Division 3 Validated direct measurements as referred to in paragraph 2(d) above shall mean:F1

measuring the reduction of viability/infectivity of: endogenous indicator organisms during the process, where the indicator is:

• consistently present in the raw material in high numbers;

• not less resistant to the lethal aspects of the treatment process, but also not significantly more resistant than the pathogens for which it is being used to monitor;

• relatively easy to quantify, to identify and to confirm; or

using a well-characterised test organism or virus introduced in a suitable test body into the starting material.

If several treatment steps are involved, an assessment must be performed on the degree to which individual titre reduction steps are additive, or whether early steps in the process may compromise the efficacy of subsequent steps;

reporting complete results by

1. (i)

   describing in detail the used methodology;

2. (ii)

   describing the nature of samples which have been analysed;

3. (iii)

   showing that the number of samples analysed is representative;

4. (iv)

   justifying the number of tests performed and the selection of measuring points;

5. (v)

   indicating the sensitivity and the specificity of the detection methods used;

6. (vi)

   providing data on the repeatability and statistical variability of the measurements obtained during the experiments;

7. (vii)

   justifying, if used the significance of prion surrogates;

8. (viii)

   showing, where in absence of direct measurements, models or comparisons with other processes are used, that the factors leading to risk reduction are well known and the model of risk reduction is well established;

9. (ix)

   providing data for the entire process on direct measurements of all factors leading to the risk reduction which demonstrate that these factors are homogenously applied throughout the treated batch.