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  • BATCH NO.: G00721 MONITORING DATE:19/08/2021 Start Time:05Hrs End Time:6Hrs

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    prakash
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    The document describes the results of environmental monitoring of different areas in an injectable sterile facility using settle plate exposure techniques over three time periods. Tables of data show the bacterial and fungal counts observed for each monitored location compared to specified limits. For most locations, counts were within limits, though some areas like airlocks showed higher counts during later monitoring periods. The monitoring was conducted to confirm the sterility of the different areas in the facility.

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    The document describes the results of environmental monitoring of different areas in an injectable sterile facility using settle plate exposure techniques over three time periods. Tables of data show the bacterial and fungal counts observed for each monitored location compared to specified limits. For most locations, counts were within limits, though some areas like airlocks showed higher counts during later monitoring periods. The monitoring was conducted to confirm the sterility of the different areas in the facility.

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    17 views10 pages

    BATCH NO.: G00721 MONITORING DATE:19/08/2021 Start Time:05Hrs End Time:6Hrs

    Uploaded by

    prakash
    The document describes the results of environmental monitoring of different areas in an injectable sterile facility using settle plate exposure techniques over three time periods. Tables of data show the bacterial and fungal counts observed for each monitored location compared to specified limits. For most locations, counts were within limits, though some areas like airlocks showed higher counts during later monitoring periods. The monitoring was conducted to confirm the sterility of the different areas in the facility.

    Copyright:

    © All Rights Reserved
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    of 10

    ENVIRONMENT MONITORING OF INJECTABLE STERILE AREA BY SETTLE PLATE EXPOSURE TECHNIQUE

    Table 1:
    BATCH NO.: G00721 MONITORING DATE:19/08/2021
    START TIME:05HRS END TIME:6HRS
    CODE LOCATION GRADE Limit(cfu/90mmlate/4hrs) Observed count
    NUMBER (cfu/90mmPlate/4hrs)
    ALERT ACTION STATUTORY BACTERIA FUNGI TOTAL
    SPI1 Air lock 1 D 60 80 100 NA NA NA
    SPI2 Airlock 2A C 30 40 50 NA NA NA
    SPI3 Airlock 2B C 30 40 50 NA NA NA
    SPI4 Airlock 3 B ≤3 NA NA NA
    SPI5 Material pass C 30 40 50 0 0 0
    box
    SPI6 Sterile corridor B ≤3 NA NA NA
    NA NA NA
    SPI7 B ≤3 NA NA NA

    SPI8 Near ampoule B ≤3 NA NA NA


    leak test
    autoclave
    SPI20 Dynamic pass B ≤3 NA NA NA
    box
    SPI19A Filtration room A <1 NA NA NA
    LAF
    SPI19B Filtration room A <1 NA NA NA
    LAF
    SPI10 Filtration room B ≤3 NA NA NA
    SPI11A Cooling zone A <1 NA NA NA
    SPI11B LAF NA NA NA
    SPI11C NA NA NA
    SPI12 Cooling zone B ≤3 NA NA NA
    SPI13A Filling room 1 B ≤3 NA NA NA
    SPI13B NA NA NA
    SPI14A Filling room 1 A <1 NA NA NA
    SPI14B LAF NA NA NA
    SPI15A Filling room 2 B ≤3 NA NA NA
    SPI15B NA NA NA
    SPI16A Filling room 2 A <1 NA NA NA
    SPI16B LAF NA NA NA
    SPI17A Filling room 3 B ≤3 NA NA NA
    SPI17B NA NA NA
    SPI18A Filling room 3 A <1 NA NA NA
    SPI18B LAF NA NA NA
    SPI19A Bulk C 30 40 50 0 0 0
    SPI19B manufacturing 0 0 0
    -VE NA NA NA NA NA 0 0 0
    Table 2:
    BATCH NO.: G00721 MONITORING DATE:19/08/2021
    START TIME:06HRS END TIME:10HRS
    CODE LOCATION GRADE Limit(cfu/90mmlate/4hrs) Observed count
    NUMBER (cfu/90mmPlate/4hrs)
    ALERT ACTION STATUTORY BACTERIA FUNGI TOTAL
    SPI1 Air lock 1 D 60 80 100 97 02 99
    SPI2 Airlock 2A C 30 40 50 10 0 10
    SPI3 Airlock 2B C 30 40 50 16 0 16
    SPI4 Airlock 3 B ≤3 01 0 01
    SPI5 Material pass C 30 40 50 0 0 0
    box
    SPI6 Sterile corridor B ≤3 0 0 0

