Dialysis solutions water quality

Because irrigations are used in or on body areas that are usually sterile or have a low degree of contaminatiOTi, there are strict requirements for their production and quality control. In this chapter the use, the design of formulation and preparation method as well as the on site preparation of irrigations will be discussed. With regard to solutions for various types of dialysis, the use of concentrates, the water quality and the requirements for bacterial endotoxins are fully discussed. 

However, the limit should be even lower a patient receives 60 L of water per dialysis treatment. A treatment lasts for 3 h. That means an intravenous administration of 20 L in 1 h. According to the Ph. Eur. the allowed maximum amount of bacterial endotoxins for parenteral use is 5 lU per kg bodyweight in 1 h. This means for a 60 kg patient that 300 lU bacterial endotoxins are allowed to be present in 20 L resulting in a requirement of <0.015 lU/mL. At this moment the assay technique allows an endotoxin limit of 0.025 lU/ mL to be detected and present water treatment units are able to produce water of this quality. This topic and other requirements are under discussion within the Ph. Eur. committee on dialysis solutions. 

Quality requirements for concentrates for dialysis, the water for dilution and solutions for haemo(dia)filtration are to be found in the Ph. Eur. and in ISO 13959 2009 [6]. Quality requirements for concentrated solutions for haemo(dia) filtration and water to dilute them, are not yet defined in the Ph. Eur. 

Irrigations have various uses, and therefore various users. Not only the one who prepares and dispenses them should know their purpose, but also the patient or the professional caregiver. Solutions for the different types of dialysis form a separate category. Surveillance and monitoring of the whole process, but especially the quality management of the installation for the production of water for the dilution of concentrated solutions, are often more difficult than the preparation of the concentrates themselves. 

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