auto-edge detection (for sharp-edged zones), circle-fitting (for elliptical or asymmetric zones), and manual three-point circle definition (for low-contrast or diffuse edges)
• Pharmacopoeial compliance: built-in one-dose (USP), two-dose, and three-dose assay modes aligned with Chinese Pharmacopoeia 2025 and EP 10.0 standards

Sample Compatibility & Compliance

The IN-YJ300 accommodates standard Petri dishes (90–110 mm diameter) and supports agar-based media including Mueller-Hinton, Nutrient Agar, Sabouraud Dextrose Agar, and Chromogenic formulations. Fluorescent colony detection is enabled via optional UV excitation and long-pass filter integration. All measurement outputs—including raw images, annotated overlays, CFU counts, zone diameters, and potency calculations—are traceable to NIST-traceable calibration standards. The system adheres to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and supports 21 CFR Part 11-compliant electronic signatures when deployed with validated identity management and audit trail modules.

Software & Data Management

The proprietary analysis suite features bilingual (English/Chinese) UI, role-based access control (RBAC), and encrypted local database storage. Each user account maintains isolated data partitions with versioned image archives. Audit trails record timestamped entries for all critical actions: image acquisition, parameter modification, result export, and user login/logout events. Raw image files (.TIFF) and processed metadata (.CSV, .JSON) are immutable post-acquisition. PDF reports include instrument ID, operator ID, calibration status, environmental conditions (optional), and pharmacopoeial reference codes. Cloud synchronization is available via TLS 1.3–secured API endpoints, enabling remote review and cross-site data harmonization without compromising data sovereignty.

Applications

• Pharmaceutical QC: sterility testing, bioburden assessment, antimicrobial efficacy verification per ICH Q5C and WHO TRS 992 Annex 2
• Food & beverage safety: total viable count (TVC), coliform screening, and preservative challenge testing per ISO 6887 and FDA BAM Chapter 3
• Clinical microbiology: disk diffusion AST (CLSI M100), MIC endpoint determination, and fungal colony enumeration
• Cosmetic product safety: preservative efficacy testing (PET) per ISO 11930 and CTFA guidelines
• Environmental monitoring: surface swab analysis, water microbiology, and cleanroom qualification per ISO 14644 and EU GMP Annex 1
• Academic research: biofilm quantification, antimicrobial peptide screening, and CRISPR-based resistance profiling

FAQ

Does the IN-YJ300 support GLP/GMP-compliant validation documentation?
Yes—validation templates (IQ/OQ/PQ), calibration logs, and system suitability test protocols are provided as part of the installation qualification package.
Can the system integrate with LIMS or ERP platforms?
It supports HL7 v2.x and ASTM E1384-compliant data export; custom API integration is available under NDA.
What is the recommended maintenance schedule for optical calibration?
Camera and illumination calibration should be verified quarterly using certified reference plates; full recalibration is advised annually or after hardware service.
Is fluorescence mode validated for specific fluorophores (e.g., GFP, resazurin)?
Fluorescence detection is configurable via spectral filter selection; validation for specific dyes requires user-conducted contrast-to-noise ratio (CNR) assessment per ISO 17025 clause 7.7.
How does the system handle mixed-species plates with differential morphology?
Morphology-based clustering allows user-defined training sets for species-specific segmentation; supervised learning modules require external annotation datasets.