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  • CLEANING VALIDATION MATRICES 4 April 2009 PDF

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    This document contains a matrix for calculating the maximum acceptable contamination (MAC) for subsequent drug products based on previous product contamination levels. It lists two drug products - Pynmed and Abflex 4. For each product it provides the batch size, swab area, maximum daily therapeutic dose, and calculates the MAC in milligrams per swab and parts per million based on the previous product contamination and recovery factor. The minimum analytical limits for 10 parts per million criteria are 13.13 ppm and 0.13 mg per 25 square centimeters for all products.

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    This document contains a matrix for calculating the maximum acceptable contamination (MAC) for subsequent drug products based on previous product contamination levels. It lists two drug products - Pynmed and Abflex 4. For each product it provides the batch size, swab area, maximum daily therapeutic dose, and calculates the MAC in milligrams per swab and parts per million based on the previous product contamination and recovery factor. The minimum analytical limits for 10 parts per million criteria are 13.13 ppm and 0.13 mg per 25 square centimeters for all products.

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

    CLEANING VALIDATION MATRICES 4 April 2009 PDF

    Uploaded by

    Mykola
    This document contains a matrix for calculating the maximum acceptable contamination (MAC) for subsequent drug products based on previous product contamination levels. It lists two drug products - Pynmed and Abflex 4. For each product it provides the batch size, swab area, maximum daily therapeutic dose, and calculates the MAC in milligrams per swab and parts per million based on the previous product contamination and recovery factor. The minimum analytical limits for 10 parts per million criteria are 13.13 ppm and 0.13 mg per 25 square centimeters for all products.

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    TECH 003 Form 4

    MAC CALCULATION MATRIX

    Previous product : Mini. Therap. Dose (mg) 320.0 0,1% STD = 0.32 %Recovery 0.98
    Pynmed Tablets Factor (RF)=
    Batch size Batch size Swab area Comm. Contact Max. daily Dose Criteria 10 PPM Criteria
    Sl.No. Subsequent product (Units) (Kg) (Sq.cm.) surface area therapeuitc dose MAC(mg./swab) MAC (ppm) MAC(mg./swa MAC(ppm)
    [a] [A] (5x 5cm) [B] (sq. cm.) (units) E=[I4*A*B*RF]/ F=[E*1000]/10 b) H=[G*1000]/10
    [C] [D] C/D (swab soaked in G=[10*A*B*R (swab soaked in
    10 ml sol) F]/C 10 ml sol)
    1 Pynmed 250794 158 25 294738 8 1.6833 168.33 0.1313 13.13
    2 Abflex 4 249231 162 25 294738 8 1.1970 119.70 0.1347 13.47
    Min. Analytical of 10ppm criteria and Dose criteria (in ppm) 13.13
    Min Limit per Surface Area (mg/25 cm2) 0.13
    Min Analytical of all products (in ppm) : 13.13
    Min Limit per Surface Area (mg/25 cm2)of all products 0.13
    Prepared by & Date: Reviewed by & Date:

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