<p>Dose content uniformity through container life is the test which ensures the uniform dose distribution of active drug(s) throughout the life of an MDI/DPI/NSP canister/bottle/container. The same test for Nasal Spray (NSP) is called Single Actuation Content (SAC) through container life. The test checks the active drug(s) content of one (sometimes two or three) MDI/DPI/NSP container(s). For Example, 1 MDI unit is randomly collected from a lot. Then the MDI is actuated 10 times (3 in the beginning + 4 in the middle + 3 at the end) in 10 different collection tubes to collect the doses. These 10 collection tubes containing the actuated doses are then assayed to measure the active drug content. The result of this assay helps to identify if there is any unapproved variation in active drug contents in the tested MDI product throughout its life.</p>
Dose content uniformity through container life is the test which ensures the uniform dose distribution of active drug(s) throughout the life of an MDI/DPI/NSP canister/bottle/container. The same test for Nasal Spray (NSP) is called Single Actuation Content (SAC) through container life. The test checks the active drug(s) content of one (sometimes two or three) MDI/DPI/NSP container(s). For Example, 1 MDI unit is randomly collected from a lot. Then the MDI is actuated 10 times (3 in the beginning + 4 in the middle + 3 at the end) in 10 different collection tubes to collect the doses. These 10 collection tubes containing the actuated doses are then assayed to measure the active drug content. The result of this assay helps to identify if there is any unapproved variation in active drug contents in the tested MDI product throughout its life.
BIO-XIN provides Dosage Unit Sampling Apparatus (DUSA) for Dose Content Uniformity (DCU) through container life. This dose collection apparatus is an arrangement of adapters, vacuum pump, flow meter, waste shot collector and collection tubes. We provide DUSA for MDI, DPI and Nebulizers. Our Single Actuation Content (SAC) through container life sampling apparatus for NSP is a one and only robotic system of the world (see picture).