    SPI7 B ≤3 0 0 0

    SPI8 Near ampoule B ≤3 0 0 0


    leak test
    autoclave
    SPI20 Dynamic pass B ≤3 0 0 0
    box
    SPI19A Filtration room A <1 0 0 0
    LAF
    SPI19B Filtration room A <1 0 0 0
    LAF
    SPI10 Filtration room B ≤3 0 0 0
    SPI11A Cooling zone A <1 0 0 0
    SPI11B LAF 0 0 0
    SPI11C 0 0 0
    SPI12 Cooling zone B ≤3 0 0 0
    SPI13A Filling room 1 B ≤3 0 0 0
    SPI13B 0 0 0
    SPI14A Filling room 1 A <1 0 0 0
    SPI14B LAF 0 0 0
    SPI15A Filling room 2 B ≤3 0 0 0
    SPI15B 01 0 01
    SPI16A Filling room 2 A <1 0 0 0
    SPI16B LAF 0 0 0
    SPI17A Filling room 3 B ≤3 0 0 0
    SPI17B 0 0 0
    SPI18A Filling room 3 A <1 0 0 0
    SPI18B LAF 0 0 0
    SPI19A Bulk C 30 40 50 01 0 01
    SPI19B manufacturing 0 0 0
    -VE NA NA NA NA NA 0 0 0
    Table:3
    BATCH NO.: G00721 MONITORING DATE:19/08/2021
    START TIME:10HRS END TIME:14HRS
    CODE LOCATION GRADE Limit(cfu/90mmlate/4hrs) Observed count
    NUMBER (cfu/90mmPlate/4hrs)
    ALERT ACTION STATUTORY BACTERIA FUNGI TOTAL
    SPI1 Air lock 1 D 60 80 100 132 06 138
    SPI2 Airlock 2A C 30 40 50 19 01 20
    SPI3 Airlock 2B C 30 40 50 17 0 17
    SPI4 Airlock 3 B ≤3 0 0 0
    SPI5 Material pass C 30 40 50 03 0 03
    box
    SPI6 Sterile corridor B ≤3 0 0 0

    SPI7 B ≤3 0 0 0

    SPI8 Near ampoule B ≤3 0 0 0


    leak test
    autoclave
    SPI20 Dynamic pass B ≤3 0 0 0
    box
    SPI19A Filtration room A <1 0 0 0
    LAF
    SPI19B Filtration room A <1 0 0 0
    LAF
    SPI10 Filtration room B ≤3 0 0 0
    SPI11A Cooling zone A <1 0 0 0
    SPI11B LAF 0 0 0
    SPI11C 0 0 0
    SPI12 Cooling zone B ≤3 0 0 0
    SPI13A Filling room 1 B ≤3 0 0 0
    SPI13B 0 0 0
    SPI14A Filling room 1 A <1 0 0 0
    SPI14B LAF 0 0 0
    SPI15A Filling room 2 B ≤3 0 0 0
    SPI15B 0 0 0
    SPI16A Filling room 2 A <1 0 0 0
    SPI16B LAF 0 0 0
    SPI17A Filling room 3 B ≤3 0 0 0
    SPI17B 0 0 0
    SPI18A Filling room 3 A <1 0 0 0
    SPI18B LAF 0 0 0
    SPI19A Bulk C 30 40 50 0 0 0
    SPI19B manufacturing 0 0 0
    -VE NA NA NA NA NA 0 0 0
    Table:4
    BATCH NO.: G00721 MONITORING DATE:19/08/2021
    START TIME:14HRS END TIME:18HRS
    CODE LOCATION GRADE Limit(cfu/90mmlate/4hrs) Observed count
    NUMBER (cfu/90mmPlate/4hrs)
    ALERT ACTION STATUTORY BACTERIA FUNGI TOTAL
    SPI1 Air lock 1 D 60 80 100 85 01 86
    SPI2 Airlock 2A C 30 40 50 07 0 07
    SPI3 Airlock 2B C 30 40 50 10 0 10
    SPI4 Airlock 3 B ≤3 02 0 02
    SPI5 Material pass C 30 40 50 0 0 0
    box
    SPI6 Sterile corridor B ≤3 02 0 02

