The cell wall components of gram-negative bacteria, such as E. coli and Pseudomonads, are designated as endotoxins. They have a hydrophilic polysaccharide and a lipophilic lipid component and, unlike the bacteria from which they originate, are highly heat and pH-stable. Endotoxins are pyrogens (i.e., they can cause fever if they come in contact with mucous membranes or enter the bloodstream). According to the prevalent
pharmacopeias, the defined limit values for endotoxin content may not be exceeded during the manufacturing process of pharmaceuticals. In mammalian cell cultures that are used to produce biopharmaceuticals, such as immunoglobulins, the presence of endotoxins can lead to cell death. For this reason, ultrapure media (i.e., ultrapure water, with levels proven to be below the limits) must be used to manufacture biopharmaceuticals or to propagate cell lines or cell cultures. The objective of this study is to demonstrate that the ultrapure water produced by the arium pro VF system exhibits an endotoxin content that is far below the prescribed limits and that can be used for the applications mentioned above.