Shen’an LDZX-30L / LDZX-50L / LDZX-75L Manual-Handle Vertical Steam Sterilizer

Overview

The Shen’an LDZX series manual-handle vertical steam sterilizers are engineered for reliable, repeatable moist-heat sterilization in academic laboratories, clinical diagnostics facilities, pharmaceutical QC labs, and biotechnology research environments. These units operate on the fundamental principle of saturated steam under controlled pressure and temperature to achieve microbial inactivation—primarily through protein denaturation and nucleic acid disruption. Designed per ISO 17665-1 (Sterilization of health care products — Moist heat) and aligned with core requirements of USP , EU GMP Annex 1, and WHO TRS No. 912, the LDZX series delivers validated lethality (F₀) across a defined operating envelope of 50–126 °C and 0–99 hours. The vertical orientation optimizes floor space while maintaining full accessibility to the chamber; the handwheel-sealed lid employs a displacement-style opening mechanism that ensures positive mechanical engagement prior to pressurization—eliminating reliance on operator torque alone for seal integrity.

Key Features

• Manual handwheel sealing system with displacement-type lid actuation—designed for intuitive operation and tactile feedback during closure verification
• Chamber constructed from medical-grade AISI 304 stainless steel (≥2.0 mm wall thickness), certified for long-term corrosion resistance and repeated autoclave cycles
• Self-expanding silicone gasket assembly ensuring consistent radial compression and leak-free performance over ≥10 years’ service life
• LCD graphical interface with scroll-based menu navigation—supports real-time display of chamber temperature, pressure, elapsed time, and phase status (pre-vacuum, heating, sterilizing, cooling)
• Microprocessor-controlled cycle logic with programmable start delay (up to 24 h), enabling unattended initiation of sterilization protocols
• Active air-purge function automatically evacuates non-condensable gases prior to steam saturation—critical for achieving uniform thermal distribution
• Dual independent overpressure safeguards: spring-loaded mechanical relief valve (ASME-compliant set point) plus electronically monitored pressure cutoff with automatic venting
• Integrated forced-air cooling fan reduces post-cycle chamber temperature below 80 °C within ≤25 minutes—minimizing operator wait time and improving throughput
• Interlocked lid mechanism: electronic pressure sensor and mechanical latch engage synchronously—lid remains physically locked until chamber pressure drops to ambient
• Comprehensive safety architecture including low-water detection, ground-fault circuit interruption (GFCI), and real-time temperature deviation correction

Sample Compatibility & Compliance

The LDZX series accommodates a broad range of load configurations—including wrapped instruments, liquid media in glass or polypropylene containers, porous textiles, and microbiological culture waste—without requiring vacuum-assisted drying cycles. Chamber geometry (cylindrical, Ø350 mm × variable height) supports uniform steam penetration verified by thermocouple mapping per ISO 11140-1. Units are supplied with a validation port (1/4″ NPT) for integration with external data loggers or third-party qualification systems. All models comply with national safety standards GB 4793.1–2019 (Electrical equipment for laboratory use) and meet electromagnetic compatibility (EMC) requirements per GB/T 18268.1–2010. Optional RS232 or USB interfaces support audit-ready data export for GLP/GMP environments; print module (optional) generates timestamped records of cycle parameters—including date, F₀ value, peak temperature, and pressure profile—for regulatory traceability.

Software & Data Management

While the base configuration operates via embedded firmware without external PC dependency, the LDZX platform supports optional connectivity modules enabling integration into centralized lab management systems. Cycle logs—including start/stop timestamps, setpoints, actual temperature/pressure curves, and fault codes—are stored internally for ≥1,000 cycles. When equipped with the thermal printer option, each sterilization event produces a hard-copy report compliant with FDA 21 CFR Part 11 requirements (user authentication, electronic signature fields, and immutable audit trail). Firmware updates are performed via secure USB drive, with version history retained in device memory. All parameter modifications require multi-step confirmation to prevent accidental changes during routine operation.

Applications

• Sterilization of surgical instruments, glassware, and reusable labware in teaching and research laboratories
• Preparation of agar media, nutrient broths, and buffer solutions in microbiology and molecular biology workflows
• Decontamination of biohazardous waste prior to disposal in BSL-2 and BSL-3 containment facilities
• Validation of sterilization processes for ISO 13485-certified medical device manufacturing
• Support of pharmacopeial methods requiring F₀-based cycle development (e.g., USP , Ph. Eur. 5.1.1)

FAQ

What is the maximum allowable working pressure and corresponding temperature?
The LDZX series is rated for a maximum working pressure of 0.142 MPa (absolute), corresponding to a saturated steam temperature of 126 °C at sea level.
Does the unit include automatic air removal functionality?
Yes—each cycle initiates with an automated air purge phase using steam flushes to eliminate non-condensable gases, ensuring optimal heat transfer efficiency.
Can the sterilizer be validated for GMP compliance?
Yes—the built-in validation port, optional data logging interface, and printable cycle reports support IQ/OQ/PQ execution per ASTM E2500 and EU Annex 15 guidelines.
Is the chamber wall thickness sufficient for long-term cyclic stress?
The AISI 304 stainless steel chamber features a minimum wall thickness of 2.0 mm, exceeding ASME BPVC Section VIII Div. 1 requirements for Class I pressure vessels in this service class.
What electrical specifications are required for installation?
A dedicated 220 V AC, 16 A circuit with grounded outlet and GFCI protection is mandatory; power consumption is rated at 3.5 kW continuous duty.