BOXUN BXW-SD Horizontal Cylindrical Steam Sterilizer (Cross-Beam Structure)

Overview

The BOXUN BXW-SD Horizontal Cylindrical Steam Sterilizer (Cross-Beam Structure) is a Class B pre-vacuum and gravity-displacement compatible autoclave engineered for reliable, repeatable sterilization of heat-stable laboratory and healthcare materials. Designed in accordance with ISO 17665-1:2017 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices), it delivers saturated steam under controlled pressure and temperature to achieve microbial lethality (≥12 log reduction of Geobacillus stearothermophilus spores). Its horizontal cylindrical chamber—constructed from high-grade 304 stainless steel and welded via argon arc welding—ensures structural integrity, corrosion resistance, and long-term vacuum-tight performance. The cross-beam structural frame enhances mechanical rigidity during repeated thermal cycling and supports uniform load distribution across the chamber floor, minimizing deformation risk during prolonged operation at 131 °C and 0.2 MPa.

Key Features

• Microprocessor-based control system with real-time display of sterilization phase, chamber temperature, elapsed time, and pressure—enabling full operational transparency and traceability.
• Dual-safety interlock mechanism: (1) Sterilization cycle cannot initiate unless the door is fully closed and mechanically locked; (2) Internal pressure > 0.01 MPa automatically engages the locking assembly, preventing manual door rotation and eliminating accidental opening under pressure.
• Self-expanding silicone gasket seal designed for progressive compression under steam pressure—providing consistent sealing force across operating cycles and extending service life beyond 5,000 cycles per ISO 15883-1 Annex D recommendations.
• Integrated electric steam generator with automatic water replenishment: A dedicated feed pump maintains optimal water level in the generator tank; low-level cutoff disables heating elements during active sterilization and triggers audible/visual alarm per EN 61000-6-2 EMC requirements.
• Pressure-regulated steam generation using precision pressure controllers; redundant mechanical safety valve set at 0.25 MPa provides fail-safe overpressure relief in compliance with PED 2014/68/EU.
• Programmable exhaust strategy—including slow exhaust, fast exhaust, and vacuum-assisted drying (G-model)—to accommodate porous loads, liquids, and wrapped instruments without boil-over or moisture retention.
• PID temperature regulation with adaptive tuning capability minimizes thermal overshoot (< ±0.5 °C deviation from setpoint), ensuring precise dwell time adherence per ANSI/AAMI ST79:2017 Annex E protocols.

Sample Compatibility & Compliance

The BXW-SD accommodates standard sterilization loads including wrapped surgical kits, glassware, stainless-steel instruments, textile packs, and polymer tubing—provided materials are rated for saturated steam exposure at ≤131 °C. It supports both gravity displacement (for non-porous items) and pre-vacuum cycles (for porous or lumened devices), meeting key international standards: ISO 13485:2016 (medical device QMS), EN 285:2015 (large steam sterilizers), and FDA 21 CFR Part 820. The G-model variant integrates a water-ring vacuum pump and dedicated drying heater, enabling residual moisture removal per ISO 15883-4:2021 criteria (≤0.2% w/w retained water post-cycle). All models include audit-ready event logging (cycle start/end, alarms, parameter deviations) suitable for GLP/GMP environments requiring electronic records per 21 CFR Part 11.

Software & Data Management

The embedded controller stores ≥10,000 cycle logs with timestamps, operator IDs (via optional RFID badge reader), and critical parameters (T, P, time). Optional RS485/Modbus RTU or Ethernet interface enables integration into central lab management systems (LIMS) or SCADA platforms. An optional thermal printer provides immediate hard-copy documentation compliant with ISO 17665-2:2021 Annex B requirements for sterilization record retention. Data export supports CSV format for statistical process control (SPC) analysis using JMP or Minitab. Firmware updates are performed via USB port with cryptographic signature verification to prevent unauthorized modification.

Applications

This sterilizer serves core functions in university research laboratories, pharmaceutical QC labs, hospital central sterile supply departments (CSSD), and contract manufacturing organizations (CMOs). Typical use cases include: terminal sterilization of reusable surgical trays prior to packaging; depyrogenation of glass vials and stoppers in bioprocess development; sterilization validation studies per ISO 11134; and routine decontamination of microbiological waste in BSL-2 facilities. Its 150 L chamber volume allows batch processing of up to 40 standard instrument sets or 120 L of liquid media (with slow-cool ramp to prevent container rupture).

FAQ

What sterilization standards does the BXW-SD comply with?
It conforms to EN 285:2015, ISO 17665-1:2017, and ANSI/AAMI ST79:2017 for large steam sterilizers, including requirements for temperature uniformity (±1 °C), leak rate (<0.13 kPa/min), and biological indicator challenge testing.
Can the unit be validated for IQ/OQ/PQ protocols?
Yes—the system provides calibrated PT100 sensors (traceable to NIST standards), configurable alarm thresholds, and uneditable cycle logs required for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) under GMP guidelines.
Is remote monitoring supported?
Via optional Ethernet module, users can access live status, download logs, and receive SNMP traps for critical alarms through enterprise network infrastructure.
What maintenance intervals are recommended?
Daily: Chamber wipe-down and gasket inspection; Quarterly: Safety valve functional test and vacuum pump oil change (G-model); Annually: Full sensor calibration and door lock mechanism certification by authorized service technician.
Does the system support custom cycle programming?
Yes—up to 99 user-defined programs may be stored, each with independent settings for pre-vacuum depth, sterilization temperature/duration, exhaust mode, and drying parameters (G-model only).