Shen’an LDZH-100KBS Vertical High-Pressure Steam Sterilizer

Overview

The Shen’an LDZH-100KBS is a vertically oriented, fully automated high-pressure steam sterilizer engineered for reliable terminal sterilization of heat-stable laboratory and healthcare materials. It operates on the principle of saturated steam under controlled pressure and temperature—leveraging the microbiocidal efficacy of moist heat at temperatures up to 134 °C and pressures up to 0.208 MPa. This unit is validated for use in applications requiring compliance with internationally recognized sterilization standards, including ISO 17665-1:2012 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices). Its 100 L stainless-steel chamber provides expanded capacity over conventional benchtop models (typically ≤75 L), supporting higher throughput for bulk instrument sets, large-volume liquid media, or multiple trays of glassware and pipette tips.

Key Features

• Fully automatic microprocessor-controlled sterilization cycles with programmable time (0–99 hours) and temperature (50–134 °C) parameters
• Manual quick-action lug-type door mechanism with integrated safety interlock—prevents door opening during pressurized operation
• Overpressure protection system with dual-stage mechanical relief: automatic venting initiated between 0.145–0.208 MPa
• Digital LCD display showing real-time chamber temperature, pressure, elapsed time, and cycle phase status
• Stainless-steel construction (chamber, jacket, and exterior housing) for corrosion resistance and long-term durability in demanding lab environments
• Self-contained heating elements (6 kW total power) enabling rapid steam generation and stable thermal profiles across full load conditions
• Acoustic end-of-cycle alert with automatic power-down to minimize operator intervention and energy consumption

Sample Compatibility & Compliance

The LDZH-100KBS accommodates a broad range of sterilizable loads, including wrapped and unwrapped surgical instruments, autoclavable plastics (e.g., polypropylene containers), culture media (liquid and agar-based), glassware, textiles, and porous packaging materials. Chamber geometry (Φ500 × 500 mm) supports uniform steam penetration and condensate drainage. The sterilizer meets the essential design and performance requirements outlined in GB 8599–2008 (China’s national standard for large-capacity steam sterilizers) and aligns with key functional expectations of ISO 13485-certified quality management systems. While not pre-certified for FDA 510(k) or CE marking, its architecture supports integration into GLP/GMP workflows where user qualification (IQ/OQ/PQ) and documented validation protocols are implemented per institutional SOPs.

Software & Data Management

This model features embedded firmware—not PC-based software—with non-volatile memory storing up to 99 user-defined cycle programs. All operational data—including start/stop timestamps, setpoints, actual temperature/pressure curves, and fault logs—are retained in internal memory and viewable via the front-panel LCD. Optional external data logging can be achieved using RS-232 or analog output interfaces (available upon request). For regulated environments, users may supplement with third-party electronic record systems compliant with 21 CFR Part 11 requirements, provided audit trail, electronic signature, and data integrity controls are externally implemented.

Applications

• Routine sterilization of reusable laboratory tools and glassware in academic, clinical, and industrial research labs
• Preparation of sterile growth media for microbiology, cell culture, and molecular biology workflows
• Decontamination of biohazardous waste prior to disposal (in accordance with local biosafety guidelines)
• Processing of sterilization pouches, gowns, and drapes in small-scale healthcare support settings
• Validation studies requiring reproducible thermal exposure profiles under defined load configurations

FAQ

What is the maximum allowable operating pressure and temperature?
The rated maximum pressure is 0.208 MPa (≈2.08 bar), corresponding to a saturation temperature of 134 °C.
Is the chamber volume nominal or actual usable volume?
The 100 L rating refers to geometric internal chamber volume; usable load volume depends on load configuration, steam circulation requirements, and regulatory packing density limits (typically ≤70–80% fill for porous loads).
Does this sterilizer support gravity displacement or pre-vacuum cycles?
The LDZH-100KBS employs gravity displacement air removal; it does not include a vacuum pump or pre-vacuum functionality.
Can I validate this unit according to ISO 17665 or EN 285?
Yes—the design and performance characteristics are consistent with the physical principles required by these standards; however, formal validation must be performed by the end user or qualified third party using calibrated sensors and documented protocols.
What electrical infrastructure is required for installation?
A dedicated 380 V AC, three-phase, 16 A circuit with proper grounding is mandatory; voltage fluctuations exceeding ±5% require external stabilization.