BOXUN YXQ-50A Vertical Steam Autoclave

Overview

The BOXUN YXQ-50A Vertical Steam Autoclave is a CE-compliant, microprocessor-controlled sterilization system engineered for precision, repeatability, and operational safety in laboratory, clinical, and research environments. It operates on the fundamental principle of saturated steam under pressure—leveraging the thermodynamic properties of water vapor at elevated temperatures and pressures to achieve microbial inactivation through protein denaturation and nucleic acid disruption. At its rated maximum operating condition of 135 °C and 0.22 MPa (≈2.2 bar gauge), the unit delivers validated sterilization cycles conforming to 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). The 50 L cylindrical chamber—constructed entirely from medical-grade SUS304 stainless steel—ensures long-term corrosion resistance against repeated exposure to condensate, alkali-based cleaning agents, and biological residues.

Key Features

• Vertical configuration with space-efficient footprint (445 × 525 mm base) and compact height (1120 mm), suitable for benchtop or floor-mounted installation in constrained lab spaces.
• Integrated safety interlock system featuring a handwheel-actuated, self-sealing door mechanism compliant with EN 13445-3 Annex C requirements for pressure vessel closures; door remains mechanically locked until chamber pressure drops below 0.02 MPa.
• Self-expanding silicone gasket (autogenous seal) ensuring leak-tight integrity across thermal cycling; validated for >10,000 sterilization cycles without replacement.
• Dual-level water level monitoring with audible/visual alarm and automatic power cutoff during low-water conditions; integrated dry-run protection prevents heater element damage.
• Three programmable cycle modes: (a) Fast exhaust (for non-liquid loads), (b) Slow exhaust (for liquid media to prevent boil-over), and (c) No exhaust (for heat-sensitive items requiring gradual depressurization).
• Automated cold air purge via gravity displacement prior to pressurization—verified by thermocouple-based temperature mapping per ANSI/AAMI ST79:2017 Annex D.
• Configurable end-of-cycle actions including timed automatic exhaust, acoustic alert (85 dB @ 1 m), and auto-shutdown; optional RS232 interface supports external data logging.

Sample Compatibility & Compliance

The YXQ-50A accommodates a broad range of load types: wrapped/unwrapped surgical instruments, glassware (e.g., pipettes, flasks), textile dressings, agar and broth media (in sealed or vented containers), and polymer-based lab consumables. Chamber geometry (Ø300 × 755 mm) permits vertical stacking of three standard baskets (Ø280 × 210 mm), enabling uniform steam penetration validated per ISO 11140-1:2014 (Biological indicators). All electrical components meet IEC 61010-1:2010 safety standards for laboratory equipment. The system supports GLP/GMP-aligned documentation when paired with optional thermal printer (model YXQ-PRT) for permanent record generation—including cycle ID, start/end timestamps, peak temperature/pressure, and operator ID—meeting traceability requirements under FDA 21 CFR Part 11 (when used with validated software).

Software & Data Management

The embedded microcontroller implements real-time PID regulation of heating elements and pressure-regulating valves, maintaining ±0.5 °C temperature stability and ±0.01 MPa pressure control throughout the sterilization phase. Cycle parameters are stored in non-volatile memory (100+ programmable protocols). Optional thermal printer output provides auditable hardcopy records compliant with ISO 13485:2016 clause 7.5.10 (Control of monitoring and measuring equipment). For integration into centralized lab informatics platforms, the RS232 port enables bidirectional communication using ASCII-based command protocol (e.g., “GET_TEMP”, “READ_CYCLE_LOG”)—supporting automated archiving in LIMS or ELN systems.

Applications

This autoclave serves core sterilization workflows across regulated and academic settings: preparation of microbiological growth media (e.g., nutrient agar, LB broth); decontamination of reusable PPE and surgical tools in university animal facilities; validation of sterility assurance levels (SAL ≤10⁻⁶) for Class II biosafety cabinet work surfaces; and routine processing of soil samples in agricultural research labs. Its precise thermal ramping and dwell control also support auxiliary functions such as agar melting (60–98 °C, 0–999 min) and post-melting temperature holding (40–60 °C, 0–999 min)—critical for preparing consistent electrophoresis gels or enzyme storage buffers.

FAQ

What standards does the YXQ-50A comply with for sterilization validation?

It meets the essential design and performance criteria outlined in ISO 17665-1:2017, EN 285:2015 (Steam sterilizers — Large sterilizers), and ANSI/AAMI ST79:2017.
Can this unit be used for liquid media sterilization?

Yes—select Mode B (slow exhaust) to prevent container rupture or boil-over; recommended for volumes up to 1.5 L per container.
Is third-party IQ/OQ/PQ validation support available?

BOXUN provides standardized validation templates and sensor calibration certificates; qualified vendors may perform site-specific qualification per ISO 13485 and GAMP 5 guidelines.
What maintenance intervals are recommended?

Daily: water level check and chamber wipe-down; quarterly: gasket inspection and safety valve functional test; annually: full thermocouple and pressure transducer calibration.
Does the unit include a built-in biological indicator port?

No—but it features a dedicated 6-mm sample test port (ISO 11140-1 compatible) for placement of spore strips or self-contained biological indicators during cycle validation.