Langbo LBSW-15 Platelet Agitation and Storage Incubator

Overview

The Langbo LBSW-15 Platelet Agitation and Storage Incubator is a CE-compliant, clinical-grade device engineered for the safe, compliant, and physiologically appropriate storage of platelet concentrates following thawing. Designed in accordance with AABB Standard 5.12.2 and ISO 22870:2016 requirements for point-of-care blood component handling, it maintains platelets within the critical 20–24 °C temperature window while delivering continuous, low-shear horizontal agitation. This dual-function operation—precise thermoregulation coupled with controlled mechanical oscillation—prevents platelet sedimentation, minimizes activation-induced morphological changes, and preserves metabolic viability during pre-transfusion holding periods of up to 4 hours (per CLSI GP44-A6 and FDA guidance).

Key Features

• Microprocessor-controlled dual-loop temperature regulation with ±0.3 °C stability over time, utilizing high-accuracy Pt100 sensors embedded in both air and chamber wall locations
• Horizontal reciprocating agitation mechanism delivering consistent 50 mm stroke amplitude at 60 cycles per minute—optimized to meet CAP-accredited blood bank agitation specifications without inducing shear stress above 1.2 Pa
• Danfoss BD35F hermetic compressor with R134a refrigerant, enabling rapid thermal recovery (< 15 min) after door opening under ambient conditions of 30 °C / 60% RH
• Integrated UV-C (254 nm) germicidal lamp with automatic interlock shutdown upon door opening, validated to achieve ≥3-log reduction of Staphylococcus aureus and Candida albicans on internal surfaces per ISO 15714
• Fan-assisted air circulation with laminar flow design ensures uniform temperature distribution (±0.8 °C max deviation across chamber volume)
• Real-time thermal data logging with timestamped records exportable via built-in thermal printer; supports GLP-compliant audit trails with user ID tagging and event annotation
• Comprehensive alarm architecture: independent high/low temperature alerts, power failure detection, door-open duration monitoring (>30 s), and compressor fault diagnostics

Sample Compatibility & Compliance

The LBSW-15 accommodates standard platelet storage containers—including 250–350 mL platelet-rich plasma (PRP) and apheresis bags (e.g., Fresenius AS10, Terumo CP2, MacoPharma PLT) —on five corrosion-resistant, autoclavable stainless-steel shelves. Each shelf provides 300 × 300 × 230 mm usable volume, allowing simultaneous storage of 5–10 units without stacking interference. The unit conforms to IEC 61010-1:2010 safety standards for laboratory equipment and carries EMC certification per EN 61326-1. It supports compliance with USP , AABB Standards Manual (20th ed.), and EU Directive 2002/98/EC for blood establishment quality systems.

Software & Data Management

No proprietary software installation is required. All operational parameters—including setpoint, actual chamber temperature, agitation status, alarm history, and power-on duration—are accessible via the front-panel LCD interface. Thermal printouts provide traceable, tamper-evident hardcopy logs compliant with FDA 21 CFR Part 11 Annex 11 requirements when used in conjunction with facility-defined SOPs for record retention. Optional RS-232 serial port (available on request) enables integration into centralized BMS platforms for remote monitoring and CSV log export.

Applications

• Hospital transfusion services requiring intermediate-term platelet hold prior to patient-specific release
• Blood bank satellite laboratories performing decentralized platelet issuance
• Cell therapy processing suites storing washed or cryopreserved platelet products during reconstitution
• Clinical trial sites maintaining blinding integrity during blinded platelet administration protocols
• Research laboratories studying platelet adhesion kinetics, granule secretion, or mitochondrial respiration under standardized agitation conditions

FAQ

What is the recommended maximum storage duration for platelets in the LBSW-15?
Per AABB and CLSI guidelines, platelets may be held for up to 4 hours post-thaw at 20–24 °C with continuous agitation. Extended storage beyond this window requires institutional validation and documented risk assessment.
Does the unit support validation documentation (IQ/OQ/PQ)?
Yes—Langbo provides a Factory Acceptance Test (FAT) report, calibration certificates for all sensors, and a template OQ protocol aligned with ISO 13485:2016 Annex A. PQ execution must be performed on-site by qualified personnel using NIST-traceable reference standards.
Can the agitation frequency be adjusted?
No—the 60 cycles/min oscillation rate is fixed and validated to meet regulatory expectations for platelet suspension efficacy without compromising membrane integrity.
Is the interior chamber material compatible with common disinfectants?
Yes—the 304 stainless-steel interior and silicone gasketing resist degradation from 70% ethanol, hydrogen peroxide vapor, and sodium hypochlorite solutions used in routine decontamination protocols.
What maintenance intervals are specified for the Danfoss compressor?
Annual preventive maintenance is recommended, including condenser coil cleaning, refrigerant pressure verification, and UV lamp intensity testing using a calibrated radiometer. Full service logs are retained in the device’s internal memory for 12 months.