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  • Cleaning Limits Selection Criteria Based On MAC Approach

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    Gursharanjit Singh Shinh
    8 views1 page
    Cleaning MAC Calculation

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    Cleaning

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    Cleaning MAC Calculation

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    8 views1 page

    Cleaning Limits Selection Criteria Based On MAC Approach

    Uploaded by

    Gursharanjit Singh Shinh
    Cleaning MAC Calculation

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    Cleaning Limits Selection Criteria based on MAC Approach:

    Maximum Allowable Carryover (MAC )=TD Batch NP1000SFLD Dose NP


    TD= Smallest therapeutic dose of active just cleaned (mg)
    Batch NP= Batch size of next product (Kg)
    SF= Safety factor (0.001 is common)
    LD Dose NP= Maximum number of daily doses of the next product (mg)

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