Scribd Logo
Upload

Welcome to Scribd!

  • 116 views

    Format Ahu Val

    Uploaded by

    Krishna Raj
    This document outlines an air validation protocol for a quality control microbiology section. It describes exposing plates in 20 different areas to test for total aerobic microbial counts, total yeast and mold counts, and presence of four pathogens. The plates would be exposed, observed, and incubated at specified temperatures and humidity. Test results would be recorded on plates identifying the air handling unit, plate number, grill number, microbial counts, and presence or absence of pathogens. The protocol provides a format for recording this air validation testing across multiple areas.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd

    Format Ahu Val

    Uploaded by

    Krishna Raj
    116 views3 pages
    This document outlines an air validation protocol for a quality control microbiology section. It describes exposing plates in 20 different areas to test for total aerobic microbial counts, total yeast and mold counts, and presence of four pathogens. The plates would be exposed, observed, and incubated at specified temperatures and humidity. Test results would be recorded on plates identifying the air handling unit, plate number, grill number, microbial counts, and presence or absence of pathogens. The protocol provides a format for recording this air validation testing across multiple areas.

    Original Title

    FORMAT AHU VAL

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Available Formats

    DOC, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document outlines an air validation protocol for a quality control microbiology section. It describes exposing plates in 20 different areas to test for total aerobic microbial counts, total yeast and mold counts, and presence of four pathogens. The plates would be exposed, observed, and incubated at specified temperatures and humidity. Test results would be recorded on plates identifying the air handling unit, plate number, grill number, microbial counts, and presence or absence of pathogens. The protocol provides a format for recording this air validation testing across multiple areas.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    116 views3 pages

    Format Ahu Val

    Uploaded by

    Krishna Raj
    This document outlines an air validation protocol for a quality control microbiology section. It describes exposing plates in 20 different areas to test for total aerobic microbial counts, total yeast and mold counts, and presence of four pathogens. The plates would be exposed, observed, and incubated at specified temperatures and humidity. Test results would be recorded on plates identifying the air handling unit, plate number, grill number, microbial counts, and presence or absence of pathogens. The protocol provides a format for recording this air validation testing across multiple areas.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 3

    FORMAT

    Page 1 of 3
    DEPARTMENT: QUALITY CONTROL – MICROBIOLOGY SECTION
    TITLE: AIR VALIDATION PROTOCOL
    EFFECTIVE REVIEW DATE
    FORMAT NO.
    SUPERSEDES ISSUE DATE DATE Not later than
    F-VAL-MD-005
    - 01/01/2007 04/01/2007 Dec. 2008
    Reason for review Change in format.

    VALIDATION PROTOCOL – I
    Plates exposed on : Exposure Time :
    Plates observed on : 1) TAMC : Incubation Temperature :1) TAMC : 30°C To 35°C
    2) TYMC : 2) TYMC : 20°C To 25°C
    Temperature: Relative Humidity:

    AHU Plates Plate Grill TAMC TYMC Pathogens


    NO. Exposed No. No. E. coli Salmonella P. S.
    aeruginos aureus
    a
    1 Sampling RM 1 S1
    Material air lock 2 S2
    Men air lock 3 S3
    2 Micro section 4 S1
    3 Liquid filling 5 S1
    Air lock 6 S2
    4 Men air lock 7 S1
    Dispensing 8 S2
    Material entry 9 S3
    5 Comp - I 10 S1
    6 Comp - II 11 S1
    7 Comp - III 12 S1
    8 Comp - IV 13 S1
    Comp - passage 14 S1
      15 S2
      16 S3
    9 Blender room 17 S1
      18 S2
    Positive control -
    Negative control -

    Done By : Checked By :
    Date : Date :

    PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

    ASSISTANT
    MICROBIOLOGIST Q. C. MANAGER Q. A. MANAGER DIRECTOR
    FORMAT
    Page 2 of 3
    DEPARTMENT: QUALITY CONTROL – MICROBIOLOGY SECTION
    TITLE: AIR VALIDATION PROTOCOL
    EFFECTIVE REVIEW DATE
    FORMAT NO.
    SUPERSEDES ISSUE DATE DATE Not later than
    F-VAL-MD-005
    - 01/01/2007 04/01/2007 Dec. 2008
    Reason for review Change in format.

    VALIDATION PROTOCOL – II
    Plates exposed on : Exposure Time :
    Plates observed on : 1) TAMC : Incubation Temperature :1) TAMC : 30°C To 35°C
    2) TYMC : 2) TYMC : 20°C To 25°C
    Temperature : Relative Humidity :

    AHU Plates Plate Grill TAMC TYMC Pathogens


    NO. Exposed No. No. E. coli Salmonella P. S.
    aeruginos aureus
    a
    10 Granulation 19 S1
      20 S2
      21 S3
      22 S4
    11 Capsule manufacturing 23 S1
      24 S2
    12 Air lock 25 S1
    EHG capsule 26 S2
    13 Capsule 27 S1
    Filling area 28 S2
    14 Strip packing 29 S1
    15 Bulk packing 30 S1
    16 Blister packing 31 S1
    17 Inspection area 32 S1
    18 Inspection area 33 S1
    19 Bulk packing 34 S1
    20 Passage pack 35 S1
      36 S2
    Positive control -
    Negative control -

    Done By : Checked By :
    Date : Date :

    PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

    ASSISTANT
    MICROBIOLOGIST Q. C. MANAGER Q. A. MANAGER DIRECTOR
    FORMAT
    Page 3 of 3
    DEPARTMENT: QUALITY CONTROL – MICROBIOLOGY SECTION
    TITLE: AIR VALIDATION PROTOCOL
    EFFECTIVE REVIEW DATE
    FORMAT NO.
    SUPERSEDES ISSUE DATE DATE Not later than
    F-VAL-MD-005
    - 01/01/2007 04/01/2007 Dec. 2008
    Reason for review Change in format.

    PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

    ASSISTANT
    MICROBIOLOGIST Q. C. MANAGER Q. A. MANAGER DIRECTOR

    You might also like