An investigation was initiated in order to know whether these shortcomings were donor or process/instrument related. A link was established between the raw material (donor), the process/instrument and the final product, and a new tool was introduced by the study of the LRS chamber. The LRS chamber content was assessed and the PLT cellular indices and PLT aggregation states compared with those obtained from the respective donor and the final product from the same origin. The storage stability of the final products was also analyzed based on these same tests to investigate if the initial low MPV had any deleterious effect during the shelf life of the components.
Twenty five plateletpheresis donors, three of them new ones, were randomly selected for this study. For the first time, the content of the LRS chamber was used as a quality tool for identification of the cause of unexpected yields. Large aggregates remained in the LRS chamber in certain donors who were prone to undergo spontaneous aggregation, making the platelet yields low and platelet MPV very small. Based on repeated failures and on this new quality parameter showing LRS chamber abnormality, two donors were temporarily deferred from the panel. While it was not possible to identify the causes, it is appropriate to raise the question whether these profiles were Trima version 4 specific or not. Hence, further investigation is needed for a better clarification. In short, the simultaneous analysis of products and LRS content provided useful information not only for the characterization of donor-related phenomena but also helped in the identification of potential shortcomings in the machine performance allowing for remedial action to be taken on evidence based data.