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Subject:
From:
Frank Settineri <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 8 May 2020 15:14:58 +0000
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In the past I worked with a company that made an inhaled dry powder product for cystic fibrosis patients and we tested the powder for B. cepacia.  I imagine the same holds true now, particularly with the issuance of <60>.  If the product is being inhaled, even if for non-CF products, it's the right thing to do (testing for Bcc). 
Thanks
Sincerely,

Frank Settineri 
Veracorp LLC 
Sparta, New Jersey 
908-499-5540 
www.veracorp.biz 
http://www.linkedin.com/in/veracorp

Strengthening Businesses, Strengthening Lives

 

    On Friday, May 8, 2020, 09:50:23 AM EDT, Timothy Cser <[log in to unmask]> wrote:  
 
 Good question Marianne.  What is the patient population?...ie asthma, etc.

Tim Cser
MilliporeSigma
MilliporeSigma is a division of Merck KGaA, Darmstadt, Germany

> On May 7, 2020, at 4:58 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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Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

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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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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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