Nebulizer Testing and Development

Nebulizer Aerosol Testing Services at ARE Labs

Nebulizer Testing and Development

Nebulizer Aerosol Testing Services at ARE Labs

Nebulizer Testing and Development

Nebulizer Aerosol Testing Services at ARE Labs

At ARE Labs, we specialize in comprehensive nebulizer aerosol testing, delivering essential insights for the development and improvement of nebulizer devices and therapies as well as spacers intended for use with nebulizers. Our expert team utilizes state-of-the-art technology to ensure that your nebulizer products meet the highest standards of efficacy, safety, and quality.

At ARE Labs, we specialize in comprehensive nebulizer aerosol testing, delivering essential insights for the development and improvement of nebulizer devices and therapies as well as spacers intended for use with nebulizers. Our expert team utilizes state-of-the-art technology to ensure that your nebulizer products meet the highest standards of efficacy, safety, and quality.

At ARE Labs, we specialize in comprehensive nebulizer aerosol testing, delivering essential insights for the development and improvement of nebulizer devices and therapies as well as spacers intended for use with nebulizers. Our expert team utilizes state-of-the-art technology to ensure that your nebulizer products meet the highest standards of efficacy, safety, and quality.

Our Advanced Testing Capabilities

Our Advanced Testing Capabilities

Our Advanced Testing Capabilities

  • Particle Size Distribution Analysis: Using sophisticated methods, we measure the particle size distribution of aerosolized drugs delivered by nebulizers. This analysis is crucial for ensuring optimal drug deposition in the lungs and effective treatment.

  • Droplet Aerosol Testing: We evaluate the droplet size and distribution to understand the nebulizer's performance in creating a breathable aerosol that can reach targeted areas in the respiratory tract.

  • Drug Delivery Efficiency: Our tests assess the efficiency of drug delivery, ensuring the maximum amount of medication is delivered to the patient with minimal wastage.

  • Customized Testing Protocols: Tailoring our services to your specific needs, we develop customized testing protocols that align with industry standards and regulatory requirements.

Testing Services Offered

Testing Services Offered

Testing Services Offered

We offer a wide array of testing services to help insure that your device is effective and compliant with regulatory requirements. Some of our testing services include:

  • Delivered Dose Testing: In order to deliver API to the lungs, the product must produce particles or droplets that are less than 5μm.  By measuring the drug particle size distribution, we are able to approximate how much drug is delivered and where it will be deposited in the lung.  Working to pharmacopeia methods we determine aerodynamic particle size distribution (APSD) by cascade impaction methods as well as laser diffraction measurements. We utilize two instruments that are commonly used to characterize the particle size distribution include the Anderson Cascade Impactor (ACI) and the Next Generation Impactor (NGI). The APSD is a critical quality attribute in the development and testing of inhaled and nasal products. Utilizing HPLC analysis we can determine the concentration of the API throughout the particle size distribution ensuring your device is producing particle sizes optimized for inhalation.

  • Laser Diffraction Particle Size Analysis: Particle or droplet size testing by laser diffraction provides a rapid screening tool and can provide valuable performance data which is particularly useful in early-stage formulation development. We utilize several different advanced laser diffraction instruments to characterize the native particle size distribution output by the device. However, this method does not discriminate between multiple components in a formulation and so must be used alongside aerodynamic cascade impaction tests later in development, unless the product is a solution. Laser diffraction produces results for Mass Median Aerodynamic particle size (MMAD), Geometric Standard Deviation (GSD) and overall particle size distribution. ARE Labs utilizes the latest laser diffraction technology such as Malvern Spraytec Laser Particle and Droplet Sizing as well as TSI Aerodynamic Particle Sizers. We also have the capabilities to measure nanoparticles (<500nm) using a TSI Fast Mobility Particle Sizer.

  • Spray Pattern and Plume Geometry: Spray pattern and plume geometry characterization during development is a regulatory requirement for Meter Dose Inhaler (MDI) and nasal spray products aimed at the US market (with the majority of European developers also including this information in their submissions). Spray pattern data is also required for release testing. The shape, angle and duration of plume is highly influential in the uniform delivery and bioavailability of the product, and therefore product efficacy. For a nasal spray, for example, the shape of the plume and how it disperses will affect where the drug product is it deposited in the lungs or nasal regions and this in turn affects absorbance and bioavailability. Our scientists use automated actuation and analysis by instruments such as the Proveris SprayView which incorporates actuation and high-speed imaging to obtain accurate and robust data that enables you to calculate various parameters. 

  • Formal Product Characterization Studies: As per the CMC guidance of inhaled products, a range of product characterization studies are required to be performed that assess the robustness of the device and formulation across various in-use situations. ARE Labs has a wealth of experience in generating appropriate protocols and performing these studies. This includes simulated lifetime testing, accelerated aging studies and stability testing.

Why Choose ARE Labs for Nebulizer Aerosol Testing?

Why Choose ARE Labs for Nebulizer Aerosol Testing?

Why Choose ARE Labs for Nebulizer Aerosol Testing?

  • Industry Expertise: With years of experience in aerosol science, our team brings an in-depth understanding of nebulizer technology and respiratory drug delivery.

  • Cutting-Edge Technology: We employ the latest in aerosol testing equipment, ensuring precise and accurate results.

  • Regulatory Compliance: Our testing services are designed to help you navigate the regulatory landscape, ensuring your products comply with FDA, ISO, and other relevant standards.

  • Client-Centric Approach: We work closely with our clients, offering personalized service and expert guidance throughout the testing process.

Partner with Us

Partner with Us

Partner with Us

Explore our nebulizer aerosol testing services and discover how ARE Labs can assist in optimizing your nebulizer products for market success. Whether you're in the early stages of product development or preparing for regulatory submission, we provide the critical testing services you need.

Contact Us Today

To learn more about our nebulizer aerosol testing services or to discuss your specific testing needs, contact us. Let ARE Labs be your partner in achieving excellence in respiratory treatment solutions.

Contact Us Today

To learn more about our nebulizer aerosol testing services or to discuss your specific testing needs, contact us. Let ARE Labs be your partner in achieving excellence in respiratory treatment solutions.

Contact Us Today

To learn more about our nebulizer aerosol testing services or to discuss your specific testing needs, contact us. Let ARE Labs be your partner in achieving excellence in respiratory treatment solutions.

At ARE Labs, we pride ourselves on adhering to the highest standards of regulatory compliance. All our testing services are conducted in strict accordance with FDA guidelines and cGLP (current Good Laboratory Practice) regulations, ensuring our clients receive results that are both reliable and recognized by regulatory bodies.

At ARE Labs, we pride ourselves on adhering to the highest standards of regulatory compliance. All our testing services are conducted in strict accordance with FDA guidelines and cGLP (current Good Laboratory Practice) regulations, ensuring our clients receive results that are both reliable and recognized by regulatory bodies.

At ARE Labs, we pride ourselves on adhering to the highest standards of regulatory compliance. All our testing services are conducted in strict accordance with FDA guidelines and cGLP (current Good Laboratory Practice) regulations, ensuring our clients receive results that are both reliable and recognized by regulatory bodies.