1.0       OBJECTIVE:

The objective of this SOP is:

1.1       To lay down a procedure for bubble test for 0.2µ membrane filter.

2.0       SCOPE:

2.1       This SOP is applicable for bubble test for 0.2µ membrane filter).

3.0       RESPONSIBILITY:

3.1       The Operator/Officer /Executive Production shall be

3.1.1    Responsible for bubble test for 0.2µ membrane filter.

4.0       ACCOUNTABILITY:

Manager Production / Head – Quality Assurance

5.0       PROCEDURE:

5.1       Pre Start Up:

5.1.1    Check and ensure that area is cleaned.

5.1.2    Connect the Silicon tube to inlet of membrane filter holder (fitted with 0.2µ membrane filter) which shall be connected with pressure vessel filled with Water for Injection (WFI).

5.1.3    Connect the silicone tube to the membrane filter holder housing outlet for checking bubble point test.

5.1.4    Outlet of silicon tube shall connect to the Stainless Steal (SS) container.

5.2       Start up:

5.2.1    Apply the nitrogen pressure to pressure vessel pass about 2-3 L WFI in SS Container.

5.2.2    As the WFI shall be forced through the filter, remove the air out of filter by slightly opening the inlet air vent and outlet air vent valve.

5.2.3    Close the inlet and outlet air vent valves as soon continuous flow of water starts.

5.2.4    About 2-3 L of WFI filtration, stop the transfer of WFI by releasing the Nitrogen pressure.

5.2.5    Connect the Nitrogen source to the membrane filter holder inlet after disconnecting it from pressure vessel.

5.2.6    Ensure that all silicone tubes shall be tightly closed.

5.2.7    Apply the Nitrogen pressure through the membrane filter holder (fitted with 0.2 µ membrane filter) and the outlet tube of the system shall be dipped into SS container containing WFI.

5.2.8    No bubble shall be seen in the SS till 2.7 kg/cm2 pressure applied.

5.2.9    If bubbles shall be noticed, membrane shall be discarded and repeat the procedure with new sterilized membrane.

5.2.10  Tight the system if any pressure drop shall be noticed.

5.2.11  If membrane passes the bubble point test then slowly release the pressure and close the inlet and outlet air vent of membrane holder.

5.2.12  Remove the silicone tube from inlet and outlet of the system and place another sterile silicon tubes.

5.2.13  Filter the Product through the membrane filter till batch shall be finished.

5.2.14  After completion of filtration recheck the bubble point test of membrane filter as per procedure used for checking the bubble point test prior to filtration.

5.2.15  If the post bubble point test fails, Product shall be kept aside and inform to QA.

5.3       Cleaning of Membrane filter

5.1.1    After completion of operation disconnect the membrane holder and other silicon tubes.

5.1.2    Remove the all leftover waste from the pressure vessel and SS container.

5.1.3    Clean the SS container, silicon tubes, pressure vessel and membrane filter with WFI properly.

5.1.4    Record the operation and cleaning activity of Membrane filter.

5.4       Cleaning frequency: Daily after operation activity.