WIGGENS Biotron™ II WCI-850CH Large-Scale Orbital CO₂ Incubator with Independent Shaking Units

Overview

The WIGGENS Biotron™ II WCI-850CH is a high-capacity, modular orbital CO₂ incubator engineered for scalable suspension culture of mammalian and insect cell lines under tightly controlled physiological conditions. Unlike conventional static CO₂ incubators, this system integrates three independently operated orbital shaking zones—each with dedicated temperature, CO₂, humidity, and motion control—enabling parallel cultivation experiments across divergent parameters without cross-contamination or thermal interference. Its core architecture employs a dual-beam infrared CO₂ sensor for real-time, drift-free gas concentration monitoring; an air-jacketed heating system with six-zone PID-controlled heaters ensuring rapid thermal equilibration and spatial uniformity; and a natural evaporation-based humidification system with a deep, wide stainless-steel water reservoir. Designed for GMP-aligned bioprocess development, the WCI-850CH supports both adherent and suspension cultures—including CHO, HEK293, and Sf9 cells—and accommodates vessels from microplates to 10 L shaker flasks via configurable stainless-steel platforms.

Key Features

• Three independent orbital shaking zones, each with individual glass doors, temperature setpoints, CO₂ regulation, and speed control (30–250 rpm, ±1 rpm accuracy, 25 mm amplitude)
• Dual-beam NDIR (Non-Dispersive Infrared) CO₂ sensor providing long-term stability and traceable calibration at 5% CO₂ (±0.3% accuracy at 37 °C)
• Air-jacketed heating with six-position PID controllers and forced-air circulation for ±1 °C temperature uniformity at 37 °C across the full 850 L chamber
• Magnetically driven orbital shakers—fully sealed and corrosion-resistant—eliminating mechanical wear, oil contamination, and failure risk in high-humidity (>95% RH) environments
• GMP-compliant interior constructed entirely from electropolished AISI 304 stainless steel, including all trays, tracks, and chamber walls
• Integrated 4 W UV-C lamp positioned adjacent to the recirculation fan, enabling continuous or intermittent air sterilization during operation
• HEPA-grade (≥99.97% @ 0.3 µm) antimicrobial filter on the intake/exhaust path, compliant with ISO 14644-1 Class 5 cleanroom air quality requirements
• Modular shelf design: removable upper-tier platforms support large-volume vessels (e.g., 5–10 L baffled flasks); pull-out stainless-steel rails facilitate ergonomic sample loading
• Intelligent humidity management with LED-displayed real-time %RH and predictive refill alerts based on evaporation kinetics
• Auto-resume functionality: shaking pauses upon door opening and resumes automatically after closure; system reboots to last operational state following power interruption

Sample Compatibility & Compliance

The WCI-850CH accommodates a broad range of culture formats—including T-flasks, roller bottles, deep-well plates (96-/384-well), Erlenmeyer flasks (up to 10 L), and custom bioreactor bags—via interchangeable adhesive mats, universal clamps, and conical flask-specific holders. All internal surfaces meet USP and ISO 10993-5 cytotoxicity standards. The system supports compliance with FDA 21 CFR Part 11 when integrated with validated LIMS or ELN platforms (audit trail, electronic signature, and user access control enabled via optional software modules). Routine validation protocols—including IQ/OQ/PQ—align with ASTM E1285 (CO₂ incubator performance testing), ISO 13408-1 (aseptic processing), and EU Annex 1 (sterile manufacturing). Chamber integrity is verified per ISO 14644-3 leak testing methodology.

Software & Data Management

The embedded controller features a 7-inch capacitive touchscreen interface with multilingual support (English, German, Chinese, Spanish), real-time graphing of temperature, CO₂, humidity, and shaking parameters, and local data logging (≥30 days at 1-min intervals). USB export enables CSV-formatted datasets compatible with MATLAB, Python pandas, or JMP for statistical process control. Optional Ethernet/Wi-Fi connectivity permits remote monitoring via SNMP or Modbus TCP; integration with LabVantage, STARLIMS, or Thermo Fisher SampleManager is supported through documented RESTful API endpoints. All logged events—including door openings, UV activation, alarm triggers, and parameter changes—are time-stamped and cryptographically signed to satisfy GLP/GMP audit requirements.

Applications

• Biopharmaceutical upstream process development: scalable suspension culture of recombinant protein- and monoclonal antibody-producing cell lines
• Viral vector production (AAV, lentivirus) requiring precise O₂/CO₂ interplay and low-shear agitation
• Stem cell expansion under dynamic conditions mimicking physiological fluid shear stress
• Microbial expression systems (e.g., Pichia pastoris) where pH-independent CO₂ buffering enhances growth kinetics
• High-throughput screening of media formulations or feeding strategies across multiple shaking regimes simultaneously
• Regulatory batch record generation for IND-enabling toxicology studies conducted under cGMP conditions

FAQ

What is the maximum flask size supported per shaking zone?
Each zone accommodates vessels up to 10 L using the removable upper-tier platform; standard configuration supports up to 5 L flasks per 520 × 520 mm tray.
Does the system comply with ISO 13485 for medical device manufacturing?
Yes—the mechanical design, material certifications (EN 10088-1), and documentation package (including FAT/SAT reports) are fully aligned with ISO 13485:2016 clause 7.5.2 (Production and service provision control).
Can CO₂ concentration be calibrated in-house without external service?
Yes—built-in zero/span calibration mode accepts certified reference gases (0% and 10% CO₂ in N₂); calibration logs are stored with operator ID and timestamp.
Is the humidification system autoclavable?
The stainless-steel water pan is removable and compatible with steam sterilization at 121 °C for 20 min; gaskets and seals meet ISO 15883-1 bioburden reduction requirements.
What safety certifications does the unit hold?
CE marked per IEC 61010-1:2010 (Safety requirements for electrical equipment), RoHS 2011/65/EU compliant, and EMC tested to EN 61326-1:2013.