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    SOP For Bubble Point Test

    Uploaded by

    Bejoy Karim
    1. The document outlines a procedure for performing bubble point tests on sterilizing grade filters used at Ethical Drugs Ltd. for filtering solutions for injection. 2. The procedure involves assembling the filtration unit, filtering water through the filter while gradually increasing pressure, and observing for bubbles which would indicate failure of the filter's integrity. 3. Bubble point tests are performed before and after filtration, and any filters failing the post-filtration test require repeating the pre-filtration test with a new filter.

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    SOP For Bubble Point Test

    Uploaded by

    Bejoy Karim
    530 views4 pages
    1. The document outlines a procedure for performing bubble point tests on sterilizing grade filters used at Ethical Drugs Ltd. for filtering solutions for injection. 2. The procedure involves assembling the filtration unit, filtering water through the filter while gradually increasing pressure, and observing for bubbles which would indicate failure of the filter's integrity. 3. Bubble point tests are performed before and after filtration, and any filters failing the post-filtration test require repeating the pre-filtration test with a new filter.

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    SOP for Bubble Point Test

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    1. The document outlines a procedure for performing bubble point tests on sterilizing grade filters used at Ethical Drugs Ltd. for filtering solutions for injection. 2. The procedure involves assembling the filtration unit, filtering water through the filter while gradually increasing pressure, and observing for bubbles which would indicate failure of the filter's integrity. 3. Bubble point tests are performed before and after filtration, and any filters failing the post-filtration test require repeating the pre-filtration test with a new filter.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    530 views4 pages

    SOP For Bubble Point Test

    Uploaded by

    Bejoy Karim
    1. The document outlines a procedure for performing bubble point tests on sterilizing grade filters used at Ethical Drugs Ltd. for filtering solutions for injection. 2. The procedure involves assembling the filtration unit, filtering water through the filter while gradually increasing pressure, and observing for bubbles which would indicate failure of the filter's integrity. 3. Bubble point tests are performed before and after filtration, and any filters failing the post-filtration test require repeating the pre-filtration test with a new filter.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 4

    STANDARD OPERATING PROCEDURE eTHICaL DrUGS LTD.

    SIDDHIRGANJ, NARAYANGANJ
    Section : Production Revision Date : 01.01.2020
    SOP No. : EDL/PRO/SOP017 Revision No. : 01
    Issue Date : 01.01.2017 Page : 1 of 2
    Title : Procedure 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 Ethical Drugs Ltd.
    RESPONSIBILITY:
    Production Officer/Executive
    ACCOUNTABILITY:
    Manager, Production/Quality Control

    PROCEDURE
    01. Perform the bubble point test before & after filtration.

    02. Assemble the filtration unit by connecting the sterilized silicon tubes at the inlet and outlet nozzles.
    Clamp the tubes firmly to the nozzles.

    03. Connect the other end of the inlet tube with 5 liter capacity of a Pressure Vessel filled with water
    for injection at room temperature.
    04. 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.
    05. After passing the water for injection through the filter dip the out let tube of the filtration assembly
    into S. S. vessel containing the filtrate.

    06. Increase the pressure on Nitrogen gas supply 0.5 Kg/cm2 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 integrity of the filtration assembly.

    07. Repeat the operation No. 06 increasing pressure gradually 1.0 Kg/cm2, 1.5 Kg/cm2 and 2.0
    Kg/cm2 and observe the bubbles. For pressure 1.0 Kg/cm2 &1.5 Kg/cm2 slow bubbling found.

    08. At pressure 2.0 Kg/cm2 a continuous stream of bubbling found that indicates the integrity of the
    filtration assembly.
    09. Now, filter the bulk solution using the same filtration assembly.

    Written by Checked by Approved by Authorized by

    Sign : Sign : Sign : Sign :


    Production Officer Sr. QC Officer QC Manager Director (Ope. & Maint.)
    Date : Date : Date : Date :

    STANDARD OPERATING PROCEDURE eTHICaL DrUGS LTD.


    SIDDHIRGANJ, NARAYANGANJ
    Section : Microbiology Revision Date : 01.01.2020
    SOP No. : EDL/MB/SOP017 Revision No. : 01
    Issue Date : 01.01.2017 Page : 2 of 2
    Title : Procedure for Bubble Point Test
    10. After completion of filtration, repeat the bubble point test.

    11. In the event of failure of the post integrity test, repeat the pre-bubble point test and operate
    filtration with a fresh set of filter.

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

    Written by Checked by Approved by Authorized by

    Sign : Sign : Sign : Sign :


    Production Officer Sr. QC Officer QC Manager Director (Ope. & Maint.)
    Date : Date : Date : Date :

    Form no. : Pr0023 Effective Date: 01.01.17 Version no. : 01

    ETHICAL DRUGS LTD.


    SIDDHIRGANJ, NARAYANGANJ.

    Bubble Point Test Report

    Product Name : Mfg. Date :

    Batch No. : Exp. Date :

    Batch Size : Date :

    A. BUBBLE POINT TEST BEFORE FILTRATION:


    Applied Nitrogen Gas Limit Result
    Pressure
    0.5 Kg/cm2 No Bubbles found
    1.0 Kg/cm2 Slow Bubbling found
    1.5 Kg/cm2 Slow Bubbling found
    2.0 Kg/cm2 Rapid & stream of Bubbling found

    B. BUBBLE POINT TEST AFTER FILTRATION:


    Applied Nitrogen Gas Limit Result
    Pressure
    0.5 Kg/cm2 No Bubbles found
    1.0 Kg/cm2 Slow Bubbling found
    1.5 Kg/cm2 Slow Bubbling found
    2.0 Kg/cm2 Rapid & stream of Bubbling found

    Remarks : The filter passes the bubble point test as per specifications.
    .. …….………….… ………………... ……………………….
    Done by Checked by Approved by
    Production Officer QA Officer QC Manager
    Date : Date : Date :

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