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May 2020

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Subject:
From:
Rick Jakober <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 14 May 2020 19:58:16 +0000
Content-Type:
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We have tested many single use products, even ones that are non-aqueous, because of the FDA's request to test anything with a preservative in it, single-use or multi-use. Their justification when asked, seems to be from these two statements from the intro to USP <51>:

"Antimicrobial preservatives are substances added to aqueous pharmaceutical products. Nonsterile dosage forms may have preservatives added to protect them from growth of microorganisms inadvertently introduced during or subsequent to the manufacturing process."

and

"Antimicrobial effectiveness, whether inherent in the product or produced because of the addition of an antimicrobial preservative, must be demonstrated for all injections packaged in multiple-dose containers or for other products containing antimicrobial preservatives."

The two sections, " Nonsterile dosage forms may have preservatives added to protect them....." and " Antimicrobial effectiveness, whether inherent in the product or produced because of the addition of an antimicrobial preservative, ........... or for other products containing antimicrobial preservatives."

The second section does not mention single or multi-use nonsterile products with the statement "or for other products containing antimicrobial preservatives." This seems to be the statement that the agency is using for any product with a preservative in it. 

Rick Jakober
Perritt Laboratories, Inc.

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Michael Barton
Sent: Thursday, May 14, 2020 11:05 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] PET test

Tony,
this would be a new developed product for a single use that has a preservative as part of formulation, not from an existing multi use.

why would it need to be justified with FDA?
and if AET is required is this just as part of development work or for routine stability assessment?

Thanks
Mike
________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Tony Cundell <[log in to unmask]>
Sent: 14 May 2020 12:37
To: [log in to unmask] <[log in to unmask]>
Subject: Re: [PMFLIST] PET test

Adding a preservative system to a single-use nasal spray would need to be justified to the FDA and when justified pass the USP <51> Antimicrobial Effectiveness Test.

Do you share the same formulation with a multiple use products? Is that the reason?

On Thu, May 14, 2020 at 1:27 AM Michael Barton <[log in to unmask]>
wrote:

> Hi All,
> if we have a single use non-sterile nasal spray that is preserved, 
> does it require PET to be performed or is this only needed for multi 
> dose product as this can be contaminated by patient during routine use?
>
> Thanks Mike
>
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> Steris - http://www.sterislifesciences.com/
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> 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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--
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

------------------
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.

------------------
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.

------------------
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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