Biomedical Engineering Reference
In-Depth Information
Fig. 2.2 A postulated, but unfounded, relationship of the ACI to particle deposition in the human
respiratory tract ( adapted from the operators' manual for the ACI )
recognized: (1) PM 10 , suspended coarse particles with d ae < 10 μm; (2) PM 2.5 ,
suspended fine particles with d ae < 2.5 μm, analogous to the majority of the fine
particles from OIPs; and (3) PM 1.0 , suspended ultrafine particles with d ae < 1.0
μ
m
(approximately equivalent to extrafines from OIPs).
The US FDA, in its 1998 draft Guidance for Industry document relating to
Chemistry, Manufacturing and Controls for OIPs [ 7 ], recommended treating cascade
impaction data as follows: “Data from full resolution CI measurements may also be
presented in terms of the percentage of the mass found on the various stages and
accessories relative to the label claim. Acceptance criteria may be proposed in terms
of appropriate groupings of stages and/or accessories. However, if this approach is
Search WWH ::




Custom Search