Dear Marianne,

If the product formulation does not contain water making it an aqueous
product formulation, there is no need to conduct USP Chapter 60 on this
non-aqueous product formulation.

Regards,
Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932

On Thu, May 7, 2020 at 7:58 PM Marianne Smith CW <[log in to unmask]> wrote:

> Dear Forum.
>
> Can anyone tell me if they are performing USP <60> testing on Non-Aqueous
> Inhalation Products?  We are getting ready to validate a microbial method
> for a new inhalation product and we were wondering if we should include the
> USP <60> tests for Burkholderia cepacia complex if there is no water in the
> formulation.
>
> Best regards,
>
> Marianne
>
>
>
>
>
>
>
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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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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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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.