Shen’an LDZM-80KCS Vertical High-Pressure Steam Sterilizer
| Brand | Shen'an / She Medical Devices |
|---|---|
| Origin | Shanghai, China |
| Model | LDZM-80KCS |
| Instrument Type | Vertical |
| Max Temperature | 134 °C |
| Max Working Pressure | 0.217 MPa |
| Design Pressure | 0.24 MPa |
| Chamber Dimensions | Ø350 × 700 mm (Diameter × Height) |
| Chamber Volume | 80 L |
| External Dimensions | 660 × 780 × 1330 mm (W × D × H) |
| Net Weight | 110 kg |
| Power Supply | 220 V / 50 Hz |
| Rated Power | 3.5 kW |
| Temperature Range | 50–134 °C |
| Time Range | 0–99 h |
| Cooling Method | Forced-air rapid cooling |
| Safety Features | Dual-pressure protection (mechanical safety valve + electronic overpressure cutoff), water-level sensor with dry-run prevention, earth-leakage protection, electronic-mechanical interlocked door, automatic air purge, validation port, USB data interface (optional), optional thermal printer support |
Overview
The Shen’an LDZM-80KCS Vertical High-Pressure Steam Sterilizer is an ISO-compliant, Class B gravity-displacement and vacuum-assisted steam sterilization system engineered for routine laboratory, clinical, and pharmaceutical applications requiring validated microbial inactivation. It operates on the fundamental principle of saturated steam under controlled pressure and temperature to achieve sterility assurance levels (SAL) of ≤10⁻⁶ for wrapped and unwrapped instruments, culture media, liquids, and porous loads. Designed to meet international standards including ISO 17665-1 (sterilization of health care products — moist heat), EN 285 (large steam sterilizers), and aligned with FDA-recommended validation practices, the LDZM-80KCS integrates precise thermodynamic control with robust mechanical architecture to ensure repeatability across consecutive cycles.
Key Features
- Vertical chamber configuration with 80 L usable volume, optimized for space-constrained labs while supporting high-throughput processing of standard instrument trays, glassware, and liquid containers.
- Dual-mode operation: programmable gravity displacement (for non-porous items) and pre-vacuum cycles (for porous or wrapped loads), enabling effective air removal prior to sterilization.
- Multi-link lever mechanism for ergonomic, low-effort lid actuation—ensures consistent sealing force and eliminates misalignment risks during repeated opening/closing.
- Self-sealing silicone gasket design with thermal expansion compensation maintains integrity across the full operating range (50–134 °C) and pressure spectrum (up to 0.217 MPa).
- Full-cycle microprocessor control with LCD graphical interface: real-time display of temperature, pressure, time, and phase status (heat-up, sterilize, exhaust, cooling); all parameters set via intuitive scroll-and-select navigation.
- Forced-air rapid cooling system reduces post-cycle cooldown time by up to 40% compared to passive cooling, minimizing total cycle duration without compromising thermal stability of sensitive media.
- Comprehensive safety architecture: dual redundant pressure protection (mechanical relief valve + electronic overpressure cutoff), interlocked door with pressure-sensing lockout, auto water-level detection with dry-run shutdown, and residual-current circuit breaker (RCCB) for electrical fault protection.
- Built-in cold-air purge function initiates automatically at cycle start to evacuate ambient air—critical for achieving uniform steam penetration and eliminating cold spots.
Sample Compatibility & Compliance
The LDZM-80KCS accommodates a broad range of load types: stainless-steel surgical instruments, autoclavable plasticware (e.g., polypropylene tubes, Petri dishes), agar and broth media (in vented bottles), textile packs, and wrapped dental tools. Chamber geometry (Ø350 × 700 mm) and included dual-tier baskets (Ø335 × 190 mm and Ø335 × 360 mm) facilitate organized loading and steam circulation. The unit supports process validation per ISO 11140 (chemical indicators) and ISO 11737-1 (microbiological methods). A dedicated validation port enables connection to external temperature and pressure loggers for IQ/OQ/PQ documentation. All control logic complies with IEC 62304 software lifecycle requirements; audit trail functionality is available via optional USB data export (CSV format) for GLP/GMP traceability.
Software & Data Management
The embedded controller records full-cycle metadata—including setpoints, actual temperature/pressure profiles, phase timestamps, and fault codes—with internal storage for ≥1,000 cycles. Data export is supported via standard USB 2.0 interface (Type-A), compatible with Windows-based validation software for trend analysis and report generation. Optional thermal printer integration provides hard-copy output of cycle ID, date/time stamp, peak temperature, dwell time, and final pressure—formatted to align with Annex 11 and 21 CFR Part 11 expectations when paired with user-defined access controls and electronic signature protocols. Firmware updates are performed offline via USB, ensuring operational continuity during regulatory audits.
Applications
This sterilizer is routinely deployed in academic research laboratories for media preparation and glassware decontamination; in quality control units for bioburden reduction of test samples prior to microbiological assay; in veterinary clinics for instrument reprocessing; and in small-scale pharmaceutical manufacturing for sterilizing excipients and component packaging. Its adjustable temperature range (50–134 °C) permits low-temperature cycles for heat-labile biologicals (e.g., serum-containing media at 115 °C/30 min), while the 134 °C/3 min cycle meets EN 285 requirements for flash sterilization of critical devices. The inclusion of a timed start function supports unattended overnight operation—ideal for batch processing in resource-limited environments.
FAQ
What sterilization standards does the LDZM-80KCS comply with?
It conforms to ISO 17665-1, EN 285, and GB 8599 (Chinese national standard for large steam sterilizers), with design and testing aligned to ISO 13485 quality management principles.
Can the unit be validated for GMP use?
Yes—equipped with a validation port, digital data logging, and optional printer, it supports IQ/OQ/PQ execution per EU Annex 15 and FDA Process Validation Guidance.
Is the chamber constructed from medical-grade stainless steel?
Yes—the inner chamber and basket components are fabricated from AISI 304 stainless steel, passivated and electropolished to ASTM A967 standards for corrosion resistance and cleanability.
Does it support automated documentation for regulatory submissions?
With USB data export and optional thermal printing, users can generate ALCOA+ compliant records (Attributable, Legible, Contemporaneous, Original, Accurate) meeting FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.
What maintenance intervals are recommended?
Daily: visual inspection of gasket integrity and chamber cleanliness; monthly: verification of safety valve operation and door interlock response; annually: full calibration of temperature and pressure sensors by an accredited service provider.
