Shen’an WDZX-120KC Horizontal Steam Sterilizer

Overview

The Shen’an WDZX-120KC Horizontal Steam Sterilizer is a Class II pressure vessel designed and manufactured in compliance with the People’s Republic of China’s Special Equipment Safety Law and TSG 21–2016 (Safety Technical Supervision Regulation for Fixed Pressure Vessels). Engineered for routine high-volume sterilization in regulated environments, this horizontal autoclave employs saturated steam under controlled pressure and temperature to achieve microbiological lethality via moist heat. Its operational principle follows gravity displacement—steam enters the chamber from the top, displacing ambient air downward through a dedicated exhaust port; once air is fully purged, the chamber seals and transitions into the sterilization phase. This method ensures uniform thermal penetration and reliable inactivation of bacterial spores, including Bacillus stearothermophilus (ATCC 7953), the biological indicator specified in ISO 17665-1 and GB 8599–2008 for steam sterilization validation.

Key Features

• Horizontal cylindrical chamber constructed from medical-grade 304 stainless steel (ASTM A240), resistant to corrosion and compliant with surface finish requirements for cleanroom-compatible equipment
• Integrated multi-layer safety architecture: automatic overpressure relief valve (set at 0.25 MPa), low-water level cutoff sensor, dual independent temperature limiters (primary control + fail-safe backup), and door interlock system preventing opening during pressurized cycles
• Microprocessor-based control system with real-time LCD interface displaying chamber pressure (MPa), temperature (°C), elapsed time (min), and cycle phase (pre-vacuum, heating, sterilization, exhaust, drying)
• Programmable cycle memory supporting up to 12 user-defined protocols, each configurable for temperature (105–135°C), holding time (0–120 min), and post-sterilization drying duration
• Gravity displacement air removal mechanism validated per EN 285 Annex C and GB/T 30690–2014 for non-porous load types

Sample Compatibility & Compliance

The WDZX-120KC accommodates a broad range of sterilizable materials, including surgical instruments, gauze and textile packs, glassware, stainless-steel containers, culture media (liquid and agar-based), and laboratory plasticware rated for repeated autoclaving (e.g., polypropylene, polycarbonate). It is not intended for use with heat-labile polymers, powders, oils, or sealed containers lacking steam-permeable venting. The unit meets national regulatory requirements for Class B medical device sterilizers as defined in YY 0504–2016 and aligns with general principles outlined in ISO 13485:2016 for quality management systems in medical device manufacturing. While not pre-certified to FDA 21 CFR Part 820 or EU MDR Annex I, its design basis supports integration into GLP/GMP workflows when accompanied by site-specific IQ/OQ/PQ validation documentation.

Software & Data Management

The embedded controller logs timestamped operational data—including cycle start/stop times, peak pressure and temperature values, dwell duration, and fault codes—for each run. Data export is supported via RS-232 serial interface to external PCs for archiving in CSV format. Optional USB data logger modules (sold separately) enable unattended long-term recording compatible with audit trail requirements under ISO 13485 and internal quality procedures. All stored records include immutable timestamps and are retained for ≥30 days in non-volatile memory. No cloud connectivity or remote access capability is included; data integrity is maintained through local write-once storage architecture.

Applications

This sterilizer serves core functions across multiple sectors requiring reproducible terminal sterilization: hospital central sterile supply departments (CSSD) processing reusable surgical kits; university and research laboratories sterilizing Petri dishes, pipette tips, and growth media; food microbiology labs preparing agar plates and dilution blanks; and biotech facilities decontaminating glass bioreactor components and sampling tools. Its 120 L chamber volume (internal dimensions: Ø500 × L600 mm) enables batch processing of standard instrument trays (up to 4 × 400 × 300 × 100 mm) or stacked media bottles (max. Ø100 mm × 300 mm height). Cycle repeatability is verified per ISO 17665-2 using thermocouple mapping during qualification.

FAQ

Is the WDZX-120KC certified to international standards such as ISO 13485 or EN 285?
No—this model is certified to Chinese national standards (GB/T 30690, YY 0504, TSG 21) and registered with the China NMPA as a Class II medical device. International conformity requires site-specific validation and third-party assessment.
Can it perform vacuum-assisted air removal?
No—the WDZX-120KC uses gravity displacement only and does not incorporate a vacuum pump. It is classified as a Type N sterilizer per EN 285.
What maintenance intervals are recommended?
Daily: chamber wipe-down and drain trap inspection. Weekly: safety valve functional test and door gasket visual check. Annually: full pressure vessel inspection by authorized NDT personnel and calibration of temperature/pressure sensors against traceable standards.
Does it support dry-heat or ethylene oxide cycles?
No—this is a dedicated saturated steam sterilizer operating exclusively within the 105–135°C, 0.1–0.22 MPa range. It lacks heating elements for dry-heat mode or gas injection ports for EO sterilization.
Is training provided for operators?
Yes—Shen’an offers on-site startup commissioning and basic operator training covering cycle selection, loading patterns, safety interlocks, and routine logbook entry. Advanced validation support is available upon request.