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    SOP For Monitoring of Compressed Air - Gases

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    This standard operating procedure outlines the process for monitoring compressed air and gases used in pharmaceutical production facilities. It describes testing the air and gases for microbiological levels, non-viable particulate matter, oil content, and moisture content on a monthly basis. Specific testing methods are provided for measuring total aerobic microbial counts, sterility, particle size and concentration, and oil and moisture levels. Acceptance criteria for each test are also defined.

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    SOP For Monitoring of Compressed Air - Gases

    Uploaded by

    Anonymous FZs3yBHh7
    1K views2 pages
    This standard operating procedure outlines the process for monitoring compressed air and gases used in pharmaceutical production facilities. It describes testing the air and gases for microbiological levels, non-viable particulate matter, oil content, and moisture content on a monthly basis. Specific testing methods are provided for measuring total aerobic microbial counts, sterility, particle size and concentration, and oil and moisture levels. Acceptance criteria for each test are also defined.

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    SOP for Monitoring of Compressed Air_Gases

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    SOP for Monitoring of Compressed Air_Gases

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    This standard operating procedure outlines the process for monitoring compressed air and gases used in pharmaceutical production facilities. It describes testing the air and gases for microbiological levels, non-viable particulate matter, oil content, and moisture content on a monthly basis. Specific testing methods are provided for measuring total aerobic microbial counts, sterility, particle size and concentration, and oil and moisture levels. Acceptance criteria for each test are also defined.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    1K views2 pages

    SOP For Monitoring of Compressed Air - Gases

    Uploaded by

    Anonymous FZs3yBHh7
    This standard operating procedure outlines the process for monitoring compressed air and gases used in pharmaceutical production facilities. It describes testing the air and gases for microbiological levels, non-viable particulate matter, oil content, and moisture content on a monthly basis. Specific testing methods are provided for measuring total aerobic microbial counts, sterility, particle size and concentration, and oil and moisture levels. Acceptance criteria for each test are also defined.

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    2017515 SOPforMonitoringofCompressedAir/Gases:PharmaceuticalGuidelines

    SOPforMonitoringofCompressedAir/Gases
    Standard operating procedure to monitor the compressed air and gas for Microbiological, NonViable Particulate, Oil and Moisture Content.
    1.0 Purpose
    To lay down the procedure to monitor compressed air/gases for microbiological, nonviable particulate, oil and moisture content.
    2.0 Scope
    Applicable for monitoring of compressed air and gases Nitrogen, Oxygen and Carbon Dioxide in different production facilities for microbiological,
    nonviable particulate, oil and moisture content.
    3.0 Responsibility
    Trained QC Microbiology Officer is responsible for performing tests as per SOP.
    4.0 Accountability
    Head of Department
    5.0 Procedure
    5.1 Microbiological Monitoring
    Note: Microbiological monitoring is performed by sterility testing for user points in aseptic zone filling and filtration area and by Total Aerobic Microbial
    Counts using M Air T CG Sampler for other user points.
    5.1.1Test for Sterility
    5.1.1.1 Prepare the Soybean Casein Digest medium as per SOP for media preparation.
    5.1.1.2 Dispense 100 ml of Soyabean Casein Digest Medium in cleaned gas sampling assembly. Close the inlet and out let tubes with air 0.2 vent filters.
    5.1.1.3 Sterilize the assembly as per SOP.
    5.1.1.4 Pre Incubate the assembly with media at 30 35C for 48 hours before use.
    5.1.1.5 Bring the sample assembly to sampling location.
    5.1.1.6 Disinfect the outer surface of sampling point by the spraying of 70% v/v isopropyl alcohol or recommended disinfected solution
    5.1.1.7 Flush the gas sample for 1 min.
    5.1.1.8 Remove the vent filter from the inlet tubing and attach to filter outlet connected to the sampling point.
    5.1.1.9 Open the air/gas sample valve slowly and take sample for 10 min.
    5.1.1.10 After collecting the sample replace the vent filter of inlet tubing and label the assembly with appropriate details viz. Sample Identification, Date an
    Initials of analyst.
    5.1.1.11 Bring the sample to laboratory and incubate assembly at 22.5 2.5oC for 7 days followed by incubation at 32.5 2.5oC for 7 days. In case of
    Nitrogen Samples, incubate the samples in anaerobic conditions.
    5.1.1.12 After completion the incubation period record the results.
    5.1.1.13 Frequency: Once in One month
    5.1.1.14 Acceptance Criteria:No Growth Should be Observed
    5.1.2Test for Total Aerobic Microbial Counts
    5.1.2.1 Transfer the pre incubated Soybean Casein Digest Agar cassette, M Air T CG Sampler and accessories to the area to be monitored in a closed
    container to avoid any contamination.
    5.1.2.2 Write the sampling location ID and date of sampling on the base of cassette.
    5.1.2.3 Connect the sampling point to M Air T CG Sampler to and perform sampling as per SOP for 1000 litres.
    5.1.2.4 After completion of air sampling close the cassette with lid.
    5.1.2.5 Collect all exposed cassette in a closed container and transfer the plates to incubators for incubation.
    5.1.2.6 Incubate the exposed cassettes along with negative control in inverted position at 3035oC for 5 Days.In case of Nitrogen Samples, incubate the
    samples in anaerobic conditions.
    5.1.2.7 After incubation observe and count the number of colonies and record the results.
    5.1.2.8 Frequency: Once in One month
    5.1.2.9 Acceptance Criteria: Shall Comply for Room Classification Limits as follows:
    Action Limit
    Grade
    CFU/m3
    Grade A 1
    Grade B 10
    Grade C 100
    Grade D 200
    Other Grades Grade E, O, etc For Information

