SheAn LDZX-50KBS Vertical Steam Autoclave

Overview

The SheAn LDZX-50KBS Vertical Steam Autoclave is a rigorously engineered Class B (EN 285-compliant) gravity displacement sterilizer designed for routine, high-reliability steam sterilization in laboratory, clinical, and research environments. It operates on the principle of saturated steam under controlled pressure and temperature to achieve microbial inactivation—including bacterial spores—through irreversible protein denaturation and nucleic acid disruption. The unit employs a gravity displacement chamber design, where ambient air is systematically evacuated by incoming saturated steam prior to pressurization, ensuring uniform thermal penetration across porous and non-porous loads. With a certified chamber volume of 50 liters and a maximum operating temperature of 126 °C at 0.145–0.165 MPa, it meets the minimum sterilization requirements defined in ISO 17665-1, EN 13060, and USP for moist heat sterilization cycles. Its all-stainless-steel construction (AISI 304 inner chamber and outer jacket) ensures long-term corrosion resistance, structural integrity, and compliance with Good Laboratory Practice (GLP) facility hygiene standards.

Key Features

• Microprocessor-controlled sterilization cycle with programmable time (0–99 h) and temperature (50–126 °C) parameters, enabling reproducible validation-ready protocols
• Manual quick-release lug-type lid mechanism with dual safety interlocks preventing accidental opening under pressure
• Integrated overpressure relief valve calibrated to activate at ≤0.17 MPa, compliant with ASME BPVC Section VIII and PED 2014/68/EU requirements
• Digital LED display with real-time monitoring of chamber temperature, pressure, elapsed time, and phase status (heat-up, sterilize, exhaust, dry)
• Dry-run protection circuitry that halts operation if water level falls below minimum threshold, preventing heater damage and thermal runaway
• Acoustic end-of-cycle alert followed by automatic power cutoff and passive cooling phase initiation
• Full AISI 304 stainless steel construction—chamber, door gasket housing, and exterior casing—for chemical resistance and ease of decontamination

Sample Compatibility & Compliance

The LDZX-50KBS accommodates a broad spectrum of sterilizable materials, including wrapped and unwrapped surgical instruments, glassware (e.g., flasks, pipettes), textile packs (gowns, drapes), liquid media (in vented containers), and polymer-based labware rated for autoclaving (e.g., polypropylene centrifuge tubes). It supports standard gravity-displacement cycles per ISO 17665-1 Annex A: 121 °C for 15–20 minutes (for wrapped goods) or 126 °C for 10 minutes (for liquids). While not equipped with vacuum-assisted air removal (i.e., not a Class B pre-vacuum autoclave), its validated gravity displacement performance satisfies sterilization requirements for non-porous, low-density loads typical in academic labs and small-scale clinical settings. Documentation packages—including factory calibration certificates and material traceability records—are available upon request to support internal audit trails and regulatory submissions under FDA 21 CFR Part 11 (when paired with optional data logging accessories).

Software & Data Management

The LDZX-50KBS features embedded firmware with non-volatile memory capable of storing up to 10 user-defined cycle profiles. Although it lacks built-in Ethernet or USB connectivity, its digital interface logs timestamped operational events—including start time, peak temperature, hold duration, and fault codes—for manual review and basic traceability. For laboratories requiring electronic record retention, third-party RS-232-compatible chart recorders or USB data loggers may be interfaced via the optional analog output port (available as field retrofit). All cycle parameters comply with the data integrity principles outlined in ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) when manually transcribed into lab notebooks or LIMS systems. Firmware updates are performed via proprietary service-mode access and require authorized technician intervention.

Applications

• Routine sterilization of reusable glassware, metal instruments, and cotton swabs in university teaching labs and core facilities
• Preparation of sterile liquid culture media (e.g., LB broth, agar solutions) in microbiology and molecular biology workflows
• Decontamination of biohazardous waste bags and sharps containers prior to disposal in BSL-1 and BSL-2 containment areas
• Validation of sterilization efficacy using biological indicators (e.g., Geobacillus stearothermophilus spore strips) per ISO 11138-3
• Processing of veterinary and agricultural samples requiring terminal sterilization before histopathological analysis
• Supporting ISO/IEC 17025-accredited testing laboratories in maintaining equipment qualification documentation (IQ/OQ)

FAQ

What is the difference between LDZX-50KBS and LDZX-50KBS Internal Exhaust Type?
The “Internal Exhaust” variant routes spent steam through an integrated condenser and drains condensate internally, eliminating external steam discharge. Standard LDZX-50KBS vents steam directly to the lab environment and requires adequate room ventilation.

Can this autoclave process liquids in sealed bottles?
No—liquids must be placed in containers with loosened caps or vented closures to prevent explosion during heating. Fully sealed vessels are prohibited.

Is the chamber volume exactly 50 L usable capacity?
The nominal 50 L refers to geometric chamber volume (Ø350 mm × 520 mm). Usable load volume is typically 60–70% of nominal capacity to ensure adequate steam circulation and air removal.

Does it meet international safety standards for export?
Yes—the unit conforms to IEC 61010-1 (Safety Requirements for Electrical Equipment) and carries CE marking for the European Economic Area. Additional country-specific certifications (e.g., UL, KC, CCC) require localized testing and labeling.

What maintenance is required for long-term reliability?
Daily: Check water level and drain chamber after each cycle. Weekly: Inspect door gasket for cracks or compression set. Annually: Verify pressure gauge accuracy and safety valve calibration by accredited service provider.