Validation of the Blood Product Transportation Process with a Stable Temperature of 2-10ºC

Abstract

Introduction: Blood and blood products play an essential role in health care. Availability, security, and easy access to blood and blood products must be guaranteed. The quality of blood and blood components depends on the starting materials, packaging materials, processing, quality control systems, premises, equipment, and facilities used, and personnel involved, including the cool box's internal temperature. This study aimed to evaluate the validation of the blood product transport process with a stable temperature of 2-10ºC.

Methods: This semi-experimental descriptive study was conducted from 12 October to 28 December 2021 at the Blood Donation Unit, Indonesian Red Cross, Bandung City, and affiliated hospitals. Blood products were transported using cold boxes with ice packs, tested under varying distances and capacities, each repeated three times. Temperatures were recorded and compared against the 2–10°C regulatory standard. Validation included documentation, measurement, and reporting, with data analyzed descriptively.

Results: Based on data collection and analysis, all sample temperature measurements remained within the acceptable range of 2–10°C across all test configurations. The lowest recorded temperature was 3.8°C, and the highest was 6.3°C. These values were obtained across both minimum and maximum capacity settings, and during transport to both near and far destinations. Ambient room temperatures during testing ranged from 22.8°C to 28.0°C.

Conclusion: The temperature remained within the acceptable standard. Therefore, the validation of the blood product transportation process with a stable temperature of 2–10ºC was deemed valid.