METHOD FOR THE VERIFICATION OF THE REMOVAL OF VIRUSES TO VALIDATE FILTERS AND FILTERING PROCESSES

摘要

Disclosed is a method for verification of the removal of viruses to validate filters, filtering processes, physical and chemical inactivation processes, or adsorptive removal processes in predefined process conditions that are simulated on a small scale. According to said method, viruses are cultured in suitable cell lines in a first step, a virus suspension is obtained after solubilizing cells in a second step, the virus suspension obtained is added in a third step to a protein solution that is to be analyzed, and the virus-containing protein solution is filtered through the filter that is to be validated, and the removal of viruses is then analyzed in a fourth step. The virus suspension is first processed via a membrane adsorber following step two, the viruses being bonded to the membrane adsorber and contaminants being removed with the aid of a detergent buffer solution, while the bonded, purified viruses are eluted from the membrane adsorber area and are added to the protein solution that is to be analyzed as a concentrated virus suspension in step three.