Shen’an LDZH-150KBS Vertical Steam Sterilizer
| Brand | Shen'an / She Medical Devices |
|---|---|
| Origin | Shanghai, China |
| Model | LDZH-150KBS |
| Instrument Type | Vertical |
| Max Temperature | 134 °C |
| Max Pressure | 0.217–0.24 MPa |
| Chamber Dimensions | Φ500 × 760 mm |
| Chamber Volume | 150 L |
| External Dimensions | 650 × 650 × 1400 mm |
| Chamber Wall Thickness | 4.0 mm |
| Construction Material | Full Stainless Steel (AISI 304) |
| Net Weight | 180 kg |
| Compliance | Registered with NMPA (ex-SFDA) as Class II medical device |
Overview
The Shen’an LDZH-150KBS Vertical Steam Sterilizer is a CE-compliant, NMPA-registered Class II medical device engineered for reliable, repeatable moist-heat sterilization in laboratory, clinical, and industrial settings. It operates on the validated principle of saturated steam sterilization—leveraging latent heat transfer to irreversibly denature microbial proteins and nucleic acids. Designed in accordance with pressure vessel safety standards (GB/T 150, TSG 21), the unit employs gravity displacement air removal to achieve ≥99.9% air evacuation prior to steam saturation, ensuring uniform thermal penetration throughout the chamber. Its 150 L stainless steel chamber (AISI 304, 4.0 mm wall thickness) supports full-cycle sterilization at temperatures up to 134 °C and pressures up to 0.24 MPa—meeting critical benchmarks for surgical instrument reprocessing, culture media preparation, and bioburden reduction in pharmaceutical QC labs.
Key Features
- Microprocessor-controlled cycle management with real-time LCD display showing temperature, pressure, time, phase status, and fault diagnostics
- Dual-safety interlock system: automatic overpressure relief (mechanical + electronic), dry-run protection via water level sensor, and independent overtemperature cutoff
- Gravity displacement air removal mechanism compliant with ISO 17665-1:2017 for steam sterilization process validation
- Full AISI 304 stainless steel construction—including chamber, door gasket, and internal trays—for corrosion resistance and long-term integrity under repeated thermal cycling
- Pre-programmed cycles for wrapped/unwrapped instruments, liquids, and porous loads, with adjustable parameters (T, P, dwell time) within regulatory limits
- Self-diagnostics at power-on and cycle completion, including door seal integrity check and pressure transducer calibration verification
Sample Compatibility & Compliance
The LDZH-150KBS accommodates standard sterilization loads including surgical kits, textile packs, glassware, rubber tubing, agar-based culture media, and PET/PP labware. Chamber geometry (Φ500 × 760 mm) permits vertical stacking of instrument trays and compatibility with DIN 58953-compliant load carriers. All sterilization cycles comply with national and international standards: GB 8599–2008 (Chinese standard for steam sterilizers), ISO 17665-1:2017, EN 285:2015, and USP . The device holds NMPA registration (Registration No. valid per latest database) and disinfection product hygiene license (valid per provincial CDC records), supporting GLP and GMP documentation requirements. Traceability is enabled through optional RS232/USB data export for audit-ready cycle logs.
Software & Data Management
The embedded control system records all critical process parameters—including chamber temperature (±0.5 °C accuracy), jacket pressure (±0.01 MPa), cycle duration, and phase transitions—with timestamped entries stored onboard for ≥1,000 cycles. Data export via USB or serial interface supports CSV format compatible with LIMS and electronic batch record systems. Optional firmware upgrade enables FDA 21 CFR Part 11-compliant user access control (role-based login), electronic signatures, and immutable audit trails—essential for regulated environments requiring ALCOA+ data integrity principles.
Applications
- Hospital central sterile supply departments (CSSD) for reusable surgical instrumentation reprocessing
- University and research laboratories performing microbiological media sterilization and equipment decontamination
- Pharmaceutical and biotech facilities conducting media fill simulations, component depyrogenation, and QC sample preparation
- Food safety labs validating thermal lethality for packaging materials and processing aids
- Clinical diagnostic centers sterilizing pipette tips, centrifuge buckets, and sample collection devices
FAQ
What pressure vessel certification does this sterilizer meet?
It conforms to China’s TSG 21–2016 Supervision Regulation on Safety Technology for Fixed Pressure Vessels and GB/T 150.1–2011 design standards.
Is validation support documentation provided with the unit?
Yes—factory-installed IQ/OQ protocols, temperature mapping templates, and a traceable calibration certificate for the integrated PT100 sensor are included.
Can the sterilizer be integrated into a facility’s BMS or SCADA system?
Via optional 4–20 mA analog output and Modbus RTU (RS485), enabling remote monitoring of chamber temperature and cycle status.
What maintenance intervals are recommended for routine operation?
Daily door gasket inspection, weekly chamber drain line flush, and annual third-party verification of pressure transducer and safety valves per GB 8599–2008 Annex D.
Does the unit support liquid cycle programming with slow-cool and anti-foaming functions?
Yes—programmable liquid cycles include controlled exhaust rate, post-sterilization hold, and pressure-assisted cooling to prevent boil-over and container breakage.
