Liofilchem performs D-Value and Z-Value analysis by direct inoculation of product or equipment using Biological Indicator Organisms (BI’s).
D-values are stated by the manufacturer on the Biological indicator but often require verification for a higher degree of accuracy and process specificity. The Pharmacopoeias and ISO11138 stress on the importance of D-value verification to ensure the accuracy of a stated manufacturer D-value.
Our Biological Indicator Evaluation Resistometer (BIER) Vessel autoclave verifies the D-value by accurately delivering a calibrated and pre-determined level of lethality.
The log reduction achieved for exposure time is assessed through the exposure of the BI for defined time points and interpretation via fractional analysis. This process allows the accurate verification of the manufacturer’s stated D-value.