Shen’an DSX-29L-I Portable Steam Autoclave

Overview

The Shen’an DSX-29L-I Portable Steam Autoclave is a CE-compliant, microprocessor-controlled sterilization system engineered for reliable, repeatable moist-heat sterilization in resource-constrained or mobile laboratory environments. It operates on the fundamental principle of saturated steam under pressure—leveraging the thermodynamic relationship between temperature, pressure, and microbial lethality—to achieve sterility assurance levels (SAL) of 10⁻⁶ for wrapped and unwrapped medical devices, culture media, glassware, and laboratory textiles. Designed to meet 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 DSX-29L-I delivers precise thermal profiles within a compact, self-contained footprint. Its fully jacketed stainless-steel chamber ensures uniform heat distribution and long-term corrosion resistance, while its integrated safety architecture conforms to EN 61010-1 (Safety requirements for electrical equipment for measurement, control, and laboratory use) and EN 61000-6-3 (EMC emission standards).

Key Features

• Quick-action cam-lock lid mechanism with positive mechanical interlock: prevents lid opening when internal pressure exceeds 0.01 MPa, satisfying ASME PTC 10 and GB/T 150.4 mandatory safety logic.
• Self-sealing silicone gasket (food-grade EPDM equivalent) that expands radially under steam pressure to ensure zero-leak integrity across repeated cycles.
• Dual-scale analog pressure gauge (0–0.25 MPa range) with redundant digital LED display showing real-time chamber pressure, setpoint temperature, elapsed time, and remaining cycle duration.
• Programmable microcontroller with non-volatile memory: stores up to one user-defined cycle (temperature/time/pressure ramp profile) and recalls last executed parameters automatically.
• Automated air removal sequence: initiates vacuum-assisted or gravity-displacement purge prior to pressurization, minimizing cold spot formation per ISO 11140-1 Annex B guidelines.
• End-of-cycle passive depressurization with controlled venting through a solenoid-actuated exhaust valve, preventing sudden steam release and minimizing condensate carryover.
• Bottom-mounted drainage port with high-temperature resistant PTFE-lined ball valve for complete residual water evacuation after each cycle.
• Integrated triple-layer safety protection: (1) electronic overtemperature cutoff at 130 °C, (2) mechanical pressure relief valve calibrated to 0.165 MPa ±0.005 MPa, and (3) dry-run protection via float-switch monitored water level sensor.
• Full AISI 304 stainless-steel chamber (2 mm wall thickness) certified to GB/T 150.1–2011 design and hydrostatic test standards; includes traceable material certification and ASME U-stamp-equivalent Chinese pressure vessel license.
• Ergonomic housing fabricated from UL94-V0 rated heat-resistant engineering polymer (glass-filled polyamide), surface temperature maintained below 45 °C during operation per IEC 61000-4-2 touch-safety compliance.

Sample Compatibility & Compliance

The DSX-29L-I accommodates standard microbiological loads including Petri dishes, test tubes, pipette tips, surgical instruments (wrapped in porous wraps), and liquid media (in vented containers). Chamber geometry (Ø269 × 370 mm) supports vertical stacking of up to 12 × 100 mL Erlenmeyer flasks or 24 × 15 mL conical tubes per cycle. All wet-heat sterilization protocols comply with national and international regulatory expectations: it satisfies China’s YY/T 0646–2015 (Automatic steam sterilizers for small loads), aligns with FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004), and supports GLP/GMP documentation requirements through timestamped cycle logs (stored internally for ≥100 cycles). The device carries a registered Class II medical device license issued by China’s National Medical Products Administration (NMPA), and its pressure vessel manufacturing qualification is independently audited—not third-party leased.

Software & Data Management

While the DSX-29L-I operates via embedded firmware without external PC connectivity, its onboard controller provides full audit-trail capability essential for regulated environments. Each sterilization cycle records: start timestamp, set temperature, actual chamber temperature profile (sampled every 10 s), pressure curve, total exposure time above 121 °C, and completion status (pass/fail based on time-at-temperature validation). Cycle data is retained in non-volatile flash memory and accessible via front-panel navigation. Optional RS-232 output (available on DSX-29L-II variant) enables integration with LIMS or electronic batch record systems compliant with 21 CFR Part 11 when paired with validated software middleware. All firmware updates follow IEC 62304 Class B medical device software lifecycle controls.

Applications

This autoclave serves core sterilization needs across academic teaching labs, field clinics, veterinary practices, pharmaceutical QC laboratories, and biotech startups requiring portable, low-infrastructure solutions. Typical validated uses include: sterilization of nutrient agar and broth media (121 °C, 15–20 min); depyrogenation of glassware (126 °C, 30 min); terminal sterilization of reusable surgical kits; and decontamination of biohazard waste (134 °C, 3 min per ISO 15883-1). Its 29 L capacity balances throughput efficiency with benchtop mobility—ideal for labs lacking dedicated sterilization rooms or requiring transport between satellite facilities.

FAQ

What pressure vessel certifications does the DSX-29L-I hold?

It is manufactured under China’s GB/T 150.1–2011 pressure vessel design code and holds a valid Pressure Vessel Manufacturing License issued directly by the Shanghai Municipal Market Supervision Administration—not subcontracted or borrowed.
Is the unit suitable for sterilizing liquids?

Yes, provided containers are vented (e.g., loosened caps or specialized autoclavable bottles) and loaded vertically to prevent boil-over; maximum recommended fill volume is 75% of container capacity.
Does it support validation documentation for ISO 13485 or GMP?

Cycle logs provide time-temperature-pressure traceability; users must perform initial IQ/OQ/PQ per ISO 17665 and maintain calibration records for pressure/temperature sensors annually.
Can the sterilization chamber be cleaned with caustic agents?

No—only neutral pH detergents and soft cloths are permitted; chlorinated or acidic cleaners will compromise the passive oxide layer on the 304 stainless steel.
What is the expected service life under routine use?

Designed for ≥10 years of daily operation (up to 3 cycles/day), contingent upon adherence to scheduled maintenance: gasket replacement every 12 months, pressure gauge calibration annually, and full safety valve functional test every 6 months.