PROCEDURE FOR INTEGRITY TESTING OF CARTRIDGE FILTER

1. OBJECTIVE

        To lay down the procedure for integrity testing of cartridge filter.

• SCOPE

This SOP is applicable in the procedure for integrity testing of cartridge filter.

• RESPONSIBILITY

Water system operators/ Engineers

:

To follow the procedure

• ACCOUNTABILITY

Head QA & Engineering                     :System Compliance

• PROCEDURE
  • Pre-Start up:
    • Close the air vent of filter housing.
    • Check the tightness of the clamp. It should not be loose at the connections.
    • Ensure that compressed air is available at pressure of 4 to 6 kg/cm2.
  • Start up:
    • Wet the cartridge filter water for injection or Iso propyl alcohol through the filter housing.
    • Open the filter housing so that air is removed from the vent and close the air vent when water for injection or Iso propyl alcohal droplet starts oozing out.
    • Connect the filter housing inlet to outlet of integrity instruments.
    • Connect the compressed air supply to the inlet of integrity testing instruments.
    • Open the valve of compressed air supply line and adjust the pressure between 4-6kg/cm2 for the integrity testing instrument.
    • Connect the power supply of the instrument and with on the instruments
    • Integrity testing instruments sis itself start the self-test programme.
    •  During this test instruments check the correct functioning of internal communication, Inlet pressure, Pressure transducer, valve and regulator are checked. An internal test also carried out.
    • After completion of self-test -instruments display the main menu press the ‘‘Bubble point’’ then after screen the bubble point test.

• Inter the pin and password then press ok. Screen display the bubble point test programme select      the test programme and press ok

• Check the test programme and enter the details.
  • Press the start to run the machine in bubble point test, pressure develop up to 700mbar (10PSI)      these instruments check the pressure leak in the filter.

• During the measurement phase of the test, pressure increased and the simultaneously instruments measure the pressure decay.

• When the develop pressure attain the specified minimum bubble point line then test result display ‘‘BP within limit’’ and if develop pressure not attain the specified bubble point line then test result display ‘‘BP outside limit’’ so filter is defective.

• If the fails in integrity on reject the filter and replace it with new filter and check its integrity

    Shut Down:

Disconnect the integrity testing apparatus from the filter housing. Increase a sterilizing grade filter which is used for filtration of nitrogen, fails in integrity test (post) , inform the production manager andquality assurance , the production manager to initiate an investigation in consultation with Q.A. for the failure.

    Frequency:

Every 15 days for airline cartridge filter/after dissembling filter from the line. Before and after sterilization of cartridge filter. Before and after filtration of water for injection /Disinfectant solution IPA.

        TRAINING

Trainer   : Head – Quality Assurance& Engineering Department.

         Trainees : Engineering- Executive & Supervisors. 

• DISTRIBUTION

Master Copy                     :           Quality Assurance

Controlled Copy               :           Engineering Department

Display Copy                    :           Engineering Department (if Required)

  ATTACHMENTS

Sr. No.	Annexure No.	Title	Format No.
1	NA	NA	NA

• REFERENCES       

In-house

   ABBREVIATION

Abbreviation	Extended Form
EG	Engineering
SOP	Standard Operating Procedure
QA	Quality Assurance
WH	Warehouse
NA	Not Applicable
MB	Microbiology

      REVISION HISTORY OF CHANGE

Sr. No.	Date	Revision Details	Revision No.