Compress air

Do we need to follow the Medical air specification given in USP or EP for Compreesed air Qualification or some other guideline.

Anup Sharma

In general, ISO 8573 (class 4) standard is widely used for air quality for pharmaceuticals & biological. It is not expected to be of same class for viable & non-viable. Choice is based on application. There are 9 parts which provides quality standard for compressed air. it includes purity, moisture, oil mist, hydro carbons etc.
Ravi Dhanbhar

The US Food and Drug Administration (FDA) has published Federal Regulation 21 CFR Part 820, Quality System Regulation. This regulation follows ISO 9000. More specific to the clean areas and cleanrooms of interest are the standards and drafts under ISO 14644. A good overview of these standards is available on the IEST web site. Similarly, European Standards provide European Nations with guidelines for GMPs.

Unfortunately you posted this question twice. Earlier a similar reply was given and you still want to dig into this question. The other gentlemen gave you the Ref Document. You still want to get that document. ISO documents are not free. You have to purchase.