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  1. #1
    teo
    Guest

    Default Compressed air for pharma plant

    Dear All,

    Since do no have special guideline on compressed air quality in pharmaceutical plant, is it mean we need to follow ISO guide line?

    If follow ISO guide, whice grade that should be followed for sterile plant, solid plant and liquid plant?

    Thank you
    Teo

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  3. #2
    eng1
    Guest

    Default

    Hi Teo

    Although I am not an expert on compressed air quality in a Pharma plant,
    I think you will find the below articles very useful.

    Hopefully other member of this community can offer a further insight

    http://www1.eere.energy.gov/industry...essed_air5.pdf

    http://www.ecompressedair.com/librar...rsystems.shtml

    Regards

  4. #3

    Default

    Teo,

    What are you doing with the compressed air? I think the requirements for the air should be based on this. If you are only powering valves and pumps, then the specs for this should apply. Secondarily, the exhaust for these types of equipment should be evaluated, based on the room criteria. If you are using compressed air in a sterile or clean environment, typically Point of Use filters are employed. I think there is a USP monograph on compressed air. I'll have to dig around for it. Plus I have some old protocols for the validation of a CA system.

  5. #4
    teo
    Guest

    Default compressed air

    Dear Meyert,

    the air is used for cleanroom and certain point may direct contact with product;

    As far as I got the info, the quality should be controlled as below:


    1) Particle: Match your room grade; If you room is Grade B, the air from the compressor also meet Grade B;

    2) Oil free compressor, and direct contact with product POU, oil free needed

    3) Dew point should be -40, but some used -20C

    4) Microbial: If the air direct contact with product, 0.2micron terminal filter need to be installed. (I have sent the catalog to Mr Ter before.)

    I have no objection on item 1, 2 and 4; But no so agreed with items 3;

    thank you and regards,
    teo

  6. #5

    Default

    The system is consistently producing the desired air quality as per ISO 8573-Class 4 as a minimum standard.

    Extract from ISO 8573: 2001 Part 1 for particulate

    see limit attached with

    • Microbial Count must be less then 0.1 CFU/cubic feet .(for Sterile Manufacturing Facility Only)

  7. #6
    Ahsan Khan
    Guest

    Default Compressed Air for Pharma Plant

    Yes, Mr Shahnawaz is absolutely right in the case.
    But to achieve the ISO 8573 -1 the series of filters from Domnick Hunter can be used as recommended along with the oil free compressor .

    for the validation of compressed air system , we have worked to first qualify the oil free compressor and then validate the system with different test procedures.

    Thanks

  8. #7
    ys.sudarsan
    Guest

    Default Compressed Air Requirements

    Dear friends,

    As per my experience, we need to do the following activities:

    1) Particulate matter:
    It should meet the room respective Grade (A / B /C / D) requirements.

    2) Oil content:
    It should be free from Oil content / traces.
    Perform this study by using Filter paper.

    3) Moistuer content:
    It should be as per the Dew point.

    Example:
    If the Dew point is -40°C, moisture content shall be 127ppm - This limit is for
    Grade 'D'.

    4) Dew point:
    It should be -40

    5) Microbial load:
    Microbial load shall be checked at generation point & user point (if the filter is 0.45 micron).

    If the finlal filter is 0.2 micron, and it is in Grade "A", sterility test shall be performed.

    If the final filter is 0.2 micron, and it is in Grade "D", the limit of Microbial load should be: NMT 100 cfu / cu.m (USP 30)

    6) Filter Integrity Test:
    For 0.2 micron filter, filter integrity should be done, as per the defined frequency of your PQ protocol / VMP / Policy


    Thanks & Regards,

    Sudarshan Reddy
    ys.sudarsan@gmail.com

  9. #8
    Ahsan Khan
    Guest

    Default

    ISO 8573 Consists Of Nine Separate Parts.
    Part 1 Specifies The Quality Requirements Of The Compressed Air And
    Parts 2 – 9 Specify The Methods Of Testing For A Range Of
    Contaminants.



