Shen’an LDZX-50L-I Vertical Autoclave

Overview

The Shen’an LDZX-50L-I is a CE-compliant vertical autoclave engineered for reliable, repeatable moist-heat sterilization in academic laboratories, clinical pathology units, pharmaceutical QC labs, and biotechnology R&D facilities. It operates on the fundamental principle of saturated steam under controlled pressure to achieve microbial inactivation—primarily targeting bacterial spores (e.g., Bacillus stearothermophilus) at temperatures up to 126 °C and pressures up to 0.24 MPa. Designed in accordance with China’s national pressure vessel standards (TSG 21–2016 and GB/T 150.1–2011), the unit integrates ASME-equivalent mechanical safety architecture with microprocessor-based process control, enabling precise regulation of temperature, pressure, time, and exhaust dynamics across diverse load types.

Key Features

• Triple-safety interlock system: Mechanical pressure–actuated lid lock prevents opening when chamber pressure exceeds 0.02 MPa; redundant protection via dual independent pressure cutoffs—mechanical safety valve (set at 0.26 MPa) and electronic overpressure sensor (trip at 0.245 MPa).
• Self-sealing gasket design: Elastomeric self-expanding seal ensures consistent radial compression against the chamber flange during pressurization, minimizing steam leakage and extending gasket service life.
• Three-stage exhaust logic: Programmable exhaust modes—full exhaust (for solid loads), fractional exhaust (for liquid media to prevent boil-over), and no-exhaust hold (for heat-labile items requiring slow depressurization).
• Integrated rapid cooling: Built-in axial fan with thermostatically regulated airflow reduces post-cycle chamber temperature from 121 °C to <50 °C within ≤25 minutes—reducing total cycle turnaround by up to 40% versus passive cooling.
• Pre-programmed sterilization profiles: Factory-configured cycles for solids (121 °C/20 min), liquids (115 °C/30 min), and melting (e.g., agar at 95 °C/15 min), all editable via intuitive LCD interface with real-time graphical progress tracking.
• Dry-run prevention: Level-sensing electrode system triggers automatic power cutoff if water level falls below minimum operational threshold, preventing heater element damage.
• Compliance-ready interfaces: Optional RS232/USB port supports data export (CSV format) of timestamped temperature, pressure, and duration logs; optional thermal printer enables 21 CFR Part 11–compliant record generation with operator ID and cycle signature.

Sample Compatibility & Compliance

The LDZX-50L-I accommodates standard laboratory loads including wrapped surgical instruments, glassware, culture media (in bottles or flasks), pipette tips, and polymer-based labware. Its 50 L stainless steel 304 chamber (≥2 mm wall thickness) resists pitting and stress corrosion in repeated steam environments. The unit conforms to ISO 17665-1:2017 (sterilization of health care products—moist heat), meets EN 285:2015 requirements for large steam sterilizers, and carries China’s mandatory Special Equipment Manufacturing License (TS2231020-2025). All electrical components comply with IEC 61010-1:2010 for laboratory equipment safety.

Software & Data Management

The embedded microcontroller executes closed-loop PID temperature and pressure regulation with ±0.5 °C thermal accuracy and ±0.01 MPa pressure resolution. Cycle parameters—including start delay (up to 24 h scheduling), hold time (0–99 h), and temperature offset calibration (±5 °C correction)—are stored in non-volatile memory. USB data logging captures full cycle metadata (date/time, setpoints, actuals, alarms) onto FAT32-formatted drives. Audit trail functionality records user logins, parameter changes, and abort events—supporting GLP/GMP documentation workflows and internal QA audits.

Applications

This autoclave serves routine sterilization in microbiology teaching labs, hospital central supply departments (CSSD), veterinary diagnostic centers, and contract manufacturing organizations (CMOs). It validates reliably for depyrogenation of glass vials (per USP ), sterilization of nutrient broths and agar plates (per ISO 11138-3), and preparation of sterile saline solutions. Its programmable pre-vacuum and gravity-displacement modes accommodate both porous and non-porous loads, while the integrated validation port permits thermocouple insertion for IQ/OQ/PQ protocol execution per Annex 1 (EU GMP) and FDA guidance.

FAQ

What pressure vessel certification does this autoclave carry?
It holds China’s Special Equipment Manufacturing License (TS2231020-2025) issued under TSG 21–2016, with design pressure rated at 0.24 MPa and maximum allowable working pressure (MAWP) at 0.217 MPa.
Can it sterilize liquid media without boil-over?
Yes—via selectable “fractional exhaust” mode, which vents steam incrementally during cooling to maintain hydrostatic head and suppress violent boiling.
Is remote monitoring supported?
Not natively; however, the optional USB interface allows periodic batch data retrieval, and the RS232 port (with external converter) enables integration into building management systems (BMS) or LIMS via Modbus RTU.
What maintenance intervals are recommended?
Gasket replacement every 12 months or 500 cycles; chamber interior inspection and safety valve certification annually per TSG 21 and local regulatory requirements.
Does it support third-party validation tools?
Yes—the dedicated validation port accepts standard 1.5 mm diameter thermocouples (K-type or T-type) for mapping studies, and the real-time analog outputs (0–5 V) interface with external data loggers for PQ verification.