    5.2Non Viable Particulate Count


    5.2.1 Take the airborne particle counter LASAIR and accessories to the respective sampling rooms.
    5.2.2 Connect the user point to a stainless steel box with inlet and out let to diffuse the high pressure of air/gas to appropriate pressure to enable
    counting. Slowly open the user point and allow some air/gas to flush the box.
    5.2.3 Place the sampling probe of the particle counter at the out let of the SS box and sample for 1cubic feet of air or volume.
    5.2.4 Take the print of the particle counter and record results.
    5.2.5 Frequency: Once in One month
    5.2.6 Acceptance Criteria: Shall Comply for Room Classification Limits as follows:
    Particles / ft3
    Grade
    0.5 5.0
    Grade A 100 1
    Grade B 100 1
    Estesiteutilizacookiesparaajudaradisponibilizarosrespetivosservios,parapersonalizaranncioseanalisar
    Grade C 10000 57
    otrfego.AsinformaessobreasuautilizaodestesitesopartilhadascomaGoogle.Aoutilizarestesite,
    Grade D 100000 571
    concordaqueomesmoutilizecookies.
    Other Grades Grade E, O, etc For Information
    OBTERMAISINFORMAES ENTENDI
    5.3 Test for Oil and Moisture Content
    http://www.pharmaguideline.com/2010/01/sopformonitoringofcompressed.html 1/2
    2017515 SOPforMonitoringofCompressedAir/Gases:PharmaceuticalGuidelines
    5.3 Test for Oil and Moisture Content
    Note: These tests are applicable for Compressed air points only.
    5.3.1 This test shall be performed by external testing laboratory as per protocol or by using gas detector tubes Gastec.
    5.3.2 Frequency:
    Sample Point from Compressed Air Generation System: Once a Month
    Process User Points: One point monthly on rotation
    5.3.3 Acceptance Criteria:
    Oil: 0.5 mg/m3
    Moisture: 0.5 g/m3
    6.0 ABBREVIATIONS
    6.1 SOP Standard Operating Procedure
    6.2 % Percent
    6.3 C Degree centigrade
    6.4 CFU Colony Forming Unit
    6.5 ft3 Cubic Feet
    6.6 m3 Cubic Meter
    6.7 g Gram
    6.8 mg Milligram

    Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widelyread pharmaceutical
    blog since 2008. Signup for the free email updates for your daily dose of pharmaceutical tips.
    Need Help: Ask Question
    Online

    Estesiteutilizacookiesparaajudaradisponibilizarosrespetivosservios,parapersonalizaranncioseanalisar
    otrfego.AsinformaessobreasuautilizaodestesitesopartilhadascomaGoogle.Aoutilizarestesite,
    concordaqueomesmoutilizecookies.

    OBTERMAISINFORMAES ENTENDI

    http://www.pharmaguideline.com/2010/01/sopformonitoringofcompressed.html 2/2

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