Shen’an LDZM-80L-I Benchtop High-Pressure Steam Sterilizer

Overview

The Shen’an LDZM-80L-I is a CE-compliant, Class II pressure steam sterilizer engineered for reliable terminal sterilization of heat-stable laboratory and clinical materials. Operating on the principle of saturated steam under controlled pressure and temperature, it achieves microbial inactivation—including spores—via moist-heat denaturation of nucleic acids and proteins. Designed to meet ISO 17665-1:2017 (Sterilization of health care products — Moist heat — Part 1: Requirements for development, validation and routine control), the unit delivers precise, repeatable cycles across solid, liquid, and instrument loads. Its 80 L stainless-steel 304 chamber supports batch processing in academic labs, QC facilities, and small-scale biomedical production environments where regulatory traceability and mechanical safety are foundational requirements.

Key Features

• Mechanically interlocked lid actuation system with multi-link synchronous lever mechanism ensures smooth, low-effort opening/closing while maintaining positive sealing integrity.
• Self-sealing silicone gasket design eliminates manual adjustment and provides consistent compression under cyclic thermal expansion.
• LCD display with real-time dynamic visualization of temperature, pressure, elapsed time, and phase status (pre-vacuum, heating, sterilization, exhaust, cooling).
• Microprocessor-based cycle controller with pre-programmed, user-configurable protocols for solids, liquids, and wrapped instruments—including dedicated melt-and-hold functionality for agar media preparation.
• Forced-air rapid cooling system with integrated axial fan reduces post-cycle cooldown time by up to 40% compared to passive dissipation, minimizing operational downtime.
• Triple-stage exhaust logic (full vent, micro-vent, no vent) enables optimized pressure release profiles for sensitive liquid loads, preventing boil-over or container rupture.
• Dual redundant safety architecture: mechanical pressure relief valve (ASME Section VIII compliant) plus electronic overpressure cutoff at 0.23 MPa; door interlock prevents lid operation above 0.02 MPa.
• Comprehensive fault diagnostics with audible/visual alerts for low water level, temperature deviation, pressure sensor drift, door seal failure, and heater open-circuit conditions.
• Automatic cold air purge via gravity displacement and steam-saturated pre-vacuum ensures uniform chamber temperature distribution and eliminates air pockets that compromise sterility assurance.
• Integrated condensate recovery tank prevents external steam discharge—meeting local environmental emission guidelines and reducing lab humidity load.

Sample Compatibility & Compliance

The LDZM-80L-I accommodates standard autoclave-compatible containers including glassware (flasks, bottles, Petri dishes), stainless-steel instruments, textile packs, and pre-filled liquid media bottles (up to 1 L volume). It complies with national GB/T 30690–2014 (Small steam sterilizers for laboratory use) and holds China’s Special Equipment Manufacturing License (TS2231870-2025) for Class II pressure vessels. All safety-critical components—including pressure vessel body, lid assembly, and control panel—are certified to IEC 61010-1:2010 for electrical safety in laboratory equipment. The unit supports GLP/GMP documentation workflows through optional USB data logging and RS232-compatible thermal printer output (date, start/end times, max temp/pressure, cycle ID).

Software & Data Management

While the base controller operates via embedded firmware without external PC dependency, the optional USB interface allows direct export of complete cycle logs (.CSV format) to removable flash drives. Each record includes timestamped entries at 10-second intervals for temperature, chamber pressure, and phase state—enabling retrospective analysis per FDA 21 CFR Part 11 principles when paired with validated user access controls. The validation port supports third-party thermocouple insertion for IQ/OQ/PQ protocol execution, facilitating compliance with ISO 13485 and EU MDR Annex I requirements for medical device reprocessing validation.

Applications

• Routine sterilization of microbiological culture media, buffers, and saline solutions in teaching and research laboratories.
• Decontamination of reusable surgical instruments, forceps, and biopsy tools prior to repackaging.
• Preparation of agar plates and slants requiring precise melt-hold-sterilize sequences.
• Terminal sterilization of animal feed, bedding, and cage components in vivarium settings.
• Validation support for cleanroom gowning protocols and barrier system component processing.

FAQ

What pressure vessel certification does this sterilizer hold?

It carries China’s official Special Equipment Manufacturing License (TS2231870-2025) for Class II pressure vessels, issued under TSG 21–2016 regulations.
Can cycle parameters be modified or user-defined?

Yes—the microprocessor supports creation and storage of up to 12 custom programs with adjustable setpoints for temperature, hold time, exhaust mode, and cooling delay.
Is the chamber constructed from medical-grade stainless steel?

The inner chamber is fabricated from AISI 304 stainless steel (EN 10088-1), passivated and electropolished to ASTM A967 standards for corrosion resistance and cleanability.
Does the unit meet international sterilization standards such as ISO 17665?

While not independently certified to ISO 17665, its thermal performance envelope (134 °C ±0.5 °C, 0.217 MPa) and cycle reproducibility align with the physical parameters specified in Clause 6.3 for steam sterilization validation.
What maintenance intervals are recommended?

Daily: visual inspection of door seal and drain strainer; weekly: chamber interior wipe-down with neutral detergent; annually: pressure transducer calibration and safety valve functional test by authorized service personnel.