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    Faas Pharmaceuticals (PVT.) Limited: Tested On: Mar 13, 2019 Next Due Date: Mar 12, 2020

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    Erum Manzoor

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    © All Rights Reserved
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    Faas Pharmaceuticals (PVT.) Limited: Tested On: Mar 13, 2019 Next Due Date: Mar 12, 2020

    Uploaded by

    Erum Manzoor
    30 views6 pages

    Original Title

    Summary

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    30 views6 pages

    Faas Pharmaceuticals (PVT.) Limited: Tested On: Mar 13, 2019 Next Due Date: Mar 12, 2020

    Uploaded by

    Erum Manzoor

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 6

    Tested On: Mar 13, 2019 Next Due date: Mar 12, 2020

    Performed by

    ________________
    Zaffar

    Written By

    ______________
    Iqra Bano

    Checked by

    ________________
    Abdul Wahid
    Mechanical officer

    Approved by

    _____________________
    Mr. Wajahat
    Head of Quality Operations

    Report submitted to (client)

    FAAS PHARMACEUTICALS (PVT.) LIMITED


    F-748L S.I.T.E, KARACHI
    Table of Content

    S. No. Content Page No.

    1 Background 1
    2 Objectives 1
    3 Documentation 1
    4 Verification Of Corrective Action Report 1
    5 Washing , Cleaning & Sanitization of entire production 2
    6 Environmental Performance Test 2
    6.2 Air Flow and Uniformity Test 2
    6.2.1 Measurement of Air Volume in Supply and Return Air Ducts 3
    6.2.2 Measurement of Differential Pressure 3
    6.2.3 Measurement Of Air Changes Per Hour 3
    6.3.3 HEPA Filter Leakage Test 4
    QUALIFICATION REPORTS OF HVAC SYSTEM, AIR BALANCING

    P a g e | 1of 4

    1.0 BACKGROUND:

    M/s FAAS PHARMACEUTICALS (PVT.) LIMITED has Carried out Air Balancing of Production


    area. Production area has designed for the manufacturing of products. Air balancing and
    qualification of HVAC system was verified for the compliance of current Good Manufacturing
    Practices (cGMP) and all other regulatory obligations.

    2.0 OBJECTIVE:

    The objectives of this validation report is


     To verify recommended corrective actions report (CAR).
     To validate the HVAC system of microbiological section and production area for the
    successful manufacturing the cephalosporin’s sterile and non sterile products.
     To verify that the HVAC, supporting utilities and the circulation pump have been built and
    installed in compliance with their design specifications.( IQ)
     To verify that the AHU, supporting utilities and the circulation pump operate in accordance
    with their design specifications. (OQ)
     To verify that the AHU specific process will consistently produce a product meeting its
    predetermined specifications and quality attributes. (PQ)
     To verify the HVAC system meets the current Good Manufacturing Practices (cGMP)
    requirements and all other regulatory obligations.

    3.0 DOCUMENTATION:
     Identity numbers of the entire air handling unit (AHU) were
    labeled.
     All the relevant drawing of HVAC system was checked.

    4. VERIFICATION OF CORRECTIVE ACTION REPORT

    Before starting air balancing , the completion of Corrective Action Report was verified.
    QUALIFICATION REPORTS OF HVAC SYSTEM, AIR BALANCING

    P a g e | 2of 4

    5. WASHING, CLEANING & SANITIZATION OF PRODUCTION AREA


    Production area were verified for the dust and microbial contamination level on surfaces. Before air
    balancing test the Production area were washed down, cleaned and disinfected with approved
    disinfectant by trained pharmacist.

    6. ENVIRONMENTAL PERFORMANCE TEST


    Production area were subjected to the following set of environmental performance tests after
    completion cleaning.
    i. HVAC System
    ii. Air Flow And Uniformity Tests
    iii. Temperature And Humidity Control Test
    iv. Differential pressure

    6.1 HVAC SYSTEM

    Description:
    The air-conditioning system for the Production area consists of the following major component.
     Three Air Cool self-contain package units,

    Following key elements were considered for implementation and control of air the HVAC system and
    air handling (AHU) system in the overall design.
     Air flow regime
     Filtration
     Pressure differential across filters and areas
     Temperature
     Humidity
    6.2 AIR FLOW AND UNIFORMITY TEST

    Air Balancing:

    Air balancing activity consists on the following steps.


    1. Measurement of air volumes in supply and return air ducts.
    2. Measurement of Differential pressure
    3. Pressure per Hour-Rooms
    QUALIFICATION REPORTS OF HVAC SYSTEM, AIR BALANCING

    P a g e | 3of 4

    6.2.1 Measurement of Air volume in supply and return air ducts.


     The test method was carrying out according approved procedure.
     Equipment:

    S.No. Equipment/ Instruments


    1 Portable Manometer
    2 Pitot tube
    3 Digital Tachometer

     Acceptance criteria:
     Allowable Tolerance for Airflow rate is ± 10% of Designed Volume.
     Reading will be taken at 40 in. above the floor in the center of the grid for minimum 15
    seconds. (If 40 inch space is not available then the reading will take at height of the false ceiling
    and length of diffuser hood)
     No object within 10 ft of the anemometer, except fixed equipment.
    6.2.2 Measurement of Differential pressure

     Pressure control test was carried out by TS services test.


     The HVAC was in continuous operation when the test was performed.
     To avoid unexpected changes in pressure and to establish a baseline, all doors in the
    production area were closed and no traffic is to be allowed during test.
     The reading was taken of the different locations mentioned in drawing.
     The results were noted which attached with report according to AHUs.

     Acceptance criteria:

    Under class 10,000 the system should meet design specification (minimum 0.05 In. w.g.)
    Under class 100,000 the system should meet design specification (minimum 0.03 In. w.g.)
    QUALIFICATION REPORTS OF HVAC SYSTEM, AIR BALANCING

    P a g e | 4of 4

    6.2.3Measurement of Air Changes per Hour


     Room Air changes per hour for the class 10,000 and 100,000 were taken from each room of the
    individual AHU.
     The readings were taken of the different locations mentioned in drawing.
     The results were noted which attached with report according to AHUs.
     Total supply air to the room will first calculate.
     Length, width and height of rooms are to be measured and volume is calculated by multiplying
    all.
     The air changes will be calculated as below:

    Calculation:

    Volume of Room = Length × Breadth × Height of the Room

    Total Actual Supply Air CFM × 60 min .


    Air Changes per hour =
    Room Volume (cu.ft )

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