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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 24 Jun 2020 18:28:27 -0400
Content-Type:
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Dear Nicholas,



From my experience, I have always used the chilling method for sampling
pressurized aerosol inhalation products in which the outside of the
containers was disinfected first with sterile 60-70% alcohol and allowed to
dry.  After the outside of the aerosol containers were dried, they were
placed into a dry ice bath or a low temperature freezer for freezing before
the containers were punctured for conducting microbial sampling.



I always wonder about the ice maker water tap line that is present in USP
Chapter 610.  I think that the device that you are looking for from USP
Chapter 610 is an actual ice maker water tap line connector that is used
normally to connect a refrigerator ice maker to a copper water line within
the house.  By connecting a sterile plastic hose to the end of the ice
maker water tap line connector that is used to deliver water to a
refrigerator ice maker, you can control the flow of the contents of an
aerosol container into a diluent or broth by puncturing a hole into the
pressurized aerosol container by using the needle of an ice maker water tap
connector and withdrawing the needle to control the flow out of the
 punctured container.  These ice maker water tap line connectors are
readily available at a hardware store.



I will admit that I have never seen a commercial sampling device with a
needle for puncturing pressurized aerosol inhalation containers since I
believe that the marketplace for such a sampling device would be
exceedingly small.



Don



Donald J. English Microbiological Quality Consulting LLC

Florham Park, New Jersey 07932

On Wed, Jun 24, 2020 at 8:31 AM Sattelberg, Nicholas <
[log in to unmask]> wrote:

> Hello,
>
> USP <610> describes alternate sampling methods for inhalation and nasal
> products; under the "room temperature method" for high-content INDP it
> mentions using a ice maker water tap line or other type of needle apparatus
> to puncture the canister and expel the contents through a line, either into
> a vessel or directly into the broth/buffer media.
>
> I was curious if anyone knows of any devices available for this specific
> purpose? We have automatic can cutters but that is an enclosed unit that
> cuts the entire top of the canister off, so that wouldn't work in this
> application. I'm looking for something that will allow controlled release
> of the MDI contents into a vessel.
>
> Thank you,
>
> Nick Sattelberg
> Group Leader, Microbiology
>
>
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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.

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