The production of sterile, injectable fluids is the foundation of several core areas of our business. For example, saline solutions are critical to our hospital products business and dialysis solutions are used for continuous renal replacement therapy, hemodialysis, and peritoneal dialysis. 

Today, our aqueous solutions are produced and terminally sterilized in large manufacturing facilities. At Baxter, we envision a future where solutions are produced at smaller scale and closer to the point-of-use. To realize this vision, we must ensure that the final solutions delivered to patients are free from endotoxins. 

Bacterial endotoxins are structural parts of gram-negative bacteria cell walls. When released during cell lysis, endotoxins can create a fever-inducing response in humans. All major manufacturing processes prescribe bacterial endotoxin testing (BET) and/or pyrogen testing to ensure pharmaceutical products are safe for use. However, there are challenges with these methods that prevent their use in small-scale manufacturing operations where the end user is less skilled and may even be the patient. These methods are also expensive, labor intensive, and not conducive to point-of-use production.