    Testing And Validation
    Iso 8573.2 To Iso 8573.9 Specify The Test Methods For The Different
    Contaminants. On-site Testing Is Often Difficult Due To The Complexity
    Of The Test Method And The Expense Of Test Equipment Required And
    For This Reason, All Domnick Hunter Filtration Products Have Been
    Tested In Accordance With The Relevant International Standards And
    Performance Verified By Lloyds Register.

    OIL-X EVOLUTION Performance Validation
    OIL-X EVOLUTION filters have been designed to provide compressed air quality that meets or exceeds the levels shown in
    the latest ISO 8573.1:2001 international air quality standard.
    Coalescing Filters
    Coalescing filter performance has been tested in accordance with ISO 8573.2 and ISO 8573.4.
    Dry Particulate Filters
    Dry particulate filter performance has been tested in accordance with ISO 8573.4.
    Oil Vapour Removal Filters
    Oil vapour removal filter performance has been tested in accordance with ISO 8573.5.
    Materials of Construction
    OIL-X EVOLUTION materials of construction have been independently verified to comply with FDA Code of Federal
    Regulations, Title 21 ’Food and Drug’.

  10. #9

    Default ok

    Quote Originally Posted by teo View Post
    Dear All,

    Since do no have special guideline on compressed air quality in pharmaceutical plant, is it mean we need to follow ISO guide line?

    If follow ISO guide, whice grade that should be followed for sterile plant, solid plant and liquid plant?

    Thank you
    Teo




    Great post. I'm just not completely sure that I'm understanding the depth to this.
    Can anybody explain this out a little bit more?

  11. #10

    Default

    Dear all,

    Please advice where can I find a copy of ISO 8573.1 part 4?

    Thank you and best regards

  12. #11

    Default Reg copy of ISO 8573.1

    Quote Originally Posted by beizi View Post
    Dear all,

    Please advice where can I find a copy of part 4?

    Thank you and best regards
    you have to pay and get it, not freely downloadable.

    Ref http://www.iso.org/iso

    Regards,
    Rajasekaran

  13. #12

    Default ISO - Compressed Air

    Hi,

    Let me know what Stnds you require. I should have the full set for the
    CompAir.

    I will look out some Tech info for you for Pharma Comp Air. Been while since I worked on it, See also ISPE Good Practice Guidelines. Remember to decide on the "Use of the CA" as to the spec required and QRM approach etc.

    Note - Inst Air is require for PCS Valves etc, the manufacturer can waive the guarantee (indeed Safety) if incorrect air quality is used.

    Hope this helps

    Bugle

  14. #13

    Default Compressed air for pharma plant

    Dear sir ,
    Myself Ajay samadhiya working as a microbiologist in Indchemie Health Specialities Pvt Ltd . Sir can u help me about testing of Compressed Air, can you provide me any Testing procedure. I will be very Thankful.


    With Regards
    Ajay samadhiya

  15. #14

    Default Compressed air for pharma plant

    Dear sir ,
    Myself Ajay samadhiya working as a microbiologist in Indchemie Health Specialities Pvt Ltd . Sir can u help me about testing of Compressed Air, can you provide me any Testing procedure. I will be very Thankful.


    With Regards
    Ajay samadhiya

  16. #15

    Default Test Procedure for Compressed Air Validation

    Check the following method May be useful to you………….

    For detail feel free to contact me.
    jpathak@gmail.com


    TESTING METHODOLOGY
    To perform the checks for following parameters
    Test for oil droplets.
    Test for moisture content.
    Test for Bioburden (Before and after 0.2micron filter)
    Test for Visual and sub visual particle counts.
    All sampling points are sampled three consecutive samples for qualification program.
    • 5.1Test for oil droplets: Done by outside agency. (Attach certificate of Analysis)
    • Test for moisture content: Done by out side agency. (Attach certificate of Analysis)
    • Test for Bioburden: this test is performed by sampling of compressed air before passing through 2.0micron filter and after 0.2 micron filter by using compressed gasses sampler for sampling of 1000 liters Make: Millipore as per SOP No.QC222. Incubate the media cassettes at 30 to 350C for 48 hrs for bacterial counts followed by 20 to 250C for further 3days for fungal counts.
    • Test for Visual and sub visual particle counts: Purge the compressed air in 100ml particle free water for injection for the time of 5 min. adjust the flow speed not the spill the water from sampling bottle, plug the sample bottle bring it to microbiology lab for visual inspection and sub visual particle counts analysis by liquid borne particle counter.
    ACCEPTANCE CRITERIA:
    Oil droplets should be absent
    Moisture should be absent.
    Bioburden level is monitored before filteration for infor mative purpose and after filteration Not More Than 5 CFU/Plate.
    Air after filtration essentially free from suspended Particulate matter while performing by Visual test, for sub visual particles should comply USP 27<788> for parental usage. ≥10µ =6000/10ml
    ≥25µ =600/10ml

