dear colleagues,
as compressed air in Pharmaceutical Industry becomes important, concerned as direct impact to product inside certain production equipment, I would like to know whether anyone can inform me how to measure the compressed air quality based on ISO 8573-1 quality classes (quality class 1) or any testing kits to have direct measurement of particle, water and oil, in particular oil concentration
thanks and regards,
We had a client that tested their compressed air quality. It wasn’t for a cleanroom or anything, just manufacturing for a class III medical device. They used a Drager moisture detection tube (#6728531) to measure water vaporand a Drager hydrocarbon detection tube (#6728071) to measure oil in the air. They used a Drager air sampling pump (Accuro #6400000) to facilitate sampling. I don’t have the details of what they did exactly but I can probably get them. I know there was a problem when they didn’t configure the sampling correctly. I think they got too much pressure in the tube and the reading was off the chart.
Hope this is somewhat helpful.
There are a variety of laboratories that can test the compressed air quality. Direct product contact, indirect product contact or OSHA. TRI Air Testing, Lawrence Factor or Atlantic Analytical.
Hi Paulus
If you look at ISO 8573 there are 9 parts associated with it.
With the 9 parts, Part 1 deals with the limits and acceptance criteria for each of the compressed gas classes, ie compressed air depending on requirement (Class 2.2.1 oil free compressed air).
Part 2 then details the test methods for oil content
Part 3 for humidity
Part 4 for solid particle count
etc
Depending on application you will need equipment that will detect oil vapour content, dewpoint/moisture level in situ,
Particle counts (should be determined using a light scattering instrument(genearlly a Climet or lazer particle counting machine or similar).
Also depending on application Drager tubes may not give results that are accurate for oil, you should record both oil content( membrane filters and FTIR spectoscopy and oil vapour (PID analyser)
Note that if you are using external contractor to complete testing ensure that method statements are provided and that results are documented as per ISO 8573 criteria. They should also document how they propose to reduce system pressure as the “pressure reduction method shall not influence theresulting partice count and particle distribution”.
Test reports should follow the statement format listed in the sections of ISO statement format.
Also important to document calibration info of testing instruments in the final test report.
Samples of test reports are provided in the ISO 8573 standards.
I have used both contract companies and developed in house test methods, depending on frequency and no points, validation/requalification you need to decide whether it will be done in house or externally.
Finally if aspectic you need to test for both viable and non- viable particles.
Hope this helps
Dear Buttons,
I aggree with ur explanation on testing of compressed air shall be done as per the procedure defined in ISO 8573 and the test equipments used to test compressed air quality shall be same as per ISO 8573l.
Dear paulus,
I know there are some testing kits available in the market from which i used one for testing compressed air in a pharmaceutical plant manufactured by M/S Gastec Corporation.
Hope this may help you.