FDM C140 Temperature and Humidity Controlled Incubator
| Origin | Italy |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | FDM C140 |
| Price Range | USD 6,800–13,600 (FOB Italy) |
| Temperature Range (with Humidification) | 0 °C to +60 °C |
| Temperature Uniformity | ±0.5 °C |
| Relative Humidity Range | 10–98 % RH ±1 % RH |
| Chamber Capacity | 140 L |
| Temperature Resolution & Setpoint Increment | 0.1 °C |
| Temperature Stability | ±0.1 °C |
| Heating Rate | +1.5 °C/min (per IEC 60068-3-5) |
| Cooling Rate | −1.2 °C/min (per IEC 60068-3-5) |
| Noise Level | <55 dB(A) |
| Power Supply | 220–230 V AC, 50 Hz |
| Construction | AISI 304 stainless steel interior & white epoxy-coated galvanized steel exterior |
| Insulation | CFC/HCFC-free polyurethane foam (≥60 mm thickness) |
| Door | Dual-hinge, auto-closing, magnetic gasket seal, thermal lockout above 90 °C |
| Shelving | Adjustable, powder-coated steel racks (2 included, max 5) |
| Controller | Dual microprocessor system (separate PID loops for temperature and humidity), 20-step standard programmability, up to 50 stored programs (optional 200-step extended firmware) |
| Humidification | Low-inertia steam generator, compatible with deionized water or softened water (CaCO₃ ≤400 ppm), supply pressure 1–10 bar |
| Safety | Manual-reset Class 1 overtemperature protection (DIN 12990), password-protected parameter limits, visual/audible alarm on deviation |
Overview
The FDM C140 Temperature and Humidity Controlled Incubator is an ISO 17025-aligned environmental test chamber engineered for reproducible, long-term biological and material stability studies under tightly regulated climatic conditions. Designed and manufactured in Italy to meet stringent EU regulatory frameworks—including Machinery Directive 2006/42/EC and Electromagnetic Compatibility Directive 2014/30/EU—the C140 integrates dual independent PID-controlled microprocessor systems to simultaneously govern temperature (0 °C to +60 °C) and relative humidity (10–98 % RH ±1 % RH) within a 140 L working volume. Its measurement architecture complies with the metrological requirements of ISO 17025 for calibration traceability, supporting GLP and GMP-compliant validation protocols. The chamber employs a low-inertia resistive heating system coupled with forced-air convection and a dedicated steam-based humidification module—ensuring rapid equilibration and minimal thermal overshoot during dynamic profile execution. All operational parameters—including setpoints, ramp rates, dwell times, and alarm thresholds—are fully programmable and auditable, satisfying FDA 21 CFR Part 11 requirements for electronic records when paired with optional audit-trail-enabled software.
Key Features
- Dual-channel microprocessor controller with separate real-time monitoring and closed-loop regulation of temperature and humidity
- 0.1 °C resolution for both setpoint entry and display; ±0.1 °C temperature stability at nominal setpoint (verified per IEC 60068-3-5)
- AISI 304 stainless steel inner chamber and corrosion-resistant epoxy-coated outer casing ensure chemical compatibility and cleanroom-grade maintainability
- 60 mm thick CFC/HCFC-free polyurethane insulation provides thermal resistance >0.8 m²·K/W, minimizing energy consumption and external heat transfer
- Auto-closing door with magnetic gasket seal and thermal interlock (disabled above 90 °C) prevents accidental exposure during high-temperature operation
- Two adjustable, load-rated powder-coated steel shelves (expandable to five), optimized for uniform airflow distribution and sample accessibility
- Programmable alarm system with configurable upper/lower limits for temperature and humidity, requiring alphanumeric password authentication for threshold modification
- Low-noise (<55 dB[A]) operation suitable for shared laboratory environments and continuous unattended runs
Sample Compatibility & Compliance
The C140 accommodates standard microbiological culture vessels (Petri dishes, flasks, multiwell plates), plant tissue culture bioreactors, polymer stability test specimens, and pharmaceutical stability samples per ICH Q1A(R2) and USP . Its internal geometry supports ISO 14644-1 Class 5–8 cleanroom-compatible workflows when operated with HEPA-filtered air recirculation (optional add-on). The unit conforms to DIN 12990 for incubator safety classification (Class 1 manual reset), EN 61000-6-3 for emission control, and EN 61000-6-2 for immunity testing. Humidity control accuracy (±1 % RH) meets ASTM E145-22 Annex A3 criteria for gravimetric verification of hygrometric performance. Calibration certificates are available with NIST-traceable thermistors and capacitive RH sensors.
Software & Data Management
The embedded controller logs timestamped temperature and humidity data at user-defined intervals (1 s to 60 min), storing up to 30 days of continuous readings internally. Data export is supported via RS-232 or USB-C interface in CSV format for integration with LIMS or ELN platforms. Optional FDM LabControl PRO software enables remote monitoring, multi-chamber synchronization, electronic signature capture, and 21 CFR Part 11-compliant audit trail generation—including operator ID, parameter changes, alarm events, and calibration history. All firmware updates are digitally signed and validated prior to installation to ensure integrity.
Applications
- Accelerated stability testing of APIs and finished dosage forms per ICH guidelines
- Microbial growth kinetics and shelf-life modeling under controlled hygrothermal stress
- Seed germination and plant phenotyping under defined climate regimes
- Material aging studies for polymers, adhesives, and packaging components
- Cell culture preconditioning and hypoxia/hyperthermia protocol development
- Reference standard storage in metrology laboratories requiring stable ambient conditions
FAQ
What is the maximum allowable water hardness for the steam humidifier?
The integrated steam generator accepts deionized water or softened water with calcium carbonate content ≤400 ppm. Water supply pressure must be maintained between 1–10 bar.
Can the C140 be validated for GxP compliance?
Yes. The unit supports IQ/OQ/PQ documentation packages, including as-found/as-left calibration reports, mapping protocols (ASTM E2297), and alarm response verification per ISO 13485 Annex C.
Is remote monitoring supported out of the box?
RS-232 serial output is standard; Ethernet or Wi-Fi connectivity requires the optional FDM NetLink module and LabControl PRO license.
How many programs can be stored without the extended firmware option?
The base configuration stores up to 50 programs, each with up to 20 time-temperature-humidity steps.
Does the unit include a built-in data logger?
Yes. Internal memory retains ≥1 million data points with automatic overwrite protection and time-stamped event logging.
