BOXUN YXQ-LS-18SI Automatic Portable Steam Sterilizer

Overview

The BOXUN YXQ-LS-18SI Automatic Portable Steam Sterilizer is a compact, electrically heated Class B-type gravity displacement steam sterilizer engineered for reliable terminal sterilization of heat-stable laboratory and clinical materials. It operates on the principle of saturated steam under pressure—achieving microbial inactivation through thermal denaturation of proteins and nucleic acids at elevated temperature and pressure conditions. Designed to meet fundamental requirements of ISO 17665-1 (Sterilization of health care products — Moist heat — Part 1: Requirements for development, validation and routine control), this unit delivers consistent sterilization cycles across a defined operating range of 110–127 °C and 0–0.142 MPa gauge pressure. Its 18 L stainless-steel chamber (SUS304) ensures corrosion resistance against repeated exposure to condensate, saline solutions, and alkaline cleaning agents—critical for long-term stability in multi-user academic, diagnostic, and agricultural research environments.

Key Features

• Electric heating system with integrated overtemperature and overpressure protection circuits
• SUS304 stainless-steel inner chamber and lid—fully compliant with ASTM A240/A240M for corrosion-resistant austenitic alloys
• Dual-scale analog pressure gauge with automatic pressure relief valve (set point: 0.165 MPa design limit)
• Self-sealing silicone gasket with positive-pressure retention mechanism for leak-tight operation
• Adjustable temperature control (110–127 °C) and programmable timer (0–60 min) with audible end-cycle alert
• Low-water cutoff sensor preventing dry-heating of heating elements and enabling safe restart after refill
• Compact footprint (Φ390 × 530 mm) optimized for benchtop or mobile cart deployment in space-constrained labs

Sample Compatibility & Compliance

The YXQ-LS-18SI accommodates wrapped and unwrapped instruments, glassware (e.g., flasks, pipettes, Petri dishes), textile dressings, liquid media (up to 500 mL per container), and porous loads—provided they are steam-permeable and non-volatile. It is not intended for sterilizing oils, powders, or hermetically sealed containers. The unit conforms to national safety standard GB 8599–2008 (China) for steam sterilizers and incorporates mechanical interlocks aligned with EN 285:2015 Annex C requirements for door safety systems. While not certified to EU MDR or FDA 510(k) as a medical device, its operational parameters support validation protocols required under GLP and basic GMP frameworks for non-clinical research use.

Software & Data Management

This model operates via an analog control interface without embedded digital logging or network connectivity. All cycle parameters—including set temperature, duration, and observed pressure—are manually recorded by the operator. For audit readiness, users are advised to maintain paper-based sterilization logs per ISO 13485:2016 clause 7.5.10, documenting load composition, cycle start/end times, and visual verification of pressure/temperature indicators. Optional external USB data loggers (e.g., calibrated thermocouple + pressure transducer units) may be employed during IQ/OQ/PQ validation to generate time-stamped, traceable cycle profiles compatible with 21 CFR Part 11–compliant review workflows.

Applications

• Routine sterilization of microbiological culture media, buffers, and reagent solutions in teaching and research laboratories
• Pre-sterilization of surgical instruments, cotton gauze, and reusable lab textiles in veterinary and field clinics
• Decontamination of soil samples and plant tissue culture tools in agricultural biotechnology facilities
• Validation support for autoclave performance testing using biological indicators (e.g., Geobacillus stearothermophilus spore strips)
• Complementary use alongside laminar flow hoods and biosafety cabinets to establish sterile workflow zones

FAQ

What is the maximum recommended load volume for effective sterilization?
For uniform steam penetration and cycle reproducibility, the chamber should not exceed 70% volumetric fill—approximately 12.6 L of loosely packed, steam-permeable items.
Can this unit sterilize liquids in sealed bottles?
No. Liquids must be placed in containers with vented closures (e.g., screw caps loosened ¼ turn) to prevent boil-over and ensure steam contact; fully sealed vessels pose explosion hazards.
Is third-party validation support available?
BOXUN provides technical documentation (chamber drawings, component certifications, material test reports) to assist qualified users in executing Installation Qualification (IQ) and Operational Qualification (OQ) per ISO 13485 and ISO 17665 guidelines.
How often should the safety valve be tested?
Per GB 8599–2008, the pressure relief valve must undergo functional verification before each daily use and full recalibration annually by an accredited metrology laboratory.
Does the unit include a drying cycle?
No. The YXQ-LS-18SI performs gravity-displacement steam sterilization only; post-cycle drying requires external forced-air ovens or ambient air-drying protocols.