Shanghai Shen YM30 Vertical Steam Autoclave

Overview

The Shanghai Shen YM30 Vertical Steam Autoclave is a Class B (gravity displacement) steam sterilizer engineered for reliable, repeatable terminal sterilization of heat- and moisture-stable laboratory and clinical materials. It operates on the principle of saturated steam under pressure—leveraging gravity displacement to evacuate ambient air from the chamber prior to steam saturation, thereby ensuring a pure, high-purity steam environment essential for microbial inactivation. Designed for routine use in academic laboratories, quality control units, pharmaceutical R&D facilities, and small-scale clinical settings, the YM30 complies with fundamental sterilization process requirements outlined in ISO 17665-1 (Sterilization of health care products — Moist heat) and supports validation protocols aligned with EN 285 and USP . Its vertical orientation optimizes floor space without compromising chamber volume (30 L), while its stainless-steel construction ensures long-term corrosion resistance and ease of cleaning.

Key Features

• Gravity displacement air removal system ensures consistent steam penetration and eliminates cold spots during cycle execution.
• PID-controlled microprocessor system with auto-tuning capability dynamically adjusts heating parameters to maintain temperature stability within ±0.5°C and uniformity better than 1°C across the chamber.
• Integrated low-water-level detection with automatic补水 (water replenishment) function and dual-mode audible/visual alarm—prevents dry-heating damage and resumes operation post-refill.
• Radial self-expanding silicone rubber door gasket provides leak-tight sealing over extended service life, minimizing maintenance intervals.
• Overtemperature protection: automatic heater cutoff and alarm activation if internal temperature exceeds setpoint by >2°C.
• Overpressure safety mechanism: spring-loaded safety valve releases steam at 0.17 MPa, complying with ASME BPVC Section VIII and local pressure equipment directives.
• Ergonomic tilting control panel with LED digital display and status indicator lights enables intuitive monitoring of phase progression (heating, sterilizing, drying, cooling).
• Submerged tubular heating elements deliver high thermal efficiency and rapid chamber warm-up.
• Braked omnidirectional casters allow secure repositioning and stable stationary operation.
• Drain valve facilitates periodic removal of condensed water and mineral deposits, reducing scale accumulation and preserving thermal performance.

Sample Compatibility & Compliance

The YM30 accommodates standard laboratory glassware (flasks, Petri dishes, pipette tips), stainless-steel instruments, textile packs, and aqueous solutions. It is not intended for heat-labile polymers, oils, or powders requiring dry-heat or ethylene oxide processing. Chamber geometry and natural convection design support sterilization of porous loads per ISO 11140-1 definitions. While not pre-certified to FDA 510(k) or CE-marked as a medical device, its operational parameters meet baseline functional criteria referenced in ISO 13485 quality management systems for sterilization process development. Users are responsible for establishing installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols—including biological indicator challenges (e.g., Geobacillus stearothermophilus spores)—to fulfill GLP/GMP documentation requirements.

Software & Data Management

The YM30 features embedded firmware with non-volatile memory storing up to 10 programmable cycles. Cycle logs—including start time, target temperature, actual chamber temperature profile, duration, and fault codes—are retained internally and viewable via front-panel navigation. Though it lacks Ethernet/Wi-Fi connectivity or PC interface ports, all logged data can be manually transcribed for audit trails. The system supports basic electronic record integrity through timestamped event logging and alarm history, facilitating compliance with FDA 21 CFR Part 11 principles when paired with procedural controls (e.g., operator logbooks, witnessed cycle verification). Optional external data loggers may be used for continuous temperature-pressure profiling during validation.

Applications

• Sterilization of microbiological culture media, buffers, and reagents in teaching and research labs.
• Decontamination of reusable surgical instruments and diagnostic tools in outpatient clinics.
• Preparation of sterile packaging materials (e.g., gauze, drapes) for small-volume aseptic assembly.
• Validation support for steam penetration studies using thermocouple mapping and biological indicators.
• Process training and SOP development for sterilization technicians under ISO 13485 or CLIA frameworks.

FAQ

What sterilization standard does the YM30 follow?

It implements gravity-displacement steam sterilization per ISO 17665-1 Annex A, suitable for non-porous and lightly porous loads.
Can the YM30 be validated for GMP-compliant production?

Yes—when integrated into a documented IQ/OQ/PQ framework, including temperature mapping, BI challenge testing, and cycle reproducibility assessment.
Is a printer or USB port available for data export?

No—data must be recorded manually from the LED display; external dataloggers are recommended for archival.
What maintenance is required to sustain performance?

Monthly chamber descaling, quarterly gasket inspection, annual safety valve testing, and biannual calibration of temperature sensors per lab SOPs.
Does the unit include a drying phase?

Yes—the microprocessor-controlled cycle includes configurable drying and cooling phases to minimize condensation on sterilized items.