Testing of buffy coat platelet concentrate pathogen inactivation by Intercept double-dose system in North Estonia Medical Centre´s Blood Centre
The aim of this thesis was to develop a method for production of buffy coat platelet concentrates suitable for use with Intercept platelet processing set with dual-storage containers and to assess the conformity of pathogen inactivated platelet products with the required and recommended quality parameters. The validation of platelet concentrate production using six buffy coats proved the conformity to requirements for platelet content, volume, plasma content, and red blood cell concentration set for platelet concentrates suitable to be processed with Intercept system. After processing with Intercept system, the platelet and white blood cell content were assessed to be appropriate. A little concern was the lower than recommended amount of volume per platelet content in about half of the products, but as those were the units containing about average or higher platelet content and storage analysis showed good platelet recovery and normal pH values at the end of shelf-life, the overall results for volume were also considered to be acceptable. Both the platelet concentrate production and Intercept treatment process were evaluated to be efficient in terms of platelet recovery.