Dynamic Powder Segregation Tester

An apparatus and method for segregation testing of powder blends, enabling determination of segregation potential under dynamic, stressed conditions, unlike conventional static content uniformity testing.

Optimize your solid dosage formulation and processing parameters at the formulation development stage using DYNASEG™, to avoid costly content uniformity problems in manufacturing.

Several formulations that passed content uniformity specification under static conditions failed when tested dynamically. Static testing alone can mislead a formulator into accepting a blend that won't hold up under real manufacturing conditions.

It's unique in subjecting the powder sample to a combination of four mechanisms of segregation, gravity flow, obstruction to flow via baffles, fluidization, and vibration, all characteristic of large-scale manufacturing.

It helps detect segregation early in development, identify robust blends before scale-up, and reduce the risk of FDA citations, batch failures, and recalls, while aligning fully with Quality by Design principles.

About 30cc of powder, with a full test taking less than 10 minutes.

Yes, it's compact and portable, and can be used in a fume hood or glove box to protect operators during testing of highly potent APIs.

Unit-dose powder samples are compacted into tablets, then analyzed for content uniformity using UV spectrophotometry, HPLC, UPLC, or process analytical technology, as appropriate for the drug candidate.

Yes, testing showed SIFT-N-BLEND® technology consistently outperformed high-speed and pin intensifiers, particularly at low drug loading or reduced intensifier speeds.

DYNASEG™ is the result of 32 years of research and five prototypes.

It is currently patent pending.