BOXUN YXQ-50G Vertical Steam Autoclave

Overview

The BOXUN YXQ-50G Vertical Steam Autoclave is a CE-compliant, microprocessor-controlled sterilization system engineered for precision, repeatability, and operational safety in regulated laboratory, clinical, and research environments. It operates on the validated principle of saturated steam under pressure—leveraging the thermodynamic properties of moist heat to achieve microbial lethality through protein denaturation and nucleic acid disruption. At its rated maximum operating conditions (135 °C at 0.22 MPa), the unit delivers a minimum F₀ value exceeding 12 min for standard biological indicator challenge loads (e.g., Geobacillus stearothermophilus spores), meeting ISO 17665-1:2017 requirements for steam sterilization process validation. Designed for routine use in hospitals, pharmaceutical QC labs, academic core facilities, and agricultural biotechnology centers, the YXQ-50G supports both liquid and solid load sterilization cycles while maintaining strict thermal uniformity across its 50 L stainless-steel chamber.

Key Features

• Vertical configuration with space-efficient footprint (485 × 605 mm base) and 1120 mm total height—optimized for benchtop or floor-mounted installation in constrained lab spaces
• Full SUS304 stainless steel construction: chamber, inner jacket, baskets, and exterior housing resist corrosion from repeated exposure to condensate, saline solutions, and alkaline cleaning agents
• Interlocked handwheel door mechanism with self-expanding silicone gasket ensures positive sealing and prevents inadvertent opening during pressurized operation per EN 285:2015 clause 5.3.2
• Automated pre-vacuum cold-air purge cycle eliminates air pockets prior to sterilization—critical for achieving uniform temperature distribution in porous or wrapped loads
• Dual-stage safety architecture: mechanical overpressure relief valve (set at 0.25 MPa design limit) plus redundant electronic overtemperature cutoff (138 °C hardware limit) and low-water level detection with automatic heater shutdown
• Three-phase programmable cycle logic: (a) sterilize-only; (b) sterilize → exhaust → drain; (c) sterilize → exhaust → drain → drying—enabling full post-cycle moisture removal for glassware and instruments
• Integrated 3 L condensate collection bottle with internal recirculation path minimizes external drainage requirements and reduces ambient humidity impact

Sample Compatibility & Compliance

The YXQ-50G accommodates a broad spectrum of sterilizable materials—including wrapped surgical kits, unwrapped metal instruments, culture media (in vented bottles), cotton gauze, rubber tubing, and borosilicate glassware—provided load configuration adheres to ISO 11140-1:2014 placement guidelines. Its chamber geometry (Ø400 × 640 mm) and dual-tier basket system (Ø360 × 240 mm × 2) support stacked or staggered loading without impeding steam penetration. The autoclave conforms to national GB 8599–2008 standards for steam sterilizers and incorporates design elements aligned with FDA 21 CFR Part 820 (QSR) and EU MDR Annex I essential requirements. Optional printer integration enables ALCOA+ compliant record generation (time-stamped cycle parameters, temperature/pressure profiles, operator ID) suitable for GLP/GMP audits.

Software & Data Management

Equipped with an embedded 8-bit microcontroller and LCD interface, the YXQ-50G provides real-time monitoring of chamber temperature, pressure, elapsed time, and phase status. All user-defined cycles—including custom sterilization (4–120 min), drying (30–240 min), melting (60–98 °C), and holding (40–60 °C)—are stored in non-volatile memory with password-protected access. When configured with the optional RS232/USB thermal printer, the system logs complete cycle metadata including start/stop timestamps, peak temperature, pressure deviation, and alarm events—supporting traceability per ISO 13485:2016 clause 7.5.9. Audit trail functionality meets basic 21 CFR Part 11 expectations for electronic records when paired with controlled user authentication protocols.

Applications

• Routine sterilization of reusable surgical instruments and dental tools in outpatient clinics and university teaching hospitals
• Preparation of microbiological growth media (e.g., agar, broth) in academic and industrial fermentation labs
• Decontamination of biohazardous waste (BSL-2 compliant loads) prior to autoclave validation or off-site disposal
• Processing of plant tissue culture vessels and hydroponic nutrient solutions in agricultural research stations
• Validation support for ISO 11134 and ISO 11140-4 biological indicator testing using standardized challenge loads
• Material compatibility testing of packaging components (Tyvek®, medical-grade paper) under accelerated steam exposure

FAQ

What is the F₀ value achievable at 121 °C for 15 minutes?
At 121 °C with a 15-minute hold time and verified steam saturation, the YXQ-50G consistently delivers an F₀ ≥ 15.2 min under standard load conditions, as confirmed by thermocouple mapping per ISO 17665-2:2021 Annex C.
Can the unit sterilize liquids in sealed containers?
No—liquid sterilization requires vented closures (e.g., loosened caps, silicone stoppers) to prevent boil-over or container rupture. Sealed vials must be processed using dedicated liquid-cycle parameters with extended exhaust and slow-cool phases.
Is third-party IQ/OQ/PQ documentation available?
Yes—BOXUN provides template qualification protocols aligned with ASTM E2500-13 and EU GMP Annex 15. Site-specific execution requires qualified service engineers and calibrated reference sensors (Class A PT100, ±0.1 °C).
Does the drying function meet ISO 15883-1 requirements for washer-disinfector residual moisture limits?
The integrated drying phase reduces surface moisture to ≤ 0.1 g/m² for flat metal instruments after 90 min at 105 °C—sufficient for immediate packaging but not equivalent to vacuum-drying systems specified in ISO 15883-1 Table 2.
What maintenance intervals are recommended for steam trap and safety valve calibration?
Steam trap inspection every 6 months; ASME-certified safety valve recalibration annually or after 10,000 cycles—whichever occurs first—as mandated by local pressure equipment regulations (e.g., PED 2014/68/EU).