Assessing the inactivation capabilities of two commercially available platelet component pathogen inactivation systems: effectiveness at end of shelf life.

Background And Objectives: The inactivation capabilities of the two current commercially available pathogen inactivation (PI) systems for platelet components (PC), Mirasol and Intercept, were investigated by determination of the absence of viable bacteria at the end of shelf life by testing the entire contents of the PC by enrichment culture (terminal sterility).

Methods: A pool-and-split method was used, with two treated units and one untreated control per inoculum concentration. Pairs of PC bags were inoculated with a single bacterial species. Three concentrations (n = 2 per concentration), which incremented tenfold, were tested initially based on published data from the manufacturer. Dependent on these results, the concentrations subsequently tested were either increased or decreased until the inactivation capability of the system was derived. Bacterial count was determined post-spiking, immediately prior to treatment (2 h from spiking), immediately after treatment and at the end of shelf life (day seven). Enrichment culture was performed immediately prior to treatment, after treatment and at the end of shelf life.

Results: The inactivation capabilities, in CFU/ml, of Intercept and Mirasol, respectively, at the end of PC shelf life were as follows: Staphylococcus aureus ≥ 10 , <10 ; Staphylococcus epidermidis ≥10 , <10 ; Klebsiella pneumoniae 10 , <10 ; Streptococcus bovis ≥10 , 10 , Escherichia coli ≥10 , <10 ; Streptococcus pneumoniae ≥10 , 10 ; Streptococcus mitis ≥10 , 10 ; Listeria monocytogenes ≥10 , 10 ; Streptococcus dysgalactiae ≥10 , <10 ; Serratia marcescens 10 , <10 ; Pseudomonas aeruginosa 10 , Mirasol not tested; and Bacillus cereus < 10 , Mirasol not tested.

Conclusion: The inactivation capability of Intercept was greater than that of Mirasol. Inactivation capability (by terminal sterility) is the most meaningful measure to evaluate a PI system for bacteria, rather than logarithmic reduction assessed immediately after treatment by plate count. PI offers a possible alternative to bacterial screening if treatment is performed at an appropriate time dependent on the inactivation capabilities of the system.