Shen’an LDZM-40KCS-II Vertical Steam Sterilizer
| Brand | Shen'an / She Medical Devices |
|---|---|
| Origin | Shanghai, China |
| Model | LDZM-40KCS-II |
| Instrument Type | Vertical |
| Max Temperature | 134 °C |
| Max Pressure | 0.24 MPa |
| Chamber Dimensions | Ø370 × 380 mm |
| External Dimensions | 660 × 780 × 950 mm |
| Chamber Volume | 40 L |
| Power Supply | 220 V / 50 Hz |
| Rated Power | 3.5 kW |
| Net Weight | 93 kg |
| Sterilization Temp Range | 50–134 °C |
| Time Range | 0–99 h |
| Safety Pressure Rating | 0.217 MPa (rated working pressure) |
| Cooling | Fan-assisted rapid cooling system |
| Interface | USB port (optional data logging), validation port |
Overview
The Shen’an LDZM-40KCS-II Vertical Steam Sterilizer is a fully automated, microprocessor-controlled Class B gravity displacement and pre-vacuum compatible sterilization system engineered for reliable, repeatable terminal sterilization of heat-stable laboratory and clinical materials. Operating on saturated steam under controlled pressure and temperature, it conforms to the fundamental principles of moist-heat sterilization defined in ISO 17665-1 and EN 285, achieving sterility assurance levels (SAL) of 10−6 for wrapped and unwrapped instruments, culture media, glassware, and porous loads. Its vertical orientation optimizes floor space utilization in compact laboratories while maintaining full compliance with international safety and performance standards for steam sterilization equipment.
Key Features
- Multi-link lever actuation mechanism ensures smooth, synchronized lid opening/closing with mechanical self-locking at pressure — eliminating manual force and reducing operator fatigue.
- Double-walled chamber construction: inner vessel fabricated from medical-grade AISI 304 stainless steel; outer casing combines high-temperature resistant engineering polymers and stainless steel for thermal insulation and structural integrity.
- Self-sealing silicone gasket system with automatic compression during pressurization, ensuring leak-tight integrity across repeated cycles without manual retightening.
- Large LCD graphical interface with intuitive scroll-based menu navigation — all sterilization parameters (temperature, time, cycle type) configured via single-touch selection.
- Real-time dynamic process visualization: animated status indicators display phase progression (pre-heat, exhaust, sterilization, drying, cooling) with simultaneous numeric readouts of chamber temperature, pressure, and elapsed time.
- Fan-assisted rapid cooling system reduces post-cycle cooldown time by up to 40%, enabling earlier access to sterilized loads while minimizing condensation in wrapped items.
- Dual-safety architecture: electromechanical interlock prevents lid opening when chamber pressure exceeds 0.02 MPa; redundant overpressure protection includes both spring-loaded mechanical safety valve (set at 0.26 MPa) and electronic pressure cutoff (0.24 MPa).
- Comprehensive fault diagnostics: continuous self-monitoring of water level, heating element continuity, door seal integrity, temperature sensor calibration drift, and pressure transducer signal stability — faults displayed with standardized error codes per IEC 62304.
- Integrated cold-air purge and automatic post-cycle exhaust management with internal condensate collection tank — zero visible steam emission during operation or venting.
Sample Compatibility & Compliance
The LDZM-40KCS-II supports sterilization of solid non-porous items (e.g., surgical instruments, glassware), wrapped packages (EN 868-compliant wraps), and liquid media (with anti-boilover control). Pre-programmed cycles include “Solid Load”, “Wrapped Instruments”, “Liquids”, and “Biotin-Free” modes — each with validated hold times, ramp rates, and cooling profiles. The unit meets essential requirements of the EU Medical Device Regulation (MDR 2017/745) Annex I GSPRs, complies with GB 8599–2008 (Chinese national standard for steam sterilizers), and is designed to support validation per ISO 13485 quality management systems. Optional validation port enables connection to external thermocouple/data loggers for IQ/OQ/PQ documentation.
Software & Data Management
The embedded control firmware supports traceable sterilization records compliant with GLP and basic GMP documentation needs. USB interface (standard) allows export of cycle logs (date/time stamp, setpoints, actual profiles, operator ID, error history) to external PCs for archiving. Optional thermal printer module (sold separately) provides hard-copy output of cycle reports including sterilization date, start/end times, peak temperature/pressure, and pass/fail status — formatted to align with FDA 21 CFR Part 11 audit trail expectations for electronic records. All data are stored in non-volatile memory with timestamped write protection and no user-editable fields.
Applications
This sterilizer serves routine decontamination and terminal sterilization tasks across academic research labs, pharmaceutical QC facilities, veterinary clinics, and diagnostic centers. Typical use cases include preparation of microbiological growth media (e.g., agar, broth), sterilization of reusable labware (pipette tips, Petri dishes, centrifuge tubes), processing of biohazardous waste prior to disposal, and conditioning of filtration membranes and chromatography columns. Its precise temperature control (±0.5 °C) and pressure regulation (±0.01 MPa) make it suitable for applications requiring strict thermal consistency, such as spore challenge testing using Bacillus stearothermophilus biological indicators.
FAQ
What sterilization standards does the LDZM-40KCS-II comply with?
It meets GB 8599–2008, ISO 17665-1, and EN 285 requirements for steam sterilizers, and its design supports validation per ISO 13485 and FDA 21 CFR Part 11 when equipped with optional data logging and printing modules.
Can the unit sterilize liquids without boil-over?
Yes — the “Liquids” cycle employs slow heating and controlled pressure release to prevent violent boiling and container rupture, supporting volumes up to 2 L per container.
Is validation support included?
A dedicated validation port is built-in for third-party temperature/pressure probe integration; IQ/OQ protocols and DQ documentation templates are available upon request from Shen’an technical support.
What maintenance is required for long-term reliability?
Daily drain of the condensate tank, weekly cleaning of the chamber gasket and water reservoir, and annual verification of safety valves and sensor calibration — all procedures detailed in the bilingual (EN/CN) operation manual.
Does the system support remote monitoring?
While not Ethernet-enabled, real-time cycle data can be exported via USB for integration into local lab information systems (LIS) or centralized monitoring dashboards using custom scripts or third-party middleware.
