LDZX-30FB Automatic Vertical Stainless Steel Steam Sterilizer (Stainless Steel Chamber)
| Origin | Shanghai, China |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Domestic (China) |
| Model | LDZX-30FB |
| Pricing | Available Upon Request |
Overview
The LDZX-30FB Automatic Vertical Stainless Steel Steam Sterilizer is a Class B pre-vacuum and gravity displacement compatible steam sterilization system engineered for precision, repeatability, and regulatory compliance in laboratory, clinical, and industrial settings. It operates on the fundamental principle of saturated steam under controlled pressure and temperature—typically 121 °C at 103 kPa (15 psi) or 134 °C at 205 kPa (30 psi)—to achieve microbial inactivation through protein denaturation and nucleic acid disruption. Designed to meet ISO 17665-1:2019 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices), the unit integrates automated cycle selection, real-time process monitoring, and chamber integrity verification to ensure consistent lethality (F0 ≥ 12 min for standard loads). Its vertical orientation optimizes floor space utilization while maintaining full accessibility for loading, unloading, and maintenance.
Key Features
- Robust 304 stainless steel sterilization chamber and door seal assembly, resistant to corrosion and thermal fatigue over extended operational life
- Microprocessor-controlled PLC system with intuitive touchscreen interface supporting programmable cycles: gravity, pre-vacuum, liquid, and wrapped/unwrapped load modes
- Integrated vacuum pump enabling air removal prior to steam admission—critical for effective sterilization of porous loads and lumened devices
- Automatic water level detection, overtemperature/overpressure safety interlocks, and dual independent pressure transducers for redundancy
- Self-diagnostic startup sequence and real-time alarm logging compliant with IEC 62304 software lifecycle requirements
- Steam jacketed chamber design ensures uniform temperature distribution (±0.5 °C across chamber volume per ISO 17665 Annex C)
Sample Compatibility & Compliance
The LDZX-30FB accommodates a broad range of sterilizable materials including surgical instruments, cotton gauze and linen packs, glassware (e.g., pipettes, flasks), microbiological culture media (agar, broth), pharmaceutical solutions, and heat-stable lab consumables. It is not intended for heat-labile polymers, electronic components, or powders requiring dry-heat methods. All sterilization cycles are validated per EN 285:2015 (Steam sterilizers — Large sterilizers) and support documentation for GLP/GMP environments. Optional validation ports allow connection to data loggers for IQ/OQ/PQ protocols. The device conforms to GB 8599–2008 (Chinese national standard for large steam sterilizers) and includes built-in cycle traceability features aligned with FDA 21 CFR Part 11 requirements for electronic records and signatures when paired with compliant software.
Software & Data Management
The embedded control firmware supports full-cycle data capture—including chamber temperature, pressure, time, vacuum depth, and phase transitions—with timestamped storage for ≥10,000 cycles. USB export enables seamless integration into LIMS or quality management systems (QMS). Optional PC-based software provides graphical cycle review, statistical trend analysis (e.g., F0 deviation, come-up time variability), and PDF report generation with digital signature fields. Audit trail functionality records all user actions—including parameter modifications, cycle aborts, and maintenance events—with immutable timestamps and operator IDs, satisfying ALCOA+ data integrity principles.
Applications
This sterilizer serves critical roles across multiple sectors: in university and research laboratories for preparing sterile media and glassware; in hospital central sterile supply departments (CSSD) for processing reusable surgical kits; in food microbiology labs for sterilizing sample preparation tools; and in biotech pilot facilities for batch sterilization of fermentation vessels and transfer lines. Its versatility extends to veterinary clinics, dental practices, and pharmaceutical QC labs where reproducible terminal sterilization of non-critical and semi-critical items is required. Routine use supports ISO 13485:2016 quality system requirements for medical device manufacturers.
FAQ
What sterilization standards does the LDZX-30FB comply with?
It meets GB 8599–2008, ISO 17665-1:2019, and EN 285:2015 for steam sterilization performance and safety.
Can it sterilize liquids without boil-over?
Yes—the dedicated liquid cycle employs slow exhaust and post-sterilization cooling under pressure to prevent container rupture and media degradation.
Is third-party validation support available?
Yes—qualified validation partners provide IQ/OQ/PQ services, including thermocouple mapping, biological indicator testing (e.g., Geobacillus stearothermophilus spores), and F0 verification.
What maintenance intervals are recommended?
Daily: chamber wipe-down and door gasket inspection; Quarterly: vacuum pump oil change and safety valve calibration; Annually: full performance qualification and pressure vessel inspection per local regulatory authority guidelines.
Does it support remote monitoring?
Via optional Ethernet or RS485 interface, enabling integration with building management systems (BMS) or centralized sterilization dashboards for multi-unit oversight.
