7/6/2017 SOP for Bubble Point Test : Pharmaceutical Guidelines

SOP for Bubble Point Test

Standard operating procedure for bubble point test of sterilizing grade filter.
1.0 OBJECTIVE
To lay down a procedure for bubble point test of sterilizing grade filter.
2.0 SCOPE
This procedure applies to the manufacturing facilities.
3.0 RESPONSIBILITY
Officer &Executive
4.0 ACCOUNTABILITY
Asst. Manager
5.0 PROCEDURE
5.1 Bubble test procedure:
5.1.1 Perform the integrity testing (Bubble point test) before and after filtration.
5.1.2 Assemble the filtration assembly by connecting the sterilized silicon tubes at the inlet and outlet nozzles of the filtration membrane. Clamp the tubes
firmly to the nozzles.
5.1.3 Connect the other end of the inlet tubes with a 5-litre capacity bubble point tank filled with water for injection at room temperature, from the
compounding side.
5.1.4 Filter 5 liters of water for injection present in the bubble tank by gradually pressurizing the bubble tank. Collect the filtrate in a 5.0-litre pressure vessel.
5.1.5 After passing the water for injection through the filter dip the outlet tube of the filtration assembly into a 100 ml beaker filled with filtrate.
5.1.6 Increase the pressure of nitrogen gas supply to 0.5 Kg/ cm and hold this pressure for 30 seconds and observe bubbles. Continuous stream of bubbles
indicate the failure of the integrity of the filtration assembly.
5.1.7 If the filtration assembly is intact at 0.5 Kg / cm, then increase the pressure up to 2.8 Kg/ cm gradually and hold in this pressure for 30 seconds and
observe for bubbles. continuous stream of bubbles indicate the failure of the integrity of the filtration assembly.
5.1.8 After ascertaining the integrity, release the nitrogen pressure and connect the solution tank to the filter. If not, change the filtration assembly and
repeat the process of filter integrity testing.
5.1.9 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
filtration with a fresh set of filter.
5.1.10 Send the filtration assembly to the washing area for cleaning immediately after completion of filtration.
5.2 Integrity testing for hydrophobic filters:
5.2.1 Hydrophobic filters are used as bacterial retentive filters on nitrogen line and as vent filters on water storage tanks.
Types:
5.2.1.1 On nitrogen line and air vents for product receivers.
5.2.1.2 On water storage tanks (Purified water and water for injection)
5.3 Filtration procedure for nitrogen line and air vent:
5.3.1 Wet the filter with 70% Isopropyl alcohol in water for injection at room temperature.
5.3.2 Apply nitrogen pressure from the upstream side.
5.3.3 Observe for the stream of bubbles less than 16 psi (bubble point of the filter being tested).
5.3.4 Bubbles at less than the bubble point indicates test failure and should not be used.
5.3.5 Record the same.
5.4 Filtration procedure for cartridge filter on water storage tank:
5.4.1 Wet the filter with 60% Isopropyl alcohol in water for injection at room temperature.
5.4.2 Apply nitrogen pressure from the upstream side.
5.4.3 Observe for the stream of bubbles less than 13 psi (bubble point of the filter being tested).
5.4.4 Bubbles at less than the bubble point indicates test failure and should not be used.
6.0 ABBREVIATIONS
6.1 NA - Not Applicable
6.2 NO. - Number
6.3 SOP - Standard operating procedure

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical
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