Boxun YXQ-30SII Vertical Steam Sterilizer

Overview

The Boxun YXQ-30SII Vertical Steam Sterilizer is a Class B gravity-displacement and pre-vacuum compatible steam sterilization system engineered for precision, repeatability, and regulatory compliance in laboratory, pharmaceutical, and academic environments. It operates on the principle of saturated steam under controlled pressure and temperature to achieve microbial inactivation—including bacterial spores—via protein denaturation and nucleic acid disruption. Designed in accordance with 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 YXQ-30SII supports both gravity-based air removal and optional vacuum-assisted cycles (when equipped with auxiliary vacuum pump), enabling effective sterilization of porous loads, wrapped instruments, and liquid media without boil-over risk.

Key Features

• Stainless steel (SUS304) quick-opening door with ergonomic handwheel mechanism and integrated pressure interlock—ensures mechanical and electrical safety during operation and prevents door opening under pressure.
• Self-expanding silicone sealing gasket provides consistent radial compression and long-term integrity across repeated thermal cycling (tested to ≥10,000 cycles).
• Microprocessor-based control system with real-time digital display of chamber temperature, pressure, and remaining time; supports programmable cycle parameters including pre-heat, sterilization hold, exhaust, and drying phases.
• Automated cold-air purge function eliminates non-condensable gases prior to sterilization—critical for achieving uniform steam penetration and validating sterility assurance levels (SAL ≤ 10⁻⁶).
• Dual-level safety architecture: hardware-based overtemperature cutoff (139 °C design limit), mechanical pressure relief valve (0.25 MPa setpoint), dry-run detection, and automatic overpressure venting.
• Integrated G1/2A female-threaded port located at chamber top allows direct insertion of calibrated temperature/pressure sensors or biological indicator carriers for process validation per ISO 11140 and EN 285.

Sample Compatibility & Compliance

The YXQ-30SII accommodates a broad range of load types within its 30 L cylindrical chamber (Φ300 × 485 mm): unwrapped solid instruments, textile packs, glassware, stainless steel trays, and up to 12 L of aqueous solutions (with optimized slow-cool cycle to prevent container rupture). Its chamber geometry and steam distribution design comply with EN 285:2015 requirements for large steam sterilizers, supporting validation protocols aligned with FDA 21 CFR Part 820, EU Annex 1 (Manufacture of Sterile Medicinal Products), and Chinese GMP (2010) Annex I. The system meets GB/T 30690–2014 (Portable steam sterilizers for laboratory use) and is CE-marked for conformity with the EU Medical Device Regulation (MDR 2017/745) when used as ancillary equipment in sterile processing workflows.

Software & Data Management

While the YXQ-30SII operates via embedded firmware without external PC connectivity, its controller logs critical cycle parameters—including start time, peak temperature, hold duration, final pressure, and alarm events—in non-volatile memory (retention ≥10 years). Cycle records can be manually transcribed or exported via optional RS232/USB interface module (sold separately), enabling integration into Laboratory Information Management Systems (LIMS) or electronic batch records compliant with 21 CFR Part 11 when paired with validated audit-trail software. All parameter changes require operator authentication via key-lock override, satisfying GLP/GMP traceability requirements for documented evidence of process consistency.

Applications

• Sterilization of culture media (e.g., nutrient agar, LB broth) in conical flasks and screw-cap bottles.
• Decontamination of reusable labware including pipette tips, Petri dishes, and centrifuge tubes.
• Preparation of sterile surgical drapes, gauze, and instrument sets in research animal facilities.
• Validation support for autoclave mapping studies using thermocouple arrays and biological indicators (e.g., Geobacillus stearothermophilus spore strips).
• Compliance-driven sterilization in QC labs performing USP <1211> or EP 5.1.2 microbiological testing procedures.

FAQ

What is the maximum allowable load volume for liquid sterilization?
The chamber supports up to 12 L of liquid in standard configuration; however, fill level must not exceed 75% of container capacity to prevent boil-over during heating.
Does the YXQ-30SII meet international validation standards for steam sterilization?
Yes—the design, safety systems, and operational parameters align with ISO 17665-1, EN 285, and GB/T 30690, enabling IQ/OQ/PQ execution by qualified third-party vendors.
Can the unit be validated with biological indicators?
Yes—via the standard G1/2A threaded port, which permits placement of spore strips or self-contained indicators at the coldest point of the load for lethality verification.
Is a printer or data logger included as standard equipment?
No—these are optional accessories; cycle data is stored internally and requires manual review or optional interface hardware for export.
What maintenance intervals are recommended for long-term reliability?
Daily: visual inspection of door seal and chamber interior; weekly: cleaning of water reservoir and drain filter; annually: calibration of temperature/pressure sensors and full safety system functional test per manufacturer’s service manual.