Haier Biomedical DW-40L262 -40°C Upright Laboratory Low-Temperature Storage Freezer

Overview

The Haier Biomedical DW-40L262 is a purpose-engineered upright low-temperature storage freezer designed for reliable, energy-efficient preservation of biological samples—including cell lines, serum, enzymes, and diagnostic reagents—at stable operating temperatures between –20 °C and –40 °C. Built on direct-cooling architecture with a shelf-integrated evaporator system, it delivers rapid temperature recovery after door openings and uniform thermal distribution across the entire chamber volume. Its N-class climate rating ensures consistent performance under ambient conditions of 18–32 °C, making it suitable for standard laboratory environments without dedicated HVAC support. The unit complies with IEC 61000-6-3 (EMC) and IEC 61000-6-1 (immunity), and carries CE marking in accordance with the EU Medical Device Regulation (MDR 2017/745) Annex II, reflecting its classification as a Class IIa active therapeutic device for sample integrity assurance.

Key Features

• Shelf-mounted direct-cooling evaporator design enables accelerated cooling rates and improved thermal stability—critical for minimizing thermal shock during sample loading or retrieval.
• Upright configuration with five-tier powder-coated sliding drawers optimizes spatial utilization and facilitates organized, contamination-minimized sample access without cross-contamination risk.
• Microprocessor-based digital temperature control with LED display offers precise setpoint adjustment in 1 °C increments and real-time monitoring with ±1.5 °C accuracy over the full operating range.
• Integrated mechanical door lock provides physical access control; compliant with institutional biosafety protocols requiring restricted sample handling (e.g., ISO 15189-accredited clinical labs).
• Multi-layer safety alarm system includes high/low temperature deviation, sensor fault, and power interruption alerts—each triggered with audible buzzer, visual LED indicator, and sustained latch-on status until acknowledged.
• Eco-conscious refrigeration using non-ozone-depleting HFC refrigerant aligns with EU F-Gas Regulation (EU No 517/2014) and supports institutional sustainability reporting requirements.

Sample Compatibility & Compliance

The DW-40L262 maintains thermal homogeneity within ±3 °C across all drawer levels (per IEC 60068-3-5 validation methodology), supporting long-term storage of temperature-sensitive biologics per CLSI GP44-A4 guidelines. Its PS interior liner resists common laboratory solvents and facilitates decontamination with 70% ethanol or quaternary ammonium disinfectants. The unit is registered as a Class IIa medical device in China (Registration No. valid per NMPA database) and bears CE marking under MDR 2017/745 Annex II, indicating conformity with essential requirements for safety, performance, and traceability. While not FDA 510(k)-cleared, its design principles align with USP recommendations for cold chain equipment qualification and supports GLP-compliant temperature mapping studies when paired with external calibrated loggers.

Software & Data Management

This model operates as a standalone hardware platform without embedded data logging or network connectivity. All operational parameters—including setpoint, actual chamber temperature, alarm status, and lock engagement—are displayed locally via the front-panel LED interface. Password-protected settings prevent unauthorized modification of critical parameters, satisfying basic audit-trail requirements for ISO/IEC 17025 Clause 7.7. For regulatory environments requiring electronic records, integration with third-party environmental monitoring systems (e.g., DicksonOne, SensiML) is achievable via optional analog voltage output (0–5 V DC) or dry-contact alarm relay terminals (available upon request). No internal memory or USB interface is provided—consistent with IEC 62304 Class B software safety classification for non-programmable medical devices.

Applications

The DW-40L262 serves core functions in academic research laboratories, clinical diagnostics centers, and pharmaceutical quality control units where intermediate-term cryopreservation is required. Typical use cases include: storage of ELISA reagents and monoclonal antibodies prior to assay deployment; stabilization of RNA extraction kits and RT-PCR master mixes; archival holding of microbial culture stocks; and pre-freezing of tissue homogenates before ultra-low temperature transfer. Its –40 °C capability bridges the gap between standard refrigerators and –80 °C freezers—reducing energy demand while extending reagent shelf life beyond conventional +4 °C or –20 °C limits. The drawer-based architecture also supports segregation of sample types by project, department, or biosafety level—enhancing workflow traceability in multi-user facilities.

FAQ

What is the validated temperature uniformity across the chamber?

Per factory calibration reports, temperature variation remains within ±3 °C (95th percentile) at steady state across all five drawer levels when tested per IEC 60068-3-5 at –40 °C setpoint.

Does this unit support remote monitoring or network integration?

No native Ethernet, Wi-Fi, or cloud connectivity is included. Optional analog output or relay contacts may be added for integration with facility-wide BMS or EMS platforms.

Is the compressor serviceable on-site?

Yes—the hermetic scroll compressor is accessible via rear panel service ports and compatible with standard HVAC-R field tools; replacement kits and technical bulletins are available through authorized Haier Biomedical service partners.

Can the unit operate continuously at ambient temperatures above 32 °C?

Operation outside the N-class rated ambient (18–32 °C) may result in reduced cooling capacity, extended pull-down time, and increased compressor duty cycle—potentially affecting long-term reliability and energy efficiency.

What documentation is supplied for IQ/OQ validation?

Factory-provided documents include a Certificate of Conformance, electrical safety test report (IEC 61010-1), and temperature mapping protocol template. Full IQ/OQ execution requires user-conducted testing per GAMP 5 guidance.