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Foreign Particle Studies and Routine Analysis:

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.

Particle Source in Respiratory Drugs

Our Experience:

Studies show that more than 95% of all foreign particles in this substance class are organic by origin and, therefore cannot be attributed to any substance found through REM/EDX analysis. The Single Particle Explorer detects, enumerates and identifies particles in this substance class. rap.ID technology utilizes unique methods to provide rapid and relevant information about inhalables from 2-10 µm.

Foreign particle status of formulations, agents and excipients; foreign particle load in administered doses

Method development and validation of foreign particle studies

Routine foreign particle monitoring in nasal spray suspensions

Testing for particulate matter release on capsules and inhaler parts

Quality assurance and foreign particle analytics in inhalable drugs

Cleanliness analyses for incoming inspection of inhaler component parts

Typical Applications:

Foreign Particles in Dry Powder Inhaler

Troubleshooting in Clean Production Processes

Fast chemical mapping of a Dry Powder Inhaler Formulation

Dry Powder Inhaler Study:

This particular study, conducted in cooperation with a leading dry powder inhaler manufacturer, provides evidence that a specific foreign particle profile can be attained after successful method development analysis.



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