Shen’an WDZX-300KC Horizontal Steam Sterilizer
| Brand | Shen'an / She Medical Devices |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | WDZX-300KC |
| Pricing | Available Upon Request |
Overview
The Shen’an WDZX-300KC Horizontal Steam Sterilizer is a Class II pressure vessel engineered for reliable, repeatable moist-heat sterilization in compliance with GB 150 (Chinese Pressure Vessel Standard) and GB 8599–2008 (National Standard for Large Steam Sterilizers). It operates on the validated principle of saturated steam sterilization via gravity displacement: steam enters the chamber from the top, displacing ambient air downward through a dedicated exhaust port until full saturation is achieved. At predetermined temperature–time profiles—typically 121 °C for 15–20 minutes or 134 °C for 3–5 minutes—the latent heat of condensation denatures microbial proteins and nucleic acids, achieving a sterility assurance level (SAL) of ≤10⁻⁶ as verified per ISO 17665-1. Designed for continuous operational duty in regulated environments, the unit integrates ASME-compliant safety architecture—including overpressure relief valves, low-water cutoff sensors, and independent temperature-limiting thermostats—to ensure fail-safe operation under variable load conditions.
Key Features
- Horizontal cylindrical chamber constructed from medical-grade 304 stainless steel (ASTM A240), with electropolished interior surfaces to minimize biofilm retention and support cleanability validation.
- Microprocessor-based control system with real-time LCD interface displaying chamber temperature, pressure, elapsed time, phase status (pre-vacuum, sterilization, drying, cooling), and fault diagnostics.
- Dual-safety interlock system: door cannot be opened during pressurized cycles; automatic pressure release prior to door unlocking sequence.
- Gravity displacement air removal mechanism compliant with EN 285 Annex C and ISO 17665-1 Clause 6.2 for non-porous load sterilization.
- Integrated PT100 platinum resistance thermometers (±0.2 °C accuracy) and calibrated pressure transducers traceable to national metrology standards.
- Self-diagnostics at startup including door seal integrity check, water level verification, and sensor calibration validation.
Sample Compatibility & Compliance
The WDZX-300KC accommodates standard sterilization loads including wrapped surgical instruments, textile packs, rubber tubing, glassware, culture media (in sealed containers), and laboratory utensils. It is not intended for sterilizing oil-based substances, powders, or porous materials requiring vacuum-assisted air removal (e.g., lumened devices), which fall outside gravity-displacement capability per ISO 17665-1 Annex A. The sterilizer meets regulatory requirements for use in GLP-compliant laboratories, hospital central sterile supply departments (CSSD), pharmaceutical R&D facilities, and academic biosafety Level 2 (BSL-2) laboratories. Documentation includes Factory Acceptance Test (FAT) report, material certificates for pressure-bearing components, and conformity statement to GB/T 19001–2016 (ISO 9001:2015 equivalent).
Software & Data Management
The embedded controller supports configurable cycle programming with up to 10 user-defined protocols, each storing setpoints, dwell times, and alarm thresholds. All operational events—including cycle start/stop timestamps, parameter deviations, door open/close actions, and safety interlock triggers—are logged with date/time stamps and retained for ≥10,000 cycles. Optional RS-485 Modbus RTU output enables integration into facility-wide SCADA systems or LIMS platforms. Audit trail functionality satisfies basic data integrity expectations per ALCOA+ principles; however, full 21 CFR Part 11 compliance requires third-party electronic signature and access-control middleware deployed at the enterprise level.
Applications
- Hospital CSSD departments processing reusable surgical kits, gowns, drapes, and instrument trays.
- University and research institute microbiology labs sterilizing agar plates, broth media, pipette tips, and glassware.
- Pharmaceutical and biotech QA/QC labs validating sterilization processes for excipient containers and process equipment components.
- Food safety testing laboratories decontaminating sampling tools and culture vessels prior to pathogen isolation.
- Veterinary clinics and diagnostic centers ensuring biohazard containment for necropsy instruments and specimen containers.
FAQ
What is the chamber volume and maximum working pressure?
The WDZX-300KC features a 300 L effective chamber volume with a maximum allowable working pressure (MAWP) of 0.22 MPa (2.2 bar gauge), rated for continuous operation at 0.21 MPa during sterilization cycles.
Does this model support vacuum-assisted air removal?
No—this is a gravity-displacement sterilizer. Vacuum pulsing is not implemented; it relies solely on steam saturation via natural air displacement. For vacuum-dependent loads, consult the WDZX-V series.
Is third-party IQ/OQ/PQ validation support available?
Yes—Shen’an provides protocol templates and factory witness documentation. On-site qualification services are delivered by authorized partners certified to ISO/IEC 17025 for sterilization equipment validation.
What maintenance intervals are recommended?
Daily: visual inspection of door gasket and drain strainer. Quarterly: calibration verification of temperature and pressure sensors. Annually: full pressure vessel inspection per GB/T 150.1–2011 requirements.
Can the unit be integrated into a building management system (BMS)?
Yes—via optional analog 4–20 mA outputs for chamber temperature and pressure, or digital Modbus RTU communication for full parameter readout and remote cycle initiation.
