Zealway GI Series 54L Benchtop Steam Sterilizer
| Brand | Zealway |
|---|---|
| Origin | Fujian, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | Zealway Fully Automatic Vertical Steam Sterilizer GI-54L (Laboratory Waste Sterilizer) |
| Instrument Type | Vertical |
| Max Temperature | 135 °C |
| Max Pressure | 0.28 MPa |
| Chamber Dimensions | Ø320 mm × 725 mm (cylindrical) |
| External Dimensions | 460 mm × 542 mm × 1105 mm |
| Chamber Volume | 54 L |
| Display | 7-inch Color TFT LCD with Multilingual UI (English/Chinese) |
| User Access Levels | 5-tier Password-Protected Permission System |
| F₀ Calculation | Built-in Real-Time F₀ Algorithm |
| Cooling Fan | Integrated Post-Cycle Forced-Air Cooling |
| Filter Monitoring | Real-Time PTFE Filter Temperature & Cycle Count Display |
| Exhaust Filtration | 0.2 µm Hydrophobic PTFE Membrane (Imported) |
| Validation Interface | Dual Calibration Ports for Temperature & Pressure (Compatible with IQ/OQ/PQ Probes up to 15 Channels) |
| Connectivity | Optional Wi-Fi Module + Dedicated iOS/Android App for Remote Monitoring & Audit Trail Export |
Overview
The Zealway GI Series 54L Benchtop Steam Sterilizer is a fully automatic vertical high-pressure steam sterilization system engineered for reliable terminal sterilization of laboratory waste, glassware, media, and non-porous instruments in research, clinical, and quality control environments. Operating on the validated principle of saturated steam under elevated pressure—compliant with ISO 17665-1, EN 285, and USP —the unit achieves microbial lethality through precise thermal exposure quantified via real-time F₀ calculation. Its cylindrical 54 L stainless steel chamber (Ø320 mm × 725 mm) supports uniform heat distribution and rapid steam penetration, while integrated saturation monitoring ensures residual air removal prior to sterilization phase initiation—critical for achieving sterility assurance level (SAL) of 10⁻⁶.
Key Features
- Five-Tier Access Control Architecture: Role-based user permissions (Administrator, Supervisor, Technician, Operator, Guest) enforced via individual password authentication; each level restricts access to specific functions including program editing, cycle start/abort, calibration, and data export—supporting GLP/GMP-aligned operational accountability.
- Integrated Hydrophobic Filtration System: Equipped with a certified 0.2 µm imported PTFE membrane filter installed on the exhaust line; retains aerosols, microorganisms, viral particles, and condensed moisture during venting, releasing only sterile, dry air—meeting biosafety requirements per WHO Laboratory Biosafety Manual and CDC/NIH guidelines.
- Real-Time F₀ Monitoring & Documentation: Onboard algorithm computes cumulative F₀ values based on dynamic chamber temperature profiles; optional thermal printer support enables traceable hardcopy output compliant with FDA 21 CFR Part 11 when paired with audit-trail-enabled software.
- Post-Cycle Active Cooling: Programmable forced-air cooling fan reduces chamber temperature to safe handling levels (<50 °C) within defined time thresholds—minimizing operator wait time without compromising material integrity or condensation risk.
- Validation-Ready Infrastructure: Dual calibrated ports accommodate simultaneous insertion of up to 15 thermocouples or pressure transducers; compatible with standard 3Q validation kits (IQ/OQ/PQ) for installation, operational, and performance qualification per ISO 13485 and GAMP 5 frameworks.
Sample Compatibility & Compliance
The GI-54L accommodates diverse load types including autoclavable plastics (e.g., polypropylene containers), stainless steel tools, wrapped surgical packs, liquid media (with anti-boil-over programming), and solid biohazardous waste in leak-proof bags. Chamber geometry and steam jacket design ensure consistent thermal delivery across heterogeneous loads. All sterilization cycles adhere to internationally recognized standards: ISO 17665-1:2017 (Moist Heat Sterilization), EN 61010-1 (Safety Requirements for Electrical Equipment), and IEC 62304 (Medical Device Software Lifecycle). The system supports routine verification using biological indicators (e.g., Geobacillus stearothermophilus spores) and chemical integrators aligned with ISO 11140 series.
Software & Data Management
A dedicated mobile application (iOS/Android) provides remote visualization of active cycle status—including real-time temperature/pressure curves, F₀ accumulation, filter temperature, and alarm history. Historical cycle logs are stored locally with timestamped metadata (operator ID, program name, start/end times, deviations) and exportable in CSV or PDF format. When connected to institutional IT infrastructure, the system supports secure TLS-encrypted data transfer to centralized LIMS or electronic lab notebooks (ELN), fulfilling ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Sterilization of non-infectious and Category B biological waste in university and pharmaceutical R&D labs
- Preparation of culture media and reagents requiring depyrogenation
- Decontamination of reusable glassware and metal instruments in QC microbiology suites
- Terminal sterilization of empty vials, syringes, and filtration assemblies prior to aseptic processing
- Supporting ISO 13485-certified medical device manufacturing cleanroom maintenance protocols
FAQ
What validation documentation is provided with the GI-54L?
Factory-supplied documentation includes Factory Acceptance Test (FAT) report, electrical safety certification (IEC 61010-1), and materials compliance statement (RoHS/REACH). Site-specific IQ/OQ protocols and blank PQ templates are available upon request.
Can the unit be integrated into a building management system (BMS)?
Yes—via optional Modbus RTU or Ethernet/IP interface modules, enabling remote status polling, alarm forwarding, and cycle acknowledgment signals to central SCADA platforms.
Is third-party calibration supported?
The dual calibration ports accept industry-standard PT100 sensors and digital pressure modules; Zealway provides traceable NIST-equivalent calibration certificates upon request.
How often must the PTFE filter be replaced?
Filter replacement interval is tracked automatically; the display shows cumulative usage cycles and triggers visual alerts at preconfigured thresholds (typically 500–1,000 cycles depending on load composition and steam quality).
Does the system support custom cycle development?
Yes—up to 99 user-defined programs can be saved in non-volatile memory, retaining parameters through power loss; each program includes configurable hold times, ramp rates, drying phases, and F₀ targets.
