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///Nebulizer Performance – In Vitro Test Study Plan for 510(k) Submissions

Nebulizer Performance – In Vitro Test Study Plan for 510(k) Submissions

About this Chemistry, Manufacturing and Controls Documentation

Next Breath is a full service cGMP compliant laboratory for analytical testing of nebulizers for pre-market 510(k) approval. We have extensive experience with air-jet, ultrasonic and small volume/high output nebulizers. Next Breath has also worked with nebulizers intended for use with ventilators and oxygen/helium compressed air sources. Using the study design as described below for a model air-jet nebulizer, Next Breath will customize a program to meet your requirements, help select a predicate device, conduct the relevant experiments, interpret the test results and generate a report suitable for inclusion in your regulatory submission. We also offer cleaning validation experiments and a full range of biocompatibility testing such as volatile organic components.

Next Breath also has expertise testing add-on devices such as spacers and holding chambers. In addition, NextBreath provides formulation development services of active pharmaceutical ingredients (API) for nebulized platforms.

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2017-11-19T01:18:53+00:00