Particle size plays a particularly significant role in inhalable drug production because particles from 2-15 µm do not disappear after inhalation, but rather settle in the alveolus. Therefore, regulatory agencies and manufacturers alike follow strict regulations regarding proper detection of foreign particles in inhalable drugs. rap.ID technology implements FDA initiatives including: Process Analytic Technology (PAT) and Quality by Design (QbD) in production and validation analyses to ensure quality.
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