AAMI ISO 23500-4:2019 pdf download – Preparation and quality management of fluids for haemodialysis and related therapies
4.1.1.1 Liquid solute concentrations
All electrolytes identified on the label shall be present within ± 5 % or ± 0,1 mEq/l (expressed as dialysis fluid concentrations), whichever is greater, of the stated concentration, with the exception of sodium, which shall be present within ± 2,5 % of the labelled concentration or shall be present according to approved specifications by the local regulations. If used, glucose shall be present within ± 5 % or ± 0,05 g/l (when measured as properly diluted dialysis fluid), whichever is greater, of the labelled concentration, or shall be present according to approved specifications by the local regulations. Where concentrates include non-traditional constituents, such as antioxidants and iron compounds, these constituents shall be present at nominal concentrations with ± 5 % tolerances or shall be present according to approved specifications by the local regulations. If alternate, locally approved tolerances are used, the tolerances shall be similarly stated and the rationale for their use documented. Most concentrates are manufactured with standard traditional chemicals such as sodium chloride, potassium chloride, magnesium chloride, calcium chloride, acetic acid, and glucose. New concentrates are available which include additional chemicals or in which certain chemicals have been substituted by others; for example, citric acid has been substituted for acetic acid. Where this occurs, the labelling shall correctly reflect this and the substitute chemicals shall be present at nominal concentrations with ± 5 % tolerances, or shall be present according to approved specifications by the local regulations. If alternate, locally approved tolerances are used, the tolerances shall be similarly stated and the rationale for their use documented.
4.1.3.2 Bacteriology of bicarbonate concentrates
Concentrate containing bicarbonate supplied as a liquid shall be provided in a sealed container and manufactured by a process validated to produce dialysis fluid meeting the microbiological requirements of ISO 23500-5, when used according to the manufacturer’s instructions. Bicarbonate powder intended for the preparation of concentrate at a dialysis facility shall be capable of producing dialysis fluid meeting the microbiological requirements of ISO 23500-5, when used according to the manufacturer’s instructions.
4.1.4 Endotoxin levels
The concentrate shall be formulated and packaged using a process validated to produce dialysis fluid meeting the endotoxin requirements of ISO 23500-5 or the applicable pharmacopoeia when used according to the manufacturer’s instructions.
4.1.5 Fill quantity
The excess fill volume of liquid containers and the excess fill weight of powder containers used with batch systems for a single dialysis treatment shall be within 2 % of the labelled volume or weight. The fill weight of bulk delivered powdered concentrate shall be such that, when mixed according to the manufacturer’s instructions, it produces liquid concentrate that meets the requirements of 4.1.1.1. The fill weight of a concentrate generator shall be such that the device performs as intended. For all other applications, the fill volume or weight shall be ≥ 100 % of the stated volume or weight.
4.1.6 Chemical grade
All chemicals shall meet the requirements of the applicable pharmacopoeia, including all applicable portions of the general notices and of the general requirements for tests and assay. If all other requirements are met, monograph limits for sodium, potassium, calcium, magnesium, and/or pH can be exceeded provided that correction is made, if necessary, for the presence of those ions in the final formulation. Also, any pharmacopoeia requirements that the chemicals be labelled for use in haemodialysis need not be complied with if the manufacturer is performing its own testing to meet the requirements of the applicable pharmacopoeia.