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.
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.
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’.
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.
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.
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.
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
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.[/quote]
Dear Teo,
Could you please tell me, where can i locate the USP monograph on compressed air.