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  • Cleaning Validation MACO v2.0

    Încărcat de

    Ovais08
    3K vizualizări2 pagini
    Version2 of the earlier spreadsheet. The spreadsheet calculates three limits (for cleaning validation studies) (a) MACO, (b) Limit/Surface Area and (c) Analytical Limit.

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    © Attribution Non-Commercial (BY-NC)

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    Version2 of the earlier spreadsheet. The spreadsheet calculates three limits (for cleaning validation studies) (a) MACO, (b) Limit/Surface Area and (c) Analytical Limit.

    Drepturi de autor:

    Attribution Non-Commercial (BY-NC)
    Descărcați ca XLS, PDF, TXT sau citiți online pe Scribd
    Indicator pentru conținut neadecvat
    3K vizualizări2 pagini

    Cleaning Validation MACO v2.0

    Încărcat de

    Ovais08
    Version2 of the earlier spreadsheet. The spreadsheet calculates three limits (for cleaning validation studies) (a) MACO, (b) Limit/Surface Area and (c) Analytical Limit.

    Drepturi de autor:

    Attribution Non-Commercial (BY-NC)
    Descărcați ca XLS, PDF, TXT sau citiți online pe Scribd
    Indicator pentru conținut neadecvat
    din 2

    Determination of Acceptance Criteria for Cleaning Validation (CV) Studies

    Add Company Name/Logo Here


    ORAL PRODUCTS

    Equipment Details
    Equipment Name V-Mixer Equipment ID SB-MIX-02
    Equipment Location Solid Block (Mixing Room: 05) Equipment FunctionPowder Mixing

    Cleaning Validation Details


    Cleaning SOP ABC-Cleaning of V-Mixer-Rev01 Cleaning Type Manual
    Validation Protocol ABC-CV-Cleaning validation protocol for V-Mixer-Rev00 Validation Incharge Ovais
    INSTRUCTI
    INSTRUCTIO
    Details for calculation of Acceptance Criteria
    Fillin
    Fill inall
    allthe
    then
    (readthe
    (read thecom
    com
    Sampling Method Swab Sampling Acceptance Criteria Dose, Toxicology, 10ppm & Visual
    Product A Product Abc Tablets Active (Product A) Mefenamic Acid
    Product B1 Product G Tablets Product B2 Product E Tablets
    I 50.000 mg/day J 16.000 Units/day
    K 240000.000 Units/Batch L 5000.000 cm²
    N 15.000 Kg/Batch U 25.000 cm²
    LD50 Value 740.000 mg/kg W 70.000 Kg
    SF 0.00100 RAF 0.00100
    D 10.000 mL VRL 5.000 μg/cm²
    RF 70.000% V 50.000 L INSTRUCT
    INSTRUCTI
    Selectthe
    Select theac
    a
    chart)from
    chart) fromt
    Cleaning Validation Acceptance Criteria Cleaning Validation Acceptance Criteria
    Criterion MACO (mg/batch) Limit/surface area Analytical Limit
    MACO (mg/batch)

    mg/batch
    Dose 750.000 mg/batch 150.000 μg/cm² 262.500 μg/mL
    10 ppm 150.000 mg/batch 30.000 μg/cm² 52.500 μg/mL 800

    Visual Limit 25.000 mg/batch 5.000 μg/cm² 8.750 μg/mL 700


    600
    Toxicological 388.500 mg/batch 77.700 μg/cm² 135.975 μg/mL
    500
    Acceptance Limit 25.000 mg/batch 5.000 μg/cm² 8.750 μg/mL
    400
    300
    Compilation
    200
    Compiled by Ovais 100
    Checked by Mr Manager 0

    Date Compiled October 15, 2009 Dose 10ppm Visual Tox.


    100
    0
    Dose 10ppm Visual Tox.

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