English to Russian Medical Medical: Pharmaceuticals

Growth downstream of the size control filter will be identified as B. diminuta using standard biochemical test methods.
Recovery of the test organism downstream of the size control filter will be verification of the adequacy of the assay filter recovery method used to evaluate filter performance.
In the event that the 0.45 µm test filter fails the post test bubble point, an Off-line size control test will be performed if possible according to SOP 006349080.
In the event that the assay filter for the 0.45 (xm test filter fails to have positive growth of the B. diminuta challenge organism, the TSB (Trypticase Soy Broth) incubation procedure will be performed according to SOP 0063464SO.
The results will be presented to the Customer for acceptance.
3.
Assurance of test system sterility will be demonstrated by the absence of contaminating microbial growth on the assay filter downstream of the 0.22 µm test filters.
This will be considered the negative control.
4.
The occurrence of any bacterial cell reduction, after rinsing the test membrane, will be demonstrated by equivalent cell count values when comparing cell counts from the control sample with the cell counts from an inoculated rinse filtrate (final 50 mL of *rinse filtrate*).