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    Selection of The Worst Case and Acceptance Criteria For The Contamination

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    ziaddd
    1) The document outlines maximum allowable carryover (MACO) limits and acceptance criteria for contamination between products manufactured using shared equipment. 2) Sampling procedures involve visual inspections, swab sampling of product contact surfaces, and rinse sampling to test for residues from the previous product. 3) Specific equipment are identified for sampling, including number and locations of swabs/rinses to be taken based on surface area and risk of carryover contamination. Non-contact surfaces are also identified for sampling.

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    Selection of The Worst Case and Acceptance Criteria For The Contamination

    Uploaded by

    ziaddd
    37 views11 pages
    1) The document outlines maximum allowable carryover (MACO) limits and acceptance criteria for contamination between products manufactured using shared equipment. 2) Sampling procedures involve visual inspections, swab sampling of product contact surfaces, and rinse sampling to test for residues from the previous product. 3) Specific equipment are identified for sampling, including number and locations of swabs/rinses to be taken based on surface area and risk of carryover contamination. Non-contact surfaces are also identified for sampling.

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    1) The document outlines maximum allowable carryover (MACO) limits and acceptance criteria for contamination between products manufactured using shared equipment. 2) Sampling procedures involve visual inspections, swab sampling of product contact surfaces, and rinse sampling to test for residues from the previous product. 3) Specific equipment are identified for sampling, including number and locations of swabs/rinses to be taken based on surface area and risk of carryover contamination. Non-contact surfaces are also identified for sampling.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    37 views11 pages

    Selection of The Worst Case and Acceptance Criteria For The Contamination

    Uploaded by

    ziaddd
    1) The document outlines maximum allowable carryover (MACO) limits and acceptance criteria for contamination between products manufactured using shared equipment. 2) Sampling procedures involve visual inspections, swab sampling of product contact surfaces, and rinse sampling to test for residues from the previous product. 3) Specific equipment are identified for sampling, including number and locations of swabs/rinses to be taken based on surface area and risk of carryover contamination. Non-contact surfaces are also identified for sampling.

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    © All Rights Reserved
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    Download as docx, pdf, or txt
    of 11

    SELECTION OF THE WORST CASE AND

    ACCEPTANCE CRITERIA FOR THE


    CONTAMINATION

        8.1    MAXIMUM ALLOWABLE
    CARRYOVER (MACO)

                                    TD X BS X SF
                 MACO =   ……………………
                                          LDD         

    Where,
    MACO   : The maximum allowable
    carryover of previous product into next
    product.
    TD         : Minimum therapeutic dose of
    previous product A.
    BS         : Batch Size of the next product.
    SF         : Safety factor (1/1000)
    LDD      : Largest daily dose of the next
    product.
                

    A)  For Swab,
        

                 mg of permissible active per


    swab   =        MACO  X  Swab Area  
                                                                        
             -----------------------------------
             
    Common Surface Area

    B) Maximum Allowable residue per swab


        

    based on 10 ppm Criteria, mg of


    permissible active per swab      
                                10 X B S (kg)
    =                     --------------------------- X
    Swab Area
                                 Common Surface Area

    9.0              ACCEPTANCE CRITERIA:

    A. For Visual Inspection Criteria:


        

     There shall not be any visual evidence of


             

    previous product on the product contact


    parts and other equipment surface after
    cleaning.
     
    B. 10 ppm Criteria:
         

     Not more than 10 ppm of previous


             

    product residue shall appear in the Next


    Product.

    C. 0.001 % Dose Criteria:


        
     Not more than 0.001 % of previous
             

    product residue shall appear in the


    maximum daily dose of the next product.

    D. For Microbial Contamination:


        

    Sr. Swab Acceptance limit


     
    No. Sample
    01 Total NMT 100 CFU/Swab
    Bacterial
    Count
    02 Total NMT  10  CFU/Swab
    Fungal
    Count
                  Based on these acceptance
    criteria lowest value shall be
    considered for determination of
    cleaning validity.

