Grade a garments must meet category i?

Hi all,

could you tell me if there is any guideline or a cGMP/FDA requirement according to which the garments used for grade A/B cleanrooms should meet category I on particle shedding as per the Helmke-drum test (IEST-RP-CC003.03)?

Thanks in advanced for your help.

-The guideline very clearly refers reduction of particle generation from materials or processes or procedures or persons working in controlled areas.

This directly indicate why the test is performed and how you select fabric material.