(P-IG-38) The Influence of a DEHP Primary Container on AS-1 Red Blood Cells (RBCs) Under Two Different Storage Conditions

Whole blood units (CPD anticoagulant) were collected into FDA approved BPUs (DEHP plasticizer), then transferred to a DEHP-free pooling container within 15 minutes of collection to minimize contamination from the collection process. Blood was then split evenly into the primary container of two types of BPUs, where this container was plasticized either with BTHC or DEHP, and the remaining BPU components were non-DEHP except for molded parts in the top seal. The whole blood pairs were processed into leukoreduced AS-1 red cells following a hold time of either < 8 hours at ambient (N=10) or 3-day cold storage (N=10).  AS-1 RBCs were then stored at 1-6°C for 42 days, with analysis conducted on Day 0/3 and Day 42 for DEHP measurements and %hemolysis. 

Results/Findings:

On Day 42, ambient units held in a BPU with a BTHC primary container exhibited a DEHP concentration of 0.5 ppm and 0.33% hemolysis, compared to DEHP primary container units which resulted in 8.4 ppm DEHP and a lower hemolysis of 0.27% (p=0.000 and p=0.002, respectively). A similar pattern was observed in BTHC primary container cold-hold units, which had 0.48% hemolysis and a DEHP concentration of 0.3 ppm, compared to DEHP primary container units where the DEHP concentration was 7.0 ppm and 0.40% hemolysis on Day 42 (p= 0.000 and p=0.064, respectively). Regardless of hold/processing condition, similar DEHP concentrations were observed for the same primary container types.

Conclusions:

Use of a primary container with DEHP results in some red cell quality differences at end of storage as compared to a DEHP-free primary container. Hold and processing conditions did not affect the DEHP content in the stored product.