BOXUN YXQ-75SII Vertical Steam Sterilizer

Overview

The BOXUN YXQ-75SII Vertical Steam Sterilizer is a Class B gravity-displacement and pre-vacuum compatible steam sterilization system engineered for precision, safety, and regulatory compliance in laboratory, clinical, and research environments. It operates on the fundamental principle of saturated steam under controlled pressure and temperature to achieve microbial inactivation—primarily through protein denaturation and nucleic acid disruption. Designed to meet international sterilization standards including ISO 17665-1 (Sterilization of health care products — Moist heat), EN 285 (Large steam sterilizers), and aligned with FDA-recommended validation practices for steam sterilization processes, the YXQ-75SII delivers reproducible lethality (F₀ ≥ 12) across load configurations. Its vertical orientation optimizes floor space utilization without compromising chamber volume or thermal uniformity, making it suitable for routine sterilization of wrapped instruments, porous loads, hollow devices, culture media, and laboratory glassware.

Key Features

• Robust stainless-steel construction: Chamber, inner jacket, and sterilization baskets fabricated from SUS304 austenitic stainless steel—resistant to corrosion from repeated exposure to steam, condensate, and alkaline cleaning agents.
• Intelligent microprocessor control system with real-time monitoring of temperature, pressure, time, and phase status; programmable cycle parameters stored in non-volatile memory.
• Self-tightening silicone gasket seal with automatic expansion under pressure ensures leak-tight integrity throughout the sterilization cycle.
• Integrated cold-air purge function initiates automatically at cycle start to evacuate non-condensable gases—critical for achieving uniform steam penetration in porous and wrapped loads.
• Comprehensive safety architecture: Dual redundant temperature sensors, mechanical and electronic overpressure relief valves (set at 0.25 MPa design limit), door interlock mechanism preventing opening during pressurized operation, and audible end-of-cycle alarm.
• Low-water-level detection with automatic power cutoff prevents dry-heating damage to heating elements; visual and acoustic alerts activate prior to critical threshold.
• Standard 10-mm diameter process sampling port enables integration with external temperature/pressure loggers or validation thermocouples per ISO 11140 and ANSI/AAMI ST79 guidelines.

Sample Compatibility & Compliance

The YXQ-75SII accommodates a wide range of load types—including wrapped surgical kits, textile packs, liquid media in sealed bottles (with vented caps), glassware, and polymer-based lab consumables—provided they are validated for steam sterilization. Chamber geometry (Φ400 mm × 720 mm) supports dual-tier basket loading (two 360 mm Ø × 280 mm deep baskets), enabling efficient throughput without compromising steam circulation. All operational parameters comply with national and international regulatory frameworks governing medical device reprocessing: GB 8599–2008 (Chinese standard for large steam sterilizers), ISO 13485–2016 (quality management for medical devices), and support documentation required for GLP/GMP audits. Cycle traceability is enhanced by optional RS232/RS485 interfaces for printer integration (not included as standard).

Software & Data Management

While the YXQ-75SII features an embedded controller without cloud connectivity, its firmware supports full cycle logging—including timestamped start/end times, setpoints, actual temperature/pressure profiles, and fault codes—with data retention for ≥100 cycles. The interface allows manual export via serial output to external PCs running compliant data acquisition software. For laboratories operating under FDA 21 CFR Part 11 requirements, the system supports user-defined access levels (operator, technician, administrator) and audit trail generation when paired with validated third-party data capture solutions. All parameter changes are logged with operator ID, timestamp, and pre/post values—satisfying ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Applications

• Sterilization of reusable surgical instruments and dental handpieces in hospital central sterile supply departments (CSSD).
• Preparation of microbiological growth media, buffers, and reagent solutions in academic and industrial R&D labs.
• Decontamination of biohazardous waste prior to autoclave-compatible disposal pathways.
• Validation of sterilization protocols for ISO 11138-compliant biological indicators (e.g., Geobacillus stearothermophilus spores).
• Processing of animal husbandry equipment and veterinary diagnostic tools in agricultural research facilities.
• Supporting ISO/IEC 17025-accredited testing laboratories requiring documented, repeatable thermal processing conditions.

FAQ

What is the maximum allowable working pressure and temperature for routine operation?
The rated maximum working pressure is 0.22 MPa at 135 °C. The design pressure and temperature are 0.25 MPa and 138 °C respectively, providing a defined safety margin per ASME BPVC Section VIII requirements.
Does the unit support vacuum-assisted air removal for porous load sterilization?
Yes—the YXQ-75SII incorporates programmable pre-vacuum pulses prior to steam admission, meeting EN 285 Class B performance criteria for effective air removal in wrapped and porous items.
Is validation documentation provided with the instrument?
Factory-installed IQ/OQ documentation templates are supplied; PQ validation must be performed on-site using calibrated thermocouples and biological indicators per ISO 17665-2.
Can the sterilizer be integrated into a laboratory LIMS or MES platform?
Via optional RS232/RS485 communication modules, raw cycle data can be transmitted to external systems; however, native HL7 or OPC UA support is not available.
What maintenance intervals are recommended for optimal performance?
Daily: Chamber inspection, gasket cleaning, drain line flush. Quarterly: Safety valve functional test, door seal integrity check. Annually: Full calibration of temperature and pressure transducers by accredited service provider.