Jihepu TM-XD24D Benchtop Rapid Steam Sterilizer

Overview

The Jihepu TM-XD24D Benchtop Rapid Steam Sterilizer is a compact, microprocessor-controlled Class B steam sterilization system engineered for precision, repeatability, and operational safety in regulated laboratory, clinical, and pharmaceutical environments. It operates on the validated principle of saturated steam under pressure—complying with core physical requirements of ISO 17665-1 (Sterilization of health care products — Moist heat) and supporting alignment with EN 13060:2014 (Small steam sterilizers). Designed for rapid-cycle processing, it delivers full-saturation sterilization at 134 °C and 0.22 MPa, enabling cycle times as short as 4–6 minutes for wrapped or porous loads—ideal for high-turnover settings such as dental clinics, ophthalmic instrument reprocessing, and academic research labs handling reusable surgical tools, glassware, culture media, textiles, and heat-stable pharmaceutical preparations.

Key Features

• Automated water replenishment: Integrated 1.2 L distilled water reservoir supports 4–5 consecutive sterilization cycles without manual refilling.
• Full-cycle microprocessor control: Fully automated sequence covering pre-vacuum air removal, steam generation, sterilization hold, exhaust, and post-sterilization drying—requiring no operator intervention after program initiation.
• Dual-stage safety architecture: Includes redundant overtemperature protection (cut-off at 138 °C), overpressure relief (safety valve activation ≥0.24 MPa), dry-run detection (heating element cut-off at >150 °C), and overcurrent circuit interruption.
• Internal steam recirculation system: Eliminates external steam venting, maintaining ambient lab humidity and reducing condensate discharge—critical for ISO Class 7/8 cleanroom-adjacent installations.
• Optimized chamber design: Cylindrical stainless steel chamber (SUS304, wall thickness ≥2.5 mm) ensures structural integrity, corrosion resistance, and uniform thermal distribution (≤±1 °C across load zone).
• Ergonomic safety interface: Hinged door with thermal shield prevents operator contact with hot surfaces; LED digital display shows real-time temperature, elapsed time, phase status, and audible confirmation tones at key process transitions.

Sample Compatibility & Compliance

The TM-XD24D accommodates a broad range of sterilizable materials compatible with saturated steam exposure, including but not limited to: stainless steel surgical and dental instruments, borosilicate glassware, cotton gauze and linen packs, agar-based microbiological media, and heat-stable pharmaceutical excipients. Its Class B classification per EN 13060 confirms capability for vacuum-assisted air removal—essential for effective sterilization of porous loads and lumened devices. While not certified for terminal sterilization of sterile-grade injectables (which require ISO 11134-compliant validation), it meets routine decontamination and reprocessing requirements aligned with WHO HTM 01-01, CDC Guidelines for Disinfection and Sterilization, and USP principles for non-critical and semi-critical device reprocessing.

Software & Data Management

The embedded controller logs critical process parameters—including chamber temperature, pressure, cycle phase timestamps, and fault events—with non-volatile memory retention. Though not equipped with Ethernet or USB export, all cycle data are accessible via front-panel review mode and support manual documentation for GLP/GMP traceability. The system adheres to fundamental ALCOA+ data integrity principles: attributable (operator ID input optional), legible (clear LED readout), contemporaneous (real-time logging), original (uneditable internal storage), accurate (calibrated sensor inputs), complete (full-phase capture), consistent (sequential timestamping), enduring (10-year memory retention), and available (on-demand retrieval during audit). Optional external thermal mapping (per ISO 17665 Annex C) and biological indicator challenge testing (e.g., Geobacillus stearothermophilus spores) are recommended for initial qualification and periodic requalification.

Applications

• Routine sterilization of reusable ophthalmic, dental, and minor surgical instruments in outpatient clinics and university teaching hospitals.
• Preparation of sterile culture media, buffers, and saline solutions in microbiology and cell culture laboratories.
• Decontamination of textile drapes, gowns, and absorbent pads prior to autoclave-compatible reuse.
• Validation support for sterilization SOP development in GMP-regulated QC/QA departments handling raw material testing equipment.
• Emergency sterilization response in resource-constrained field labs or mobile medical units requiring rapid turnaround.

FAQ

What is the maximum load capacity for a single cycle?

The 24 L chamber accommodates up to three standard stainless steel trays (400 × 200 × 30 mm each), with optimal loading defined as ≤75% chamber volume to ensure steam penetration and thermal uniformity.

Does the unit comply with FDA 21 CFR Part 11 requirements?

No—this model lacks electronic signature capability, audit trail export, or user-access controls required for Part 11 compliance. It is intended for non-GxP documentation environments or as a secondary sterilizer where paper-based records suffice.

Can it sterilize liquids in sealed containers?

No. The TM-XD24D is not designed for liquid cycle programming (e.g., slow-cool ramping); use only for solid or porous dry loads. Liquid sterilization requires dedicated gravity-displacement or vacuum-pulse liquid cycles unavailable on this platform.

Is third-party validation support available?

Yes—Jihepu provides IQ/OQ protocol templates and calibration certificate documentation for pressure and temperature sensors traceable to NIST standards, facilitating user-led validation under ISO 13485 or ISO 9001 quality systems.