In vivo recovery and in vitro quality assessment of apheresis red blood cells stored for 42 days in non-DEHP disposable sets.

BACKGROUND AND

objectivesDi(2-ethylhexyl) phthalate (DEHP) has been used in blood bag manufacturing for decades, but concern about its potential toxicity has prompted regulatory efforts to eliminate it from medical devices, including blood bags. As manufacturers transition to non-DEHP materials, evaluation is required to ensure blood component quality in modified bag systems. Investigational Trima Accel disposables were developed using plasticizers approved as DEHP alternatives per the European Pharmacopoeia. Red blood cells (RBCs) were collected, and two consecutive studies evaluated in vitro quality and in vivo RBC recovery. STUDY DESIGN AND

methodsLeukoreduced RBCs (LR-RBCs) were stored in Additive Solution 3 (AS-3) at 2-6°C for 42 days. In vitro quality parameters measured on days 0, 35 and/or 42 were assessed against US Food and Drug Administration (FDA) and European Directorate for the Quality of Medicines & HealthCare (EDQM) acceptance criteria. A radiolabelling study evaluated in vivo 24-h RBC recovery using the FDA criteria.

resultsKey FDA criteria were met, including haemolysis, which remained below the acceptable limit throughout 42 days of storage. All EDQM criteria were met except Day 0 haematocrit, with 8 units outside the specified range and the confidence interval (CI) lower bound at 77.6%. All FDA criteria for in vivo 24-h RBC recovery were met.

conclusionApheresis LR-RBCs collected with Trima Accel systems using non-DEHP disposables and stored for 42 days met key FDA and EDQM criteria, with any in vitro parameter failures considered artefactual. Products also met FDA's 24-h in vivo RBC recovery criteria, supporting their use as acceptable transfusable products.