Device Testing and Device
Selection Services from Cirrus
Several pharmaceutical and biotechnology
products employ devices. Selection or development of an appropriate
device is critical for overall product performance. Cirrus’
scientists have expertise with several types of devices including:
- Nebulizer
- Dry Powder Inhaler (DPI)
- Metered Dose Inhaler (MDI)
- Nasal Spray
- Catheter
- Stent
Device Testing Services
- Product performance testing
- Device-formulation compatibility testing
- In-use stability testing
- Extractables and Leachables testing
- Simulated patient use studies
Product Performance Testing
- Geometric particle size distribution by laser diffraction
- Aerodynamic particle size distribution and respirable
fraction by inertial impaction methods
- Emitted dose
- Output rate
- Leakage rate
- Tail-off characteristics
- Cyr test
- Drop test
Cirrus can design and conduct experiments
for device performance testing and can recommend a suitable
delivery device or assist in development of devices. The work
can be conducted under GMP or GLP conditions to be included
in a regulatory submission. Furthermore, our senior staff,
who have many years of industry experience both with device
development and regulatory filing, can provide support with
the device regulatory submission. |
