Shen’an LDXF-30L Vertical Steam Autoclave

Overview

The Shen’an LDXF-30L Vertical Steam Autoclave is a CE-compliant, Class B (EN 13060) laboratory-grade steam sterilizer engineered for reliable thermal decontamination of heat-stable materials in research, clinical, and quality control environments. It operates on the fundamental principle of saturated steam under controlled pressure to achieve microbial lethality—primarily through protein denaturation and nucleic acid disruption—validated per ISO 17665-1 and aligned with WHO TRS 992 Annex 5 requirements for moist heat sterilization. Designed for routine sterilization of glassware, surgical instruments, culture media, and liquid preparations, the LDXF-30L integrates mechanical robustness with microprocessor-driven process control to ensure repeatability, traceability, and regulatory readiness in GLP- and GMP-aligned workflows.

Key Features

• Vertical chamber configuration with 30 L usable volume (Ø350 × 400 mm), constructed from medical-grade AISI 304 stainless steel with ≥2 mm wall thickness for long-term structural integrity and corrosion resistance.
• Handwheel-actuated, lateral-shift lid mechanism with self-sealing silicone gasket—ensures leak-tight closure and eliminates manual torque calibration errors.
• Dual-safety interlock architecture: mechanical pressure-activated latch prevents lid opening above 0.01 MPa; redundant protection via spring-loaded safety valve (0.142–0.165 MPa) and electronic overpressure cutoff.
• Integrated forced-air cooling system with programmable post-cycle fan activation—reduces chamber cooldown time by up to 40% compared to passive dissipation, enabling faster turnaround without compromising sterility assurance.
• LCD interface with real-time dynamic display of temperature, pressure, elapsed time, and phase status (pre-vacuum, heating, sterilization, exhaust, drying); supports 12 pre-programmed cycles including liquid, solid, and wrapped-item modes.
• Programmable pre-heating function for agar media dissolution (temperature/time adjustable); delayed start scheduling (up to 24 h); and automatic cold air purge prior to pressurization—critical for eliminating air pockets and ensuring uniform steam penetration.
• Comprehensive fault diagnostics with audible/visual alerts for low water, door misalignment, sensor drift, heater failure, and pressure deviation—each logged with timestamp and error code.
• Embedded PT100 Class A temperature sensor and calibrated 0–0.4 MPa Bourdon-tube pressure gauge; digital temperature offset correction capability for long-term metrological stability.

Sample Compatibility & Compliance

The LDXF-30L accommodates standard autoclave-compatible loads: stainless steel trays, borosilicate glassware, PET/PP labware, and sealed liquid containers (with vented caps). Its chamber geometry and steam distribution design meet EN 285:2015 requirements for load uniformity testing. The unit is manufactured under China’s Special Equipment Safety Law (TSG 21-2016) with full in-house pressure vessel certification—no third-party licensing delegation. It supports validation per ISO 13485 and FDA 21 CFR Part 820, and includes a dedicated validation port for thermocouple insertion (3 mm diameter, NPT thread). All electrical components comply with IEC 61010-1 for laboratory equipment safety.

Software & Data Management

While the base model operates via embedded firmware without external software dependency, optional modules extend auditability: a needle-printer interface enables hard-copy recording of cycle parameters (date, start/end time, max temp/pressure, operator ID) compliant with ALCOA+ principles. A USB 2.0 port supports direct export of complete cycle logs (CSV format) to encrypted U-disks—retaining timestamps, sensor readings at 10-second intervals, and alarm history. Data files include digital signatures verifying unaltered integrity, satisfying basic FDA 21 CFR Part 11 requirements for electronic records when paired with institutional access controls.

Applications

• Routine sterilization of microbiological media (e.g., nutrient agar, LB broth) in academic and diagnostic labs.
• Decontamination of reusable PPE, pipette tips, and centrifuge rotors in biosafety level 2 (BSL-2) facilities.
• Preparation of sterile saline solutions and buffer stocks for cell culture and molecular biology workflows.
• Validation support for sterilization process development, including BI (biological indicator) challenge studies using Geobacillus stearothermophilus.
• Regulatory submissions requiring documented evidence of consistent F₀ delivery—achievable via integrated cycle logging and external data correlation.

FAQ

Does the LDXF-30L comply with international sterilization standards such as EN 13060 or ISO 17665?
Yes—it meets EN 13060:2022 Class B requirements for small steam sterilizers and implements core principles of ISO 17665-1:2017 for validation of moist heat processes.
Is the pressure vessel certified for long-term use under Chinese special equipment regulations?
Yes—the unit holds an in-house TSG 21-2016 manufacturing license issued by the Shanghai Municipal Market Supervision Administration, with no reliance on external certification transfer.
Can cycle data be exported for quality audits or regulatory review?
Yes—via optional USB module (CSV export) or integrated thermal printer (time-stamped hard copy), both supporting traceable, tamper-evident records.
What safety mechanisms prevent accidental opening during pressurized operation?
A dual-redundant interlock system: mechanical latch engagement below 0.01 MPa and independent electronic pressure sensor verification—both must confirm zero pressure before lid release is permitted.
Is the chamber suitable for sterilizing liquids in sealed bottles?
Yes—provided containers are fitted with steam-permeable closures (e.g., loosened caps or filter membranes); the pre-vacuum and slow exhaust functions minimize liquid boil-over and container rupture risk.