Shen’an LDZX-75KBS Vertical Steam Sterilizer

Overview

The Shen’an LDZX-75KBS Vertical Steam Sterilizer is a Class B gravity displacement and steam-flush vacuum-assisted sterilization system engineered for reliable, repeatable terminal sterilization of heat-stable laboratory and medical loads. It operates on the fundamental principle of saturated steam under controlled pressure and temperature to achieve microbial inactivation—primarily through protein denaturation and nucleic acid disruption. Designed in accordance 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), the LDZX-75KBS delivers validated lethality (F₀ ≥ 12 min) across diverse load configurations, including wrapped instruments, glassware, culture media, and porous materials. Its vertical orientation optimizes floor space utilization in compact labs while maintaining full compliance with national and international safety standards for pressurized equipment (GB 8599–2008, ASME BPVC Section VIII Div. 1).

Key Features

• Full 304 stainless steel chamber and jacket construction ensures corrosion resistance, structural integrity, and long-term thermal stability under repeated sterilization cycles.
• Microprocessor-controlled programmable interface with backlit LCD display enables precise setting of temperature (50–126 °C), exposure time (0–99 hours), and cycle stage sequencing—including pre-vacuum, sterilization, exhaust, and drying phases.
• Manual handwheel-type quick-opening door with dual-seal gasket and mechanical pressure interlock prevents accidental opening during pressurized operation, meeting EN 13060:2014 safety requirements for small steam sterilizers.
• Integrated overpressure relief valve set at 0.145–0.165 MPa provides passive mechanical fail-safe protection independent of electronic controls.
• Automatic cycle termination with audible alarm and power cutoff ensures operator awareness and energy efficiency; optional internal steam condensation (not standard) reduces external venting requirements.
• Dry-run protection safeguards heating elements when water level falls below operational threshold—critical for uninterrupted media sterilization and glassware processing.

Sample Compatibility & Compliance

The LDZX-75KBS accommodates a broad range of sterilizable items: microbiological culture media (agar, broth), Petri dishes, pipette tips, glass flasks and tubes, surgical instruments, textile packs, and non-woven pouches. Load configuration supports both solid and porous item categories per ISO 11140-1 classification. The unit meets GB/T 30690–2014 (General requirements for small steam sterilizers), complies with Chinese NMPA registration requirements for Class II medical devices, and aligns with foundational principles referenced in FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004). While not certified to EN 285 for large-scale industrial autoclaves, its design incorporates equivalent engineering safeguards—including temperature uniformity verification ports and documented thermal mapping capability—for lab-scale validation protocols.

Software & Data Management

The LDZX-75KBS features embedded firmware without external PC connectivity or network interfaces. All operational parameters and cycle logs—including start time, setpoints, actual chamber temperature/pressure curves, and completion status—are retained in non-volatile memory for up to 100 cycles. Cycle records can be manually reviewed via the LCD interface and exported only through visual documentation (e.g., photography or note-taking). For laboratories requiring audit-ready traceability, integration with external data loggers (via optional 4–20 mA or RS485 analog outputs, available upon request) supports GLP/GMP-aligned record retention. Though lacking native 21 CFR Part 11 compliance (no electronic signatures or user-level access control), its deterministic control logic and mechanical redundancy make it suitable for educational, QC, and R&D environments where procedural adherence—not digital signature enforcement—is the primary regulatory focus.

Applications

This sterilizer serves core functions across academic, pharmaceutical, food safety, and clinical research settings: preparation of sterile microbiological growth media for bacteriology and mycology workflows; decontamination of reusable labware prior to aseptic handling; sterilization of inoculation loops, forceps, and other metal instruments; validation of sterilization efficacy using biological indicators (e.g., Geobacillus stearothermophilus spore strips); and routine maintenance of laminar flow hoods and biosafety cabinets. Its 75 L chamber volume supports batch processing of up to 12 standard 1000 mL Erlenmeyer flasks or 48 Petri dish stacks—ideal for teaching labs conducting parallel experiments or mid-scale fermentation media preparation.

FAQ

What is the maximum allowable operating pressure and corresponding temperature?
The LDZX-75KBS is rated for a maximum working pressure of 0.165 MPa (gauge), corresponding to a saturated steam temperature of 126 °C at sea level.
Does the unit support vacuum-assisted air removal?
Yes—the LDZX-75KBS implements a steam-flush vacuum cycle (gravity displacement enhanced by intermittent vacuum pulses) to improve steam penetration into porous loads, consistent with Class B sterilizer functionality per EN 13060.
Is the chamber volume verified per ISO 17665 definitions?
Chamber volume (75 L) refers to geometric internal capacity; users must perform load-specific heat distribution studies to confirm F₀ delivery and cold spot identification per validation protocols.
Can this sterilizer be used for liquid media sterilization without boil-over?
Yes—its programmable slow exhaust mode and adjustable post-sterilization cooling phase minimize thermal shock and prevent container rupture during depressurization of liquid loads.
What maintenance intervals are recommended for optimal performance?
Daily: Chamber inspection, gasket cleaning, and water level check. Monthly: Safety valve functional test and door seal integrity verification. Annually: Calibration of temperature and pressure sensors by an accredited service provider.