  17. #16

    Default Test for oil aerosol content in Compressed air

    Hi,

    Please advise if there's any instrument in the market that can test the oil aerosol content in compressed air for Pharma Plant which is <0.01mg/m3.

    Regards,
    Phyllis

  18. #17

    Default

    Quote Originally Posted by ys.sudarsan View Post
    Dear friends,

    As per my experience, we need to do the following activities:

    1) Particulate matter:
    It should meet the room respective Grade (A / B /C / D) requirements.

    2) Oil content:
    It should be free from Oil content / traces.
    Perform this study by using Filter paper.

    3) Moistuer content:
    It should be as per the Dew point.

    Example:
    If the Dew point is -40°C, moisture content shall be 127ppm - This limit is for
    Grade 'D'.

    4) Dew point:
    It should be -40

    5) Microbial load:
    Microbial load shall be checked at generation point & user point (if the filter is 0.45 micron).

    If the finlal filter is 0.2 micron, and it is in Grade "A", sterility test shall be performed.

    If the final filter is 0.2 micron, and it is in Grade "D", the limit of Microbial load should be: NMT 100 cfu / cu.m (USP 30)

    6) Filter Integrity Test:
    For 0.2 micron filter, filter integrity should be done, as per the defined frequency of your PQ protocol / VMP / Policy


    Thanks & Regards,

    Sudarshan Reddy
    ys.sudarsan@gmail.com


    I need a clarification in this.
    Which grade has to be followed to Compressed air (which will be used for the jet milling of an API).

    Any seasonal variation has to be taken into account?

    What are all the parameters which has to be monitored after validation?

    Any specific quideline is available?

    Please guide......

    Thanks & regards
    Shameem
    API-QA

  19. #18

    Default

    Quote Originally Posted by meyert View Post
    Teo,

    What are you doing with the compressed air? I think the requirements for the air should be based on this. If you are only powering valves and pumps, then the specs for this should apply. Secondarily, the exhaust for these types of equipment should be evaluated, based on the room criteria. If you are using compressed air in a sterile or clean environment, typically Point of Use filters are employed. I think there is a USP monograph on compressed air. I'll have to dig around for it. Plus I have some old protocols for the validation of a CA system.
    Dear Teo,

    Could you please tell me, where can i locate the USP monograph on compressed air.

    Thanks & regards
    Shameem
    API-QA

  20. #19

    Default Validation officer

    We have a compressed machine with a dew point of +3 degree celsius. is this acceptable in Grade D Environment?

  21. #20
    Piyush Raval
    Guest

    Default Compressed Air Quality

    Compressed Air Quality : Is Quality of air require to be tested for CO and CO2 level ?.

  22. #21

    Default

    Health Canada Guideline

    Air that comes into direct contact with primary contact surfaces and/or the product should be monitored to control the level of particulates, microbial contamination, and the absence of hydrocarbons. Limits used should take into consideration the stage of manufacture, product, etc. Additional tests might be required due to the nature of the product. Gas used in aseptic processes must be sterile and filters checked for integrity.

    ICH Q7A

    To verify the contents of the gas system at factories that comply with GMP, a complete gas analysis should be carried out at least once a year. This is particularly important in cases where the gas is in contact with the finished product. For example, in the GMP guide for APIs issued by the International Conference on Harmonization (ICH), Q7A -7.31 states that complete analysis should be carried out at suitable intervals (i.e. at least once a year).
    Durga Prasad

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