Boxun BXM-110FI Vertical Steam Sterilizer

Overview

The Boxun BXM-110FI Vertical Steam Sterilizer is a CE-compliant, Class B vacuum-assisted steam sterilization system engineered for routine and demanding laboratory, clinical, and pharmaceutical applications. It operates on the fundamental principle of saturated steam under pressure—leveraging precise thermal energy transfer to achieve microbial inactivation via protein denaturation and nucleic acid disruption. Designed in accordance with ISO 17665-1 (Sterilization of health care products — Moist heat), EN 285 (Large sterilizers), and aligned with FDA guidance for steam sterilization validation, the BXM-110FI delivers reproducible, auditable sterilization cycles across heterogeneous loads—including wrapped instruments, porous textiles, liquid media in bottles, and solid waste containers. Its 110 L chamber volume supports high-throughput processing without compromising cycle integrity, while the integrated vacuum drying function enables post-sterilization moisture removal in a single chamber—eliminating manual transfer and associated contamination risks.

Key Features

• PMMA II microprocessor-based control system with 7-inch capacitive touchscreen interface, displaying real-time graphical representation of temperature, pressure, time, and phase progression
• Eight pre-programmed cycles (sterilization, drying, melting, holding) plus six user-definable protocols with adjustable parameters including dwell time, ramp rate, and hold conditions
• Positive-pressure pulsing with up to six-stage air removal cycles—ensuring complete cold-air evacuation from dense or wrapped loads prior to steam saturation
• Multi-stage pressure release (six selectable rates) for controlled depressurization, minimizing thermal shock to sensitive materials
• Triple-stage cooling system: forced-air convection + secondary water-cooling + built-in condenser—reducing chamber cooldown time by up to 40% versus conventional air-cooled units
• Three-tier access control (Engineer, Administrator, Operator) supporting role-based parameter locking, audit trail generation, and password-protected firmware updates
• Integrated vacuum drying (80–130 °C, 10–6000 min), validated for uniform residual moisture reduction in surgical drapes, gowns, and stainless-steel instrument sets
• Comprehensive safety architecture: independent electronic overpressure cutoff, mechanical pressure lock, lid self-check sensor, dry-run protection, overtemperature shutdown, ground-fault circuit interruption, and leak-current monitoring

Sample Compatibility & Compliance

The BXM-110FI accommodates diverse load types: liquid culture media (up to 3 L per bottle), glassware, stainless-steel trays, autoclavable plastics (e.g., polypropylene), wrapped surgical kits, and biohazardous waste in certified autoclave bags. Its chamber geometry (Ø400 × 835 mm) and triple-layered stainless-steel construction ensure optimal steam distribution and thermal stability. All sterilization cycles meet the requirements of EN 13060 (Small steam sterilizers) for Class B performance, and the system supports validation per ISO 11140 (Chemical indicators) and ISO 11737 (Microbiological methods). Optional accessories—including a 0.2 µm high-temperature/pressure-rated exhaust filter, calibrated PT100 sample temperature probes for F₀ calculation, and a thermosensitive printer with USB storage—enable full compliance with GLP, GMP, and 21 CFR Part 11 data integrity standards.

Software & Data Management

Equipped with embedded firmware supporting automated event logging (start/stop times, deviations, alarms, operator IDs), the BXM-110FI generates timestamped, non-erasable records compliant with ALCOA+ principles. The optional thermal printer outputs traceable hard copies of cycle parameters, temperature profiles, and calculated F₀ values when paired with a validated probe. RS-485 interfaces support integration into centralized laboratory information management systems (LIMS) or building automation platforms. Data export via USB flash drive facilitates external review, regulatory submission, and periodic revalidation per ISO 13485 and EU MDR Annex I requirements.

Applications

• Routine sterilization of microbiological growth media, Petri dishes, pipette tips, and glassware in academic and industrial research labs
• Decontamination of sharps, forceps, clamps, and other reusable surgical instruments in hospital central sterile supply departments (CSSD)
• Processing of textile packs (linen, gowns, drapes) requiring both sterility and low-residual-moisture endpoints
• Validation-grade sterilization of reference standards, calibration tools, and QC test samples in regulated QA/QC environments
• High-altitude operation enabled by programmable boiling-point adjustment—maintaining target sterilization temperatures at elevations up to 3000 m above sea level

FAQ

What sterilization standards does the BXM-110FI comply with?
It conforms to ISO 17665-1, EN 285, EN 13060, and supports validation per ISO 11140 and ISO 11737.
Can the unit be validated for F₀-based cycles?
Yes—when equipped with an optional calibrated sample temperature probe and thermal printer, it calculates and prints F₀ values in real time.
Is remote monitoring or network integration possible?
RS-485 ports enable Modbus RTU communication for integration with SCADA or LIMS; Ethernet or Wi-Fi modules are not standard but may be added via third-party gateways.
How does the vacuum drying function prevent recontamination?
By completing drying inside the sealed, sterile chamber—eliminating exposure to ambient air during transfer to external dryers.
What safety certifications apply to this model?
It carries CE marking under the EU Machinery Directive 2006/42/EC and Low Voltage Directive 2014/35/EU, with internal design meeting IEC 61010-1 for laboratory equipment safety.