BOXUN BXM-120M Vertical Steam Sterilizer

Overview

The BOXUN BXM-120M Vertical Steam Sterilizer is a fully integrated, microprocessor-controlled Class B vacuum-assisted steam sterilization system engineered for high-reliability operation in clinical laboratories, pharmaceutical QC facilities, and academic research settings. It operates on the fundamental principle of saturated steam under elevated pressure—leveraging the thermodynamic properties of moist heat to achieve microbial inactivation through irreversible protein denaturation and nucleic acid disruption. With a validated chamber volume of 120 L and a maximum operating temperature of 135 °C at 0.22 MPa, the BXM-120M complies with internationally recognized sterilization standards including ISO 17665-1, EN 285, and GB 8599–2008. Its vertical orientation optimizes floor space utilization while maintaining full accessibility for loading/unloading large instrument trays, glassware sets, and wrapped medical devices. The unit features a dual-channel automatic water supply system, integrated air filtration, and real-time temperature monitoring via a calibrated probe—ensuring reproducible cycle performance across daily operational loads.

Key Features

• Intelligent one-touch automatic door mechanism with dual mechanical self-locking and electronic interlock safety systems, meeting EN 61010-1 requirements for operator protection.
• High-resolution capacitive touchscreen interface with intuitive icon-driven navigation and multilingual support (English, Spanish, French, Chinese), enabling rapid parameter selection and cycle initiation.
• 16 programmable user-defined cycles—including sterilization, drying, melting, and insulation modes—with non-volatile memory storage and USB-based data export capability (CSV format).
• SUS304 stainless steel chamber and triple-layered sterilization baskets resistant to corrosion from acidic, alkaline, and saline solutions—ensuring long-term structural integrity and compliance with ISO 7405 biocompatibility guidelines.
• Integrated cooling fan and forced-air circulation system reducing post-cycle cooldown time by up to 40% compared to passive cooling methods.
• C.W.S. (Condensate Water Reuse System) recaptures and reuses condensate during sterilization, minimizing freshwater consumption and supporting sustainability objectives.
• W.P.S. (Waste Purification System) filters exhaust steam and condensate vapors through a multi-stage activated carbon and HEPA-grade particulate filter before atmospheric release—reducing environmental emissions and odor generation.
• Standard single-point temperature probe (PT100) mounted at chamber center for real-time load temperature monitoring; optional wireless temperature sensors (calibrated at 0 °C, 60 °C, and 121 °C per ISO/IEC 17025) available for IQ/OQ/PQ validation protocols.

Sample Compatibility & Compliance

The BXM-120M accommodates a broad range of sterilizable materials: porous loads (e.g., textile packs, gauze), hollow instruments (including lumened devices up to 1.5 m length), liquids in sealed containers, and solid laboratory ware. Its pulse vacuum system ensures complete air removal prior to steam penetration—critical for achieving sterility assurance level (SAL) of 10⁻⁶ per ISO 11134 and ISO 11135. All control logic and safety circuits are designed in accordance with IEC 62304 (Medical Device Software Lifecycle) and include audit-trail functionality compliant with FDA 21 CFR Part 11 for electronic records. Optional accessories—including softening units, auxiliary lifting mechanisms, and thermal printers with U-disk storage—enable seamless integration into GLP/GMP environments requiring traceable documentation.

Software & Data Management

The embedded firmware supports full-cycle logging with timestamps, temperature/pressure profiles, alarm events, and user authentication metadata. Data export is performed via USB 2.0 port in CSV format compatible with LIMS platforms and statistical process control (SPC) software. Optional wireless temperature recorders provide synchronized multi-point validation datasets exportable as PDF, Excel, or XML files—facilitating automated report generation per ISO 13485 Annex A and EU Annex 15 requirements. Firmware updates are delivered via encrypted firmware packages with SHA-256 signature verification to maintain cybersecurity integrity.

Applications

• Routine sterilization of surgical kits, pipette tips, Petri dishes, and media bottles in hospital central sterile supply departments (CSSD).
• Preparation of sterile culture media and buffers in microbiology and cell biology labs.
• Validation of autoclave performance in pharmaceutical manufacturing under cGMP Annex 1 guidelines.
• Decontamination of biohazardous waste (BSL-2/3) using extended exposure cycles at 134 °C.
• Processing of dental handpieces and orthopedic implants requiring vacuum-assisted steam penetration.

FAQ

What safety certifications does the BXM-120M hold?

It conforms to EN 61010-1 (electrical safety), EN 61326-1 (EMC), and GB 4793.1–2007 (Chinese national standard for lab equipment). CE marking is available upon request with EU Declaration of Conformity.
Is the unit suitable for liquid sterilization cycles?

Yes—equipped with slow-cool and anti-boil-over algorithms, it supports safe sterilization of aqueous solutions up to 15 L per cycle with programmable venting rates.
Can the sterilizer be integrated into a facility’s building management system (BMS)?

Optional RS485 Modbus RTU interface enables remote status monitoring and alarm signaling—compatible with most industrial BMS platforms.
What validation support is provided for regulatory submissions?

BOXUN supplies factory-installed temperature mapping reports, IQ/OQ templates, and calibration certificates traceable to NIM (National Institute of Metrology, China); third-party PQ services are available globally via authorized partners.
Does the unit require external drainage or dedicated ventilation?

No—W.P.S. filtration eliminates need for external exhaust ducting; wastewater collection tank (optional) allows operation in facilities without floor drains.