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 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 microorganisms. 

Industry best practice prescribes microbial testing for bacteria, yeast, and mold to ensure that pharmaceutical products are safe for use. However, traditional microbial measurement techniques present challenges in locations without well-equipped laboratories, such as small-scale manufacturing facilities or in the patient’s home. For example, traditional culture methods can take several days to weeks to incubate and grow microbial samples in petri dishes before laboratories can visually analyze the results. Biotechnological approaches, such as polymerase chain reaction (PCR), fluorescence analysis, and traditional enzyme-linked immunoassay (ELISA), are also costly and require special laboratory equipment along with trained operators.