LDZX-50FAS Vertical Steam Sterilizer with Flip-Top Lid and Automatic Control System

Overview

The LDZX-50FAS is a vertically oriented, flip-top lid steam sterilizer engineered for reliable, repeatable moist-heat sterilization under saturated steam conditions at elevated pressure and temperature. It operates on the fundamental principle of thermal inactivation—utilizing pressurized saturated steam to achieve microbial lethality through protein denaturation and nucleic acid disruption. Designed to meet ISO 17665-1:2019 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices), the unit delivers validated sterilization cycles suitable for laboratory-grade instruments, surgical dressings, glassware, culture media, pharmaceutical solutions, and food samples. Its robust stainless-steel construction (AISI 304 grade chamber and outer casing), integrated automatic control logic, and mechanical safety redundancies ensure compliance with GLP and basic GMP environmental requirements in academic, clinical, and industrial R&D settings.

Key Features

• Full AISI 304 stainless-steel construction—including sterilization chamber, door, and exterior housing—for corrosion resistance and long-term structural integrity
• Flip-top hinged lid design enabling rapid, ergonomic access without requiring lateral clearance—ideal for space-constrained lab environments
• Microprocessor-based control system with digital PID temperature regulation and real-time cycle monitoring
• Adjustable sterilization parameters: temperature range 116–127 °C; time range 0–70 minutes; pressure setpoint maintained between 0.145–0.165 MPa
• Automatic overpressure relief mechanism compliant with EN 285:2015 Annex C, activating within ±0.005 MPa tolerance
• Self-expanding silicone gasket ensuring leak-tight sealing during pressurization and eliminating manual torque adjustment
• Dual-scale Class II pressure gauge (MPa and psi) with independent mechanical verification capability per ASME B40.100
• Low-water level cutoff sensor preventing dry-heating damage and enabling fail-safe shutdown prior to heating phase initiation
• LED status indicators for power-on, heating, sterilization, exhaust, and completion phases—supporting visual operational traceability

Sample Compatibility & Compliance

The LDZX-50FAS accommodates standard laboratory load configurations including wrapped instrument sets, unsealed Petri dishes, liquid-filled flasks (with vented caps), autoclavable plastic containers, and pre-packaged sterile barrier systems. Load geometry must conform to EN 285:2015 Clause 6.2.3 (maximum height-to-diameter ratio ≤ 2.5) to ensure uniform steam penetration. The unit supports gravity displacement air removal and is not rated for vacuum-assisted pre-vacuum cycles. It complies with national Chinese standards YY 0504–2005 (Horizontal/Vertical Steam Sterilizers) and meets essential performance criteria referenced in FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004). While not independently certified to ISO 13485 or CE-MDR, its design aligns with foundational sterilization process controls required for ISO 9001:2015 quality management systems.

Software & Data Management

The LDZX-50FAS operates via embedded firmware without external PC connectivity or proprietary software. All cycle parameters are stored in non-volatile memory and retain settings after power interruption. Cycle logs—including start time, set temperature, actual chamber temperature profile (recorded at 10-second intervals), elapsed time, and end status—are viewable on the front-panel LCD but not exportable. For regulated environments requiring audit trails, users may integrate optional third-party USB data loggers compatible with RS-232 output (available as accessory). The system supports basic electronic recordkeeping aligned with FDA 21 CFR Part 11 principles when paired with validated documentation workflows, though native electronic signature or user-role authentication is not implemented.

Applications

• Sterilization of reusable surgical instruments and dental tools in university teaching hospitals and outpatient clinics
• Preparation of microbiological growth media (e.g., agar, broth) and sterilization of empty glassware in academic and industrial microbiology labs
• Thermal decontamination of biohazard waste prior to incineration or chemical treatment
• Processing of food samples for pathogen enumeration (e.g., ISO 6579 for Salmonella) and shelf-life studies
• Validation of sterilization protocols for small-batch bioprocessing equipment components
• Supporting ISO/IEC 17025-accredited testing laboratories where documented thermal lethality cycles are required for method validation

FAQ

What is the maximum recommended load volume for optimal sterilization efficacy?
The chamber’s 50 L internal volume supports up to 40 L of porous load (e.g., wrapped instruments) or 35 L of liquid load (e.g., 500 mL flasks filled to 80% capacity) to maintain adequate steam circulation and condensate drainage.
Does this unit support programmable multi-step cycles (e.g., liquid vs. solid modes)?
No—it provides a single fixed-cycle architecture optimized for saturated steam exposure. Separate cycle optimization for liquids requires manual parameter adjustment per load type and is not automated.
Is the pressure gauge calibrated and traceable to national standards?
The dual-scale gauge is factory-calibrated and supplied with a manufacturer’s calibration certificate. Field recalibration is recommended annually using NIST-traceable deadweight testers per ISO 6789-2:2017.
Can the LDZX-50FAS be installed in a fume hood or ventilated enclosure?
No—exhaust steam must be discharged into a dedicated floor drain or condensate collection system. Installation requires ambient room ventilation meeting ASHRAE 110 guidelines for heat dissipation and humidity control.
What maintenance intervals are recommended for long-term reliability?
Daily: Visual inspection of gasket integrity and chamber cleanliness. Monthly: Verification of pressure relief valve operation and water level sensor response. Annually: Full system performance qualification (SPQ) including Bowie-Dick test, Helix test, and biological indicator challenge (Geobacillus stearothermophilus spores).