Product D-Value Study - Part 2, Heat-Sensitive & Atypical Aqueous Liquids

By Laurent Berliet and Silvia Rizzi

For heat-sensitive products and low F0 cycles, the Biological Indicator-Bioburden method is preferred with the possibility of using liquid submersible biological indicators (BIs) such as MagnaAmp or SterilAmp inoculated with a lower population (10⁴) of Geobacillus stearothermophilus, or SterilAmp inoculated with Bacillus subtilis 5230.

When the characteristics of the product may be degraded by the overkill sterilization processes, time and temperature parameters must be reassessed so as not to affect the quality of the product.

In these cases, the validation approach is based on the Biological Indicator-Bioburden method.