Inhaler Testing Method Development

You have all the right equipment – how come the results seem a little crazy??

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Good Automated Manufacturing Practices

Testing inhalers is way too routine!  I'm ready to put in some machines but...what machines?  A User Requirements Specification is the right start.  Regulatory agencies demand and thrive upon proper documentation all the way through.  Tell me what you want to do -- I will guide and/or write your documentation, so you move down the trail that leads to the proper destination.

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Training

Why is the only drug-specific inhaler protocol in the USP over 30 years old?  What flow rate is correct for a breath-actuated metered-dose inhaler?  Why can't I get enough flow through my inhaler???

Don't let aerosols put a fog over your team's mindset!  I can help clear the air!

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Make it Look Easy

Your highly skilled staff can make inhaler testing look easy -- I am here to help you shorten the time it takes to get them to this point!!

You are so fortunate to have the skilled professionals on your team who are ready to get the data necessary for product development and batch release.  Help them not waste their time -- let me help you get them going the right direction at the outset.  And when the unexpected happens, let's put our heads together to figure it out.

Is testing in Mexico City the same as testing in the US East Coast -- of course, when properly understood.  Does the density of the particle matter?  Probably not.  Is that coating the right thickness?  Could be.  Let's talk before the problems come up -- droberts@particleprinciples.com; 612-845-3293

 

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It's Your Call...

Plan it, think it through -- so often it is possible to execute well but be on the wrong path -- my job is to corral the possibilities for you so you can get where you need to go, effectively.