BOXUN YXQ-70A Vertical Steam Autoclave

Overview

The BOXUN YXQ-70A Vertical Steam Autoclave is a fully integrated, microprocessor-controlled sterilization system engineered for precision, safety, and operational reliability in 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 inactivation through protein denaturation and nucleic acid disruption. Designed in accordance with ISO 17665-1 (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-70A delivers consistent lethality (F₀ ≥ 12 min) across its 75 L chamber volume when operated within validated cycles. Its vertical configuration optimizes floor space without compromising loading capacity or thermal uniformity, making it suitable for medium-throughput facilities requiring GxP-aligned sterilization workflows.

Key Features

• Intelligent microcomputer control system with real-time monitoring of temperature, pressure, time, and phase status
• Self-sealing, self-tightening silicone gasket (autogenous seal ring) ensuring leak-free operation up to 0.22 MPa
• Dual-safety interlock mechanism: mechanical handwheel door lock synchronized with pressure sensor feedback to prevent accidental opening during pressurized cycles
• Automatic cold air purge function prior to sterilization onset, ensuring complete air removal for uniform steam penetration
• Three programmable exhaust modes: rapid exhaust (for dry items), slow exhaust (for liquid media to prevent boil-over), and no exhaust (for vacuum-assisted drying or specialized protocols)
• Integrated high-capacity 3 L condensate collection bottle with internal recirculation path to minimize external venting and improve energy efficiency
• Multi-level safety protection: overtemperature cutoff (138 °C design limit), low/high water level detection, automatic dry-run shutdown, and overpressure relief valve (0.25 MPa rated burst pressure)
• Standard 10 mm diameter sample test port for optional thermocouple or data logger integration during validation studies

Sample Compatibility & Compliance

The YXQ-70A accommodates a broad range of load types—including wrapped surgical instruments, unwrapped metal tools, glassware, textile packs, liquid culture media (up to 2 L per container), and polymer-based labware—without compromising cycle reproducibility. Chamber geometry (Ø400 × 720 mm) and dual-tier stainless steel baskets (Ø360 × 280 mm × 2) support staggered loading to maximize airflow and steam distribution. All wetted components—including inner chamber, door liner, and baskets—are fabricated from AISI 304 stainless steel, offering resistance to chloride-induced pitting and compatibility with standard alkaline and acidic cleaning agents used in ISO 15883-compliant washer-disinfectors. The unit meets GB/T 30690–2014 (Chinese national standard for small steam sterilizers) and supports alignment with FDA 21 CFR Part 820, EU MDR Annex I (General Safety and Performance Requirements), and WHO TRS 910 Annex 2 for steam sterilization validation.

Software & Data Management

While the YXQ-70A operates via embedded firmware (no external PC dependency), its control architecture supports full audit trail generation for critical parameters—including start/stop timestamps, setpoints, actual temperature/pressure profiles, and alarm events—with non-volatile memory retention for ≥1000 cycles. Optional RS232 interface enables connection to external thermal printers for hard-copy cycle reports compliant with GLP/GMP documentation requirements. When paired with calibrated Class A thermocouples and third-party validation software (e.g., ValSuite™ or SteriTrak®), the unit supports IQ/OQ/PQ execution per ISO 13485 and ISO 14971 risk management frameworks. Cycle logs are exportable in CSV format for trend analysis, deviation investigation, and regulatory submission.

Applications

• Sterilization of reusable surgical instruments and dental handpieces in outpatient clinics and university teaching hospitals
• Preparation of sterile agar plates, broth media, and buffered saline solutions in microbiology and molecular biology labs
• Decontamination of biohazardous waste (e.g., sharps containers, pipette tips, Petri dishes) prior to autoclave-safe disposal
• Validation of sterilization processes for ISO 11138-compliant biological indicators (e.g., Geobacillus stearothermophilus spore strips)
• Support of USP and compounding pharmacy workflows requiring terminal sterilization of non-sterile preparations
• Routine maintenance of cleanroom tooling and laminar flow hood accessories in pharmaceutical QC laboratories

FAQ

What is the maximum allowable fill volume for liquid loads in the YXQ-70A chamber?
For safe operation and avoidance of boil-over, liquid containers should not exceed 75% of their total volume; total liquid load per cycle must remain ≤45 L to ensure adequate headspace and thermal equilibration.
Does the YXQ-70A support gravity displacement or pre-vacuum sterilization cycles?
It employs gravity displacement only—suitable for porous loads and liquids—but does not include vacuum pumps or pulsing functionality required for pre-vacuum (Type B) cycles per EN 13060.
Can the unit be validated for use in GMP-regulated environments?
Yes—when equipped with qualified temperature/pressure sensors, calibrated recording devices, and executed under documented IQ/OQ/PQ protocols, it meets baseline requirements for Annex 1 and PIC/S PE 009-16 compliance.
Is the control system compliant with FDA 21 CFR Part 11?
The embedded controller does not provide electronic signature capability or audit trail encryption natively; however, external data acquisition systems connected via RS232 can be configured to meet Part 11 requirements for electronic records.
What maintenance intervals are recommended for long-term reliability?
Daily: chamber wipe-down and gasket inspection; Weekly: drain valve flush and water level sensor calibration; Annually: safety valve certification, pressure transducer recalibration, and door seal integrity testing per manufacturer’s service manual.