BOXUN BXW-JDM Horizontal Pulsed Vacuum Steam Sterilizer

Overview

The BOXUN BXW-JDM is a horizontally oriented, pulsed vacuum steam sterilizer engineered for reliable, repeatable terminal sterilization of heat-stable medical devices, laboratory instruments, glassware, textiles, and bulk liquids in regulated healthcare, pharmaceutical, and research environments. It operates on the principle of saturated steam under controlled pressure and temperature, combined with multiple vacuum pulses to remove air from porous loads—ensuring complete steam penetration and eliminating cold spots. The sterilization cycle conforms to internationally recognized standards including ISO 17665-1 (Sterilization of health care products — Moist heat), EN 285 (Large steam sterilizers), and supports validation protocols aligned with FDA 21 CFR Part 820 and EU Annex 1 requirements for sterile product manufacturing.

Key Features

• Robust chamber construction using ASTM A240 S30408 stainless steel for corrosion resistance and long-term integrity; jacket fabricated from ASME Section VIII-compliant boiler-grade carbon steel.
• Microprocessor-based control system with color touchscreen interface providing real-time visualization of temperature, pressure, time, and phase status (pre-vacuum, heating, sterilization, exhaust, drying).
• Configurable multi-stage pulsed vacuum system: up to 99 programmable vacuum cycles with adjustable positive pulse (0.065–0.09 MPa) and negative pulse (−0.05 to −0.09 MPa); air removal efficiency >99% after ≥3 pulses.
• Integrated safety interlocks compliant with EN 61010-1 and EN 62304: door cannot be opened when chamber pressure exceeds 0.01 MPa; sterilization cycle will not initiate unless door is fully sealed and locked.
• Mechanically actuated gasket compression for manual doors; pneumatically actuated sealing for motorized doors—optimized for uniform contact force and extended gasket service life.
• PID temperature regulation with auto-tuning capability to minimize thermal overshoot and maintain ±0.5 °C stability during hold phases.
• Self-contained steam generator option includes automatic water level control, overheat protection, dual-level pressure regulation (0.3–0.5 MPa output), and redundant safety valve set at 0.25 MPa (set point) / 0.22 MPa (reseat).

Sample Compatibility & Compliance

The BXW-JDM accommodates diverse load types—including wrapped surgical kits, hollow instruments, pipette tips, culture media bottles, and non-porous labware—within its 240 L chamber. Load configuration follows ISO 11140-1 guidelines for biological indicator placement and EN 13060 Annex C for cycle development. Built-in BD test and vacuum leak rate verification (<0.13 kPa/min) support routine performance qualification per HTM 2030 and AAMI ST79. All critical parameters are logged with time-stamped audit trails meeting FDA 21 CFR Part 11 requirements for electronic records and signatures when paired with optional validated software.

Software & Data Management

The embedded controller stores full-cycle data—including temperature/pressure profiles, vacuum sequence timing, door status, and alarm history—for minimum 10,000 cycles. Optional Ethernet or RS485 connectivity enables integration with Laboratory Information Management Systems (LIMS) or centralized sterilization monitoring platforms. Data export is supported via USB flash drive in CSV format for traceability and regulatory reporting. Firmware updates are performed offline with version-controlled checksum verification to ensure system integrity.

Applications

This sterilizer serves as a primary terminal sterilization solution in hospital central sterile supply departments (CSSD), GMP-compliant pharmaceutical QC labs, academic research facilities handling BSL-2 agents, and contract manufacturing organizations (CMOs) producing single-use devices. Its flexibility supports both routine processing (e.g., instrument packs, linen rolls) and specialized applications such as depyrogenation validation studies, media preparation for microbiological testing, and pre-sterilization conditioning of filtration assemblies.

FAQ

What vacuum leak rate does the BXW-JDM achieve during routine verification?
The unit maintains a maximum vacuum decay of ≤0.13 kPa/min when tested per EN 285 Annex D.
Can the sterilizer operate with externally supplied steam?
Yes—models are available with either integrated steam generators or external steam inlet ports compatible with plant-supplied saturated steam at 0.3–0.5 MPa.
Is the control system compliant with FDA 21 CFR Part 11?
When configured with optional audit-trail-enabled firmware and user access controls, the system meets electronic record and signature requirements for regulated environments.
What is the maximum allowable pulse count during pre-vacuum phase?
The controller supports up to 99 programmable vacuum pulses, enabling optimization for highly porous or complex load configurations.
Does the unit include BD test functionality?
Yes—integrated BD (Bowie-Dick) test mode is provided for daily air removal efficacy verification prior to sterilizing porous loads.