SOP for Bubble Point Test

OBJECTIVE

To lay down a procedure for Bubble Point Test of sterilizing grade filter.

SCOPE

This SOP is applicable to the filter used for the filtration of solution for injection in PharmaInfo Ltd.

RESPONSIBILITY

Production Officer/Executive

ACCOUNTABILITY

Manager, Production/Quality Control

PROCEDURE

• Perform the bubble point test before & after filtration.
• Assemble the filtration unit by connecting the sterilized silicon tubes at the inlet and outlet nozzles. Clamp the tubes firmly to the nozzles.
• Connect the other end of the inlet tube with the 5-liter capacity of a Pressure Vessel filled with water for injection at room temperature.
• Filter 5 liter of water for injection present in the Pressure Vessel by gradually pressurizing the Pressure Vessel. Collect the filtrate in a 5-liter S.S. vessel.
• After passing the water for injection through the filter dip the outlet tube of the filtration assembly into S. S. vessel containing the filtrate.
• Increase the pressure on the Nitrogen gas supply 0.5 Kg/c㎡ and hold this pressure for 30 seconds and observe the bubbles but no bubble is found. The continuous stream of bubbles indicates the failure of the integrity of the filtration assembly.
• Repeat operation No. 06 increasing pressure gradually 1.0 Kg/c㎡, 1.5 Kg/c㎡ and 2.0 Kg/c㎡ and observing the bubbles. For pressure 1.0 Kg/c㎡ & 1.5 Kg/c㎡ slow bubbling was found.
• At pressure 2.0 Kg/c㎡ a continuous stream of bubbling was found indicating the integrity of the filtration assembly.
• Now, filter the bulk solution using the same filtration assembly.
• After completion of filtration, repeat the bubble point test.
• In the event of failure of the post-integrity test, repeat the pre-bubble point test and operate filtration with a fresh set of filters.

• After completion of the bubble point test, immediately send the filtration assembly to the washing area for cleaning. Dry the components of the assembly and preserve them properly.
• Keep the bubble point test record.

ANNEXURE

REVISION HISTORY

Nil

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