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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:
Tue, 30 Jun 2020 18:59:08 +0000
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Hi Robert,
thanks for the information.
even though you were not involved in the set up have you had experience of being questioned about the practice by regulatory bodies and explain the reasoning? how was it received etc..

Im assuming that in your product the fluid will also then flow through the applicator into the patient. do you do any tetsing of these applicator parts to show low bioburden and have assembly controls to then minimise any additional contamination risk?

i can see good points for both situations (in a clean room and not in a cleanroom) for assembing the device around the sealed vial/bottle. if you are testing for micro via the final the shot collections through the assembled device then you should pick up any challenge from the whole process. overall it is if we deem acceptable risk of this assembly part outside a cleanroom that could add contamination and result in a failure to meet spec.

i just cant see any clear instructions on this step of device assembly and hoping it is how we can justify the practice.

Mike
________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Robert Pritchett <[log in to unmask]>
Sent: 30 June 2020 14:06
To: [log in to unmask] <[log in to unmask]>
Subject: Re: [PMFLIST] non-sterile product - component parts testing and assembly

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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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.

------------------
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/


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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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