Bubble Point Test For Cartridge Filter
1.
Purpose:-
This procedure is developed to test integrity of cartridge
filter by Bubble Point Test Method.
2.
Scope:-
This procedure applies to perform bubble point test of Cartridge
Filters.
3.
HSE
Statement:-
3.1. Follow
the following instructions to perform subjected job in safe manners.
3.1.1. Only
trained and knowledgeable persons perform the subjected job.
3.1.2. All
work is performed in accordance with applicable regulatory requirements.
3.1.3. Standard
operating procedures are in place to perform the process.
3.1.4. Report
any job related injuries or illnesses, questions on health and safety, or any
unsafe or unhealthy working conditions to their supervisor.
3.1.5. Personal
protective equipment necessary for safe use of the equipment,
4.
Responsibilities:-
4.1.
Lab. Assistant
is responsible to conduct assigned tasks in a safe manner and report to
supervisor in case of any problem.
4.2.
Microbiologist
is responsible to monitor the subjected process.
4.3.
Microbiologistis
responsible to manage all activities include operator training, record keeping,
proper use of personal protective equipment & other related tasks.
5.
Materials:-
Compressed air or nitrogen
SS Housing
Cartridge / Capsule Filter
Silicon pipe
Pressure gauge
Beaker / Flask
6.
Definition:-
6.1. Bubble Point Test
A forward bubble point
integrity test is a procedure which measures the pressure needed to be applied
to the upstream side of a filter causing bulk or open pore flow through the
largest pores of a wetted filter. This measurement is taken from the downstream
side of the filter housing where a flexible piece of tubing has been attached
and the other end submerged into a beaker of water. The bubble point is
indicated by vigorous bubbling from the tubing. The accuracy of this test will
rely on the operator’s ability to successful recognize this point.

6.2. Cartridge Filter
Cartridge filters are
defined as fabric or polymer-based filters designed primarily to remove
particulate material from fluids.

1.
Description:-
Perform this test before use of a new filter and
whenever required.
Filter Brand Used For
Sarto Pure Liquids, gases / air
Sarto Flour Nitrogen & compressed air
Sarto Bran Liquids
1.1. Installation of Filter:-
1.1.1.1.
Remove the cartridge filter from the box.
1.1.1.2.
Check whether the packing of the filter is intact.
1.1.1.3.
Cut open the
plastic bag / wrapper at the bottom end of the cartridge – i.e. on the O –
Ring.
1.1.1.4.
Wet the O – Ring with the sterile WFI or solution to be
filtered (70 % IPA in case of N2 / Air filter).
1.1.1.5.
Insert the filter cartridge carefully by turning into
the place while holding onto the base of the cartridge.
1.1.1.6.
Lock the flanges carefully in the catches on the
housing base.
1.1.1.7.
When the cartridge is securely on the place, remove the
plastic bag / wrapper and close the housing.
1.2. Wetting of Filter
1.2.1.1.
Open the vent valve.
1.2.1.2.
Fill the filter cartridge housing with freshly prepared
70 % IPA solution for Sarto flour and use sterile water for Injection or
solution to be filtered for wetting Sarto Bran and Sarto Pure Filters.
1.2.1.3.
Ensure that all the air has been removed by keeping the
vent valve slightly opened for 1st minute of flushing and then close it and
rinse for 3 – 5 minutes (use 3 – 4 liter of wetting solution)
1.2.1.4.
Drain the solution by opening the drain valve by
applying compressed air / N2 at a max pressure of 0.5 Bar / 7 PSI.
1.2.1.5.
When the housing is empty close all the valves, the
filter has been wetted completely.
1.3. Bubble Point Test
1.3.1.1.
Close the inlet outlet as well as vent and drain valves
of the filter housing.
1.3.1.2.
Connect a flexible tube to the open downstream test
valve.
1.3.1.3.
Place the free end of the tube into a beaker / flask
containing sterile liquid.
1.3.1.4.
Slowly apply
increasing pressure to the housing via the upstream inlet. The bubble point of
the filter is achieved when a continuous flow of gas bubble appears in the
liquid.
1.3.1.5.
Record the
bubble point test in.
1.4. Pressure Limit
ü
Limit : 2.0 – 3.0 Bar.
Note: Ideally it should be achieved at ~ 2.5 Bar.
1.5. Precautions
Keep the plastic bag /
wrapper over the cartridge filter until the filter is securely installed.
2.
Reference:-
2.1.
NA
3.
Distribution:-
Sr. #
|
Distributed
to
|
Received
(Current)
|
Returned
(Obsolete)
|
01
|
Quality Control Department
|
|
|
02
|
Quality Assurance Department
|
|
|
03
|
Quality Management Department
|
|
|
4.
Revision
History:-
Date Changes
N/ A
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