    SPI7 B ≤3 02 0 02

    SPI8 Near ampoule B ≤3 0 0 0


    leak test
    autoclave
    SPI20 Dynamic pass B ≤3 0 0 0
    box
    SPI19A Filtration room A <1 0 0 0
    LAF
    SPI19B Filtration room A <1 0 0 0
    LAF
    SPI10 Filtration room B ≤3 0 0 0
    SPI11A Cooling zone A <1 0 0 0
    SPI11B LAF 0 0 0
    SPI11C 0 0 0
    SPI12 Cooling zone B ≤3 0 0 0
    SPI13A Filling room 1 B ≤3 0 0 0
    SPI13B 0 0 0
    SPI14A Filling room 1 A <1 0 0 0
    SPI14B LAF 0 0 0
    SPI15A Filling room 2 B ≤3 01 0 01
    SPI15B 0 0 0
    SPI16A Filling room 2 A <1 0 0 0
    SPI16B LAF 0 0 0
    SPI17A Filling room 3 B ≤3 01 0 01
    SPI17B 0 0 0
    SPI18A Filling room 3 A <1 0 0 0
    SPI18B LAF 0 0 0
    SPI19A Bulk C 30 40 50 0 0 0
    SPI19B manufacturing 0 0 0
    -VE NA NA NA NA NA 0 0 0
    Table:5
    BATCH NO.: G00721 MONITORING DATE:19/08/2021
    START TIME:18HRS END TIME:22HRS
    CODE LOCATION GRADE Limit(cfu/90mmlate/4hrs) Observed count
    NUMBER (cfu/90mmPlate/4hrs)
    ALERT ACTION STATUTORY BACTERIA FUNGI TOTAL
    SPI1 Air lock 1 D 60 80 100 94 0 94
    SPI2 Airlock 2A C 30 40 50 04 0 04
    SPI3 Airlock 2B C 30 40 50 05 0 05
    SPI4 Airlock 3 B ≤3 0 0 0
    SPI5 Material pass C 30 40 50 01 0 01
    box
    SPI6 Sterile corridor B ≤3 0 0 0

