Shen’an LDZM-80KCS Intelligent Vertical Steam Autoclave (80 L)

Overview

The Shen’an LDZM-80KCS Intelligent Vertical Steam Autoclave is a CE-compliant, Class B (EN 13060) laboratory-grade steam sterilizer engineered for reliable, repeatable terminal sterilization of heat- and moisture-stable materials in pathology labs, clinical microbiology units, and biomedical research facilities. Operating on saturated steam under pressure, the system achieves microbial inactivation—including bacterial spores, viruses, and prions—through precise thermal energy delivery governed by time-temperature-pressure relationships defined in ISO 17665-1 and EN 285. Its vertical orientation optimizes floor space utilization while maintaining full compliance with ASME BPVC Section VIII Div. 1 design standards for pressure vessels. The 80 L working chamber accommodates standard instrument trays, glassware racks, textile packs, and porous loads up to 30 cm × 30 cm × 60 cm, supporting both gravity displacement and pre-vacuum-assisted cycles where optional vacuum modules are installed.

Key Features

• Intelligent microprocessor-based control system with real-time monitoring of chamber temperature, pressure, and cycle phase
• Digital LCD interface with intuitive Chinese-language navigation and one-touch parameter input for temperature (50–134 °C) and duration (0–99 h)
• Rotating quick-opening lid with mechanical interlock: prevents door operation unless chamber pressure drops to ambient and temperature falls below 80 °C
• Double-wall insulation and polymer-coated outer shell provide surface temperatures ≤45 °C during operation—meeting IEC 61010-1 touch-safety requirements
• Internal exhaust system eliminates external steam discharge at cycle termination, reducing lab humidity and eliminating need for dedicated vent ducting
• Integrated low-water cutoff sensor halts heating if water level falls below minimum operational threshold, preventing dry-heating damage
• Acoustic end-of-cycle alert followed by automatic power-down and cooling-phase initiation
• 304 stainless steel construction throughout chamber, door gasket seat, and structural frame ensures corrosion resistance and long-term integrity in high-humidity environments

Sample Compatibility & Compliance

The LDZM-80KCS supports sterilization of wrapped and unwrapped instruments, culture media (e.g., agar, broth), surgical textiles, rubber tubing, and porous composite loads. It is validated for use with standard biological indicators (e.g., Bacillus stearothermophilus spore strips per ISO 11138-3) and chemical integrators conforming to ISO 11140-1. The autoclave meets essential safety and performance criteria outlined in EN 61010-1 (electrical safety), EN 61326-1 (EMC), and EN 13060 (small steam sterilizers). While not FDA 510(k)-cleared as a medical device in the U.S., it complies with ASTM E1114 for validation methodology and supports GLP/GMP documentation workflows when paired with optional thermal printer or audit-trail-enabled software (sold separately).

Software & Data Management

Standard operation requires no PC connection; all cycle parameters and status logs are retained in non-volatile memory for ≥1,000 cycles. An optional RS232/USB thermal printer module enables hard-copy generation of cycle reports including date/time stamp, setpoints, actual chamber temperature/pressure profiles, and pass/fail status per load. For regulated environments, third-party validation software packages (e.g., ValSuite™ or SteriTrak™) may be deployed to generate IQ/OQ/PQ protocols, export CSV-formatted temperature log data, and enforce 21 CFR Part 11-compliant electronic signatures and audit trails—subject to user-configured access controls and password policies.

Applications

• Routine sterilization of reusable surgical instruments and diagnostic tools in pathology core labs
• Preparation of sterile culture media and reagents for histopathology and microbiology workflows
• Decontamination of biohazardous waste prior to disposal (in accordance with local biosafety level 2/3 protocols)
• Validation of sterilization processes using biological and chemical indicators
• Support of CAP-accredited laboratory quality systems requiring documented traceability and cycle reproducibility
• Integration into centralized sterilization services serving multiple research groups or clinical departments

FAQ

What is the maximum operating pressure of the LDZM-80KCS?

The chamber is rated for a maximum working pressure of 0.22 MPa (2.2 bar gauge), sufficient to achieve 134 °C saturated steam conditions.
Does this autoclave support vacuum-assisted air removal?

The base model uses gravity displacement only; vacuum capability requires the optional vacuum pump module (LDZM-VAC-KIT), enabling pre- and post-steam pulses per EN 13060 Annex A.
Can the unit be validated per ISO 17665?

Yes—its temperature uniformity (±0.5 °C across chamber volume per EN 285 Annex C), pressure control accuracy (±5 kPa), and data logging resolution meet minimum requirements for validation protocol execution.
Is the chamber drain valve autoclavable?

Yes—the integrated bottom-mounted drain valve features a steam-tight seal and is designed to withstand repeated sterilization cycles without degradation.
What maintenance intervals are recommended?

Daily: chamber wipe-down and gasket inspection; Quarterly: safety valve functional test and door seal integrity check; Annually: full calibration of temperature/pressure sensors by accredited service provider.