Ashish Kushwaha,
Ritik Srivastava,
Arun K. Maurya,
Lalit Bisht,
Arvind Negi,
Lalita Kumari,
Shipra Omar,
Abhishek Chauhan,
- Assistant Professor, Department of Pharmacology, JBIT College of Pharmacy, Dehradun,, Uttarakhand,, India
- Assistant Professor, Department of Pharmacology, JBIT College of Pharmacy, Dehradun, Uttarakhand, India
- Professor, Department of Pharmaceutical Chemistry, JBIT College of Pharmacy, Dehradun, Uttarakhand, India
- Professor, Department of Pharmaceutics, JBIT College of Pharmacy, Dehradun, Uttarakhand, India
- Professor, Department of Pharmacognosy, JBIT College of Pharmacy, Dehradun, Uttarakhand, India
- Assistant Professor, Department of Pharmaceutical Chemistry, JBIT College of Pharmacy, Dehradun, Uttarakhand, India
- Assistant Professor, Department of Pharmacy Practice, School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun, Uttarakhand, India
- Assistant Professor, Department of Pharmacognosy, Subharti Institute of Pharmacy, Dehradun, Uttarakhand, India
Abstract
Ensuring the safety and quality of transfusion products is a cornerstone of transfusion medicine. The presence of leucocytes in blood components can lead to adverse reactions and increase the likelihood of transfusion-related complications, highlighting the importance of minimizing their content prior to transfusion. Elevated leucocyte levels have been detected in unfiltered fresh frozen plasma (FFP) units prepared from whole blood processed after a short holding time (SHT) – the interval between blood collection and component separation. Protein concentration, another crucial indicator of plasma quality, must also be maintained within acceptable limits. In this study, 100 non-filtered FFP units processed after SHT were compared with 100 units processed following an overnight, long holding time (LHT). Unit volumes, residual leucocyte counts (RLC), and protein concentrations (PC) were measured and statistically analysed. Results demonstrated that longer holding times were associated with significantly lower RLC and higher PC. Statistical process control (SPC) analysis revealed that the SHT process was borderline to incapable of maintaining consistent product quality, even after outlier adjustments. These findings indicate that shorter holding times may compromise plasma uniformity and quality. Therefore, revising the minimum holding time is advisable to achieve optimal leucocyte reduction and protein preservation in FFP.
Keywords: Fresh frozen plasma, holding time, residual leucocytes, plasma proteins, leukoreduction, transfusion safety
[This article belongs to International Journal of Antibiotics ]
References
1. European Directorate for the Quality of Medicines & HealthCare (EDQM). Guide to the preparation, use and quality assurance of blood components. 21st ed. Strasbourg: Council of Europe; 2023. Available from: https://www.edqm.eu/en/web/edqm/blood-guide 2. Yousif D, Sammut M, Zammit V. Holding time optimisation in fresh frozen plasma: A critical factor worth investigating. Int Blood Res Rev. 2025;16(4):1–10. doi: 10.9734/ibrr/2025/v16i3364. 3. Serrano K, Scammell K, Weiss S, Culibrk B, Levin E, Gyöngyössy-Issa M, et al. Plasma and cryoprecipitate manufactured from whole blood held overnight at room temperature meet quality standards. Transfusion. 2010;50(2):344–353. doi: 10.1111/j.1537-2995.2009.02441.x. 4. Cardigan R, Van der Meer PF, Pergande C, Cookson P, Baumann-Baretti B, Cancelas JA, et al. Coagulation factor content of plasma produced from whole blood stored for 24 hours at ambient temperature: Results from an international multicenter BEST Collaborative study. Transfusion. 2011;51 Suppl 1:50S–57S. doi: 10.1111/j.1537-2995.2010.02963.x. 5. Moroff G, AuBuchon JP, Pickard C, Whitley PH, Heaton WA, Holme S. Evaluation of the properties of components prepared and stored after holding of whole blood units for 8 and 24 hours at ambient temperature. Transfusion. 2011;51 Suppl 1:7S–14S. doi: 10.1111/j.1537-2995.2010.02958.x. 6. Thibault L, Beauséjour A, de Grandmont MJ, Lemieux R, Leblanc JF. Characterization of blood components prepared from whole-blood donations after a 24-hour hold with the platelet-rich plasma method. Transfusion. 2006;46(8):1292–1299. doi: 10.1111/j.1537-2995.2006.00894.x. 7. Beckman N, Nightingale MJ, Pamphilon D. Practical guidelines for applying statistical process control to blood component production. Transfus Med. 2009;19(6):329–339. doi: 10.1111/j.1365-3148.2009.00942.x. 8. van der Meer PF, de Korte D. The effect of holding times of whole blood and its components during processing on in vitro and in vivo quality. Transfus Med Rev. 2015;29(1):24–34. doi: 10.1016/j.tmrv.2014.10.001.9. Lu FQ, Kang W, Peng Y, Wang WM. Characterization of blood components separated from donated whole blood after an overnight holding at room temperature with the buffy coat method. Transfusion. 2011;51(10):2199–2207. doi: 10.1111/j.1537-2995.2011.03137.x. 10. Alhumaidan H, Cheves T, Holme S, Sweeney J. Stability of coagulation factors in plasma prepared after a 24-hour room temperature hold. Transfusion. 2010;50(9):1934–1942. doi: 10.1111/j.1537-2995.2010.02648.x. 11. Dogra M, Sidhu M, Vasudev R, Dogra A. Comparative analysis of activity of coagulation factors V and VIII and level of fibrinogen in fresh frozen plasma and frozen plasma. Asian J Transfus Sci. 2015;9(1):6–8. doi: 10.4103/0973-6247.150936. 12. Kretzschmar E, Kruse F, Greiss O, Paunovic D, Kallweit T, Trobisch H. Effects of extended storage of whole blood before leucocyte depletion on coagulation factors in plasma. Vox Sang. 2004;87(3):156–164. doi: 10.1111/j.1423-0410.2004.00563.x. 13. van der Meer PF, de Wildt-Eggen J. The effect of whole-blood storage time on the number of white cells and platelets in whole blood and in white cell-reduced red cells. Transfusion. 2006;46(4):589–594. doi: 10.1111/j.1537-2995.2006.00778.x. 14. Thomas S. Ambient overnight hold of whole blood prior to the manufacture of blood components. Transfus Med. 2010;20(6):361–368. doi: 10.1111/j.1365-3148.2010.01025.x. 15. Gaudard M, Boissier E, Talon L, Douxfils J, Sapin AF, Sinegre T, et al. Stability of coagulation parameters in plasma samples at room temperature after one freeze/thaw cycle. Int J Lab Hematol. 2022;44(3):610–618. doi: 10.1111/ijlh.13794.

International Journal of Antibiotics
| Volume | 03 | |
| Issue | 02 | |
| Received | 08/04/2026 | |
| Accepted | 11/04/2026 | |
| Published | 21/04/2026 | |
| Publication Time | 13 Days |