Evaluation of the Endosafe(R) Portable Testing SystemTM for the Rapid Analysis of Biopharmaceutical Samples.

The Endosafe® Portable Testing System™ (PTS™) portable system for endotoxin testing was evaluated to analyze biopharmaceutical samples such as raw materials and finished products. The installation, operational, and performance qualification procedures were successfully implemented and verified to determine the system functionality under good manufacturing practices. During the validation stages the PTS™ was compared to the gel-clot test method in terms of presence or absence of endotoxin substances, ease of use, completion time, resource optimization, and sample volume. Water for injection and product samples were analyzed with both methods. All water for injection and product samples were negative for the presence of endotoxin by both methods. However, PTS™ results were obtained after 15 min while the gel-clot completion time was 1 h. Miniaturization of endotoxin testing by the PTS™ allowed optimization of testing procedures by reducing sample volume, analyst manipulations, accessory materials, and turnover time, and by minimizing the risk of exogenous contamination of the reaction.