COPAN Cyclone Automated Industrial Microbiology Solution
| Brand | COPAN |
|---|---|
| Origin | Italy |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Imported |
| Model | Cyclone |
| Pricing | Available Upon Request |
Overview
The COPAN Cyclone Automated Industrial Microbiology Solution is a fully integrated, benchtop platform engineered for high-precision, reproducible preparation of microbiological culture plates in industrial and clinical reference laboratories. Built upon core principles of volumetric dispensing, controlled rotational deposition, and programmable fluidic handling, the Cyclone system executes standardized plate inoculation methods—including pour plating, spiral plating, and surface spreading—under defined environmental and mechanical parameters. Its architecture supports ISO 17025-compliant workflows by minimizing manual intervention, reducing operator-induced variability, and ensuring traceable execution of each step from sample loading to agar solidification. Designed specifically for regulated environments, the system operates within validated temperature and humidity envelopes to preserve media integrity and microbial viability during processing.
Key Features
- Fully automated plate preparation using three standardized microbiological inoculation modalities: pour plating (with pre-sterilized molten agar delivery), spiral plating (per ASTM E2871–22 guidelines), and surface spreading (with calibrated loop or spreader actuation)
- Modular protocol engine supporting customizable parameters: sample container type (e.g., tubes, swabs, vials), inoculum volume (0.1–1.0 mL range), pre-inoculation mixing cycles, serial dilution schemes (up to 10−6), and agar formulation selection (e.g., TSA, CHROMagar™, MacConkey, blood agar)
- Bi-directional LIMS integration via ASTM E1394-compliant HL7 or RESTful API interfaces, enabling automatic sample ID recognition, protocol assignment based on test requisition, and real-time status reporting (e.g., “plate prepared”, “incubation initiated”, “image acquired”)
- Multi-agar compatibility: simultaneous handling of up to four distinct agar types per run, with independent temperature control (45–55 °C) and viscosity compensation algorithms for consistent dispensing across formulations
- Integrated environmental monitoring: onboard sensors log ambient temperature, relative humidity, and cabinet airflow velocity to support GLP/GMP documentation requirements
Sample Compatibility & Compliance
The Cyclone platform accepts primary sample containers compliant with ISO 8573-1 (sterile air quality) and CLSI M42-A3 standards, including flocked swabs, liquid transport media vials (e.g., Amies, Cary-Blair), and sterile urine cups. It accommodates both direct specimen processing and pre-enriched cultures. All hardware surfaces contacting samples or media are constructed from electropolished 316L stainless steel and autoclavable polymer components meeting USP material safety criteria. The system is CE-marked under IVD Directive 98/79/EC and conforms to IEC 61010-1:2010 for laboratory equipment safety. Validation documentation includes IQ/OQ/PQ protocols aligned with FDA 21 CFR Part 11 for electronic records and signatures.
Software & Data Management
CycloneControl™ software provides a secure, role-based interface for method development, run scheduling, and audit trail review. Each plate preparation event generates a timestamped digital record containing metadata: operator ID, instrument firmware version, calibration certificate ID, environmental logs, and full parameter set used. Audit trails are immutable and exportable in CSV or PDF/A-2 format for regulatory submission. The software supports 21 CFR Part 11 compliance through electronic signatures, user authentication (LDAP/Active Directory integration), and configurable retention policies. Raw data—including dispensing pressure curves, motor torque profiles, and thermal history—are retained for ≥15 years per internal data governance policy.
Applications
- High-throughput environmental monitoring in pharmaceutical cleanrooms (ISO 14644-1 Class A–D), including water-for-injection (WFI) and compressed gas testing
- Antimicrobial susceptibility testing (AST) plate preparation for CLSI M02/M07-compliant workflows
- Food and beverage pathogen screening (e.g., Listeria monocytogenes, Salmonella spp.) requiring ISO 6579-1:2017 and ISO 11290-1:2017 compliance
- Vaccine manufacturing QC: colony-forming unit (CFU) enumeration of master cell banks and working cell banks per ICH Q5A(R2)
- Contract testing laboratories serving biotech clients requiring ISO/IEC 17025 accreditation and full chain-of-custody tracking
FAQ
Does the Cyclone system require dedicated infrastructure such as compressed air or external chillers?
No—it operates on standard 100–240 VAC power and integrated Peltier-based thermal management; no external utilities are required.
Can the system be validated for use in GMP-regulated production environments?
Yes—full validation support packages (including URS, FRS, DQ/IQ/OQ/PQ templates and executed reports) are provided with every installation.
Is remote monitoring and troubleshooting supported?
Yes—via encrypted TLS 1.2–enabled web portal with live diagnostics, predictive maintenance alerts, and secure screen-sharing capability for COPAN Field Application Engineers.
What level of training is included with purchase?
Standard offering includes two days of on-site operator training, one day of administrator training, and annual refresher courses delivered virtually or in-person at COPAN’s Milan Training Center.
How frequently must the fluidic system be recalibrated?
Calibration verification is performed automatically before each run; full volumetric calibration is recommended every six months or after 5000 plate preparations, whichever occurs first.
