Jihepu TM-T24D Benchtop Steam Sterilizer

Overview

The Jihepu TM-T24D Benchtop Steam Sterilizer is a compact, fully automated gravity-displacement steam sterilization system engineered for precision, repeatability, and regulatory compliance in laboratory, clinical, and pharmaceutical environments. It operates on the principle of saturated steam under controlled pressure and temperature to achieve microbial inactivation—including bacterial spores—via protein denaturation and nucleic acid disruption. Designed to meet internationally recognized sterilization process requirements, the unit delivers validated 134 °C rapid cycles (4–6 minutes) suitable for wrapped and unwrapped instruments, glassware, culture media, textiles, and heat-stable pharmaceutical preparations. Its 24 L stainless steel chamber supports routine batch processing without compromising thermal uniformity (≤ ±1 °C across the load), ensuring consistent bioburden reduction per ISO 17665-1 and EN 285 standards.

Key Features

• Fully automatic cycle control with pre-programmed and user-defined parameters—no manual intervention required during operation.
• Gravity displacement chamber design ensures efficient air removal and uniform steam penetration, minimizing cold spots and supporting reliable sterilization validation.
• Dual redundant safety systems: mechanical pressure relief valve actuating at 0.24 MPa and electronic overtemperature cutoff (>150 °C at heater surface) with integrated water-level monitoring and audible alarm.
• Three perforated, lidded stainless steel trays (340 × 200 × 30 mm) facilitate organized loading, promote condensate drainage, and allow post-cycle containment to prevent recontamination.
• Robust 304 stainless steel construction throughout—chamber, door gasket, and outer housing—for corrosion resistance, long-term dimensional stability, and ease of cleaning per GMP hygiene protocols.
• Intuitive digital interface with real-time display of temperature, pressure, elapsed time, and phase status (pre-vacuum, sterilization, exhaust, drying).

Sample Compatibility & Compliance

The TM-T24D accommodates a broad range of sterilizable materials including surgical and dental instruments, ophthalmic tools, borosilicate glassware, cotton gauze and linen packs, agar-based microbiological media, and thermally stable excipients or APIs. It is not intended for heat-labile polymers, electronics, or liquids requiring vacuum-assisted sterilization. The unit complies with fundamental design and performance criteria outlined in ISO 13485 (medical device quality management), ISO 17665-1 (moist heat sterilization validation), and EN 61010-1 (safety requirements for electrical equipment). While not pre-certified to FDA 21 CFR Part 820 or EU MDR Annex I, its operational parameters and documentation architecture support integration into GLP/GMP workflows where user-generated IQ/OQ/PQ validation is performed.

Software & Data Management

This model features embedded firmware with non-volatile memory capable of storing up to 99 cycle logs—including date/time stamp, setpoints, actual temperature/pressure profiles, and fault codes. Cycle data can be exported via USB port for audit trail generation and long-term archiving. All critical events—including safety interlock activations—are timestamped and retained independently of power loss. The system supports traceability requirements under FDA 21 CFR Part 11 when paired with external validated software for electronic signature and access control; however, native electronic signatures are not implemented. Optional RS-232 or Ethernet modules (sold separately) enable remote monitoring and integration with laboratory information management systems (LIMS) or building automation platforms.

Applications

• Routine sterilization of reusable labware and hand instruments in university research labs and core facilities.
• Pre-sterilization preparation of culture media, buffers, and diluents in microbiology and cell culture suites.
• Terminal sterilization of surgical kits, dental burs, and ophthalmic implants in outpatient clinics and ambulatory surgery centers.
• Validation support for small-batch pharmaceutical manufacturing—particularly for non-aseptic compounding and packaging component prep.
• Compliance-driven decontamination of biohazardous waste containers and PPE prior to disposal or reuse.

FAQ

What is the maximum validated load configuration for a 134 °C rapid cycle?
A full 24 L chamber load must be validated per ISO 17665-2; typical rapid-cycle validation uses ≤ 75% chamber volume with defined load density and thermocouple mapping.
Does this unit support vacuum-assisted air removal or drying phases?
No—the TM-T24D utilizes gravity displacement only and lacks a vacuum pump or active drying stage; residual moisture must be managed externally.
Can it be used for liquid sterilization (e.g., nutrient broths)?
Yes, but only in vented containers with slow exhaust to prevent boil-over; cycle parameters must be adjusted per EN 285 Annex D for liquid loads.
Is third-party IQ/OQ documentation available from the manufacturer?
Jihepu provides basic technical specifications and safety manuals; site-specific qualification protocols and reports must be developed by the end user or qualified service provider.
What maintenance intervals are recommended for optimal performance?
Daily: chamber wipe-down and gasket inspection; monthly: safety valve functional test and drain line flush; annually: full calibration verification of temperature and pressure sensors by accredited metrology lab.