All,
i think that this stetement is making things unclear


''The tests are designed to determine whether a substance or preparation complies with an established specification for microbiological quality and/or to evaluate whether products—especially those for inhalation use or aqueous preparations for oral, oromucosal, cutaneous, or nasal use—contain members of the Bcc''

it says especially, so to me it is telling you that you need to do it for these products.

it also doesnt clarify if its a DPI or pMDI with propellant, but it singles out those for inhalation use from the aqueous preparation. i interpret that as inhalation products need testing and not just the aqueous products.

thoughts?

Mike.

________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Donald English <[log in to unmask]>
Sent: 08 May 2020 00:04
To: [log in to unmask] <[log in to unmask]>
Subject: Re: [PMFLIST] USP <60> Testing on Non-Aqueous Inhalation Products

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
>
>
>
>
>
>
>
> ------------------
> 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.