Shanghai Shen YX600W Horizontal Cylindrical Steam Sterilizer
| Brand | Shanghai Shen |
|---|---|
| Origin | Shanghai, China |
| Model | YX600W |
| Convection Type | Natural Convection |
| Temperature Range | Ambient + 5°C to 138°C |
| Temperature Control Accuracy | ±0.5°C |
| Temperature Uniformity | ≤1°C |
| Heating Power | 12 kW |
| Internal Chamber Dimensions (Diameter × Height) | φ60 cm × 100 cm |
Overview
The Shanghai Shen YX600W Horizontal Cylindrical Steam Sterilizer is a Class B (EN 285-compliant) gravity-displacement steam sterilization system engineered for reliable, repeatable terminal sterilization of heat- and moisture-stable laboratory and clinical loads. Unlike dry heat sterilizers—which rely on conduction and prolonged high temperatures—the YX600W utilizes saturated steam under positive pressure to achieve microbial inactivation via protein denaturation and nucleic acid hydrolysis. Its horizontal cylindrical chamber design facilitates efficient steam penetration into porous loads, wrapped instruments, and hollow devices when operated with appropriate pre-vacuum or gravity cycles (as configured per user-defined programs). The unit complies with core sterilization process standards including ISO 17665-1 (sterilization of health care products — moist heat), EN 13060 (small steam sterilizers), and supports validation protocols aligned with FDA 21 CFR Part 820 and EU Annex 1 requirements for sterile product manufacturing environments.
Key Features
- Stainless steel chamber and jacket construction (AISI 304 grade) ensuring corrosion resistance, structural integrity, and long-term thermal stability.
- Microprocessor-based control system with dual independent PID algorithms—one for chamber temperature regulation and another for water reservoir temperature—enabling precise thermal management across dynamic load conditions.
- Real-time LED digital display showing setpoint temperature, actual chamber temperature, elapsed time, remaining time, and water level status simultaneously.
- Dual-pressure monitoring: separate transducers for chamber pressure and water reservoir pressure, each with independent visual indicators and safety interlocks.
- Automatic water replenishment system with low-water cutoff, refill initiation, and resumption of heating only after minimum water level is restored—preventing dry-heating damage and ensuring consistent steam generation.
- Electronic door interlock mechanism compliant with EN 61000-6-2/6-4 and IEC 62061 SIL1 requirements: sterilization cycle cannot initiate unless door is fully closed and locked; chamber remains mechanically and electrically sealed during pressurized operation.
- Self-sealing silicone rubber gasket (food-grade, FDA-listed elastomer) with auto-expansion under pressure, delivering uniform sealing force and >10,000-cycle service life under routine use.
- Selectable post-sterilization exhaust modes—including slow vent, fast vent, and vacuum-assisted drying—to accommodate diverse load types (e.g., liquids, textiles, glassware, and wrapped instrument sets).
Sample Compatibility & Compliance
The YX600W accommodates a broad range of sterilizable materials: stainless steel and aluminum instruments, borosilicate glassware, autoclavable plastics (e.g., polypropylene, polycarbonate), textile packs, and liquid media in sealed containers (with validated venting protocols). It is not suitable for heat-labile or moisture-sensitive items such as powders, oils, or electronic components. The sterilizer meets national safety standards GB 8599–2008 (Large Steam Sterilizers) and conforms to electromagnetic compatibility (EMC) requirements per GB/T 18268.26. Validation documentation—including IQ/OQ/PQ templates, temperature mapping reports, and biological indicator test records—can be generated in accordance with ISO 13485 and GLP/GMP audit expectations. All critical parameters (temperature, pressure, time) are logged with timestamped, non-erasable records supporting 21 CFR Part 11 compliance when paired with optional audit-trail-enabled software.
Software & Data Management
The embedded controller stores up to 99 programmable cycles with customizable parameters: pre-vacuum depth, sterilization hold time, temperature ramp rate, exhaust mode, and drying duration. Cycle logs—including start/stop timestamps, peak temperature/pressure values, deviation alerts, and operator ID—are retained internally for ≥1,000 cycles. Optional RS-485 or Ethernet interface enables integration with laboratory information management systems (LIMS) or centralized sterilization monitoring platforms. Data export is supported in CSV format for traceability review, statistical process control (SPC), and regulatory submission. Firmware updates are performed via USB port using digitally signed packages to maintain system integrity and cybersecurity posture.
Applications
This sterilizer serves core functions across academic research laboratories, hospital central sterile supply departments (CSSD), pharmaceutical QC labs, and biotech pilot facilities. Typical applications include: sterilization of surgical kits and reusable diagnostic tools; preparation of microbiological growth media and buffer solutions; decontamination of biohazardous waste prior to disposal; conditioning of glassware and metal parts for cleanroom assembly; and validation support for ISO 11134 and ISO 11140-compliant processes. Its 60 cm diameter × 100 cm height chamber volume (~283 L) supports batch processing of medium-to-large instrument trays, stacked petri dishes, or multiple liters of liquid media—making it particularly suited for mid-scale institutional throughput requirements.
FAQ
What is the maximum operating pressure of the YX600W?
The chamber is rated for a maximum working pressure of 0.22 MPa (≈2.2 bar gauge), corresponding to a saturation temperature of 138°C.
Does the YX600W support vacuum-assisted air removal?
Yes—it offers configurable pre-vacuum cycles (up to three pulses) to enhance air removal from porous and hollow loads, improving steam penetration efficacy per EN 13060 Annex A.
Can the unit be validated for GMP environments?
Yes—its deterministic control architecture, data logging capability, and mechanical safety redundancies meet baseline requirements for IQ/OQ/PQ execution under EU GMP Annex 1 and WHO TRS 986.
Is the drying function fully automated?
Yes—the integrated drying phase activates automatically after sterilization and exhaust, utilizing residual chamber heat and controlled airflow without requiring external compressed air.
What maintenance intervals are recommended?
Daily: chamber wipe-down and gasket inspection; weekly: drain valve cleaning and water quality verification; annually: pressure sensor calibration, safety valve certification, and door seal compression testing per manufacturer’s service manual.
