RADOBIO Celstar 185 Six-Sided Heated CO₂ Incubator

Overview

The RADOBIO Celstar 185 is a precision-engineered, air-jacketed CO₂ incubator designed for demanding cell culture applications in academic research laboratories, biopharmaceutical QC/QA environments, and clinical cell therapy facilities. It operates on the fundamental principle of maintaining physiologically relevant conditions—stable temperature, controlled CO₂ partial pressure (to buffer bicarbonate-based media), and high relative humidity—to support optimal proliferation and viability of mammalian cells, stem cells, primary isolates, and sensitive co-cultures. Unlike water-jacketed systems, its six-sided direct-heating architecture delivers rapid thermal recovery (<10 min after a 30-second door opening at 37°C), superior spatial uniformity (±0.3°C), and reduced condensation risk through laminar, fan-assisted airflow over a stainless-steel humidified chamber. The integrated IR-based CO₂ sensor—sourced from a globally recognized OEM supplier—ensures long-term stability and immunity to drift caused by humidity fluctuations or frequent access, meeting the metrological requirements of ISO 13485-aligned workflows and GLP-compliant documentation practices.

Key Features

• Six-Sided Air-Jacketed Heating: Independent heating elements embedded across all interior surfaces—including door, floor, ceiling, and side walls—eliminate thermal gradients and deliver exceptional temperature homogeneity without relying on convection alone.
• 140°C Dry-Heat Decontamination Cycle: A validated, single-step sterilization protocol that eradicates bacteria, yeasts, molds, and mycoplasma from all internal stainless-steel surfaces (including corners and seams), eliminating the need for autoclaving removable parts or chemical disinfection.
• True HEPA Air Filtration System: An internally mounted Class H14 HEPA filter continuously recirculates and purifies chamber air, achieving >99.99% particle removal efficiency at 0.3 µm. Full chamber air exchange occurs within 5 minutes post-door opening, minimizing contamination exposure during routine handling.
• Stainless Steel Humidification Architecture: A removable 4 L 304 stainless steel water pan ensures consistent humidity up to 95% RH at 37°C while preventing cold-spot condensation via optimized cavity geometry and low-turbulence airflow design.
• IR-Based CO₂ Monitoring & Control: Dual-beam infrared detection provides real-time, drift-free CO₂ concentration feedback independent of ambient humidity or temperature transients—critical for labs with high-throughput access patterns or unstable environmental conditions.
• Regulatory-Ready Data Integrity: All operational parameters—including temperature, CO₂, humidity (optional), alarms, and sterilization cycles—are logged with immutable timestamps. Data export via USB adheres to ALCOA+ principles and supports audit readiness for FDA 21 CFR Part 11 and EU Annex 11 compliance.

Sample Compatibility & Compliance

The Celstar 185 accommodates standard T-flasks (up to T225), multi-well plates (6–96-well), Petri dishes, roller bottles, and custom bioreactor vessels within its 185 L chamber. Its polished 304 stainless-steel interior (with seamless, radius-corner construction) complies with ISO 14644-1 Class 5 cleanroom surface requirements when operated under HEPA filtration. The system meets IEC 61010-1 safety standards for laboratory equipment and is compatible with ISO/IEC 17025 calibration traceability protocols. Dry-heat sterilization validation reports (DQ/IQ/OQ documentation available upon request) align with USP and EP 5.1.5 guidelines for cell culture equipment qualification.

Software & Data Management

The 5-inch capacitive touch interface runs an embedded real-time operating system with intuitive navigation, multilevel password protection, and configurable alarm thresholds (audible + visual). Historical trend curves—temperature, CO₂, and optional humidity—are viewable directly on-screen with zoom and scroll functionality. Data logging intervals are user-selectable (30 s to 9999 s), supporting up to 250,000 timestamped entries stored in non-volatile memory. Exported .CSV files include metadata headers compliant with LIMS integration standards. No proprietary software installation is required; raw data is human-readable and compatible with Excel, GraphPad Prism, and electronic lab notebook (ELN) platforms.

Applications

• Mammalian cell line maintenance (HEK293, CHO, HeLa, etc.)
• Stem cell expansion and differentiation assays
• Primary neuron and organoid culture under low-oxygen priming conditions (when paired with optional O₂ module)
• Biological safety level (BSL)-2 compliant viral propagation and titer determination
• Regulatory submission-supporting stability studies per ICH Q5C
• Cell banking and cryopreservation workflow staging

FAQ

What CO₂ supply pressure is recommended for optimal performance?
A regulated inlet pressure of 0.05–0.1 MPa (0.5–1.0 bar) is required; higher pressures may cause valve instability, while lower pressures extend gas recovery time.
Can the incubator be validated for GMP use?
Yes—the Celstar 185 supports full DQ/IQ/OQ/PQ execution with documented protocols, sensor calibration certificates (NIST-traceable), and change control logs suitable for FDA and EMA inspections.
Is humidity monitoring included as standard?
Relative humidity sensing is optional; the base configuration maintains humidity passively via the stainless steel water pan, with accuracy verified per ASTM E2807-22 for incubator humidity performance testing.
How often must the HEPA filter be replaced?
Under continuous operation in ISO Class 7 environments, the HEPA filter is rated for 12 months or 8,000 operating hours—whichever occurs first—with replacement tracked automatically in the system log.
Does the dry-heat cycle affect sensor longevity?
No—the IR CO₂ sensor and PT100 temperature probes are thermally isolated during sterilization and resume operation immediately post-cycle without recalibration.