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    Standard Operating Procedure Somatec: Title: Sop For Pao Test

    Uploaded by

    Majed Hossain
    This standard operating procedure outlines the process for performing a PAO test on HEPA filters at Somatec Pharmaceuticals Ltd. The test is conducted by an outside agency using a calibrated photometer to measure penetration of PAO aerosol upstream and downstream of filters. The test acceptance criteria is penetration of less than 0.01% through the filter media and zero penetration through mounting joints. Filters are replaced if leakage exceeds this and retested. PAO tests are performed once a year for HVAC systems and process equipment, and once every six months for laminar airflow stations.

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    Standard Operating Procedure Somatec: Title: Sop For Pao Test

    Uploaded by

    Majed Hossain
    774 views3 pages
    This standard operating procedure outlines the process for performing a PAO test on HEPA filters at Somatec Pharmaceuticals Ltd. The test is conducted by an outside agency using a calibrated photometer to measure penetration of PAO aerosol upstream and downstream of filters. The test acceptance criteria is penetration of less than 0.01% through the filter media and zero penetration through mounting joints. Filters are replaced if leakage exceeds this and retested. PAO tests are performed once a year for HVAC systems and process equipment, and once every six months for laminar airflow stations.

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    SOP for PAO Test

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    This standard operating procedure outlines the process for performing a PAO test on HEPA filters at Somatec Pharmaceuticals Ltd. The test is conducted by an outside agency using a calibrated photometer to measure penetration of PAO aerosol upstream and downstream of filters. The test acceptance criteria is penetration of less than 0.01% through the filter media and zero penetration through mounting joints. Filters are replaced if leakage exceeds this and retested. PAO tests are performed once a year for HVAC systems and process equipment, and once every six months for laminar airflow stations.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    774 views3 pages

    Standard Operating Procedure Somatec: Title: Sop For Pao Test

    Uploaded by

    Majed Hossain
    This standard operating procedure outlines the process for performing a PAO test on HEPA filters at Somatec Pharmaceuticals Ltd. The test is conducted by an outside agency using a calibrated photometer to measure penetration of PAO aerosol upstream and downstream of filters. The test acceptance criteria is penetration of less than 0.01% through the filter media and zero penetration through mounting joints. Filters are replaced if leakage exceeds this and retested. PAO tests are performed once a year for HVAC systems and process equipment, and once every six months for laminar airflow stations.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 3

    SOMATEC

    STANDARD OPERATING PROCEDURE PHARMACEUTICALS LTD.

    TITLE: SOP FOR PAO Test


    Department: Engineering Doc. No.: EN/SOP/0025 Version No.: 01
    Effective From: 17/01/2021 Next Revision: 17/12/2023 Page 1 of 02

    Md. Riazul Islam Signature:


    Prepared by
    Executive, Engineering Dept. Date:

    Raisul Islam Signature:


    Checked by
    Head of Engineering, Date:

    Md. Abdul Mottalib Signature:


    Approved by
    Manager, Quality Assurance Date:

    Name: Signature:
    Authorized by
    Plant Manager Date:

    Issuing Department: Quality Assurance

    List of Distribution:

    01. Quality Assurance


    02. Engineering
    03. Central Archive (Master Copy)

    Contact Department:
    In the event of any queries or request for copies, please contact:
    Quality Assurance Department
    SOMATEC Pharmaceuticals Ltd.
    Sarulia, Demra, Dhaka.

    Form No.: QA/FRM/001/02 .


    TITLE: SOP FOR SOP
    Department: Engineering Version No.: 02
    Document No.: EN/SOP/001 Approved by:

    1.0 OBJECTIVE
    To lay down the procedure for PAO testing (Integrity Testing) of HEPA filter.
    2.0 POLICY/REFERENCE
    2.1 Pharmaceuticals and hospitals – the ISO EN14644 part 3
    2.2
    3.0 SCOPE AND PURPOSE
    This SOP shall be is applicable for HVAC system, Laminar Air Flow stations and air handlers
    of process equipment of all departments at SOMATEC Pharmaceuticals Ltd., Sarulia, Demra,
    Dhaka, Bangladesh.
    4.0 RESPONSIBILITIES
    4.1 Personnel of Engineering Department shall be responsible for implementation of the
    procedure.
    4.2 Manager, Quality Assurance or person assigned by him shall be accountable for
    training and implementation of the procedure.
    5.0 PRECAUTIONS/GENERAL INSTRUCTIONS

    6.0 PROCEDURE
    6.1 PAO test of HEPA filters to be performed by an outside agency and the head
    engineering should ensure that this SOP is followed by outside agency.
    6.2 The measurement to be done by using a calibrated photometer having traceability to
    national standards.
    6.3 Feed the PAO aerosol at the fresh air inlet of AHU.
    6.4 Connect one end of PAO measuring probe to the upstream port of photometer.
    6.5 Turn the knob provided on photometer at the upstream position.
    6.6 Hold the detector of PAO measuring probe before HEPA filter or at the port provided
    in the plenum.
    6.7 Press a key for 100% concentration.
    6.8 Photometer will scan the PAO for 100% concentration.
    6.9 Connect the PAO Measuring probe to a downstream port of Photometer.
    6.10 Turn the knob provided on photometer at a downstream position.
    6.11 Do the scanning after HEPA filter at a distance of 25 mm from the filter face or at the
    port provided on the plenum. Wherever access of filter is not possible to take three
    samples to check the repeatability.
    6.12 The Filter and its installation should not show leakages greater than 0.01 %
    concentration.
    6.13 If the downstream leakage exceeds 0.01 %, the installation to be rectified for any
    leakages near flanges using silicon sealant.
    Form No.: QA/FRM/001/02 Page 2 of 3
    TITLE: SOP FOR SOP
    Department: Engineering Version No.: 02
    Document No.: EN/SOP/001 Approved by:

    6.14 Again scan the filter and the installation with PAO.
    6.15 If the downstream leakage exceeds 0.01 %, the filter shall be sent for testing.
    6.16 After rectification of the leakages if the leakage does not fall within 0.01%, replace the
    HEPA filter with new and repeat the PAO tests as per the steps 5.1 to 5.10.
    6.17 The PAO test for the HEPA filters of HVAC system and process equipment shall be
    performed once in a year and HEPA filters of the LAF shall be performed once in a six
    months.
    6.18 The PAO testing shall be carried out as per PAO testing schedule.

    ACCEPTANCE CRITERIA:

    During scanning percentage of the PAO penetration shown by the photometer shall be less than
    0.01% through the filter media and shall be ‘zero’ through mounting joints.

    FREQUENCY OF THE TEST

    Once in every six months or at Every Filter replacement.

    7.0 ANNEXURES
    ANNEXURE-I:
    ANNEXURE-II:
    8.0 REVISION HISTORY

    Sl. No. Revision Status Prepared by Version Reason for Revision


    01. 00 Executive, Engineering 01 1) First issue.

    Form No.: QA/FRM/001/02 Page 3 of 3

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