Compressed Air Validation

Blow a known volume of the air through a filter or a particle trap of some sort and count the particles.
(Yes I am being serious)
Or use filters of known proven documented traceable performance and validate the rest of the system for 'no leaks'.
There must be standard clean room procedures for this sort of thing?
Del

First question: is the air in contact with the product?

yes in the coating machine........

No. No one here has the experience for "compressed air validation in pharmaceuticals company."

And if they did they would charge you thousands of monetary units to perform the validation.

The cat can't do it. His dander is rampant. But, his advice does count.

Do you not suppose that your location might have some influence on the answer?

Hire a competent consultant with experience in the field.

The commercial section, Search GlobalSpec can help.

Free advice is worth what it costs. Nothing.

Firstly an oil free compressor has to be used. Standard pharma filters for filtering the air to class 100 or better are available from reputed manufacturers like Sartorius with required certification. They also give the equipment and the test protocol for checking. http://www.sartorius-stedim.com/WW/en/pharma_and_biotech/p8glk1q9g0u_artikel_liste.htm We use them routinely. Bioramani

Compressed air used for Hospital application need to confirm HTM – Health Technical Memorandum Standards U.K. You can refer these standards for more information

o The initiative taken for the concern is very serious and need an attention of every one. This is the concern which exists in thesociety and needs to be eliminated from the society as soon aspossible.

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Compressed air systen shall be validated and should comply ISO8573.

For nonviable particle count study in compressed air,instruments are also available. Basic principle is reduce the air pressure/ flow to app. 200 CFM/ 1 bar and feed the reduced pressure to infeed of particle counter. It should comply the lilmit of the area in which sample point is located.