Aerosol Research and Engineering Labs

Whether you have an existing device or need a device developed to meet your specif formulation and delivery characteristics we can help in all stages. We provide Complete Project Solutions from start to finish for Devices. Design, Computational Fluid Dynamics Modeling, In-house rapid Prototyping and testing.

Specialties

ARE Labs can provide you a full host of services for all your pharmaceutical aerosol related business operations. ARE Labs’ staff has experience in materials processing for enhanced aerosol dispersion.

• Nebulizer/Inhaler characterization testing
  
• Medical Device Regulatory Compliance Testing: 510(k), USP-601, etc..
  
• Particle size distribution and mass measurement
  
• Stability/ Life-time Testing
  
• Reproducibility and lot-to-lot variability testing
  
• Design and Computation Fluid Dynamic Modeling
  

Device Support

• Nebulizers
  
• Metered Dose Inhalers (MDI’s)
  
• Nasal pulmonary delivery
  
• Dry Powder Inhalers
  
• Spacers
  
• Masks (aerosol delivery, O2 delivered, CO2 re breathing)
  
• Novel aerosol delivery devices
  
• Compressors
  
• Ventilators
  
• Filtration Efficiency
  

Testing Support

• Regulatory Compliance testing such as: FDA 510(k), USP-601, USP-467, etc…
  
• Nebulizer characterization
  
• Metered Dose Inhaler characterization
  
• Particle size distribution and mass measurement
  
• Respirable Mass/ Delivered Patient Dose
  
• Generation efficiency testing
  
• Aerosol mass transfer and reproducibility testing
  
• Stability testing
  
• Plume Geometry
  
• EN13544
  
• Simulated Lifetime
  

Formulation Support

• Dry Powders and Suspensions
  
• Jet milling
  
• Micro fluidization
  
• Cyclone elutriation
  
• Eductor processing
  
• Charge masking
  
• Encapsulation and surfactant coatings
  

ARE Labs specializes in using computer modeling and simulation to improve the understanding of our clients devices and exposure systems used to test them.

The benefits of computer modeling applied to the design and testing process include:

• Insight into system design
  
• Foresight by applying ‘what ifs’ to existing systems
  
• Efficiency and performance improvements
  

The science of the predicting fluid flow, heat and mass transfer, chemical reactions, and related phenomena by solving numerically the set of governing mathematical equations is a critical step to the design and testing process.

This key step is unfortunately routinely overlooked by larger commercial research laboratories, but here at ARE Labs we place great importance on the science of computational fluid dynamics modeling.

Computation Fluid Dynamics Modeling Fundamentals

• Steady State and Non-Steady State Modeling
  
• Particle and Multiphase Flow
  
• Reactions and Mixing Kinetics (including Particle Reactions)
  
• Moving and deforming objects (dynamic meshing)
  
• Heat transfer (including particle evaporation)
  
• Custom Physics models through user defined functions
  

Once a computer model is setup and calibrated to laboratory test data many different independent variable can be tested in the simulation at a significant cost saving over running perhaps hundreds of physical laboratory tests. In addition the computer model allows the investigator to more rapidly determine any fundamental errors or discontinuities should one arise.

Modeling Specialties

ARE Labs specializes in using computational dynamics models to predict, not only fluid flow, but particle flow using either Lagrangian or Eulerian models. In addition more complex physics models can be employed, depending on the system being studied. These include: particle collision, coagulation, breakup, surface catalyzed reactions, evaporation and condensation.

• Aerosol delivery and capture devices
  
• Particle delivery and aerosol tract deposition
  
• Particle evaporation and reacting flows
  
• Exposure Systems characterization and validation
  
• Multi species chemical vapor flow
  
• Atmospheric transport for Chem/Bio release scenarios
  

ARE Labs can provide you with critical insight into how your device functions under a variety of different configurations and conditions using computational fluid dynamics modeling.

Particle Deposition

CFD can be used to model complex structures and provide key insight that would be very difficult and costly to perform in the lab. This model can then be used to evaluate the impact on the delivery of the aerosol if the aerosol properties are changed ie. Pure material density, particle density (including porosity), particle size, particle shape, etc…

Delivery of aerosol particles into a complex geometry such as the throat and lungs can even be modeled. The figure to the left illustrates particle impaction efficiency within the mouth and throat based on particle aerodynamic diameter. These models can then be used to optimize the delivery device for drug delivery.

*Atmospheric Dispersion Simulations

Atmospheric Dispersion simulation is a growing field which studies aerosol and vapor dispersion over a large or very large scale. Traditionally these models have used Gaussian dispersion models with to simulate long range dispersions from pollution sources to Chemical Biological or Nuclear attacks.

With the increase in computer power it is now possible to model medium to large scale dispersion with CFD which provides improved accuracy at the cost of computation time. At ARE Labs we have experience in modeling atmospheric dispersion using both Gaussian Dispersion Software and CFD.

Atmospheric Dispersion SimulationsIn addition to the standard models we can help develop a number of additional algorithms to forecast additional effects that are not natively built into standard dispersion models. These custom algorithms could be used to develop: solar obscuration models, modified weather models, traceable source location models or many other models that could simulate the desired effect you are trying quantify.

Inhalation toxicology testing for EPA and FDA compliance and evaluation of industrial compounds, pharmaceuticals, and biological and chemical materials are needed for lethality and toxicity analysis. We have extensive experience in government and Industrial aerosol toxicity testing to evaluate lethal dose and exposure limits through chronic and sub chronic studies. Our expertise is in whole-body and nose-only exposure system design, characterization, and program development and management.