    SPI7 B ≤3 0 0 0

    SPI8 Near ampoule B ≤3 0 0 0


    leak test
    autoclave
    SPI20 Dynamic pass B ≤3 0 0 0
    box
    SPI19A Filtration room A <1 0 0 0
    LAF
    SPI19B Filtration room A <1 0 0 0
    LAF
    SPI10 Filtration room B ≤3 0 0 0
    SPI11A Cooling zone A <1 0 0 0
    SPI11B LAF 0 0 0
    SPI11C 0 0 0
    SPI12 Cooling zone B ≤3 0 0 0
    SPI13A Filling room 1 B ≤3 0 0 0
    SPI13B 0 0 0
    SPI14A Filling room 1 A <1 0 0 0
    SPI14B LAF 0 0 0
    SPI15A Filling room 2 B ≤3 0 0 0
    SPI15B 0 0 0
    SPI16A Filling room 2 A <1 0 0 0
    SPI16B LAF 0 0 0
    SPI17A Filling room 3 B ≤3 0 0 0
    SPI17B 0 0 0
    SPI18A Filling room 3 A <1 0 0 0
    SPI18B LAF 0 0 0
    SPI19A Bulk C 30 40 50 0 0 0
    SPI19B manufacturing 04 0 04
    -VE NA NA NA NA NA 0 0 0
    Table:6
    BATCH NO.: G00721 MONITORING DATE:19/08/2021, 20/08/21
    START TIME:22HRS END TIME:02HRS
    CODE LOCATION GRADE Limit(cfu/90mmlate/4hrs) Observed count
    NUMBER (cfu/90mmPlate/4hrs)
    ALERT ACTION STATUTORY BACTERIA FUNGI TOTAL
    SPI1 Air lock 1 D 60 80 100 71 02 73
    SPI2 Airlock 2A C 30 40 50 07 0 07
    SPI3 Airlock 2B C 30 40 50 18 0 18
    SPI4 Airlock 3 B ≤3 02 0 02
    SPI5 Material pass C 30 40 50 0 0 0
    box
    SPI6 Sterile corridor B ≤3 01 0 01

    SPI7 B ≤3 0 0 0

    SPI8 Near ampoule B ≤3 0 0 0


    leak test
    autoclave
    SPI20 Dynamic pass B ≤3 0 0 0
    box
    SPI19A Filtration room A <1 0 0 0
    LAF
    SPI19B Filtration room A <1 0 0 0
    LAF
    SPI10 Filtration room B ≤3 0 0 0
    SPI11A Cooling zone A <1 0 0 0
    SPI11B LAF 0 0 0
    SPI11C 0 0 0
    SPI12 Cooling zone B ≤3 0 0 0
    SPI13A Filling room 1 B ≤3 0 0 0
    SPI13B 0 0 0
    SPI14A Filling room 1 A <1 0 0 0
    SPI14B LAF 0 0 0
    SPI15A Filling room 2 B ≤3 0 0 0
    SPI15B 0 0 0
    SPI16A Filling room 2 A <1 0 0 0
    SPI16B LAF 0 0 0
    SPI17A Filling room 3 B ≤3 0 0 0
    SPI17B 0 0 0
    SPI18A Filling room 3 A <1 0 0 0
    SPI18B LAF 0 0 0
    SPI19A Bulk C 30 40 50 0 0 0
    SPI19B manufacturing 0 0 0
    -VE NA NA NA NA NA 0 0 0
    Table:7
    BATCH NO.: G00721 MONITORING DATE:20/08/21
    START TIME:02HRS END TIME:06HRS
    CODE LOCATION GRADE Limit(cfu/90mmlate/4hrs) Observed count
    NUMBER (cfu/90mmPlate/4hrs)
    ALERT ACTION STATUTORY BACTERIA FUNGI TOTAL
    SPI1 Air lock 1 D 60 80 100 123 0 123
    SPI2 Airlock 2A C 30 40 50 17 0 17
    SPI3 Airlock 2B C 30 40 50 05 0 05
    SPI4 Airlock 3 B ≤3 01 0 01
    SPI5 Material pass C 30 40 50 0 0 0
    box
    SPI6 Sterile corridor B ≤3 0 0 0

