All lots of serum that are intended for use as a sterile product are sampled and tested for sterility.

Samples are filled into the same lot container, with the same capacity and closure, and taken randomly during the sterile filling process. The maximum number of samples is 20. The direct inoculation method is utilized

Number of final
containers filled

Number of 20 ml samples
to be taken

0 - 50

6

51 - 200

10

201 - 250

12

251 - 300

14

301 - 350

16

351 - 400

18

401 and more

20

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