Thermo Scientific™ 370 Series Steri-cycle™ High-Temperature Dry-Heat Sterilizable CO₂ Incubator

Overview

The Thermo Scientific™ 370 Series Steri-cycle™ is a Class II, direct-heating, high-temperature dry-heat sterilizable CO₂ incubator engineered for demanding cell culture applications where sterility assurance, reproducibility, and regulatory compliance are non-negotiable. Unlike conventional CO₂ incubators relying solely on UV or periodic chemical decontamination, the Steri-cycle™ integrates a fully validated, in-chamber dry-heat sterilization cycle capable of achieving a ≥6-log reduction of bacterial endospores—including Bacillus atrophaeus and Geobacillus stearothermophilus—in accordance with ISO 14937:2009 and EN 556-1:2015. The system utilizes a proprietary T/C CO₂ sensor housed behind a 0.2 µm HEPA filter, ensuring continuous real-time gas monitoring without compromising sterility integrity. Chamber temperature is maintained via a microprocessor-controlled, PID-regulated direct-heating system with independent air-jacketed walls and forced-air convection, delivering exceptional thermal stability and spatial uniformity across the full 184.1 L working volume.

Key Features

• Validated high-temperature dry-heat sterilization cycle (180 °C for ≥3 hours), fully automated and programmable via touchscreen interface
• Continuous HEPA filtration (Class 100 / ISO 5 air quality) with ≥60 air exchanges per hour, maintaining sterile internal atmosphere during routine operation
• Direct-heating architecture with triple-wall insulation and independent chamber wall heating elements to minimize thermal gradients
• CO₂ concentration control via infrared (IR) sensor with automatic compensation for temperature and pressure drift; accuracy ±0.1% CO₂ (0–20%)
• Integrated humidity management system with stainless-steel water reservoir and ultrasonic humidifier (optional), supporting stable RH control between 5–50% RH
• Full audit trail capability compliant with FDA 21 CFR Part 11 requirements, including user access logs, parameter change history, and sterilization cycle reports
• Fail-safe interlocks: automatic power cutoff and audible/visual alarm upon door opening during sterilization; external cabinet surface remains ≤40 °C during cycle

Sample Compatibility & Compliance

The Steri-cycle™ 371 supports long-term cultivation of sensitive mammalian cell lines (e.g., stem cells, primary neurons, hybridomas), microbial cultures requiring stringent contamination control, and bioprocess development workflows under GLP/GMP conditions. All internal surfaces are electropolished 316L stainless steel with welded seams and radiused corners to eliminate harborage points for biofilm formation. The system complies with IEC 61010-1 (Safety Requirements for Laboratory Equipment), ISO 13845:2017 (Good Manufacturing Practice for In Vitro Diagnostic Medical Devices), and meets essential requirements for CE marking under the EU IVDR framework. Optional IQ/OQ/PQ documentation packages are available to support qualification under ISO/IEC 17025-accredited laboratories.

Software & Data Management

The embedded Thermo Fisher Connect™ incubator software provides intuitive touchscreen navigation, multi-level password protection, and configurable event logging. Real-time data—including chamber temperature, CO₂ concentration, relative humidity, door status, and sterilization cycle phase—is timestamped and exportable in CSV or PDF format. Remote monitoring and alerting are supported via Ethernet or Wi-Fi (optional), enabling integration into centralized lab information management systems (LIMS) or enterprise asset tracking platforms. All data modifications are recorded with user ID, timestamp, and reason-for-change fields, satisfying ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Applications

• Regulated biologics manufacturing environments requiring routine chamber sterilization between batches
• Stem cell banking and regenerative medicine labs adhering to AABB or FACT-Cell Therapy Standards
• Academic core facilities supporting high-throughput screening where cross-contamination risk must be minimized
• Vaccine development workflows involving low-passage primary human cells or pathogen-associated cultures
• Contract research organizations (CROs) performing GLP-compliant toxicology or pharmacokinetic studies
• Quality control laboratories validating sterility assurance levels for medical device packaging processes

FAQ

What sterilization standards does the Steri-cycle™ 371 validate against?

It meets ISO 14937:2009 for sterilization agent validation and EN 556-1:2015 for sterility assurance level (SAL) verification using biological indicators.
Can the incubator operate while the sterilization cycle is scheduled?

Yes—sterilization cycles can be programmed to run autonomously during off-hours without interrupting normal incubation functions.
Is the humidification system standard or optional?

Humidification is optional; the base configuration includes passive humidity retention, while the active ultrasonic humidifier requires separate ordering.
How is temperature uniformity verified across the chamber?

Uniformity is measured per ISO 13845 Annex B using nine calibrated thermocouples placed at defined positions within the working volume at 37 °C.
Does the system support third-party calibration services?

Yes—Thermo Fisher-certified field service engineers perform annual calibration and performance verification aligned with ISO/IEC 17025 requirements.