BOXUN BXM-60VF Vertical Steam Sterilizer

Overview

The BOXUN BXM-60VF Vertical Steam Sterilizer is a fully integrated, microprocessor-controlled Class B vacuum-assisted steam sterilization system engineered for laboratories, research facilities, and quality control environments requiring reliable, repeatable, and compliant terminal sterilization of heat-stable materials. It operates on the fundamental principle of saturated steam under pressure—leveraging precise temperature and pressure control to achieve microbial inactivation through protein denaturation and nucleic acid disruption. Designed to meet international standards for steam sterilization—including ISO 17665-1 (Sterilization of health care products — Moist heat), EN 285 (Large steam sterilizers), and supporting validation requirements per FDA 21 CFR Part 11 and EU Annex 15—this unit delivers full-cycle processing with programmable phase transitions: pre-vacuum pulse removal, sterilization hold, post-sterilization vacuum drying, and rapid cooling. Its vertical configuration optimizes floor space while maintaining a 60 L chamber volume suitable for high-throughput loads including wrapped instruments, textile packs, large-volume culture media bottles (up to 2 L), and solid waste containers.

Key Features

• PMMA II intelligent microcomputer control system with 7-inch capacitive touchscreen interface, enabling real-time visualization of process stage, temperature/pressure curves, and operational status diagrams
• Eight pre-programmed cycles (sterilization, drying, melting, holding) plus six user-definable protocols with customizable time, temperature, pressure, and vacuum parameters
• Positive-pressure pulsing with up to six programmable air removal stages to ensure complete cold air evacuation—critical for achieving uniform steam penetration into porous and dense loads
• Vacuum-assisted drying function (80–130 °C) eliminates post-cycle handling; prevents recontamination during transfer and supports ISO 11140-compliant dry storage readiness
• Three-tier access control (Engineer, Administrator, Operator) with password protection and audit-trail-capable event logging
• Multi-stage pressure release (six selectable rates) for controlled depressurization, minimizing thermal shock to sensitive items
• Integrated rapid cooling system combining forced-air convection, secondary water-cooling, and condenser recovery—reducing lid-open wait time by up to 40% versus conventional gravity-cooled units
• Comprehensive safety architecture: independent electronic overpressure cutoff, mechanical pressure lock, lid-closure self-check, dry-run protection, overtemperature shutdown, short-circuit/leakage/overload protection, and ambient overheating safeguards

Sample Compatibility & Compliance

The BXM-60VF accommodates a broad range of load types validated for steam sterilization per ISO 11138-1 (Biological indicators) and ISO 11140-1 (Chemical indicators). Compatible materials include stainless-steel surgical instruments, glassware, autoclavable plastics (e.g., polypropylene, polycarbonate), wrapped textile packs, liquid media in vented bottles, and biohazard waste in autoclave bags. The chamber’s Ø400 × 635 mm geometry and dual 370 × 245 mm trays support staggered loading configurations to maximize steam circulation. Optional validation accessories—including 0.2 µm high-temperature/pressure-rated exhaust filters, calibrated PT100 sample temperature probes for F₀ calculation, and G1/2A threaded verification ports—enable IQ/OQ/PQ documentation aligned with GLP, GMP, and ISO/IEC 17025 laboratory accreditation frameworks.

Software & Data Management

The embedded PMMA II OS supports traceable data capture without external PCs. All cycles log timestamped records of chamber temperature, jacket pressure, vacuum level, door status, and alarm events—stored internally with USB export capability. Optional thermal printer (SPR-200 series) provides hard-copy output of cycle parameters, real-time temperature profiles, and calculated F₀ values when paired with a validated probe. Data integrity complies with FDA 21 CFR Part 11 requirements via electronic signature support, user-level permissions, and immutable audit trails. RS-485 interfaces enable integration into centralized facility monitoring systems (BMS/SCADA) using Modbus RTU protocol.

Applications

• Terminal sterilization of microbiological growth media, buffers, and reagents in academic and industrial labs
• Pre-sterilization preparation of surgical kits, endoscopic trays, and dental instruments in clinical support settings
• Decontamination of Category B biological waste prior to disposal or downstream processing
• Validation studies for sterilization process development, including cycle mapping, Bowie-Dick testing, and lethality profiling
• Regulated manufacturing environments requiring documented, repeatable thermal processing (e.g., pharmaceutical excipient preparation, medical device packaging support)

FAQ

What sterilization standards does the BXM-60VF comply with?
It meets core requirements of ISO 17665-1, EN 285, and supports validation per ISO 11138 and ISO 11140 for biological and chemical indicator use.
Can the unit perform sterilization at high-altitude locations?
Yes—the boiling point adjustment function compensates for reduced atmospheric pressure, ensuring accurate temperature setpoint attainment regardless of elevation.
Is F₀ calculation supported?
Yes, when used with an optional calibrated sample temperature sensor and thermal printer, the system calculates and prints F₀ values in accordance with USP and ISO 11138-1 Annex C.
What cooling methods are integrated?
The system combines active air cooling, secondary water cooling, and an internal condenser to accelerate cooldown—reducing post-cycle waiting time without compromising chamber integrity.
Are third-party validation services supported?
Standard G1/2A verification ports and RS-485 communication allow seamless integration with external data loggers and qualification platforms used by certified validation providers.