Shen’an WDZX-200KC Horizontal Steam Sterilizer

Overview

The Shen’an WDZX-200KC 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). It operates on the validated principle of saturated steam sterilization—leveraging latent heat transfer under controlled temperature and pressure to irreversibly denature microbial proteins and nucleic acids. As a gravity-displacement sterilizer, it utilizes natural convection to purge ambient air from the chamber via a bottom-mounted exhaust port, ensuring complete replacement with saturated steam prior to the sterilization hold phase. This method conforms to internationally recognized wet-heat sterilization fundamentals described in ISO 17665-1:2019 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices) and supports validation protocols aligned with national medical device regulatory frameworks.

Key Features

• Horizontal cylindrical chamber constructed from high-grade 304 stainless steel (ASTM A240), engineered for long-term corrosion resistance and repeated autoclave cycles.
• Integrated microprocessor-based control system with real-time LCD interface displaying chamber temperature, pressure, elapsed time, phase status (pre-vacuum, heating, sterilizing, drying, cooling), and fault diagnostics.
• Multi-layer safety interlock architecture: automatic overpressure relief (mechanical safety valve set at ≤0.25 MPa), low-water cutoff protection, and independent overtemperature shutdown (dual PT100 sensors with redundancy).
• Gravity displacement air removal cycle optimized for uniform steam penetration; configurable pre-sterilization dwell time to accommodate variable load density and cold spot mitigation.
• Programmable sterilization cycles—including standard instrument, wrapped item, liquid, and porous load profiles—with user-defined temperature setpoints (105–135 °C), pressure ranges (0.02–0.22 MPa gauge), and hold durations (0–120 min).
• Chamber volume of 200 L, suitable for medium-throughput laboratory, clinical, and industrial applications requiring batch processing of surgical instruments, culture media, glassware, textiles, and heat-stable pharmaceutical excipients.

Sample Compatibility & Compliance

The WDZX-200KC accommodates a broad range of sterilizable materials including metal surgical tools, cotton gauze and linen packs, borosilicate glass containers, silicone tubing, and agar-based microbiological media. It is not intended for use with heat-labile polymers, electronic components, or oil-based substances. All operational parameters adhere to GB 8599–2008 (National Standard of the PRC for Large Steam Sterilizers), and design documentation satisfies requirements for registration filing under NMPA’s “Registration Management Measures for Medical Devices” (Order No. 48). The unit incorporates mechanical and electrical safeguards meeting IEC 61010-1:2010 (Safety requirements for electrical equipment for measurement, control, and laboratory use).

Software & Data Management

While the base model features embedded firmware without external PC connectivity, optional RS485/Modbus RTU interface enables integration into centralized facility monitoring systems for remote parameter logging and alarm notification. Cycle records—including start/end timestamps, peak temperature/pressure values, and anomaly flags—are retained in non-volatile memory for ≥1,000 cycles. Audit trail functionality supports GLP-compliant documentation practices; printed output (via optional thermal printer module) includes operator ID, cycle number, load identification, and signature fields for manual verification per institutional SOPs.

Applications

• Hospital central sterile supply departments (CSSD) for reprocessing reusable surgical kits and anesthesia equipment.
• University and research institute microbiology labs performing routine sterilization of Petri dishes, pipette tips, nutrient broths, and fermentation vessels.
• Biotechnology and pharmaceutical QC laboratories validating sterilization processes for raw material containers and buffer preparation systems.
• Food safety testing facilities sterilizing sampling tools, homogenizer bags, and culture media prior to pathogen isolation assays.
• Veterinary clinics and diagnostic centers requiring reliable decontamination of dental and surgical instruments between procedures.

FAQ

Is the WDZX-200KC compliant with international sterilization standards such as ISO 17665?
Yes—the sterilization methodology, validation prerequisites, and performance criteria align with the scientific principles and procedural requirements outlined in ISO 17665-1:2019. Full compliance with regional regulatory submissions requires site-specific installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) executed by certified third-party providers.
What is the maximum allowable working pressure and temperature?
The chamber is rated for a maximum allowable working pressure (MAWP) of 0.22 MPa (gauge) and a corresponding saturation temperature of 134 °C. Safety margins are maintained per TSG 21–2016 design factors.
Can the unit be validated for use in GMP environments?
Yes—when coupled with documented IQ/OQ/PQ protocols, calibrated reference sensors (traceable to CNAS-accredited laboratories), and defined load configurations, the WDZX-200KC supports routine sterilization operations under pharmaceutical GMP guidelines (e.g., China GMP Annex 1, EU GMP Annex 1).
Does it support vacuum-assisted air removal?
No—the WDZX-200KC employs gravity displacement only. For loads with complex geometry or lumened devices requiring enhanced air removal, a vacuum-pulse sterilizer (e.g., Class B type per EN 13060) is recommended.
What maintenance intervals are specified for critical components?
Daily checks include water level verification and door gasket inspection. Monthly tasks involve drain filter cleaning and safety valve functional testing. Annual preventive maintenance—performed by Shen’an-certified technicians—includes chamber integrity assessment, sensor calibration, and control board diagnostics.