Shen’an LDZF-75KB-II Vertical Steam Sterilizer

Overview

The Shen’an LDZF-75KB-II is a CE-compliant, vertically oriented steam sterilizer engineered for reliable, repeatable terminal sterilization of heat-stable laboratory and clinical materials. It operates on the fundamental principle of saturated steam under elevated pressure—leveraging the well-established relationship between temperature, pressure, and microbial lethality defined in ISO 17665-1 and EN 285. At its rated working pressure of 0.217 MPa (≈2.2 bar), the chamber achieves sterilization temperatures up to 134 °C, enabling validated 3-log to 6-log reductions of bacterial spores—including *Geobacillus stearothermophilus*—within defined exposure times. Designed for routine use in university core facilities, pharmaceutical QC labs, and hospital central sterile supply departments (CSSD), the LDZF-75KB-II integrates mechanical robustness with regulatory-aware automation, supporting GLP-aligned documentation practices through optional USB data export and validation port connectivity.

Key Features

• Multi-link toggle mechanism for smooth, low-effort lid actuation—ensuring precise alignment and uniform sealing force distribution across the full gasket perimeter
• Self-sealing silicone gasket design that expands radially under pressure to maintain leak-tight integrity throughout the cycle
• Double-safety architecture: mechanical spring-loaded safety valve (ASME BPVC Section VIII compliant) paired with redundant electronic overpressure cutoff at 0.24 MPa design limit
• Pressure-activated interlock system prevents lid opening while chamber pressure exceeds 0.02 MPa—mechanically and electronically enforced
• Integrated forced-air cooling module reduces post-cycle cooldown time by up to 40% compared to passive dissipation, minimizing throughput latency
• Dual-mode programmable control: preconfigured cycles for solids (e.g., glassware, instruments) and liquids (e.g., culture media, buffers), each with independent ramp-hold-cool profiles
• Real-time dynamic status display showing phase progression (pre-vacuum, heating, sterilization, exhaust, cooling), pressure/temperature tracking, and elapsed time
• Auto-purge function evacuates non-condensable air prior to pressurization—critical for achieving uniform thermal penetration and avoiding cold spots
• Comprehensive fault diagnostics with alphanumeric error codes (e.g., E03 = low water level, E12 = temperature sensor drift) and audible/visual alerts

Sample Compatibility & Compliance

The LDZF-75KB-II accommodates standard autoclave-compatible loads including wrapped surgical kits, stainless-steel instruments, porous textile packs, liquid-filled bottles (up to 1 L volume per container), and microbiological agar plates. Its 75 L chamber supports two included perforated stainless-steel baskets (Ø335 × 190 mm and Ø335 × 360 mm), optimized for vertical steam flow and condensate drainage. The unit complies with national safety standards GB 8599 and YY 0504, and its control logic aligns with IEC 61010-1 for electrical safety in laboratory equipment. While not certified to ISO 13485 out-of-box, its validation port enables third-party IQ/OQ/PQ execution per FDA Guidance for Industry (2022) and EU Annex 1 requirements for sterilizing medical devices.

Software & Data Management

The embedded microcontroller runs a deterministic real-time OS with non-volatile parameter storage. All user-defined cycles—including custom temperature/time setpoints, delay start times, and cooling thresholds—are retained after power loss. Optional USB interface (USB-B port) enables direct connection to Windows-based PCs for time-stamped CSV log export (cycle ID, start/end timestamps, T/P profiles, alarm events). When paired with Shen’an’s optional thermal printer module (sold separately), the system generates audit-ready hardcopy records compliant with ALCOA+ principles—capturing date, operator ID (via manual entry), sterilization parameters, and pass/fail status. Data integrity safeguards include write-protected memory sectors and sequential event logging with timestamped entries—supporting basic 21 CFR Part 11 readiness when deployed with controlled access protocols.

Applications

This sterilizer serves as a primary or backup terminal sterilization platform across regulated and academic environments. Typical applications include: depyrogenation of glass vials and syringes in preclinical formulation labs; sterilization of reusable laparoscopic instruments in ambulatory surgery centers; preparation of bacteriological growth media in teaching microbiology labs; decontamination of biohazard waste containers in BSL-2 facilities; and validation of sterilization process parameters during method transfer studies. Its wide temperature range (50–134 °C) also supports low-temperature pasteurization protocols for thermolabile biological reagents where extended dwell times compensate for reduced thermal intensity.

FAQ

What is the maximum allowable load weight per cycle?
The chamber is rated for a maximum gross load of 35 kg—including basket weight—to maintain adequate steam circulation and thermal uniformity.
Does the unit support vacuum-assisted air removal?
No—the LDZF-75KB-II relies on gravity displacement (air purge via steam flush) rather than vacuum pumps; it is not designed for porous load sterilization requiring deep vacuum cycles.
Can validation be performed without optional accessories?
Yes—the built-in validation port accepts standard PT100 probes (IEC 60751 Class A) for thermocouple mapping; however, external data loggers are required for full chamber qualification.
Is routine maintenance documented in the manual?
Yes—the operation manual includes quarterly inspection checklists for gasket integrity, safety valve function, water level sensor calibration, and door seal torque verification.
What is the expected service life under typical lab usage?
With biannual professional servicing and adherence to water quality specifications (conductivity <10 µS/cm), the sterilizer maintains operational reliability for ≥8 years based on field performance data from 2019–2023 installations.