Dear Michael,
If the formulation is used in a product package that is used in a single application, there is no need to conduct USP Chapter 51 testing. If the same formulation is used in a product package that is multi dose, challenge testing would be required on that product formulation. With a single use product formulation, you need to justify the inclusion of a preservative and it cannot be used to take care of any manufacturing issues.
Regards,
Don
Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932
Sent from my iPhone
> On May 14, 2020, at 9:04 AM, "[log in to unmask]" <[log in to unmask] wrote:
>
> Single use does not require PET.
>
> Michael
>
>
>
> Sent from my iPhone
>> On May 14, 2020, at 1:29 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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>> 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
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>> BD Industrial Media - http://www.bd.com/ds/
>>
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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.
------------------
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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