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June 2020

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Subject:
From:
Michael Barton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 29 Jun 2020 19:09:09 +0000
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Hi All,
a few questions related to componentry please


  1.
If i have a nasal spray do i have to test the component parts that are primary packaging for the non-sterile product?
  2.
If i have a design where the product is filled into a small bottle with a stopper (Grade D cleanroom), however this bottle/stopper is then packaged into a device that acts as a nasal spray and when activated the product flows up through the nasal spray nozzle, does this additional packing step still need to be done in the Grade D area?

It seems to me that my product is contained in its primary packaging so its quality is protected, but it will flow through a device part that could add micro bioburden.  I have though about other examples and in an inhaler you have a synchroner mouthpiece that you put in your mouth and wouldnt test this and wouldnt expect to have the packing line in a Grade D room. Its unlikley to maintain classification with these processes.

thanks
Mike



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