Approaches to the organization of water quality control for pharmaceutical purposes in the field

The article discusses the materials for quality control of water for pharmaceutical use (purified water and water for injection), obtained using a sterilization-distillation unit SDP-4. Data on the categorization of water for pharmaceutical use in domestic and foreign practice are given. A comparative assessment of the requirements for water quality showed that there are significant differences in the list of quality indicators, in the norms and methods for their determination. The problem of assessing the quality of water obtained with the help of SDP-4 in the field has been scientifically justified, and two points of control are provided. Microbial contamination has been shown to be the greatest risk to pharmaceutical water quality. In the SDP-4 design, this risk is minimized. The control measures carried out in accordance with their stages, together guarantee the proper level of determination of the quality of the water received. In the process of testing SDP-4 prototypes, it was confirmed that the quality of the obtained purified water met the requirements of the pharmacopoeial article FS.2.2.0020.18 and water for injection – the requirements of FS.2.2.0019.18.