    Cleaning Procedure: Reference SOP


                

    (Page No. 7/17) & SOP No. PRT-022


    10.0    SAMPLING PROCEDURES &
    SAMPLING PLAN:

    I. SAMPLING PROCEDURE
                                          

     Prior to swab sampling, cleaned


             

    equipment shall meet “Visual Clean”


    criteria.
     After cleaning of the equipment visual
             

    inspection shall be done and reported in


    report.
     After Visual Inspection is found
             

    satisfactory sampling shall be carried out.


     Use Hand gloves and mask during
             

    sampling.

    A).  For Swab Sampling:

    Soak the swab for about 10 minutes in Purified water in a test tube. Swab the area of not less

    than 100 cm2 and transfer the swab back into the test tube containing Purified water and cover

    the same. Sonicate the test tube for about 2 minutes and filter the solution
     The Swabbing shall be done in horizontal
             

    or vertical strokes like below shown


    procedure in the marked area assuring
    that the entire area is swabbed.
     
                

                

                

             

    After swabbing, rinse the swabbing location by


            

    purified water to remove the traces of solvent.


             through Whatman No. 2 filter paper.
             B).   For Rinse Sampling:
     Rinse the entire equipment with the
             

    specified quantity of the Purified water


    and collect the rinse in a clean container.
    Remove appropriate quantity of rinse
    sample and filter through Whatman No. 2
    filter paper.
                      Prior to sampling, cleaned
    equipment shall meet “Visual Clean”
    criteria.
    Sampling shall be carried out as per
    current version of SOP No. SQA- 075
    according to sampling diagram attached
    in the Annexure I. Number Of locations
    shall be sampled as mentioned below.   
      
    II. SAMPLING PLAN:
                

    a. Swab sample for chemical/Microbial


          

    analysis
    Product Contact Sampling Locations Total
    Name of
    Surface Area Nos. of
    Equipment
    (In cm2) Swabs

     Outlet of feeder hopper (S3)

    Sifter 100  Inner Surface of Sifter Bowl (S4) 4

     Sifter Sieve surface (S5)


            Gasket of Sifter Ring (S6)

     Discharge Valve (S7)

    Rapid Mixer
    100
     Below the chopper (S8)
    4


    Granulator    (RMG)
    Below the Mixer  (S9)

      Gasket (S10)

     Discharge Chute(S11)

    FBD/FBP 100
     Upper Plenum(S12)
    4

     Product Bowl Sieve(S13)

     Bowl(S14)
           Blades of multimill (S15)
    Multimill 100 2
            Sieve of multimill (S16)

     Side Wall Corner  (S17)


    Blender 100 3
    Discharge Port  (S18)
            Gasket (S19)


    Compression 100 5
    Machine Die Cavity of Turret (S20)

     Discharge Chute (S21)

     Inner Surface of Hopper – (S22)


     Punch Tip – (S23)

     Inner Surface of Die – (S24)

    b. Rinse Sampling For Chemical/


          

    Microbial Analysis

    Name of Equipment Sampling Locations Quantity of rinse (ml)

    Collect the 500 ml rinse samples after rinsing the


    FBD/FBP Outlet of hose pipe (R1) equipment with purified water.

    Collect the 500 ml rinse samples after rinsing the


    Compression machine
    Outlet of hose pipe (R2) equipment with purified water.

    III. SAMPLING PLAN FOR CHEMICAL


                

    ANALYSIS
    (NON CONTACT PARTS):
    Swab Location Sample No

    Wall NC 1
    Ceiling NC 2
    Return Grill NC 3
    Wall NC 4
    Ceiling NC 5
    Return Grill NC 6

    CHEMATIC DIAGRAM WITH SAMPLING


    LOCATIONS FOR EQUIPMENTS:

    a) SIFTER
          
    b) RMG
         

    c) FBP/FBD
          

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