BOXUN BXM-150M Vertical Steam Sterilizer

Overview

The BOXUN BXM-150M Vertical Steam Sterilizer is a fully automated, microprocessor-controlled Class B vacuum-assisted steam sterilization system engineered for high-reliability applications in clinical laboratories, pharmaceutical QC facilities, biomedical research centers, and university core labs. It operates on the fundamental principle of saturated steam under controlled pressure and temperature to achieve microbial inactivation—including bacterial spores—through irreversible protein denaturation and nucleic acid disruption. Designed in accordance with ISO 17665-1 (Sterilization of health care products — Moist heat), EN 285 (Large steam sterilizers), and aligned with FDA 21 CFR Part 820 requirements for medical device sterilization validation, the BXM-150M supports both gravity displacement and vacuum-assisted cycles to ensure complete air removal from porous loads and hollow devices—critical for sterility assurance in wrapped instruments, pipette tips, culture media, and biohazard waste.

Key Features

• Robust chamber construction using medical-grade SUS304 stainless steel for long-term resistance to corrosion, acidic/alkaline reagents, and repeated thermal cycling
• Dual automatic water supply system with independent inlet ports for deionized water and municipal tap water—enabling flexible source selection and fail-safe operation during low-level conditions
• Integrated C.W.S. (Condensate Water Saving) recirculation system that captures, cools, and reuses condensate generated during sterilization phases—reducing total water consumption by up to 40% compared to conventional systems
• W.P.S. (Waste & Process Steam) purification module featuring HEPA-grade particulate filtration and activated carbon adsorption to neutralize volatile organic compounds and residual bioburden before exhaust discharge—meeting local environmental emission guidelines
• Intelligent dual-locking door mechanism combining mechanical interlock and electronic safety verification; door remains sealed until chamber pressure drops to ambient and temperature falls below 80 °C
• High-resolution capacitive touchscreen interface with intuitive icon-driven navigation, real-time graphical cycle status display, and multilingual UI support (English, Spanish, French, Chinese)
• 16 user-definable sterilization, drying, melting, and holding programs with password-protected editing and versioned parameter recall
• Built-in cooling fan assembly enabling rapid post-cycle air-cooling (<15 min from 135 °C to 60 °C), minimizing turnaround time without compromising load integrity
• Standard integrated PT100 temperature probe for direct monitoring of load temperature—providing traceable process data compliant with ISO 13485 and GMP Annex 1 requirements

Sample Compatibility & Compliance

The BXM-150M accommodates a broad range of sterilizable materials including glassware, stainless-steel surgical instruments, textile packs, autoclavable plastics (e.g., polypropylene, polycarbonate), liquid media in sealed bottles (up to 2 L), and biohazardous waste in UN-certified bags. Its 150 L chamber volume and Ø500 × 870 mm cylindrical geometry support stacking of four standard 460 × 180 mm stainless-steel baskets. All operational parameters—including dwell time, temperature ramp rate, vacuum depth, and drying profile—are programmable and auditable. The system meets CE marking requirements under the Medical Device Regulation (MDR 2017/745) and carries conformity documentation for ISO 13485:2016 quality management systems. Optional wireless temperature sensors (validated at 0 °C, 60 °C, and 121 °C per ISO/IEC 17025-accredited calibration certificate) enable IQ/OQ/PQ protocol execution and thermal mapping per HTM 2030 or PDA TR-1 guidelines.

Software & Data Management

Equipped with embedded non-volatile memory, the BXM-150M stores ≥10,000 complete cycle logs—including timestamps, setpoints, actual values, alarms, and operator IDs—with full export capability via USB 2.0 port in CSV or XML format. Audit trail functionality records all parameter modifications, user logins, and emergency interventions—satisfying FDA 21 CFR Part 11 electronic record requirements when paired with optional digital signature authentication. Optional thermal printers (Epson ribbon or domestic thermal models) provide real-time hardcopy output of cycle curves and summary reports, while optional remote control units allow hands-free door actuation from adjacent workstations—enhancing ergonomic workflow integration in high-throughput environments.

Applications

This sterilizer serves as a primary processing unit for terminal sterilization in regulated environments: preparation of microbiological growth media (e.g., agar, broth), depyrogenation of labware prior to aseptic filling, sterilization of reusable surgical kits in hospital SPD departments, inactivation of Category B biological waste per WHO biosafety standards, and validation support for cleanroom garment laundering protocols. Its precise thermal uniformity (<±0.5 °C across chamber volume per EN 285 Annex C) and repeatable vacuum performance make it suitable for routine use in GLP-compliant toxicology studies and preclinical device testing where documentation integrity and process reproducibility are mandated.

FAQ

What vacuum capabilities does the BXM-150M support?
It features programmable pulse vacuum cycles (2–99 pulses) for efficient air removal from porous and lumened loads, though it does not implement full pre-vacuum or post-vacuum drying sequences typical of Class S or Class N sterilizers.
Is the system compatible with third-party validation hardware?
Yes—standard RS485 and analog 4–20 mA outputs allow integration with external data loggers; optional wireless temperature sensors include Bluetooth 5.0 connectivity and dedicated validation software for compliance reporting.
Can the BXM-150M be used for liquid sterilization without boil-over?
Yes—its intelligent pressure-relief algorithm modulates steam admission and venting rates during heating and cooling phases to prevent violent boiling, ensuring stable liquid sterilization at 121 °C for durations up to 120 minutes.
Does the unit meet international regulatory requirements for pharmaceutical manufacturing?
While classified as a general-purpose sterilizer, its design, documentation package, and optional validation accessories support alignment with EU GMP Annex 1, USP , and PIC/S PI 007-6 when operated within validated parameters and maintained under a qualified preventive maintenance program.
What maintenance intervals are recommended?
Daily: Chamber wipe-down and door gasket inspection; Weekly: Air filter replacement and drain line flush; Annually: Full pressure vessel inspection, safety valve certification, and temperature sensor recalibration per ISO/IEC 17025-accredited laboratory protocol.