Zealway GL85SA Vertical Autoclave
| Brand | Zealway |
|---|---|
| Origin | Fujian, China |
| Manufacturer Type | Direct Manufacturer |
| Instrument Type | Vertical Autoclave |
| Model | GL85SA |
| Maximum Temperature | 138 °C |
| Maximum Working Pressure | 0.30 MPa |
| Chamber Dimensions | Φ400 × 700 mm |
| Chamber Volume | 85 L |
| External Dimensions | 582 × 735 × 1060 mm |
| Design Pressure | 0.42 MPa |
| Temperature Range | 105–138 °C |
Overview
The Zealway GL85SA Vertical Autoclave is a fully automated, Class B (EN 13060-compliant) steam sterilization system engineered for precision, safety, and regulatory adherence in research laboratories, clinical diagnostics, pharmaceutical QC labs, and academic institutions. It operates on the principle of saturated steam under controlled pressure and temperature to achieve microbial inactivation—including spores—via irreversible protein denaturation and nucleic acid disruption. With a certified chamber volume of 85 L and a maximum operating temperature of 138 °C at 0.30 MPa working pressure (design pressure 0.42 MPa), the GL85SA supports both gravity displacement and vacuum-assisted air removal cycles, ensuring complete penetration into porous loads, wrapped instruments, and liquid media. Its vertical configuration optimizes floor space while maintaining full compliance with ISO 17665-1 (sterilization of health care products) and supports validation protocols aligned with FDA 21 CFR Part 11 and EU Annex 1 requirements for sterile process qualification.
Key Features
- 7-inch full-color capacitive touchscreen interface with intuitive icon-driven navigation—eliminates multi-layer menu structures and reduces operator training time.
- Pre-programmed and user-customizable cycle library: 10 fully automated sterilization programs covering liquids, solids, wrapped instruments, textiles, rubber, agar, biohazard waste, and drying phases—all selectable via one-touch activation.
- Integrated saturated steam monitoring system that continuously verifies air removal efficiency during pre-vacuum and gravity phases, ensuring ≥99.9% air elimination per EN 13060 Annex C.
- Intelligent vacuum control with six adjustable exhaust modes—enabling precise post-cycle cooling rate management to prevent boil-over in liquid loads or thermal shock in heat-sensitive materials.
- Dual-stage condensate management: high-efficiency integrated condenser coupled with automatic chamber rinse function (programmable or manual trigger) minimizes residual moisture and eliminates external steam discharge.
- Five-tier hierarchical access control (admin, engineer, supervisor, technician, operator) supporting ALCOA+ data integrity principles and audit-ready role-based permissions.
- Real-time remote monitoring capability via optional integration with LIMS (e.g., LabVantage, STARLIMS) and SCADA platforms using standard OPC UA or Modbus TCP protocols.
Sample Compatibility & Compliance
The GL85SA accommodates a broad spectrum of load types: stainless-steel instrument sets, glassware, culture media (including large-volume flasks up to 5 L), pipette tips, gowns, and biohazardous waste bags. Its Φ400 × 700 mm cylindrical chamber allows vertical stacking of trays and compatibility with standard autoclave baskets (ISO 15883-5 compliant). All sterilization cycles meet or exceed requirements of EN 13060:2014 for small steam sterilizers, ASTM E1114 for biological indicator validation, and USP for sterile processing in pharmaceutical environments. Optional IQ/OQ documentation packages are available for GMP-regulated facilities requiring formal installation and operational qualification.
Software & Data Management
The embedded control firmware logs all critical process parameters—including chamber temperature, jacket pressure, vacuum depth, steam saturation status, and door interlock states—with timestamped records stored internally (≥10,000 cycles) and exportable via USB or Ethernet. Audit trails comply with 21 CFR Part 11 requirements, featuring electronic signatures, immutable records, and change history tracking. Optional cloud-enabled telemetry provides encrypted remote alerting (SMS/email) for cycle completion, fault conditions, or maintenance reminders—fully configurable within institutional IT security policies.
Applications
- Routine sterilization of microbiological media, buffers, and reagents in academic and industrial R&D labs.
- Terminal sterilization of surgical instruments, dental tools, and implant packaging in hospital CSSDs.
- Decontamination of Category B biological waste prior to disposal per WHO and CDC biosafety guidelines.
- Validation support for aseptic processing lines in API manufacturing and cell therapy cleanrooms.
- Steam sterilization protocol development and bioburden reduction studies under ISO 11134 and ISO 11140 standards.
FAQ
What sterilization standards does the GL85SA comply with?
It conforms to EN 13060:2014 (Class B small steam sterilizers), ISO 17665-1:2019, and supports validation against ISO 11134 and ISO 11140 series for biological and chemical indicators.
Can the GL85SA perform liquid cycle validation per USP ?
Yes—its programmable slow-cool exhaust profile, temperature uniformity ≤±0.5 °C (per EN 285 Annex D), and integrated data logging enable full compliance with USP liquid sterilization requirements.
Is remote monitoring supported out-of-the-box?
Standard Ethernet port enables local network access; optional LIMS/SCADA integration requires configuration by qualified systems engineers using documented APIs.
What safety certifications does the unit hold?
CE-marked per PED 2014/68/EU (Pressure Equipment Directive), EMC Directive 2014/30/EU, and RoHS 2011/65/EU; design verified per ASME BPVC Section VIII Div. 1.
How is traceability ensured during routine operation?
Each cycle generates a unique digital record with operator ID, cycle ID, timestamps, parameter curves, and pass/fail status—exportable as PDF or CSV with cryptographic hash verification.
