BOXUN BGM-90FE Vertical Steam Sterilizer
| Brand | BOXUN |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | BGM-90FE |
| Instrument Type | Vertical |
| Max Temperature | 135 °C |
| Max Working Pressure | 0.24 MPa |
| Chamber Dimensions | Ø380 mm × 735 mm |
| External Dimensions | 605 mm × 513 mm × 1040 mm |
| Chamber Volume | 90 L |
| Design Pressure | 0.39 MPa |
| Temperature Resolution | 0.1 °C |
| Temperature Uniformity | ≤1 °C |
| Temperature Fluctuation | ±1 °C |
| Sterilization Time Range | 0–240 min |
| Melting/Insulation Time Range | 0–6000 min |
| Power Input | 3.6 kW |
| Operating Ambient | 5–40 °C, 20–80% RH |
Overview
The BOXUN BGM-90FE Vertical Steam Sterilizer is a CE-compliant, Class B vacuum-assisted steam sterilization system engineered for reliable terminal sterilization of heat-stable laboratory and clinical loads—including wrapped and unwrapped instruments, glassware, media, and porous materials. It operates on the fundamental principle of saturated steam under pressure, where microbial inactivation is achieved through protein denaturation at elevated temperatures (105–135 °C) sustained for validated time intervals. The unit complies with ISO 17665-1:2017 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices) and supports validation protocols aligned with EN 285:2015 (Steam sterilizers — Large sterilizers). Its vertical orientation optimizes floor space while maintaining full compliance with ASME BPVC Section VIII Div. 1 design standards for pressure vessels.
Key Features
- Intelligent BRIGHT II Control System: Self-compensating algorithm adjusts setpoints based on ambient temperature and humidity drift; supports real-time parameter tuning without interrupting active cycles.
- 7-inch High-Resolution Touchscreen Interface: Displays chamber temperature, sample temperature (via optional PT100 probe), elapsed time, program status, alarm history, and calendar clock simultaneously—enabling full situational awareness during operation.
- Ergonomic Adjustable Display Mount: Fully articulating screen arm allows vertical tilt adjustment to minimize glare and optimize viewing angle across varied operator heights and lab lighting conditions.
- Pedal-Actuated Lid Mechanism: Foot-operated hinged lid integrates mechanical self-locking and redundant electronic interlock circuits—preventing lid opening unless chamber pressure and temperature fall below safe thresholds (configurable down to 45 °C).
- Thermal Safety Architecture: Integrated high-molecular-weight thermal barrier on upper housing reduces external surface temperature to <45 °C during sterilization, meeting IEC 61010-1 touch-safety requirements.
- Rapid Cooling Function: Programmable post-cycle forced-air cooling accelerates chamber depressurization and temperature reduction—reducing total cycle turnaround time by up to 35% versus passive cooling.
- Segregated Wiring & Piping Layout: Electrical wiring routed independently from steam/water lines along opposing side panels—eliminating electromagnetic interference risks and simplifying maintenance access.
- Mirror-Finish Stainless Steel Chamber: Electropolished 304 stainless steel interior (Ra ≤ 0.4 µm) resists corrosion, facilitates visual inspection, and minimizes biofilm retention—critical for GLP/GMP environments.
- Large-Radius Rolled Chamber Rim: Eliminates sharp flange transitions at the chamber opening—reducing risk of glove abrasion or hand injury during basket insertion/removal.
Sample Compatibility & Compliance
The BGM-90FE accommodates standard sterilization loads including autoclave bags, wrapped instrument sets, liquid media in sealed bottles (with vented caps), and porous textiles. Its six-stage programmable exhaust system enables load-specific steam removal strategies—e.g., slow exhaust for liquids, fast exhaust for dry goods, and vacuum-assisted drying for wrapped items. All sterilization cycles meet the minimum F0 ≥ 12 requirement for SAL 10−6 (ISO 11138-1). The system supports installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) documentation templates compliant with FDA 21 CFR Part 11 and EU Annex 11 data integrity expectations. Built-in dual water-level protection (conductive probe + dry-run thermal cutoff) prevents heater activation under low-water conditions—fulfilling EN 61000-6-2 EMC immunity and EN 61000-6-4 emission standards.
Software & Data Management
The embedded controller logs all critical events—including alarms, parameter deviations, door operations, cycle starts/stops, and user logins—with timestamped UTC records stored internally for ≥12 months. Data export is performed via USB 2.0 port using write-once, read-many (WORM) file format (.csv with SHA-256 hash), ensuring audit-trail integrity per ALCOA+ principles. The system implements role-based access control (RBAC) with 20 configurable user accounts and 12 granular permissions (e.g., “Modify Program”, “Export Logs”, “Calibrate Sensors”). Eight-point temperature calibration routines support traceable adjustments for both chamber and optional external probe inputs, with calibration certificates exportable alongside raw data. Calendar-based scheduling allows precise start-time definition up to 30 days in advance—supporting unattended overnight sterilization in regulated facilities.
Applications
- Terminal sterilization of microbiological culture media (agar, broth, selective media)
- Decontamination of reusable surgical instruments and dental tools
- Preparation of sterile saline, buffers, and reagent solutions
- Validation of sterilization processes per ISO 11138 biological indicator standards
- Research-grade sterilization in academic and pharmaceutical development labs requiring documented repeatability
- Compliance-driven workflows in clinical diagnostics laboratories operating under CAP, CLIA, or ISO 15189 accreditation
FAQ
Does the BGM-90FE support vacuum-assisted air removal?
Yes—it features programmable positive-pressure pulse exhaust (up to 6 cycles) to evacuate non-condensable gases prior to sterilization, ensuring complete steam penetration into porous and hollow loads.
Can the unit be validated for use in GMP environments?
Yes—the system provides full electronic audit trails, RBAC, calibrated temperature monitoring, and WORM data export—meeting core requirements of FDA 21 CFR Part 11 and EU GMP Annex 11.
What is the maximum allowable altitude for operation?
The device includes adjustable boiling point compensation (80–105 °C range), enabling stable sterilization performance at elevations up to 3000 m above sea level.
Is third-party calibration support available?
BOXUN provides NIST-traceable calibration services and certifies all factory calibrations against ISO/IEC 17025-accredited reference standards.
How is firmware updated?
Firmware upgrades are delivered via encrypted USB key with digital signature verification—ensuring version control and preventing unauthorized modifications.
