BOXUN BXM-120M Vertical Steam Sterilizer

Overview

The BOXUN BXM-120M Vertical Steam Sterilizer is a fully automated, microprocessor-controlled Class B vacuum-assisted steam sterilization system engineered for rigorous compliance with ISO 17665-1, EN 285, and applicable sections of FDA 21 CFR Part 820 and EU MDR Annex I. It operates on the fundamental principle of saturated steam under controlled pressure and temperature to achieve microbial inactivation—primarily through protein denaturation and nucleic acid disruption. Designed for high-throughput laboratories, central sterile supply departments (CSSDs), and pharmaceutical R&D facilities, the BXM-120M delivers validated, repeatable sterilization cycles across diverse load types—including wrapped/unwrapped instruments, porous loads, hollow devices, and liquid media—without requiring gravity displacement pre-vacuum steps. Its 120 L chamber volume supports batch processing of large instrument trays, glassware sets, or multiple culture flasks, while its dual-pressure design (0.22 MPa working / 0.25 MPa safety-rated) ensures operational robustness under sustained thermal cycling.

Key Features

• Integrated dual-channel water supply system with automatic level detection and refill—supports both purified water and municipal tap water inputs, reducing dependency on external softening infrastructure.
• Intelligent touch-screen HMI with embedded real-time clock, enabling up to 99-hour delayed start and persistent storage of up to 16 user-defined cycle protocols with full parameter recall.
• Mechanical + electronic dual-interlock door system compliant with EN 13060:2014 requirements for Class B sterilizers—prevents opening during pressurized operation and enforces post-cycle cooldown verification.
• SUS304 stainless steel chamber and triple-layered perforated baskets ensure long-term corrosion resistance against repeated exposure to acidic, alkaline, and saline solutions.
• Forced-air cooling module reduces post-sterilization dwell time by up to 40% versus passive cooling, accelerating workflow turnaround without compromising thermal uniformity.
• C.W.S. (Condensate Water System) recaptures and reuses sterilization condensate for subsequent pre-vacuum humidification, minimizing water consumption and reducing wastewater volume.
• W.P.S. (Waste Processing System) incorporates multi-stage filtration—including particulate capture and activated carbon adsorption—to treat exhaust vapor and condensate before atmospheric release, meeting local environmental discharge regulations.
• Standard integrated Pt100 sample temperature probe enables real-time monitoring of load core temperature, supporting cycle validation per ISO 11134 and ASTM F1878.

Sample Compatibility & Compliance

The BXM-120M accommodates heterogeneous loads: solid metal instruments, textile-wrapped packs, porous polymer components, and heat-stable liquids (e.g., agar media, saline solutions). Its programmable pulse vacuum capability allows optimized air removal from complex geometries, satisfying EN 13060’s “B-type” classification for mixed-load sterilization. All cycle parameters—including temperature ramp rates, hold times, vacuum depth, and drying profiles—are configurable and audit-trail logged. The system meets GLP/GMP documentation requirements via optional data export (USB) and supports 21 CFR Part 11-compliant electronic signatures when paired with validated software modules. Third-party IQ/OQ/PQ documentation packages are available upon request.

Software & Data Management

Cycle execution, parameter logging, and alarm history are stored internally with timestamped records retained for ≥10,000 cycles. Data export is supported via USB interface in CSV format compatible with LIMS integration. Optional wireless temperature sensors (validated at 0°C, 60°C, and 121°C per ISO/IEC 17025-accredited calibration certificate) enable thermocouple mapping and routine performance verification. An optional thermal printer (Epson or domestic thermal unit) provides hard-copy output of cycle curves, pass/fail status, and critical event logs—essential for internal audits and regulatory inspections.

Applications

This sterilizer serves biomedical research labs performing microbiological culture preparation; clinical diagnostics centers sterilizing reusable surgical tools; pharmaceutical QA/QC units validating autoclave processes for excipient containers; and academic institutions maintaining aseptic tissue culture workflows. Its precise thermal control and documented repeatability make it suitable for sterilizing sensitive biological reagents where overexposure risks degradation, and its drying efficiency (<1% residual moisture) ensures rapid readiness of instruments for immediate use.

FAQ

Does the BXM-120M support vacuum-assisted sterilization cycles?

Yes—it implements programmable pulse vacuum sequences essential for effective air removal from porous and hollow loads, fulfilling EN 13060 Class B requirements.
Can cycle data be exported for regulatory submission?

Yes—via USB port in CSV format; optional thermal printer provides compliant hard-copy records with cycle ID, timestamps, and deviation flags.
Is the chamber material compatible with aggressive cleaning agents?

Yes—SUS304 stainless steel resists corrosion from common disinfectants including sodium hypochlorite, hydrogen peroxide, and quaternary ammonium compounds.
What safety certifications does this model carry?

It conforms to GB 8599-2008 (Chinese national standard for sterilizers), EN 61010-1 (electrical safety), and EN 61000-6-3 (EMC emissions). CE marking is available upon configuration-specific conformity assessment.
Can the system be integrated into a facility’s building management system (BMS)?

Not natively—but analog 4–20 mA outputs and dry-contact relay signals are available as factory options for remote status monitoring and alarm triggering.