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June 2020

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Subject:
From:
"Sattelberg, Nicholas" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 16 Jun 2020 18:40:43 +0000
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Hello,

We are being asked to test the placebo of a product in an MDI canister for MET as part of the release spec.  We do test these types of products, the only problem is for this placebo there is nothing  in the formulation besides HFA. Once opened the HFA is going to evaporate leaving you with nothing but an empty canister. I am not sure what approach to take on this besides just doing a rinse of the inside of the canister? There's not really any guidance on something like this since there is no solid/liquid product to test and it's not a something you would test like a device.

I was curious if anyone has run across a scenario like this. The only other option I could think of would be to expel the HFA through a filter but I'm not sure if that would be the best approach.

Nick Sattelberg
Group Leader, Microbiology


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