Procedure for performing
Bubble point test.
Procedure
Precautions
And Instructions:
Bubble
point testing of membrane filter assembly should be performed before and after
aseptic filtration of the solution by manufacturing chemist, and record there
of should be maintained in the B.M.R.
Requirements:
Bubble point test assembly.
Procedures:
Remove
the sterilized membrane filter assembly in sterile area.
Attach
sterile silicon tubing at both ends.
Fill
2 liters sterile water for injection in bubble point test apparatus.
Attach
upper end of silicon tube to the bubble point test apparatus and lower end to
another sterile glass flask.
Filter
2 liters of sterile distilled water through membrane using Nitrogen pressure.
Remove
the upper silicon tube and attach Nitrogen tube to the upper end of membrane
holder.
Gradually
increase the Nitrogen pressure up to 25 PSI
(1.5 lbs) and check for 30 seconds.
No
bubble should come out from lower end of lower tube (which is dipped in the
sterile distilled water) and there should be no fall in pressure,
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