Shen’an LDZM-40L / LDZM-40L-I Vertical Stainless Steel High-Pressure Steam Sterilizer (40 L)
| Brand | Shen'an / She Medical Devices |
|---|---|
| Origin | Shanghai, China |
| Model | LDZM-40L / LDZM-40L-I |
| Chamber Volume | 40 L |
| Max Operating Temperature | 134 °C |
| Max Working Pressure | 0.217 MPa |
| Chamber Dimensions | Ø350 × 400 mm |
| External Dimensions | 570 × 690 × 1020 mm |
| Power Supply | 220 V / 50 Hz |
| Rated Power | 3.5 kW |
| Design Pressure | 0.24 MPa |
| Vessel Wall Thickness | ≥2 mm |
| Service Life | ≥10 years |
| Safety Certification | China Special Equipment Pressure Vessel License (GB/T 150, TSG 21) |
Overview
The Shen’an LDZM-40L and LDZM-40L-I are vertically oriented, Class B high-pressure steam sterilizers engineered for reliable terminal sterilization of heat-stable laboratory, clinical, and pharmaceutical materials. Based on saturated steam under controlled pressure and temperature—principally operating at 121 °C (0.11 MPa) or 134 °C (0.217 MPa)—these units comply with ISO 17665-1 (Sterilization of health care products — Moist heat) and GB 8599 (Chinese national standard for large steam sterilizers). The 40 L stainless steel chamber (AISI 304, wall thickness ≥2 mm) supports gravity displacement and pre-vacuum assisted air removal, enabling effective sterilization of wrapped instruments, culture media, glassware, and porous loads. The LDZM-40L is microprocessor-controlled with manual initiation and fixed cycle logic; the LDZM-40L-I adds full automation—including programmable start delay, automatic air purge, real-time parameter logging, and optional thermal printer integration—making it suitable for GLP-compliant environments requiring audit-ready records.
Key Features
- Dual-mode sealing system: Self-expanding silicone gasket combined with precision-machined flange interface ensures leak-tight integrity across repeated thermal cycles.
- Multi-link lever mechanism: Ergonomic, low-effort lid actuation with synchronized motion minimizes operator fatigue and eliminates misalignment risk during closure.
- Integrated safety architecture: Dual redundant protection includes mechanical spring-loaded safety valve (set at 0.24 MPa) and electronic overpressure cutoff with automatic venting; interlocked lid lock prevents opening under pressure per ASME PVHO-1 principles.
- Intelligent process control: LCD graphical interface with scroll-based menu navigation enables intuitive selection of temperature (50–134 °C), time (0–99 h), and cycle type (liquid, solid, wrapped, unwrapped).
- Active cooling system: Built-in axial fan initiates post-cycle forced-air cooling, reducing chamber surface temperature to <50 °C within ~15 minutes—accelerating throughput without compromising material integrity.
- Comprehensive fault diagnostics: Real-time self-checking of water level, temperature sensor drift, pressure transducer calibration, door seal status, and heating element continuity—with error codes displayed and logged.
- Validation-ready design: Equipped with dedicated 3× Pt100 probe ports (standard), supporting IQ/OQ/PQ execution per ISO 13485 and FDA 21 CFR Part 820 requirements.
Sample Compatibility & Compliance
The LDZM-40L series accommodates a broad range of load configurations, including stainless-steel instrument trays (supplied: one φ335 × 190 mm basket), borosilicate glass bottles, autoclavable polymer containers, and wrapped surgical packs. Its gravity-displacement + vacuum-assisted air removal capability meets EN 285 Annex C criteria for porous load penetration. All models carry the Chinese Special Equipment Manufacturing License (TSG 21-2016) and conform to GB/T 150.1–150.4 for pressure vessel design. Structural compliance with ISO 13485:2016 and alignment with EU MDR Annex I essential requirements support use in regulated quality systems. Optional RS232/USB data export and thermal printer enable traceability aligned with FDA 21 CFR Part 11 (when paired with validated software).
Software & Data Management
The LDZM-40L-I features an embedded real-time clock and non-volatile memory storing ≥1000 complete cycle logs—including date/time stamp, setpoint profiles, actual temperature/pressure curves (sampled every 5 s), alarm events, and operator ID (if configured). Data export via USB or serial interface supports CSV formatting compatible with LIMS and ELN platforms. Firmware supports user-defined cycle templates, password-protected parameter modification, and configurable audit trail depth. When integrated with Shen’an’s optional validation software package, users can generate IQ/OQ reports, perform trend analysis on sterilization lethality (F0), and produce PDF certificates compliant with ISO 17665 Annex D.
Applications
These sterilizers serve core functions across academic research laboratories, hospital central sterile supply departments (CSSD), contract development and manufacturing organizations (CDMOs), and biotech pilot facilities. Typical applications include: depyrogenation of glassware prior to aseptic processing; sterilization of microbiological growth media (e.g., agar, broth); decontamination of biohazardous waste (BSL-2); preparation of sterile surgical kits; and routine maintenance of pipette tips and plastic consumables. The 134 °C extended cycle option satisfies accelerated sterilization protocols for dense or fluid-filled loads, while the 50–100 °C range supports delicate item pasteurization or enzyme inactivation where full sterilization is not required.
FAQ
What is the difference between LDZM-40L and LDZM-40L-I?
The LDZM-40L is a microprocessor-controlled sterilizer with manual start and fixed cycle presets. The LDZM-40L-I adds full automation—including delayed start, auto-air-purge, dynamic parameter logging, and optional thermal printing—enabling unattended operation and regulatory documentation.
Does this unit meet international sterilization standards?
Yes. It complies with ISO 17665-1, EN 285, GB 8599, and GB/T 150. Its pressure vessel certification (TSG 21) and design margin (0.24 MPa test pressure vs. 0.217 MPa working pressure) satisfy global mechanical integrity expectations.
Can I validate this sterilizer for GMP use?
Yes. With its three Pt100 port access, real-time data logging, and optional printer, it supports IQ/OQ/PQ execution. Validation documentation templates and calibration guidance are available upon request from Shen’an Technical Support.
Is a water level sensor included?
Yes. An ultrasonic water level detection system triggers automatic shutdown and audible alarm if water falls below minimum operational threshold—preventing dry-heating damage.
What electrical infrastructure is required?
A dedicated 220 V AC / 50 Hz circuit with ≥20 A breaker and proper grounding is mandatory. Voltage fluctuation must remain within ±10% to ensure stable heater and control module performance.
