Improving materials and methods for storage of blood components

Project leader: Dirk de Korte PhD

The blood bank is a producer of blood products under Good Manufacturing Practice (GMP) conditions and needs to know the limits of the methods in use, for example with respect to temperature effects during collection and preparation. Some studies in this field were performed in 2011. Another aspect of this research line is the quality of blood components in relation to the use of alternative plasticizers for blood bag foils.

Storage of whole blood at +18°C or +25°C and the effect on blood component quality
Based on European Directives, the storage temperature for whole blood (WB) is +20°C to +24°C. In the blood bank, room temperature mostly varies between +18°C and +25°C. It was investigated whether the quality of blood components was affected by initial storage for 24 h (maximal allowed time until component preparation) at +18°C or +25°C (worst case scenario). For this study, after collection under standard conditions, two series of WB were placed in a climate cabinet for 24 h, one series at +18°C and one series at +25°C. After 24 h the WB was processed into white blood cell (WBC)-reduced red blood cells (RBCs), buffy coat (BC), and plasma. The BCs were further processed into platelet concentrates (PCs) derived from a single BC. Only minimal differences were found for the WB stored under different conditions and for the various components prepared from this WB, which were subsequently stored under standard conditions. It was concluded that the current limits should be maintained, but that deviations during the first 24 h of storage within the range +18°C to +25°C would be acceptable.

Use of DEHP-free blood bags for collection and storage of blood products
The plasticizer di(2-ethylhexyl)-phthalate (DEHP) is a common component in medical plastics. DEHP is non-covalently bound to the PVC polymer and can leach from PVC devices when the surface comes into contact with fluids. There are concerns that exposure to phthalates might induce developmental and reproductive toxicity. In blood collection systems DEHP is also often used as a plasticizer. Fresenius HemoCare Netherlands BV has developed a whole blood collection system of which all components are made of non-DEHP PVC. In these systems, the tubings and bags were made from DINCH (Hexamoll diisononyl-1,2-cyclohexane dicarbonic acid, BASF Corp., Germany) plasticized PVC.

The in vitro quality of plasma and red blood cell concentrates, collected and stored in a DINCH system was compared to products in the conventional DEHP-containing system. 
Whole blood (500 ml ± 10%) was collected into DEHP-PVC (n=37) and DINCH-PVC (n=38) collection systems. After overnight hold, WB was centrifuged and separated into plasma, buffy coat and RBCs. Plasma was assayed for coagulation and activation markers. After the addition of additive solution, SAG-M or PAGGS-M, the RBCs were leukodepleted and stored at 2-6°C for 42 days. A panel of in vitro red cell characteristics was determined during storage. DEHP and DINCH levels were determined at the beginning and end of the storage period.

The complete absence of DEHP in the collection system has no effect on WB processing and plasma coagulation characteristics. During storage of RBCs in SAGM, the absence of DEHP resulted in increased cell swelling and hemolysis, but all other parameters showed similar changes. With alternative additive solutions, like PAGGSM, the absence of DEHP had much less detrimental effects on cell swelling and red cell stability. Leakage of DINCH into the blood product during storage was much less pronounced than that of DEHP.

Key publications

Last edited on: 2 October 2012