Chu Ding Technology LDZX-30KBS Automatic Vertical Steam Sterilizer (Stainless Steel)
| Brand | Chu Ding Technology |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | LDZX-30KBS |
| Price | USD 980 (FOB Shanghai) |
Overview
The Chu Ding Technology LDZX-30KBS is an automatic vertical steam sterilizer engineered for reliable, repeatable moist-heat sterilization 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) for 15–20 minutes or 134 °C at 205 kPa (30 psi) for 3–5 minutes—to achieve a sterility assurance level (SAL) of 10⁻⁶, compliant with ISO 17665-1:2017 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices). Designed with a fully jacketed stainless steel chamber and integrated programmable controller, the LDZX-30KBS ensures uniform heat distribution, rapid heating/cooling cycles, and precise dwell-time management—critical for validating terminal sterilization of heat-stable materials.
Key Features
- Vertical cylindrical chamber constructed from high-grade 304 stainless steel (inner chamber and door), corrosion-resistant and compliant with ISO 8573-1 for clean steam compatibility
- Microprocessor-based control system with LCD interface, supporting up to 6 pre-programmed sterilization cycles (e.g., solid load, liquid load, wrapped/unwrapped instruments) with adjustable time, temperature, and drying parameters
- Automatic water replenishment and over-temperature/over-pressure dual safety cutoffs meeting GB 8599–2008 (Chinese national standard for large steam sterilizers) and ASME BPVC Section VIII Div. 1 design requirements
- Gravity displacement air removal mechanism ensuring >99.5% air evacuation prior to steam saturation—validated per EN 285:2015 Annex C for steam quality and chamber air removal efficiency
- Integrated pressure relief valve, safety interlock door lock, and real-time monitoring of chamber pressure, temperature, and cycle phase via digital display
- Self-diagnostic function with error code logging and audible/visual alarms for abnormal conditions (e.g., low water level, door seal failure, temperature deviation >±1.0 °C)
Sample Compatibility & Compliance
The LDZX-30KBS accommodates a broad range of sterilizable loads including surgical instruments, glassware (e.g., flasks, pipettes), culture media (liquid and agar-based), textiles (gowns, drapes), and non-porous lab consumables. It is not intended for sterilizing heat-labile polymers, oils, powders, or sealed containers without venting. All sterilization cycles are traceable and support basic GLP documentation requirements; optional RS232/USB data export enables manual audit trail generation. While not FDA 21 CFR Part 11–compliant out-of-the-box (lacking electronic signature and immutable audit log features), the unit meets foundational regulatory expectations for Class B small steam sterilizers per EN 13060:2014 and supports IQ/OQ protocol execution when paired with external temperature mapping probes and calibrated reference thermometers.
Software & Data Management
The embedded firmware provides cycle parameter storage, runtime logging, and event timestamping (date/time stamp for start/end/completion). Cycle records—including setpoints, actual chamber temperature/pressure profiles, and alarm history—are retained onboard for up to 100 cycles and exportable via USB flash drive in CSV format. No proprietary software installation is required; exported logs are compatible with Excel, LabArchives, or ELN platforms for long-term archiving. For laboratories operating under GMP or ISO 13485 quality systems, users may integrate third-party validation software (e.g., ValSuite™ or SteriTrak™) to generate IQ/OQ/PQ reports aligned with ASTM E2500–13 and EU Annex 15 guidelines.
Applications
This sterilizer serves core functions across multiple sectors: microbiology labs use it for autoclaving nutrient broths, Petri dishes, and inoculation loops; hospital central sterile supply departments (CSSD) deploy it for reprocessing reusable surgical kits; food safety labs apply it to sterilize sample diluents and homogenizer bags; and biotech R&D facilities rely on it for preparing sterile buffers and single-use bioreactor components. Its 30 L chamber volume (Ø300 × H450 mm) balances throughput and footprint—ideal for mid-volume workflows where floor space is constrained but batch consistency remains critical.
FAQ
What is the maximum operating temperature and pressure of the LDZX-30KBS?
The unit operates at up to 134 °C and 205 kPa (30 psi), with safety valves certified to release at ≤220 kPa.
Does the LDZX-30KBS support vacuum-assisted air removal?
No—it utilizes gravity displacement only; vacuum pulsing is not implemented. For porous load sterilization requiring enhanced air removal, a Class B prevacuum sterilizer is recommended.
Can I validate this unit for ISO 13485 compliance?
Yes—provided IQ/OQ protocols are executed using NIST-traceable sensors, documented procedures, and qualified personnel; PQ must be performed with biological indicators (e.g., Geobacillus stearothermophilus spores) per ISO 11138-3.
Is distilled water required for operation?
Deionized or distilled water is strongly recommended to prevent scale buildup in the heater and chamber jacket; tap water use may void warranty and impair long-term thermal stability.
What maintenance intervals are specified by the manufacturer?
Daily: chamber wipe-down and door gasket inspection; monthly: safety valve test and drain filter cleaning; annually: full calibration of temperature/pressure sensors and door interlock verification by authorized service technician.
