Development of a procedure for sterilizing filtration validation

Abstract

Validation of sterilizing filtration is extremely difficult in the realities of a working production. To prevent the negative impact of sterilizing filtration validation on the quality of the environment, a model of the process has been developed in the laboratory. On the basis of the developed model, validation tests were carried out to the extent that allows assessing the stability and reproducibility of the process. The obtained results showed the suitability of the process of sterilizing filtration of sodium luminol, as part of the process of aseptic production of the medicinal product.