Inhalation Toxicity Toxicity Studies

Aerosol Research and engineering is a key provider for inhalation toxicology studies for pharmaceutical, biotechnology, chemical and consumer clients. We support a wide variety of projects such as vaccine efficacy, testing for inhalational delivered of drugs, agrochemicals, governmental agencies and more recently e-cigarettes and associated consumer delivered inhalation products.

We provide specific studies to conform to:

• OECD – Test No. 403 Acute Inhalation Toxicity
  
• OECD – Test No. 412 Subacute Inhalation Toxicity 28-Day Study
  
• OECD – Test No. 413 Subchronic Inhalation Toxicity 90-day
  
• OECD – Test No. 436 Acute Inhalation Toxicity
  
• 40 CFR 799.9346 – 90-day inhalation toxicity Studies
  
• All 14-day, 28-day and 90-day inhalation studies
  

We can customize any to study to meet your projects required goals. We provide extremely competitive pricing and accurate scientific expertise and analysis. Our staff have perform hundreds of inhalation toxicity exposures with over 20 years experience. We assure you that no other lab can deliver the same expertise and quality when it comes to invitational studies.

Specialties

ARE Labs experience in inhalation toxicology allows for the assessment of the pathogenic effects of viable biological and chemical threat materials and compounds for various animal model population exposure LD50 testing, as well as vaccine efficacy against biological threat agents and nerve agent inhibitor efficacy.

• Nose-only and whole-body exposure systemsSpecialties
  
• In-vivo vaccine efficacy studies
  
• Compound LD50 testing
  
• Aerosol liquid, powder and vapor challenge exposures
  

ARE Labs has the personnel to provide you with a complete analysis for virtually all your inhalation toxicological studies in an efficient and straight forward manner.

Nozzles for bottles, canisters, and sprayers need to be to be rigorously evaluated for specific use for home or industrial applications. A few of these applications include Paints, cleaning compounds, solvents, lubricants, and cosmetics. We have the capability to perform repetitive spray nozzle and pressurized canister aerosol characterization testing including mass output, delivery reproducibility, and particle size distribution analysis.

We also evaluate multiple intra and inter lot aerosol characteristics to assess manufacturing reproduction quality, and also provide aerosol characterization testing and assessment of prototypes. Unbiased head to head comparison testing and operational optimization testing of nozzles from multiple vendors can also be performed to enhance the development, cost effectiveness, and maturation of your product.

Specialties

ARE Labs specializes in evaluate multiple intra and inter-lot aerosol characteristics to assess manufacturing reproduction quality, and provide aerosol characterization testing and assessment of prototypes.

• Aerosol spray device testing and optimization
  
• Particle size distribution and mass measurement
  
• Aerosol can/device reproducibility, stability, and accelerated aging testing
  
• Design services for custom aerosol devices
  
• Dry powder, solution, and suspension analysis
  

Additional Aerosol Services

Devices

• Aerosol Cans
  
• Spray Nozzles
  
• Dry Powders Devices
  
• Utrasonic Devices
  
• Processing Devices
  
• Filtration
  
• Particle/Aerosol Concentrators
  
• Cyclones
  

Testing

• Particle Size Characterization
  
• Plume Geometry
  
• Mass Rates
  
• Respirable Dose Estimates
  
• Effeciency Testing
  
• Reproducibility Testing
  
• Stability Testing
  
• Accelerated Aging
  

Design & Development

• Nozzle Selection
  
• Off-the-Shelf Comparisons
  
• Specialty Device Design
  
• Propellent Formulation
  
• Homogenization
  
• CFD Analysis
  
• Chemical Analysis
  

Pharmaceutical Aerosol Testing, Evaluation and Design

We have extensive experience in aerosol drug delivery device characterization and assessment. Crucial parameters need to be rigorously evaluated before spray devices and drug formulations can be released for clinical trials, FDA approval [510(k) studies], and can be marketed to the public. Our GLP compliant laboratory can help with all aspects of respiratory drug delivery.

We can perform repetitive intra-lot and inter-lot aerosol generation device characterization testing including mass output, drug delivery reproducibility, particle size distribution, and shelf life aerosol stability analysis. We also provide aerosol characterization testing and assessment of single or multiple device prototypes and can performed unbiased head to head comparison testing and operational optimization testing that can enhance the development and maturation of your product.

We offer a complete package for Medical Delivery Device Design and Testing for IR&D and Regulatory Approval. Whether you already have a device that needs testing or you need assistance with the device design we can help. We offer a complete or partial package for Pharmaceutical Aerosol Devices.

Specialties

ARE Labs can provide you a full host of services for all your pharmaceutical aerosol related business operations. ARE Labs’ staff has experience in materials processing for enhanced aerosol dispersion.

• Nebulizer/Inhaler characterization testing
  
• Medical Device Regulatory Compliance Testing: 510(k), USP-601, etc..
  
• Particle size distribution and mass measurement
  
• Stability/ Life-time Testing
  
• Reproducibility and lot-to-lot variability testing
  
• Design and Computation Fluid Dynamic Modeling
  

Manufacturing Services

Formulation & Manufacturing Services

Fabrication Services

Devices Services

Fluid Analysis Services

Physical Analysis Methods Services

Engineering & Devices Services

In vivo Toxicity Testing Services