Shen’an LDZM-60KCS 60L Vertical Steam Sterilizer (Intelligent Model)

Overview

The Shen’an LDZM-60KCS is a vertically oriented, fully jacketed steam sterilizer engineered for reliable, repeatable terminal sterilization of heat-stable laboratory and clinical materials. It operates on the principle of saturated steam under controlled pressure and temperature—complying with internationally recognized sterilization physics defined in ISO 17665-1 and EN 285 for moist-heat sterilization processes. Designed for routine use in university research labs, pharmaceutical QC facilities, and hospital central sterile supply departments (CSSD), this unit delivers precise thermal lethality (F₀) through programmable exposure profiles, ensuring microbial inactivation of vegetative bacteria, fungi, viruses, and bacterial spores—including highly resistant *Geobacillus stearothermophilus* (ATCC 7953) biological indicators.

Key Features

• Stainless steel 304 chamber and outer casing with reinforced structural integrity for long-term corrosion resistance and compliance with GMP cleanroom-grade surface finish requirements.
• Intelligent microprocessor-based control system with backlit LCD display showing real-time temperature, pressure, elapsed time, remaining time, and phase status (heating, sterilizing, exhausting, drying).
• One-touch digital interface enabling rapid setup of sterilization cycles—including gravity displacement, pre-vacuum, and liquid cycles—with user-defined parameters stored in non-volatile memory.
• Rotary quick-release door mechanism with dual safety interlocks: mechanical latch engagement verification and electronic pressure-sensing lockout preventing accidental opening during pressurized operation.
• Integrated water-level monitoring and automatic cut-off circuitry to prevent dry-heating damage to heating elements and chamber integrity.
• Internal exhaust system with condensate management—eliminates external steam venting during cooldown, enhancing lab safety and reducing ambient humidity impact.
• Programmable sterilization duration from 0 to 99 hours and temperature setpoints from 50 °C to 134 °C, supporting both standard autoclaving and low-temperature applications such as media warming or depyrogenation validation studies.

Sample Compatibility & Compliance

The LDZM-60KCS accommodates a broad range of load configurations: wrapped instrument packs, porous loads (e.g., gauze, linen), glassware, stainless steel tools, culture media in bottles or flasks, and polymer-based consumables rated for repeated autoclave exposure. Chamber geometry (Φ370 × 560 mm) allows vertical stacking of standard 1-L Erlenmeyer flasks or nested Petri dish carriers. All operational logic adheres to regulatory expectations for documented sterilization processes per ISO 13485, FDA 21 CFR Part 820, and EU MDR Annex I essential requirements. While the base configuration supports manual cycle documentation, integration with optional thermal printer modules enables ASME BPE-compliant record generation for audit readiness.

Software & Data Management

The embedded controller provides full cycle traceability via timestamped event logging—including start/stop times, peak temperature/pressure values, and fault codes. Optional thermal printer connectivity (RS-232 or USB) permits hard-copy output of cycle reports meeting GLP/GMP documentation standards. Firmware supports firmware version identification and diagnostic self-tests at startup. Though not natively networked, the unit’s serial interface allows integration into centralized lab asset monitoring platforms via third-party middleware compliant with IEEE 11073 or HL7 protocols.

Applications

• Routine sterilization of reusable surgical instruments, pipette tips, and centrifuge tubes in academic and clinical settings.
• Preparation and sterilization of microbiological growth media, buffers, and reagents for cell culture and molecular biology workflows.
• Validation support for sterilization process development—including BI challenge testing, thermocouple mapping, and F₀ calculation verification.
• Depyrogenation of glass vials and stoppers where extended dwell at ≥121 °C ensures endotoxin reduction per USP .
• Decontamination of biohazardous waste prior to disposal in accordance with WHO Laboratory Biosafety Manual (4th ed.) recommendations.

FAQ

What is the maximum allowable working pressure and corresponding saturation temperature?
The LDZM-60KCS is rated for a maximum design pressure of 0.217 MPa (2.2 bar gauge), corresponding to a saturated steam temperature of 134 °C per steam tables defined in IAPWS-IF97.
Does the unit comply with international sterilization validation standards?
Yes—the physical design and control architecture align with fundamental requirements of ISO 17665-1 (moist heat sterilization), EN 285 (large steam sterilizers), and ANSI/AAMI ST79 for healthcare facility use.
Can the sterilizer be validated using thermocouples or data loggers?
Absolutely—the chamber features multiple sensor ports and stable thermal mass distribution, facilitating IQ/OQ/PQ protocol execution with calibrated Class A or Class B probes per EN 60601-2-27.
Is drying functionality included by default?
No—drying is an optional add-on module requiring separate purchase and installation; it introduces post-sterilization vacuum-assisted moisture removal for wrapped instrument sets.
What electrical infrastructure is required for safe operation?
A dedicated 220 V AC, 50 Hz, 16 A grounded circuit with residual current device (RCD) protection is mandatory; continuous 3 kW power draw necessitates appropriate upstream breaker sizing and wiring gauge (≥2.5 mm² copper).