HXC-258 Blood Bank Refrigerator (4°C)

Overview

The HXC-258 Blood Bank Refrigerator is a medical-grade, upright refrigerated storage system engineered specifically for the safe, stable, and compliant preservation of whole blood, packed red blood cells (RBCs), platelet concentrates (when stored at controlled 22–24°C in alternate configurations), and other temperature-sensitive biological specimens requiring maintenance at +4 °C ± 2 °C. Designed in accordance with ISO 13485 quality management principles and aligned with core requirements of IEC 61010-1 (Safety of Laboratory Equipment) and EN 61000-6-3 (EMC Emission Standards), the unit employs forced-air circulation cooling with dual-point air distribution to ensure uniform temperature distribution across all storage zones — critical for meeting CLSI GP44-A4 and AABB Standard 3.1.1 for blood component storage. Its microprocessor-controlled thermal management system integrates high-stability NTC thermistors and adaptive PID logic to minimize temperature fluctuation (< ±0.5 °C deviation under standard load conditions), supporting long-term viability of hematological products over mandated 35-day shelf life.

Key Features

• Stable 4 °C operation with ±2 °C setpoint tolerance, validated per ISBT Technical Manual Chapter 12 and WHO Blood Safety Guidelines
• Electrically heated anti-condensation glass door—tested to remain dew-free at 32 °C ambient and 80% RH, eliminating visual obstruction during frequent access
• Hermetically sealed, internationally certified compressor (220 W), qualified via 1,000-hour “Dual 85” accelerated life testing (85 °C/85% RH)
• Five independent alarm categories: High/Low Temperature, Ambient Temperature Exceedance, Voltage Deviation, Filter Clogging, and Backup Power Battery Status
• Triple-alarm notification: Audible buzzer (≥75 dB), visual LED indicator, and dry-contact remote output compatible with BMS, SCADA, or hospital-wide alarm networks
• Adjustable stainless-steel coated shelves (50 kg load capacity each) with tool-free vertical repositioning—optimized for modular blood bag organization using standardized 400 mL dip-and-hang racks
• CFC-free polyurethane insulation and eco-friendly refrigerant compliant with EU F-Gas Regulation (EU) No 517/2014 and U.S. SNAP Program criteria

Sample Compatibility & Compliance

The HXC-258 accommodates up to 160 units of 400 mL blood bags per cycle, arranged vertically on dedicated dipping racks to prevent sediment disturbance and hemolysis risk. Its interior chamber—constructed entirely from medical-grade 304 stainless steel—meets ISO 10993-5 cytotoxicity requirements and supports routine disinfection with ethanol, hydrogen peroxide vapor, or quaternary ammonium compounds. The unit complies with Chinese Medical Device Regulatory Requirements (NMPA Registration Certificate available), and its temperature mapping protocol aligns with FDA Guidance for Industry: “Qualification of Refrigerated and Frozen Storage Areas” (2022). While not inherently 21 CFR Part 11-compliant, optional USB data logger integration enables audit-ready temperature traceability when paired with validated third-party software.

Software & Data Management

Temperature logging is supported via optional external USB-connected data recorder (sold separately), providing timestamped, tamper-evident CSV outputs compliant with GLP documentation standards. The built-in controller retains real-time temperature history for ≥30 days (non-volatile memory), with event-triggered log entries for all alarm activations and door openings. Remote dry-contact alarm outputs support integration into centralized facility monitoring systems (e.g., Siemens Desigo, Honeywell Enterprise Buildings Integrator) without proprietary protocols. No embedded Wi-Fi or cloud connectivity is included—ensuring network isolation required by HIPAA and GDPR-aligned institutional IT policies.

Applications

• Hospital blood banks maintaining ABO/Rh-typed RBC units under AABB-accredited storage conditions
• Regional transfusion centers performing daily inventory rotation and expiry tracking
• Clinical laboratories storing serological reagents, coagulation controls, and calibration standards requiring strict 2–8 °C stability
• Biobanks archiving peripheral blood mononuclear cells (PBMCs) pre-cryopreservation
• Pharmaceutical QC labs retaining reference standards for hematology assay validation (e.g., CBC instrument calibration)

FAQ

What is the validated temperature uniformity across the chamber?
Uniformity is ≤ ±0.8 °C (max deviation) at 15 defined test points under static load (IEC 60068-3-5 mapping protocol), verified during factory qualification.
Does the unit support continuous temperature monitoring with electronic records?
Yes—when equipped with the optional USB data logger, it generates time-stamped, exportable logs suitable for internal QA review and regulatory inspection.
Is the compressor serviceable on-site by authorized technicians?
The hermetic compressor is field-replaceable; full service documentation and spare parts list are provided under NDA to certified service partners.
Can the alarm relay interface with existing hospital building management systems?
Yes—the configurable NO/NC dry contact output meets EN 50131-1 Grade 2 electrical interface specifications and requires no external power supply.
What validation documentation is supplied with the unit?
Factory-issued IQ/OQ summary report, temperature mapping certificate, and electrical safety test record are included; full PQ protocol templates are available upon request.