Shen’an LDZH-100L Vertical Steam Sterilizer

Overview

The Shen’an LDZH-100L Vertical Steam Sterilizer is a fully automatic, microprocessor-controlled gravity displacement and pre-vacuum compatible steam sterilization system engineered for routine and high-throughput sterilization of heat-stable laboratory and clinical materials. 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), this 100-liter chamber unit operates on saturated steam under controlled pressure and temperature conditions to achieve a minimum sterility assurance level (SAL) of 10⁻⁶. Its vertical configuration optimizes floor space utilization while supporting efficient loading of large-volume loads—including autoclave bags, glassware trays, stainless steel instrument sets, and porous textile packs—without compromising thermal uniformity or steam penetration. The system employs gravity-assisted air removal during initial heating, followed by programmable exhaust sequencing to ensure consistent chamber conditioning prior to sterilization hold phase.

Key Features

• Robust stainless-steel construction (AISI 304) with 3.0 mm wall thickness for long-term corrosion resistance and structural integrity under repeated pressurization cycles
• Interlocked lid mechanism compliant with EN 61010-1 safety requirements, preventing accidental opening during pressurized operation
• Microprocessor-based control system with LED digital display showing real-time temperature, pressure, elapsed time, and phase status (heating, sterilizing, exhausting, drying)
• Programmable sterilization parameters: temperature range 50–134 °C; time range 0–99 hours; configurable exhaust modes (full, micro, or no exhaust) to accommodate load type and material sensitivity
• Self-inflating silicone gasket ensures reliable sealing across operational temperature and pressure ranges, minimizing maintenance and leak risk
• Dual-scale Class II analog pressure gauge (MPa/bar) with redundant verification capability for operator cross-checking
• Low-water cutoff protection prevents dry-heating damage to heating elements and chamber integrity
• Acoustic alarm signals cycle completion and fault conditions (e.g., pressure deviation, temperature overshoot, lid interlock failure)

Sample Compatibility & Compliance

The LDZH-100L accommodates a broad spectrum of sterilizable items including but not limited to: wrapped surgical instruments, culture media bottles, pipette tips, Petri dishes, rubber tubing, textile drapes, and non-porous metal tools. It supports both gravity-displacement and optional pre-vacuum-compatible cycles for improved air removal from lumened devices and porous loads. All operational protocols adhere to national and international standards, including GB 8599–2008 (Chinese standard for large steam sterilizers), ISO 17665-1, and EN 285:2015 (Steam sterilizers — Large sterilizers). The unit is suitable for use in GLP-compliant laboratories and meets essential requirements for Class B sterilizer classification per EN 13060:2014.

Software & Data Management

While the LDZH-100L operates via embedded firmware without external PC connectivity, its control architecture logs critical cycle parameters—including setpoints, actual temperature/pressure profiles, and duration—into non-volatile memory. Cycle records can be manually documented for audit trail purposes. For facilities requiring electronic record retention and 21 CFR Part 11 compliance, integration with third-party data acquisition systems (via optional RS485 or analog output interfaces) is feasible through authorized engineering support. All firmware updates and calibration procedures follow documented change control protocols aligned with ISO 9001 quality management principles.

Applications

This sterilizer serves core functions across academic research laboratories, pharmaceutical QC units, hospital central sterile supply departments (CSSD), veterinary clinics, and biotechnology production facilities. Typical applications include terminal sterilization of microbiological growth media, decontamination of biohazardous waste prior to disposal, preparation of sterile surgical packs, and validation of sterilization processes in early-stage device development. Its 100 L capacity enables batch processing of up to 12 standard instrument trays or 40 L of liquid media per cycle, significantly reducing throughput bottlenecks in medium-to-high volume settings.

FAQ

What is the maximum allowable working pressure and corresponding temperature?
The maximum working pressure is 0.217 MPa, corresponding to a saturated steam temperature of 134 °C.
Does the unit support vacuum-assisted air removal?
The base configuration uses gravity displacement; however, optional vacuum pump integration enables pre-vacuum cycles for enhanced air removal from complex or porous loads.
Is the sterilizer compliant with international regulatory standards?
Yes—it conforms to EN 285:2015, ISO 17665-1:2017, and GB 8599–2008, and is classified as a Class B sterilizer per EN 13060:2014.
What safety certifications does the LDZH-100L carry?
It incorporates electrical safety design per EN 61010-1 and mechanical safety features including pressure relief valves, overtemperature cutoffs, and lid interlock verification.
Can cycle data be exported electronically?
Native export is not supported; however, analog or RS485 outputs may be configured for connection to external SCADA or LIMS systems with appropriate interface hardware and validation.