I. Vasilenko, Pavel Romanovich Kozin, Yu. V. Krasnova
{"title":"Development of a procedure for sterilizing filtration validation","authors":"I. Vasilenko, Pavel Romanovich Kozin, Yu. V. Krasnova","doi":"10.33920/med-13-2204-01","DOIUrl":null,"url":null,"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.","PeriodicalId":12259,"journal":{"name":"Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology)","volume":"43 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.33920/med-13-2204-01","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
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.