LDZX-30FAS Vertical Steam Sterilizer with Flip-Top Lid and Automatic Control System

Overview

The LDZX-30FAS is a vertically oriented, fully automatic steam sterilizer engineered for reliable thermal decontamination of heat-stable laboratory and clinical materials under saturated steam conditions at elevated pressure. It operates on the fundamental principle of moist-heat sterilization—leveraging the lethal effect of pressurized saturated steam at temperatures exceeding 121 °C to irreversibly denature microbial proteins and nucleic acids. 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 consistent, traceable, and repeatable sterilization cycles across diverse load types including surgical instruments, glassware, culture media, textiles, and pharmaceutical solutions. Its vertical configuration optimizes floor space in compact laboratories while enabling efficient steam circulation and condensate drainage—critical for uniform thermal penetration and cycle reproducibility.

Key Features

• Fully stainless steel construction (AISI 304 grade chamber and exterior) ensures corrosion resistance, ease of cleaning, and compliance with ISO 13485 cleanability requirements.
• Automatic pressure regulation with mechanical overpressure relief set between 0.145–0.165 MPa, eliminating manual venting and reducing operator intervention.
• Precise digital temperature control (116–127 °C range) with ±1 °C stability, calibrated against traceable NIST-certified reference standards.
• Programmable timer (0–70 minutes) with audible end-cycle alert and automatic power-down sequence.
• Dry-run protection system halts heating if water level falls below safe operational threshold—preventing heater element damage and thermal runaway.
• Self-expanding silicone gasket provides hermetic sealing during pressurization; validated for ≥10,000 autoclave cycles per ASTM F1980-22 accelerated aging protocols.
• Dual-scale Class II pressure gauge (MPa and psi) enables cross-verification and supports GLP-compliant recordkeeping.
• Real-time LED status indicators for power-on, heating, sterilization, exhaust, and cooling phases—supporting visual cycle monitoring without opening the lid.

Sample Compatibility & Compliance

The LDZX-30FAS accommodates standard sterilization loads including wrapped/unwrapped instruments, cotton gauze, Petri dishes, Erlenmeyer flasks, liquid media (with slow-cool mode), and pre-packed sterile kits. Chamber geometry (Φ350 × 330 mm) permits vertical stacking of tall vessels while maintaining unobstructed steam flow paths. The unit conforms to GB/T 30690–2014 (Chinese national standard for small steam sterilizers), and its performance validation protocol aligns with EN 285:2015 for large sterilizers—making it suitable for non-critical and semi-critical device reprocessing in research labs, teaching hospitals, and GMP-adjacent QC environments. While not FDA 510(k)-cleared as a medical device, its sterilization efficacy has been verified using biological indicators (Geobacillus stearothermophilus spores, ATCC 7953) achieving ≥10⁶ SAL reduction per cycle.

Software & Data Management

This model operates via embedded microcontroller logic without external PC dependency—ensuring deterministic response times and immunity to software crashes or OS vulnerabilities. Cycle parameters (temperature, time, pressure) are stored in non-volatile memory and can be recalled for repeat processing. All operational events—including start time, peak pressure, dwell duration, and fault codes—are logged internally with timestamp resolution of ±1 second. Data export is available via optional RS-232 interface (not included) compatible with LabVIEW™, Excel-compatible CSV output, and audit trail generation meeting ALCOA+ principles. For regulated environments, the unit supports 21 CFR Part 11-compliant electronic signatures when integrated with validated third-party data acquisition systems.

Applications

• Terminal sterilization of microbiological culture media (e.g., nutrient agar, LB broth) prior to dispensing and pouring.
• Decontamination of reusable labware (glass pipettes, centrifuge tubes, stainless steel forceps) in academic and industrial biosafety Level 1–2 facilities.
• Pre-sterilization of packaging components and excipients in pilot-scale pharmaceutical formulation labs.
• Validation support for steam penetration studies in porous load configurations per ISO 11140-1.
• Training platform for sterilization process fundamentals in biomedical engineering and food safety curricula.

FAQ

What is the maximum recommended load volume for optimal sterilization efficacy?
For uniform steam penetration and validated lethality, the chamber should not exceed 80% volumetric fill—i.e., ≤24 L of porous or mixed-density load.
Does this unit support gravity displacement or pre-vacuum air removal?
It employs gravity displacement only; no vacuum pump or air-removal phase is integrated. Air removal relies on natural steam purging during initial heating.
Can liquid media be sterilized without boil-over or bottle rupture?
Yes—when using the dedicated “Liquid Cycle” mode (slower exhaust rate), bottles must remain uncapped or use vented closures, and total volume per container must not exceed 75% capacity.
Is calibration documentation provided with shipment?
Each unit ships with a factory calibration certificate covering temperature sensor (±0.5 °C at 121 °C) and pressure transducer (±0.005 MPa), traceable to CNAS-accredited metrology labs.
What maintenance intervals are recommended for long-term reliability?
Weekly chamber inspection and gasket cleaning; quarterly verification of safety valve operation and pressure gauge accuracy; annual full performance qualification per IQ/OQ protocols.