HePu WS-280YDB Horizontal Autoclave

Overview

The HePu WS-280YDB Horizontal Autoclave is a fully automated, Class B gravity displacement and vacuum-assisted steam sterilizer engineered for high-reliability terminal sterilization in regulated laboratory, pharmaceutical, clinical, and industrial environments. It operates on the principle of saturated steam under controlled pressure and temperature—leveraging the high latent heat of condensation to achieve microbial inactivation across all biological load types, including resistant bacterial spores (e.g., Geobacillus stearothermophilus). Designed to meet international sterilization process requirements, the unit delivers precise thermal exposure profiles compliant with ISO 17665-1 (Sterilization of health care products — Moist heat), EN 285 (Large steam sterilizers), and supports validation protocols aligned with FDA 21 CFR Part 11 and EU Annex 1 for aseptic processing. Its horizontal orientation enables efficient loading of large-volume or irregularly shaped items—including surgical instrument trays, glassware, culture media bottles, textile packs, and polymer-based lab consumables—while maintaining uniform heat distribution throughout the 280 L chamber.

Key Features

• Fully automated cycle control with real-time LED digital display showing phase status (pre-vacuum, heating, sterilization, exhaust, drying), elapsed time, setpoint temperature/pressure, and fault diagnostics.
• Robust 304 stainless steel construction for inner chamber, door seal, and exterior housing—ensuring corrosion resistance, structural integrity, and long-term compliance with GLP/GMP cleaning protocols.
• Dual-mode operation: selectable gravity displacement (for porous loads) and pre-vacuum cycles (for wrapped or lumened instruments), configurable within user-defined programs.
• Integrated safety interlock system: mechanical and electronic door locking prevents opening when chamber pressure exceeds 0.027 MPa; door must be fully closed and sealed before steam admission initiates.
• Comprehensive over-protection suite: pressure relief valve (set at 0.24 MPa), overtemperature cutoff (≥136 °C), low-water-level shutoff, overcurrent circuit breaker, and automatic power disconnection upon cycle completion or fault detection.
• Precise thermal management: PID-controlled heating elements maintain temperature stability within ±2 °C across the entire chamber volume during dwell phases, verified per EN 285 Annex C.

Sample Compatibility & Compliance

The WS-280YDB accommodates a broad range of sterilizable materials—including stainless steel instruments, cotton gauze, autoclavable plastics (e.g., polypropylene, polycarbonate), liquid media (in vented containers), and rubber tubing—without compromising sterility assurance levels (SAL) of 10⁻⁶. Chamber geometry (Φ600 × 1000 mm) supports standard ISO 11140-compliant test packs and biological indicators. The system meets essential requirements of the Medical Device Regulation (MDR) Annex I, carries CE marking under the Pressure Equipment Directive (PED 2014/68/EU), and is designed for integration into IQ/OQ/PQ validation frameworks. Documentation packages include factory calibration certificates, material traceability records, and FAT/SAT reports upon request.

Software & Data Management

While the base model features embedded microprocessor control without external PC connectivity, optional RS-485 or Ethernet interfaces enable integration with centralized laboratory information management systems (LIMS) or supervisory control and data acquisition (SCADA) platforms. All cycle logs—including date/time stamp, operator ID (via optional keypad login), temperature/pressure curves, phase durations, and alarm events—are stored internally with non-volatile memory retention (>10,000 cycles). Audit trail functionality complies with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and supports retrospective review for regulatory inspections under ISO 13485 or FDA 21 CFR Part 11 when paired with validated electronic signature modules.

Applications

• Hospital central sterile supply departments (CSSD) for reprocessing surgical kits and endoscopic accessories.
• Pharmaceutical R&D labs performing sterilization validation of excipients, vials, and stoppers.
• Biotechnology facilities preparing agar plates, broth media, and bioreactor components.
• Food safety testing laboratories sterilizing sampling equipment and nutrient agar media.
• Academic and government research institutions requiring repeatable, documented moist-heat sterilization for microbiology, molecular biology, and tissue culture workflows.

FAQ

What sterilization standards does the WS-280YDB comply with?
It conforms to ISO 17665-1, EN 285, and PED 2014/68/EU; validation support documentation aligns with ISO 13485 and FDA 21 CFR Part 11 requirements.

Can the autoclave process liquids in bottles or flasks?
Yes—when using appropriate vented closures and validated slow-cool-down programs to prevent boil-over or container rupture.

Is third-party IQ/OQ/PQ support available?
Yes—HePu provides optional qualification protocol templates and on-site commissioning services through authorized partners in North America and EMEA.

What maintenance intervals are recommended?
Daily checks include door gasket inspection and water level verification; quarterly maintenance covers safety valve testing, chamber drain line cleaning, and vacuum pump oil replacement (if equipped).

Does the unit support programmable multi-step cycles?
Yes—up to 10 user-defined programs can be saved, each with independent settings for pre-vacuum depth, temperature, sterilization dwell time, exhaust rate, and drying duration.