Qualifications & Instrumentation
Combining Quality People with Quality Technology to Deliver Quality Outcomes
The expertise and experience of our people drives our success. We use decades of combined experience to best interpret our partners’ requirements, then Next Breath prides itself on understanding our customers’ goals. As scientists, we are naturally curious and we put our curiosity to work to create a solution that meets our customers’ needs. If there is ever a challenge, our customers can be sure we will keep on trying until we meet their expectations.
Our scientists' subject expertise includes:
- Analytical chemistry
- Spray characterization
- Inhalation physical tests
- Particle size analysis
- Extractables and Leachables
Ensuring International Quality Standard Compliance
From our cGMP-compliant laboratory, we maintain FDA-compliance and are EQFAR certified by the Brazilian National Health Surveillance Agency (ANVISA).
Lab Qualifications:
- cGMP compliant laboratory, ISO 17025 Accredited and EQFAR certified laboratory through ANVISA
- Registered with FDA (last inspection February 2018 – no 483s)
- DEA license for controlled drug substances (schedule II-V)
- ISO 17025 Accredited and EQFAR certified laboratory through ANVISA
Leading-Edge Equipment for Optimized Outcomes
Next Breath’s scientists utilize the latest instrumentation and methodologies to provide our partners with the highest quality analysis of their MDIs, DPIs, nebulizers, or nasal drug products.
Equipment and instrumentation
Development Services
- Next Generation Impactor
- Andersen Cascade Impaction
- Unit Dose Sampling Apparatus
- Copley Critical Flow Controller
- SprayView (spray characterization)
- Malvern Spraytec (droplet size)
- Automated actuation systems
- Polarized light microscope
- Spray force tester
- Actuation force
- Breath simulator
- Karl Fischer
- FTIR
- Waters HPLC systems
- GC-MS (Gas chromatography–mass spectrometry)
- GC-HS
- LC-MS (Liquid chromatography–mass spectrometry)
Bioequivalence Testing
- Next Generation Impactor
- Andersen Cascade Impaction
- Unit Dose Sampling Apparatus
- Copley Critical Flow Controller
- SprayView (spray characterization)
- Malvern Spraytec (droplet size)
- Automated actuation systems
- Breath simulator
- Waters HPLC systems
Extractables & Leachables
- LC-MS (Liquid chromatography–mass spectrometry)
- GC-MS (Gas chromatography–mass spectrometry)
- GC-HS
- HPLC-UV
- HPLC-PDA
- UPLC
- Ion Chromatography
- ICP-MS
- FTIR
- Polarized Light Microscope
