Sentence examples for validation batch from inspiring English sources

Once the kit had been developed, a validation batch was produced by IDEXX-Montpellier SAS ("beta kit" CIRAD-Vacnada) and subjected to accelerated stability testing by incubation at 37°C for 2 months, with testing at various time points.

Excellent linearity was achieved with correlation coefficients greater than 0.999 for all validation batches.

At TPC the process validation includes three consecutive process validation batches which shall fulfill all specifications for the given radiopharmaceutical.

Table 4 Results of validation batches (directly after labelling) Parameter Validation batches ( n  = 3) Appearance Clear, colourless solution Mean pH (range) 5.0 (5.0) Filter integrity Pass Mean impurity A  ± SD 0.94 ± 0.54 Mean impurity B  ± SD 0.21 ± 0.18 SD, standard deviation.

The accuracy and precision from six validation batches of the QCs were ≤ 8.1% C.V. and ≤ 7.9% R.E., respectively.

Table 4 shows the results from the three validation batches prepared in our facility prior to the release of the final labelling procedure for routine clinical use.

The final labelling procedure was subsequently tested through the preparation of three validation batches on three separate days with quality control directly after labelling and for one batch after storage in a plastic syringe for 1.5 h as well.

Since no HPLC apparatus is available for radiopharmaceuticals at the St Antonius Hospital, initial verification of the labelling procedure was performed at ITG and involved the preparation of three validation batches in a time course of 2 days.

In addition, binding of rFIXFc to FcRn was consistent across the validation batches, with relative binding levels ranging from 104 to 124%.

Additional analytical characterization was performed with the purified product (data not shown), which further illustrated that product quality was consistent across the validation batches.

Table 3 also shows that the specific activity of rFIXFc was consistent with validation batches possessing specific activity values of 6.5 7.1 IU nmol−1 of rFIXFc, similar to levels reported previously 11.