Regulatory Compliance Testing

//Regulatory Compliance Testing
Regulatory Compliance Testing 2018-08-03T13:16:26-05:00

Andersen Cascade Impactor used for Regulatory Compliance Testing

ARE Labs Inc. has been helping clients with cGLP Regulatory Compliance Testing for drug delivery devices for over 7 years.  We have extensive experience with Meter Dose Inhaler testing and the corresponding Regulatory Compliance Testing following: FDA nebulizer 510k compliance testing, FDA MDI 510(k) compliance testing, FDA spacer 510k compliance testing and FDA 510k intranasal delivery device testing.  Additionally, we can perform regulatory compliance testing.  All of our studies come with a fully documented professional 2-coulmn journal article report suitable for publication to help increase the confidence and visibility of your product, no other lab offers this type of service.

We have a unique proprietary setup which combines standard cascade impactor method with real-time in-situ particle size analysis.  This system will not only give you cumulative data that a cascade impactor provides but also time-sensitive data such as changes in particle size distribution, MMAD (Mass Median Aerodynamic Diameter) , GSD (Geometric Standard Deviation) over the duration of the treatment time.  This added data can provide useful insight into your product that no other test methodology can provide.  Clinical in-vitro characterization of your aerosol drug device is critical for regulatory approval of your product and ARE Labs can help you navigate and provide all your testing needs.

Additional testing services include a simulated breathing human model to evaluate total inhaled drug and real-time particle size data simultaneously.  We can control tidal volume, breathing frequency and I:E ratios to gather delivered dose data under any respiratory condition.

Whatever your cGLP regulatory compliance testing needs are ARE Labs Inc. can help out.  Let us take the mystery out of FDA 510(k) compliance testing for nebulizers, meter dose inhalers (MDI’s), spacers , aerosol delivery masks and even combination devices such a ventilators.

Typical Regulatory 510(K) Testing Project Timeline

Selection of Predicate: 1 week
Device Testing: 2-3 weeks
Reporting – 1 weeks

Nebulizer Testing

Regulatory Compliance Testing

FDA 510(k) Testing

Nebulizer 510(k) Testing

Metered Dose Inhaler 510(k) Testing

Spacer 510(k) Testing

European Standards

MDI Testing

USP <601> Testing

Canadian Standards

Validation Testing

Stability Testing

Accelerated Aging Studies

Simulated Lifetime Testing

Spacer Testing

Stability Testing

Respirable Dose and Fraction

 Dose Uniformity Testing

 Treatment Time Testing

 Biocompatibility Testing

Additional Benefits for Regulatory Testing with ARE Labs

With our extensive knowledge base and our multiple real-time laser diffraction particle size analyzers we can screen may different predicates to help select the best predicate which matches your medical aerosol device.  This selection process helps to keep your cost down and helps to grantee a successful application process.

If you would like more information on nebulizer testing, MDI testing or Spacer Testing please visit our Aerosol Device Testing page.

For Additional Pharmaceutical Aerosol Services see the following: Aerosol Device DesignAerosol Device Molding and Pharmaceutical Formulation

Cascade Impactor (typically Andersen)

Integrated Real-TIme Laser Diffraction

HPLC analysis of API

FDA Guidance for Nebulizers, MDI’s and Spacer Testing

UPS guidance documents

EU standards

Custom Methods for any application

nano-HPLC with UV detection (standard)

HPLC w CAD detection (API’s without strong UV signatures)

UV/VIS Spectrophotometer

Fluorometer

albuterol sulfate

ipratropium bromide

budesonide

cromolyn sodium

fluticasone / salmeterol

mometasone / formoterol

sodium fluoride

Nebulizers

Metered Dose Inhalers

Dry Powder Inhalers

Spacers

Intranasal Vaccine Delivery Devices

Aerosol Masks

Ventilators with integrated Aerosol Delivery

Fully compliant cGLP testing

QA Reviews

Internal SOP’s

Publishable Journal Articles