Patent ID: 8389208

Claim:
A method for validating a treatment process for reducing the amount or activity of a contaminating biological agent in a sample, comprising: (i) exposing an indicator and the contaminating biological agent to the treatment process, wherein the indicator is a thermostable kinase, the contaminating biological agent comprises at least one member selected from the group consisting of bacteria, viruses, spores, proteins, peptides and prions, and the treatment process comprises an exposure to at least one member selected from the group consisting of pH, temperature, pressure, enzyme, detergent, chemical sterilant, gas-phase sterilant, and high-temperature autoclaving with steam; (ii) measuring residual kinase activity of the thermostable kinase after the treatment; and (iii) comparing said residual kinase activity of the thermostable kinase to the kinase activity of the thermostable kinase before the treatment; wherein a reduction in the kinase activity of the thermostable kinase after the treatment, as compared to the kinase activity of the thermostable kinase before the treatment, can be correlated with a reduction in the amount or activity of the contaminating biological agent.