AOAC ERP Gluten Assays - Dec 2018

Annex B

4.1.5

Accelerated Stability Study

Three independent lots of RIDASCREEN ® Total Gluten were tested to ensure consistent manufacturing between lots and to estimate the possible shelf life of the test kit by performing an accelerated stability study over 3 weeks at 37°C storage temperature (7). For the pilot scale lots the maximum shelf life is normally set to 9 months when stored at 2 – 8°C. Table 6 shows the comparison of three different lots stored at 37°C and tested over a period of 3 weeks. For each lot and time point five different samples were tested. As can be seen in table 6 there is no indication of a significant and consistent trend of results.

Table 6. Accelerated stability study at 37°C over a period of 3 weeks using 3 different pilot scale lots; five different samples were tested; results given as mg/kg gluten.

Week at 37°C

Lot 1

0

1

2

3

sample A sample B sample C sample D sample E Lot 2 sample A sample B sample C sample D sample E Lot 3 sample A sample B sample C sample D sample E

3.04 17.0 16.1 25.2 21.7 3.06 14.9 23.5 28.7 24.5 2.38 17.9 22.6 33.1 24.6

3.54 15.3 17.6 27.5 22.1 3.99 21.4 18.0 28.3 23.4 4.20 28.4 15.8 27.3 19.9

4.28 22.2 15.2 28.6 29.1 4.68 20.6 15.5 25.9 19.0 4.81 23.1 16.4 43.8 20.8

5.93 21.1 15.1 31.6 18.1 7.34 23.9 15.9 33.1 20.9 5.86 23.2 14.5 35.9 18.0

The quality assurance at R-Biopharm AG consists of a final in-process testing in the production department with all final components followed by the official product batch release testing by the quality assurance department and additional real time stability testing after regular storage intervals (usually approx. 3 to 4 months). To show that the proposed shelf life was correct, the testings are normally prolonged for an additional 6 months for each lot. Real-time stability tests for RIDASCREEN ® Total Gluten are still running until 15.08.2020 when a stability of 24 months at 2 – 8°C will be tested for all three lots.

4.1.6 Lot-to-lot comparison Data showing lot-to-lot comparability are available in this report: (1) chapter 4.1.5 - Accelerated Stability Study (2) chapter 4.1.7.7 - Precision of laboratory-internal reproducibility (3) chapter 4.1.7.3 - Trueness

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RIDASCREEN ® Total Gluten In-house validation report 2018-10-21