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  • Swab Test of Micbrobial Analysis For Cleaning Validation

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    Ali Kureishi
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    This document provides a form for reporting the results of a swab test of microbial analysis used for cleaning validation of production equipment. The form collects information on the sample area, date, production section, equipment identification number, sample locations, incubation temperature, number of colony forming units found on tryptic soy agar plates, sampling pattern, and a determination of whether the equipment passed or failed cleaning based on colony counts. It is used to evaluate the microbiological status of equipment cleaning and ensure validation of cleaning procedures.

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    This document provides a form for reporting the results of a swab test of microbial analysis used for cleaning validation of production equipment. The form collects information on the sample area, date, production section, equipment identification number, sample locations, incubation temperature, number of colony forming units found on tryptic soy agar plates, sampling pattern, and a determination of whether the equipment passed or failed cleaning based on colony counts. It is used to evaluate the microbiological status of equipment cleaning and ensure validation of cleaning procedures.

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    © All Rights Reserved
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    17 views4 pages

    Swab Test of Micbrobial Analysis For Cleaning Validation

    Uploaded by

    Ali Kureishi
    This document provides a form for reporting the results of a swab test of microbial analysis used for cleaning validation of production equipment. The form collects information on the sample area, date, production section, equipment identification number, sample locations, incubation temperature, number of colony forming units found on tryptic soy agar plates, sampling pattern, and a determination of whether the equipment passed or failed cleaning based on colony counts. It is used to evaluate the microbiological status of equipment cleaning and ensure validation of cleaning procedures.

    Copyright:

    © All Rights Reserved
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    of 4

    Form No.

    FZ-188

    SWAB TEST OF MICBROBIAL ANALYSIS FOR CLEANING


    VALIDATION

    Revision No. 00

    Effective Date: 07 J

    Next Review on: 07

    Report No.

    Sampled Area
    (cm)

    Date

    Production Section

    General / Antibiotics

    24 30 cm
    Location

    Previous Product

    30 35 C
    Area Class / Grade

    Next Product

    Equipment

    LID No.

    Sample
    Locations

    Incubation
    Temp.

    Equipment Status

    No. of Colony Forming Unit (CFU)


    TSA Plate
    1

    TSA Plate

    Average CFU Count

    TSA Plate
    2

    Note:
    C = Degree Centigrade for Temperature.
    LID No. = Equipment Identification Number.
    cm = Square Centimeter Area should be sampled.
    1

    TSA = Tryptic Soy Agar.

    CFU = Colony Forming Unit.

    Swab Sampling Scheme:

    Pattern 1

    Remarks:
    Equipment cleaning status

    Performed by:

    Pattern 2

    PASSED

    Checked by:

    Pattern 3

    FAILED

    Reviewed by:

    Microbiologist (Name/Sign./Date)

    AM Microbiology (Name/Sign./Date)

    MQC Microbiology (Name/Si

    orm No. FZ-188

    Revision No. 00

    Effective Date: 07 July 2014

    Next Review on: 07 July 2017

    Incubation
    Time

    72 Hours

    ss / Grade

    by:

    Cleaned / Dirty

    Swab Limits
    CFU / 25 cm

    50 CFU / 25 cm

    Pattern 4

    obiology (Name/Sign./Date)

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