Shen’an LDZH-200KBS Vertical Steam Sterilizer

Overview

The Shen’an LDZH-200KBS Vertical Steam Sterilizer is a Class II pressure vessel designed and manufactured in strict compliance with the People’s Republic of China Special Equipment Safety Law, TSG 21-2016 (Safety Technical Supervision Regulation for Fixed Pressure Vessels), and GB 8599-2008 (General Requirements for Large Steam Sterilizers). It employs saturated steam under controlled pressure and temperature to achieve terminal sterilization via moist heat—a well-established, internationally recognized microbiocidal mechanism. The unit operates on gravity displacement principle: steam enters the chamber from the top, displacing ambient air downward through a dedicated exhaust port; once air is fully evacuated, the chamber is sealed and pressurized to predetermined sterilization parameters (e.g., 121 °C/15 min or 134 °C/3–5 min per ISO 17665-1). This method ensures uniform thermal penetration and reliable microbial inactivation—including spores of Geobacillus stearothermophilus, the biological indicator specified in EN 285 and ISO 17665.

Key Features

• Robust chamber construction from full AISI 304 stainless steel with 4.0 mm wall thickness—engineered for long-term corrosion resistance, structural integrity under cyclic pressurization, and compliance with pharmaceutical-grade surface finish requirements (Ra ≤ 0.8 µm).
• Microprocessor-based control system with real-time LCD interface displaying chamber temperature, pressure, elapsed time, phase status (pre-vacuum, heating, sterilization, drying, cooling), and fault diagnostics.
• Multi-layer safety architecture: automatic overpressure relief valve (set at 0.25 MPa), dry-run protection (water level sensor interlock), independent overtemperature cutoff (dual PT100 sensors), door-locking mechanism with pressure-dependent mechanical and electronic interlocks, and emergency manual venting capability.
• Gravity displacement air removal—validated for routine sterilization of porous loads (e.g., wrapped instruments, gauze packs) and non-porous items (glassware, metal tools, culture media flasks) without vacuum pump dependency.
• Configurable cycle programming supporting standard cycles (B&D, liquid, wrapped/unwrapped), user-defined profiles, and password-protected parameter modification—aligned with GLP/GMP documentation expectations.

Sample Compatibility & Compliance

The LDZH-200KBS accommodates a wide range of sterilizable materials: surgical instruments, textile drapes, rubber tubing, plastic Petri dishes, nutrient agar and broth media (in vented containers), glass pipettes, and stainless-steel laboratory ware. It is certified under China’s National Medical Device Registration (Registration No.: valid per NMPA database) and Disinfection Product Health License (License No.: valid per provincial CDC registry). While not CE-marked or FDA 510(k)-cleared, its design principles and performance benchmarks align with core requirements of ISO 17665-1:2017 (Moist heat sterilization of health care products), EN 285:2015 (Steam sterilizers – Large sterilizers), and USP <1211> (Sterility Assurance). Routine validation per ANSI/AAMI ST79:2017 is recommended for regulated environments.

Software & Data Management

The embedded controller logs all critical process variables (time-stamped temperature, pressure, and phase transitions) to internal non-volatile memory (retention ≥ 10,000 cycles). Data export is supported via RS232 serial interface to external PCs running Shen’an-provided logging software—enabling generation of CSV-formatted reports compliant with basic audit trail requirements. While the system does not natively support FDA 21 CFR Part 11 electronic signatures or role-based access control, it provides foundational traceability suitable for academic labs, QC/QA departments in food and cosmetics manufacturing, and pre-clinical research facilities operating under internal SOPs.

Applications

• Hospital central sterile supply departments (CSSD) for reprocessing reusable surgical kits and linen packs.
• University and research institute laboratories sterilizing glassware, stainless-steel tools, and microbiological media (e.g., LB broth, Sabouraud dextrose agar).
• Biotechnology and pharmaceutical R&D labs performing sterilization of bioreactor components, filtration housings, and buffer preparation vessels.
• Food and beverage testing labs validating sterility of sampling containers, homogenizer parts, and culture media prior to microbial enumeration (ISO 4833-1, ISO 6887).
• Veterinary clinics and diagnostic centers requiring reliable, low-maintenance terminal sterilization of dental instruments and histology cassettes.

FAQ

Is the LDZH-200KBS suitable for sterilizing liquids?

Yes—equipped with a dedicated liquid cycle that modulates exhaust rate and post-sterilization cooling to prevent boil-over and container breakage. Users must employ vented closures and limit fill volume to ≤75% of container capacity.
Does it comply with international sterilization standards such as ISO 17665?

Its operational methodology, validation framework, and performance thresholds are fully consistent with ISO 17665-1:2017 requirements for gravity-displacement steam sterilizers. Formal conformity assessment requires site-specific IQ/OQ/PQ execution.
Can cycle data be exported for regulatory audits?

Yes—via RS232 interface and bundled software, generating time-stamped, tamper-evident CSV files containing temperature, pressure, and phase duration records.
What maintenance is required to sustain sterilization efficacy?

Daily: chamber inspection, gasket cleaning, drain filter clearing. Weekly: safety valve functional test. Annually: third-party pressure vessel inspection and temperature/pressure sensor calibration per local metrology authority requirements.
Is technical support available outside mainland China?

Shen’an collaborates with authorized regional distributors for installation supervision, operator training, and spare parts fulfillment; direct OEM service is limited to domestic markets.