    SPI7 B ≤3 0 0 0

    SPI8 Near ampoule B ≤3 0 0 0


    leak test
    autoclave
    SPI20 Dynamic pass B ≤3 0 0 0
    box
    SPI19A Filtration room A <1 0 0 0
    LAF
    SPI19B Filtration room A <1 0 0 0
    LAF
    SPI10 Filtration room B ≤3 02 0 02
    SPI11A Cooling zone A <1 0 0 0
    SPI11B LAF 0 0 0
    SPI11C 0 0 0
    SPI12 Cooling zone B ≤3 01 0 01
    SPI13A Filling room 1 B ≤3 0 0 0
    SPI13B 0 0 0
    SPI14A Filling room 1 A <1 0 0 0
    SPI14B LAF 0 0 0
    SPI15A Filling room 2 B ≤3 0 0 0
    SPI15B 0 0 0
    SPI16A Filling room 2 A <1 0 0 0
    SPI16B LAF 0 0 0
    SPI17A Filling room 3 B ≤3 0 0 0
    SPI17B 0 0 0
    SPI18A Filling room 3 A <1 0 0 0
    SPI18B LAF 0 0 0
    SPI19A Bulk C 30 40 50 01 0 01
    SPI19B manufacturing 01 0 01
    -VE NA NA NA NA NA 0 0 0
    Table:8
    BATCH NO.: G00721 MONITORING DATE:19/08/2021, 20/08/21
    START TIME:22HRS END TIME:02HRS
    CODE LOCATION GRADE Limit(cfu/90mmlate/4hrs) Observed count
    NUMBER (cfu/90mmPlate/4hrs)
    ALERT ACTION STATUTORY BACTERIA FUNGI TOTAL
    SPI1 Air lock 1 D 60 80 100 71 02 73
    SPI2 Airlock 2A C 30 40 50 07 0 07
    SPI3 Airlock 2B C 30 40 50 18 0 18
    SPI4 Airlock 3 B ≤3 02 0 02
    SPI5 Material pass C 30 40 50 0 0 0
    box
    SPI6 Sterile corridor B ≤3 01 0 01

    SPI7 B ≤3 0 0 0

    SPI8 Near ampoule B ≤3 0 0 0


    leak test
    autoclave
    SPI20 Dynamic pass B ≤3 0 0 0
    box
    SPI19A Filtration room A <1 0 0 0
    LAF
    SPI19B Filtration room A <1 0 0 0
    LAF
    SPI10 Filtration room B ≤3 0 0 0
    SPI11A Cooling zone A <1 0 0 0
    SPI11B LAF 0 0 0
    SPI11C 0 0 0
    SPI12 Cooling zone B ≤3 0 0 0
    SPI13A Filling room 1 B ≤3 0 0 0
    SPI13B 0 0 0
    SPI14A Filling room 1 A <1 0 0 0
    SPI14B LAF 0 0 0
    SPI15A Filling room 2 B ≤3 0 0 0
    SPI15B 0 0 0
    SPI16A Filling room 2 A <1 0 0 0
    SPI16B LAF 0 0 0
    SPI17A Filling room 3 B ≤3 0 0 0
    SPI17B 0 0 0
    SPI18A Filling room 3 A <1 0 0 0
    SPI18B LAF 0 0 0
    SPI19A Bulk C 30 40 50 0 0 0
    SPI19B manufacturing 0 0 0
    -VE NA NA NA NA NA 0 0 0
    ENVIRONMENT MONITORING OF INJECTABLE STERILE AREA BY VOLUMETRIC AIR SAMPLING TECHNIQUE
    BATCH NO: DATE:
    CODE LOCATION GRADE LIMIT OBSERVED COUNT FELLER
    NUMBER (CFU/M³) CORRECTED
    COUNT
    ALERT ACTION STATUTORY BACTERIA FUNGI TOTAL
    ASI1 Filling room 1 B 5 6 7
    ASI2 Filling room 1 A <1
    LAF
    ASI3 Filling room 2 B 5 6 7
    ASI4 Filling room 2 A <1
    LAF
    ASI5 Filling room 3 B 5 6 7
    ASI6 Filling room 3 A <1
    LAF
    ASI7 Filtration room A <1
    LAF
    ASI8 Filration room B 5 6 7
    ASI9 Corridor B 5 6 7
    ASI10 Corridor near B 5 6 7
    LAF
    ASI11 Colling zone LAF A <1
    ASI12 Colling zone LAF A <1
    ASI13 Colling zone LAF A <1
    ASI14 Colling zone LAF B 5 6 7
    ASI15 Air lok 3 B 5 6 7
    -VE Negative control NA NA NA NA

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