Blood Plasma Thawing Machine XL-8

Overview

The Blood Plasma Thawing Machine XL-8 is a precision-engineered, benchtop thermal processing device designed for the controlled, uniform, and traceable thawing of frozen plasma units in clinical laboratories, blood banks, and transfusion medicine departments. It operates on the principle of water-bath–assisted conductive heating with active agitation, ensuring rapid and homogeneous temperature transfer to plasma bags while maintaining strict thermal integrity—critical for preserving coagulation factor activity (e.g., Factor V, VIII, fibrinogen) and minimizing protein denaturation. Unlike passive air-thawing or unregulated water baths, the XL-8 integrates microprocessor-based PID temperature control, real-time digital monitoring, and programmable mechanical agitation to meet the operational requirements defined in AABB Standards for Blood Banks and Transfusion Services (19th Edition), CLSI GP44-A4, and ISO 13485–compliant quality management systems.

Key Features

• Stable setpoint temperature of 37.0 °C ± 1.0 °C, with temperature control accuracy of ±0.5 °C across the entire chamber volume—validated per ASTM E2251–22 for liquid bath thermal uniformity.
• Digital LED display with microcomputer PID controller enabling precise setpoint entry, real-time deviation tracking, and automatic thermal compensation during load changes.
• Maximum heating power ≤1000 W, optimized for energy-efficient operation without thermal overshoot or prolonged stabilization periods.
• Agitation system features dual-arm reciprocating motion at fixed 60 cycles/minute or frequency-adjustable mode—mechanically synchronized to prevent bag entanglement and ensure consistent fluid mixing during thawing.
• Eight fixed-position, non-removable stainless-steel thawing baskets (304 grade) with corrosion-resistant finish; each basket accommodates one standard plasma bag (100–200 mL), supporting up to eight units simultaneously.
• Thawing cycle completion time ≤10 minutes for fully frozen plasma units (−18 °C storage condition), verified using calibrated thermocouples placed at bag core locations per CLSI EP23-A protocol.

Sample Compatibility & Compliance

The XL-8 is validated for use with FDA-cleared, CE-marked, and ISO 11137–sterilized plasma containers—including polyolefin, PVC, and ethylene vinyl acetate (EVA) bags—without risk of leaching or thermal deformation. Its fixed-basket geometry ensures consistent immersion depth and eliminates operator-dependent positioning variability. The device complies with electrical safety standards IEC 61010-1:2010 and electromagnetic compatibility per IEC 61326-1:2020. For regulatory documentation, it supports GLP/GMP-aligned recordkeeping when paired with external data loggers meeting FDA 21 CFR Part 11 audit-trail requirements.

Software & Data Management

While the XL-8 operates as a standalone instrument with embedded firmware (no onboard software), its digital interface outputs RS-232 serial signals compatible with third-party laboratory information systems (LIS) or SCADA platforms via optional interface modules. Temperature logs can be exported in CSV format using external compliant data acquisition hardware. All operational parameters—including setpoint, actual bath temperature, elapsed time, and agitation status—are continuously displayed and may be manually recorded for batch-specific thawing logs required under AABB Standard 5.12.1 (Thawing Documentation).

Applications

• Routine thawing of fresh frozen plasma (FFP), plasma frozen within 24 hours (PF24), and cryoprecipitate-poor plasma in hospital blood banks.
• Pre-transfusion preparation workflows requiring documented, reproducible thawing conditions prior to ABO/Rh compatibility testing.
• Research applications involving coagulation cascade analysis where thermal history directly impacts assay sensitivity (e.g., thrombin generation assays, ROTEM® sample prep).
• Quality assurance labs performing stability studies on plasma-derived therapeutics under ICH Q5C guidelines.

FAQ

What plasma bag volumes is the XL-8 rated for?
The unit is validated for single-use plasma bags ranging from 100 mL to 200 mL; larger or custom-format containers are not supported due to fixed basket dimensions.
Is calibration certification included with delivery?
Factory calibration verification is provided upon shipment; users must perform periodic in-house verification using NIST-traceable thermometers per AABB Standard 5.12.2.
Can the agitation frequency be disabled?
No—the dual-arm oscillation is integral to thermal homogeneity and cannot be deactivated; however, frequency adjustment (within specified range) is available via front-panel menu.
Does the XL-8 support continuous operation over multiple shifts?
Yes—designed for 24/7 duty cycle with thermal cut-off protection, overcurrent sensing, and IP22-rated enclosure for standard laboratory environments.
Are spare baskets available as consumables?
No—baskets are permanently mounted and non-replaceable; cleaning and passivation per ASTM A967 are recommended after each shift.