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
HPLC
The laboratories at Next Breath contain a full regimen of Waters Acquity UPLC H-Class liquid chromatographs. These instruments enable us to quickly and effectively separate complex mixtures to perform a variety of testing. These tests include Assay, Identification, and quantitative analysis of Impurities and Degradation Products. Our HPLC lab is also equipped with PDA capabilities that can be employed to characterize the UV spectrum of any analytes of interest. This provides an orthogonal approach to confirm identity and/or evaluate unknown compounds for structural similarity.
LC-MS
For our most complex analyses, Next Breath is able to leverage the capabilities of our Waters SQD2 mass spectrometer coupled to an Acquity UPLC H-Class liquid chromatograph. This instrument starts with the powerful separation and analysis capabilities of a UPLC with a PDA detector and is able to add additional levels of specificity, sensitivity, and insight through generation of mass spectra. This technique is often utilized for non-volatile extractable and leachable analysis, impurity analysis where extreme sensitivity is required, and investigative work to support unknown identification.
GC-MS
Next Breath is equipped with GC-MS instrumentation that is capable of performing both headspace and liquid analysis. Similar to the abilities of the LC-MS system, the GC‑MS instruments are able to separate and analyze components of complex solutions. Two advantages of GC-MS analysis are the ability to analyze volatile analytes, and the ability to generate characteristic EI mass spectra for each analyte of interest. The generation and interpretation of EI mass spectra are among the most powerful tools that Next Breath can employ to identify unknown compounds. This instrumentation is often used for testing such as volatile/semi-volatile extractable and leachables and analysis of residual solvents.ity, sensitivity, and insight through generation of mass spectra. This technique is often utilized for non-volatile extractable and leachable analysis, impurity analysis where extreme sensitivity is required, and investigative work to support unknown identification.
SprayVIEW Measurement System
Next Breath is equipped with GC-MS instrumentation that is capable of performing both headspace and liquid analysis. Similar to the abilities of the LC-MS system, the GC‑MS instruments are able to separate and analyze components of complex solutions. Two advantages of GC-MS analysis are the ability to analyze volatile analytes, and the ability to generate characteristic EI mass spectra for each analyte of interest. The generation and interpretation of EI mass spectra are among the most powerful tools that Next Breath can employ to identify unknown compounds. This instrumentation is often used for testing such as volatile/semi-volatile extractable and leachables and analysis of residual solvents.ity, sensitivity, and insight through generation of mass spectra. This technique is often utilized for non-volatile extractable and leachable analysis, impurity analysis where extreme sensitivity is required, and investigative work to support unknown identification.
MalvernSPRAYTEC
Building upon Next Breath’s arsenal of nasal device analysis equipment, this instrument allows for particle and droplet size analysis of aerosols. The equipment allows for measurements of particle sizes spanning 0.1 – 2000 microns, over a wide spray concentration range. This equipment also supports automated actuations, allowing for robust particle size distribution analyses over a wide variety of drug product dispensing apparatus.
MTS
This apparatus can be utilized towards a multitude of sensitive force measurement techniques, including actuation force and cap removal force.
Oven cKF
Next Breath is able to perform accurate water content determinations on low-moisture samples utilizing our Coulometric Karl Fischer apparatus. This instrument is equipped with an oven chamber and autosampler, allowing us to offer high-throughput moisture analysis of solid material in addition to analysis in the liquid phase. These capabilities allow Next Breath to reliably support the critical need to accurately and precisely measure small amounts of moisture content in your API or Drug Product.
Light Microscope
This tool can allow us to optically examine particle size and morphology. This is important in order to ensure the homogeneity of drug product material, and to ensure the lack of foreign particulate matter. Images can be taken and compared with reference materials to ensure conformity.
