Shen’an LDZX-75L-I Vertical High-Pressure Steam Sterilizer

Overview

The Shen’an LDZX-75L-I is a CE-compliant, vertically oriented high-pressure steam sterilizer engineered for reliable, repeatable terminal sterilization of laboratory and clinical materials under saturated steam conditions. It operates on the fundamental principle of moist heat sterilization—leveraging pressurized saturated steam at elevated temperatures (up to 128 °C) to irreversibly denature microbial proteins and nucleic acids. Designed in accordance with Chinese national standards GB/T 150 (pressure vessel design) and TSG 21 (safety technical specifications for fixed pressure vessels), the unit meets essential regulatory requirements for Class I medical device sterilization equipment. Its 75-liter stainless-steel 304 chamber supports batch processing of instruments, glassware, culture media, and porous loads while maintaining strict thermal uniformity and pressure stability throughout the sterilization cycle.

Key Features

• Robust dual-seal architecture: handwheel-actuated rotary sealing mechanism combined with an elastomeric self-expanding gasket ensures leak-tight integrity across repeated thermal cycles.
• Integrated safety redundancy: dual independent overpressure protection—mechanical spring-loaded safety valve + electronic overpressure cut-off—complies with ISO 13485 risk management principles.
• Intelligent microprocessor control system with LCD graphical interface: real-time dynamic display of temperature, pressure, elapsed time, and phase status (pre-vacuum, heating, sterilization, exhaust, cooling).
• Automated air removal: programmable gravity displacement or pre-vacuum purge sequences eliminate cold spots; integrated steam-water separator prevents external steam discharge.
• Active forced-air cooling system: reduces post-cycle cooldown time by up to 40%, minimizing operator wait time before chamber access.
• Configurable preset programs: dedicated cycles for solids (e.g., wrapped instruments), liquids (with slow exhaust to prevent boil-over), and porous loads—with user-definable parameters stored in non-volatile memory.
• Comprehensive safety interlocks: electronic-mechanical联动 lock prevents lid opening when chamber pressure exceeds 0.01 MPa; automatic power cutoff upon door actuation during pressurized state.
• Fail-safe protection suite: dry-run prevention (water level sensor), earth leakage detection (30 mA RCD), and thermal fuse backup for heater elements.
• Validation-ready infrastructure: built-in RS232/USB port (optional data logging module) supports traceable process recording per ISO 17665-1 and FDA 21 CFR Part 11 guidelines (when paired with compliant software).

Sample Compatibility & Compliance

The LDZX-75L-I accommodates standard laboratory load configurations—including stainless-steel instrument trays (3 × 335 mm × 190 mm baskets), Erlenmeyer flasks, Petri dishes, and autoclavable biohazard bags—within its cylindrical 350 mm diameter × 700 mm height chamber. Load patterns must conform to ISO 11140-4 recommendations for steam penetration validation. The sterilizer is certified as a Class II pressure vessel under China’s Special Equipment Safety Law and carries the official TS registration mark. While not CE-marked for EU market placement without additional conformity assessment, its mechanical design, material traceability (SS304 chamber), and documented failure mode analysis align with foundational requirements of EN 285:2015 (large steam sterilizers) and EN 61010-1 (electrical safety). Optional IQ/OQ documentation packages are available for GMP/GLP environments requiring audit-ready validation support.

Software & Data Management

Equipped with embedded firmware supporting USB-host connectivity, the LDZX-75L-I enables direct export of cycle logs—including start/end timestamps, setpoints, actual temperature/pressure profiles, alarm events, and operator ID tags—to external PCs for long-term archival. When used with Shen’an’s optional SteriLog™ PC software (v3.2+), users gain access to graphical trend analysis, deviation flagging, PDF report generation, and electronic signature capability compliant with ALCOA+ data integrity principles. All recorded data adhere to a write-once-read-many (WORM) structure, preventing post-cycle modification—a prerequisite for FDA 21 CFR Part 11 compliance when deployed with validated access controls and audit trail configuration. The system also features a physical validation port for thermocouple or pressure transducer insertion during installation qualification (IQ) and operational qualification (OQ) procedures.

Applications

• Routine sterilization of reusable surgical instruments, pipette tips, and glassware in university teaching labs and hospital central sterile supply departments (CSSD).
• Preparation and sterilization of microbiological growth media (e.g., agar, broth) without excessive caramelization or pH shift—enabled by precise liquid-cycle control and slow exhaust logic.
• Decontamination of biohazardous waste (BSL-2/3) prior to disposal, meeting WHO and CDC-recommended exposure times at ≥121 °C.
• Processing of textile packs, gowns, and drapes where steam permeability and drying efficiency are critical to sterility assurance.
• Research applications requiring reproducible thermal treatment of polymer-based lab consumables or ceramic substrates.

FAQ

What is the maximum allowable working pressure and corresponding temperature?
The rated operating pressure is 0.142 MPa, enabling stable operation at 126 °C. The safety-rated design pressure is 0.23 MPa, with a maximum test pressure of 0.345 MPa per ASME Section VIII Division 1 equivalency.

Does the unit support third-party validation protocols?
Yes—built-in validation ports, calibrated PT100 sensors (±0.3 °C accuracy), and full-cycle digital logging meet baseline requirements for IQ/OQ/PQ execution per ISO 17665-1 and AAMI ST46.

Is remote monitoring or network integration possible?
Standard configuration includes USB and RS232 interfaces. Ethernet or Wi-Fi modules are not factory-installed but may be integrated via external industrial gateways compatible with Modbus RTU protocol.

What maintenance intervals are recommended?
Daily: visual inspection of door seal and water level; weekly: gasket cleaning and drain filter check; annually: certified pressure gauge calibration and safety valve functional test by authorized service personnel.

Can the sterilizer be used for sterilizing heat-labile liquids?
Yes—via the dedicated liquid program, which employs controlled exhaust rates and post-sterilization hold phases to minimize thermal shock and container rupture risk, consistent with USP guidance.