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June 2020

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Subject:
From:
Dnyaneshwar Talbhoge <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 30 Jun 2020 07:55:28 +0530
Content-Type:
text/plain
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text/plain (111 lines)
Hi,
Here is my suggestion

1. All the components coming in product contact required testing and
conform to established specification (this includes TAMC, TYMC and absence
of objectionable microorganisms)

2. If product delivery happens through additional connections, then YES it
is required to under classified area to avoid microbial contamination
during assembling and packaging.

3.  You should perform final testing after assembling all device
parts/pathway. This will provide quality results for your drug product
including delivery device.

Hope this will help you.

Regards
Talbhoge



On Tue, 30 Jun 2020 at 4:15 AM, Michael Barton <[log in to unmask]>
wrote:

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

D.M. Talbhoge

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The PMFList is supported by our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



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/


=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of the PMF or the sponsors of the list.

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