Gerber Colonystar 8500 Semi-Automatic Colony Counter

Overview

The Gerber Colonystar 8500 Semi-Automatic Colony Counter is an engineered solution for rapid, reproducible, and operator-independent enumeration of microbial colonies on standard agar plates. Designed in accordance with core principles of microbiological quantification—namely visual detection, spatial discrimination, and digital registration—the instrument employs high-contrast optical imaging combined with tactile probe-based input to deliver traceable colony counts without reliance on subjective manual tallying. Its architecture reflects decades of refinement in European laboratory instrumentation, particularly aligned with DIN EN ISO 4833-1:2013 (microbiology of food and animal feeding stuffs) and ISO 7218:2017 (general requirements and guidance for microbiological examinations). The device operates as a standalone benchtop unit, requiring no PC connection for basic counting functions, yet supports data integrity workflows essential for GLP-compliant environments.

Key Features

• 2× electronic magnification with adjustable LED illumination across a 145 mm diameter field—optimized for uniform brightness and minimal glare across both black and white backgrounds
• Tactile probe interface with calibrated actuation force threshold: ensures reliable signal registration only upon deliberate, non-sliding contact—reducing accidental double-counts or missed inputs
• 5-digit LCD display (0–99,999) with instant reset function; numeric output is retained until manually cleared or power-cycled
• Mechanically robust housing (ABS polymer + aluminum alloy frame) designed for sustained use in QC laboratories, cleanrooms, and field-deployed environmental monitoring stations
• Petri dish compatibility spanning 50 mm to 150 mm diameters—including standard 90 mm and 100 mm formats—accommodating both conventional and high-throughput plate configurations
• Counting resolution of 0.1 cm² enables precise localization and verification of colony distribution patterns, supporting downstream analysis such as heterogeneity mapping or growth inhibition zone assessment

Sample Compatibility & Compliance

The Colonystar 8500 accepts all standard non-fluorescent, non-translucent agar media—including TSA, PCA, VRBA, MRS, Sabouraud Dextrose Agar, and selective formulations used in pharmaceutical water testing (e.g., Soybean-Casein Digest Agar per USP ). It is validated for use with pour plates, spread plates, and membrane filtration assays. The system meets mechanical and electrical safety requirements per IEC 61010-1:2010 and carries CE marking under the EU Medical Device Regulation (MDR) Annex XVI classification for in vitro diagnostic support equipment. While not a fully automated image-analysis system, its semi-automatic operation aligns with FDA Guidance for Industry: “Process Validation: General Principles and Practices” (2011) when integrated into documented SOPs for routine microbiological testing.

Software & Data Management

As a dedicated hardware counter, the Colonystar 8500 does not incorporate embedded software or network connectivity. All count data remain local to the LCD display and are not stored, transmitted, or exported. This design intentionally eliminates cybersecurity risks and simplifies 21 CFR Part 11 compliance pathways: since no electronic records are generated, no audit trail, electronic signature, or system validation is required. For laboratories requiring traceability, users may integrate the device into manual logbook procedures or pair it with external LIMS via standardized entry protocols. Optional accessories—including calibrated reference plates and NIST-traceable colony density standards—are available through authorized Funke Gerber distributors to support periodic performance verification per ISO/IEC 17025:2017 Clause 7.7.

Applications

• Routine aerobic plate counts in food safety laboratories (ISO 4833-1, AOAC 977.27)
• Water quality assessment per ISO 9308-1 (E. coli and coliform enumeration) and EPA Method 1603
• Pharmaceutical environmental monitoring (EU GMP Annex 1, USP ) for viable particle enumeration in Grade A–D cleanrooms
• Bioburden testing of medical devices (ISO 11737-1) and raw materials in contract manufacturing organizations
• Academic research involving serial dilution assays, antimicrobial susceptibility screening, and biofilm dispersal kinetics
• Regulatory submissions requiring auditable, low-complexity enumeration methods where image-based AI counters are not yet validated

FAQ

Is the Colonystar 8500 compliant with FDA 21 CFR Part 11?
No electronic records are created or stored by the device; therefore, Part 11 requirements do not apply. Documentation must be maintained externally via paper logs or LIMS integration.
Can it count colonies on chromogenic or fluorogenic media?
Yes—provided colonies exhibit sufficient contrast against the selected background (black or white) and are not obscured by medium fluorescence under ambient lighting conditions.
What maintenance is required?
Routine cleaning of the optical surface with purified water and lens tissue; annual verification using certified reference plates is recommended per ISO/IEC 17025.
Does it support metric or imperial units?
All measurements—including counting area and resolution—are expressed in SI units (cm², mm); no unit conversion functionality is provided.
Is calibration certification included?
Factory calibration is performed prior to shipment. A certificate of conformance (CoC) is supplied; ISO/IEC 17025 calibration reports are available upon request through authorized service centers.