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June 2020

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Subject:
From:
"Shah, Samir" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 30 Jun 2020 19:14:12 +0000
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Hello Michael,

Assuming the product will require medical device file 510K. The design history file must include a proper risk assessment of all decisions made from component testing, manufacturing, filling and assembly. The risk assessment should reflect the determination of risk factors, their failure mode effect analysis. Decision made based on such well laid out risk assessment and documentation will be accepted by regulatory agency. And if your device application requires approval, this will serve as very good evidence for your decisions.

-Samir



-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Robert Pritchett
Sent: Tuesday, June 30, 2020 10:07 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] non-sterile product - component parts testing and assembly

[Use CAUTION when opening links/attachments]

Hello Michael,

I can offer up how nasal spray products are handled where I work. However, our nasal spray products were inherited from someone else and I was not personally involved with the decision making process during development or drug application submission, so please keep that in mind.

1. The stoppers and glass vials that directly contact the spray fluid are checked for bioburden as each lot of components is received.
2. The mixing and filling operations are performed in Grade D cleanrooms but the final nasal spray assembly into the final applicator is not done in a cleanroom.

-RP

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Michael Barton (External)
Sent: Monday, June 29, 2020 1:09 PM
To: [log in to unmask]
Subject: [PMFLIST] non-sterile product - component parts testing and assembly

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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Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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