BOXUN BXM-110EI Vertical Steam Sterilizer
| Brand | BOXUN |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | BXM-110EI |
| Instrument Type | Vertical |
| Max Temperature | 150 °C |
| Max Pressure | 0.38 MPa |
| Chamber Dimensions | Ø400 × 835 mm |
| External Dimensions | 535 × 640 × 1275 mm |
| Chamber Volume | 110 L |
| Temperature Uniformity | ±0.5 °C |
| Temperature Fluctuation | +1 °C |
| Sterilization Temp Range | 105–135 °C |
| Melting Temp Range | 50–100 °C |
| Holding Temp Range | 40–60 °C |
| Sterilization Time Range | 0–120 min (customizable up to 6000 min) |
| Melting/Holding Time Range | 0–6000 min |
| 预约 Time | Up to 100 h |
| Heating Power | 3.5 kW |
| Power Supply | AC 220 V ±10 %, 50 Hz ±1 Hz |
| Operating Ambient | 5–40 °C, 20–80 % RH |
| Cooling System | Standard air-cooling + secondary water-cooling + condenser |
| Safety Protections | Overtemperature cutoff, dry-run protection, overpressure mechanical & electronic relief, anti-scald insulation, overload, short-circuit, and leakage protection |
| User Access Levels | Engineer / Administrator / Operator (3-tier permission management) |
| Programmability | 8 pre-set + 6 user-defined cycles |
| Air Removal | 6-stage positive-pressure pulse with adjustable vacuum-assisted preheating |
| Exhaust Control | 6-level programmable depressurization rate |
| Optional Accessories | 0.2 µm high-temp/pressure exhaust filter, thermal printer with F₀ logging capability (requires optional sample probe), validation port adapter, wired temperature validation interface |
Overview
The BOXUN BXM-110EI Vertical Steam Sterilizer is a CE-compliant, Class B (EN 13060:2021) laboratory-grade sterilization system engineered for reliable, repeatable, and traceable steam sterilization of heat-stable materials in academic, clinical, pharmaceutical, and industrial laboratories. It operates on the validated principle of saturated steam under pressure—leveraging precise thermodynamic control to achieve microbial inactivation through protein denaturation and nucleic acid disruption. Designed for compliance with ISO 17665-1, ANSI/AAMI ST79, and relevant sections of FDA 21 CFR Part 820, the BXM-110EI delivers consistent lethality (F₀ ≥ 12 min at 121 °C) across its 110 L chamber while supporting process validation, routine monitoring, and quality assurance workflows.
Key Features
- PMMA-I intelligent microcomputer control system with a responsive 7-inch capacitive touchscreen interface for real-time visualization of cycle phase, chamber pressure, jacket temperature, load temperature (optional), and dynamic status diagrams
- Eight factory-programmed sterilization protocols (e.g., wrapped/unwrapped instruments, liquids, waste, culture media) plus six fully customizable user-defined cycles with independent time/temperature/pressure ramping logic
- 6-stage positive-pressure pulse air removal sequence with integrated preheating and automatic water replenishment—ensuring complete cold-air evacuation prior to sterilization (critical for achieving uniform steam penetration)
- Programmable 6-level depressurization profile post-cycle, enabling controlled cooling and minimizing liquid boil-over in sensitive media loads
- Triple-layer safety architecture: mechanical pressure lock + lid self-check sensor + redundant electronic overpressure release (0.38 MPa design limit; 0.22 MPa operating max)
- Three-tier hierarchical access control (Operator / Administrator / Engineer) with password-protected parameter modification, cycle editing, and calibration functions—supporting audit-ready GLP/GMP documentation practices
- Integrated rapid cooling system combining forced-air convection, secondary water-cooling circuit, and built-in condenser—reducing post-cycle wait time by up to 40% compared to passive cooling units
Sample Compatibility & Compliance
The BXM-110EI accommodates standard laboratory loads including autoclavable glassware (flasks, bottles, Petri dishes), stainless-steel surgical instruments, textile packs, liquid media (in vented containers), and regulated biohazard waste. Its chamber geometry (Ø400 × 835 mm) supports three standard baskets (Ø370 × 245 mm each) and permits vertical stacking without compromising steam circulation. The unit meets EN 285 (large sterilizers) and EN 13060 (small steam sterilizers) requirements for temperature uniformity (±0.5 °C) and stability (+1 °C fluctuation), and includes provisions for IQ/OQ/PQ validation—including G1/2A threaded validation ports, dedicated RS-485 communication interfaces (2×), and a waterproof 220 V outlet for external sensors or data loggers.
Software & Data Management
All operational parameters—including cycle start/end timestamps, setpoints, actual chamber/jacket temperatures, pressure curves, and alarm events—are logged internally with timestamped records retained for ≥10,000 cycles. Optional thermal printers (compatible with Sipure brand thermal paper) support real-time hardcopy output of sterilization curves, F₀ calculations (when paired with calibrated PT100 sample probes), and metadata (user ID, cycle name, batch ID). The system supports USB data export (FAT32-formatted drives) for offline analysis and integrates with LIMS via Modbus RTU over RS-485. Firmware complies with FDA 21 CFR Part 11 requirements for electronic signatures, audit trails, and data integrity when used with administrator-level access controls enabled.
Applications
- Routine sterilization of microbiological growth media, buffers, and reagents in teaching and research labs
- Pre-sterilization preparation of surgical kits and reusable lab tools in hospital central sterile supply departments (CSSD)
- Terminal sterilization of empty vials, syringes, and component packaging in pharmaceutical pilot-scale manufacturing
- Biohazard decontamination of solid and liquid biological waste per WHO and CDC biosafety guidelines
- Validation support for steam penetration studies using biological indicators (e.g., Geobacillus stearothermophilus spores) and chemical integrators
- High-altitude operation enabled via adjustable boiling-point compensation—ensuring accurate temperature setpoint delivery at elevations up to 3,000 m above sea level
FAQ
What standards does the BXM-110EI comply with?
It conforms to EN 13060:2021 (Class B small steam sterilizers), ISO 17665-1, ANSI/AAMI ST79, and supports IQ/OQ/PQ execution per GAMP 5 and EU Annex 15.
Can the sterilizer be validated for regulatory submissions?
Yes—equipped with validation-grade ports, RS-485 Modbus interface, F₀ calculation capability (with optional probe), and full-cycle digital logging meeting ALCOA+ data integrity principles.
Is remote monitoring supported?
Not natively via Ethernet/WiFi, but RS-485 enables integration into building management systems (BMS) or SCADA platforms using industry-standard protocol converters.
What maintenance intervals are recommended?
Daily chamber inspection and door gasket cleaning; quarterly verification of safety valves and temperature sensors; annual full calibration and leak testing per EN 285 Annex C.
Does it support liquid cycle optimization to prevent boil-over?
Yes—the 6-stage depressurization control, combined with programmable heating/cooling ramps and optional load temperature feedback, minimizes thermal shock and vapor expansion during liquid sterilization.
