Validation of the Cold Chain Product (CCP) delivery process for whole blood
Main Article Content
Keywords
Cold chain product, cool box, design validation, operational validation, performance validation
Abstract
Background: Donor blood is obtained through mobile blood donation activities and fixed Blood Transfusion Units in Jakarta Province and subsequently transported to the Blood Processing Unit using insulated containers (cool boxes). Maintaining an uninterrupted cold chain during transportation is essential to preserving blood quality. One critical factor influencing temperature stability is the proportion between blood bags and ice packs within the transport container. This study aimed to validate the Whole Blood Cold Chain Product (CCP) transportation process by determining an optimal blood bag–to–ice pack ratio capable of maintaining the required temperature range during delivery.
Methods: Validation was performed sequentially through three stages: design validation, operational validation, and performance validation. Each stage was evaluated against predefined acceptance criteria, with validation outcomes determined by comparing observed results to these criteria before proceeding to subsequent stages.
Results: Design validation confirmed that the cool box and ice pack specifications met established acceptance requirements. During operational validation, dummy blood bags were arranged with varying numbers of ice packs and exposed to three different ambient temperature conditions. Temperature measurements from the dummy bags consistently fulfilled acceptance criteria. Performance validation, conducted using actual Whole Blood units under two ambient temperature conditions, demonstrated that blood bag temperatures remained within the acceptable range when packed according to validated ratios.
Conclusion: The study confirms that specific packing configurations and ratios of blood bags to ice packs can be effectively applied to ensure controlled and reliable transportation of Whole Blood Cold Chain Products.
References
2. Hughey SB, Kotler J, Brust A, Cole JH, Itani Y, Hughey A, et al. Rethinking the Operational Blood Bank Dilemma: Out of the "Box" Blood Storage and Transportation Evaluation. J Spec Oper Med. 2025;24(4):13-16. doi:10.55460/EQ0D-4Y6W.
3. Sharley PH, Williams I, Hague S. Blood transportation for medical retrieval services. Air Med J. 2003;22(6):24-27. doi:10.1016/j.amj.2003.08.006.
4. Pramudita JJ, Widjanarko B, Munadi M, Suwondo A. Analysis of temperature effect in cooler box toward blood quality during the transportation process. Bull Natl Inst Health Sci. 2022;140(9):3131–3142.
5. World Health Organization. The blood cold chain: guide to the selection and procurement of equipment and accessories. Geneva: World Health Organization; 2002.
6. Gayathri BP, Kamaraj R. Pharmaceutical Inspection Co-operation Scheme: An Overview. Cureus. 2024;16(9):e69043. doi:10.7759/cureus.69043.
7. Hess JR. Red cell storage. J Proteomics. 2010;73(3):368-373. doi:10.1016/j.jprot.2009.11.005.
8. Tinmouth A, Fergusson D, Yee IC, Hébert PC; ABLE Investigators; Canadian Critical Care Trials Group. Clinical consequences of red cell storage in the critically ill. Transfusion. 2006;46(11):2014-2027. doi:10.1111/j.1537-2995.2006.01026.x.
9. Hardwick J. Blood storage and transportation. ISBT Sci Ser. 2020;15(Suppl 1):232–254. doi:10.1111/voxs.12599.
10. Zeenat A, Navindhra N, Thomas F, Jeanine M, Jelili B, Dirk B. A pilot experimental study of cold-chain management, haemolysis and oxidative stress of packed red blood cells in early blood transfusion: toward a blood viability model in the out-of-hospital setting. Sci Rep. 2025;15(1):35613. doi:10.1038/s41598-025-18923-w.
11. Thiele T, Steil L, Völker U, Greinacher A. Proteomics of blood-based therapeutics: a promising tool for quality assurance in transfusion medicine. BioDrugs. 2007;21(3):179-193. doi:10.2165/00063030-200721030-00005.
12. Alghamdi SY. A Review of Blood Delivery for Sustainable Supply Chain Management (BSCM). Sustainability. 2023;15(3):2757. doi:10.3390/su15032757
13. Tissot JD, Bardyn M, Sonego G, Abonnenc M, Prudent M. The storage lesions: From past to future. Transfus Clin Biol. 2017;24(3):277-284. doi:10.1016/j.tracli.2017.05.012.
14. Sowemimo-Coker SO. Red blood cell hemolysis during processing. Transfus Med Rev. 2002;16(1):46-60. doi:10.1053/tmrv.2002.29404.
15. Luten M, Roerdinkholder-Stoelwinder B, Schaap NP, de Grip WJ, Bos HJ, Bosman GJ. Survival of red blood cells after transfusion: a comparison between red cells concentrates of different storage periods. Transfusion. 2008;48(7):1478-1485. doi:10.1111/j.1537-2995.2008.01734.x.