PMFLIST Archives

May 2020

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Proportional Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Timothy Cser <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 11 May 2020 17:24:00 +0000
Content-Type:
text/plain
Parts/Attachments:
text/plain (159 lines)
Hi Marianne.  It does state that USP 60 applies to inhaled products and the fact that your product is inhaled directly by COPD patients where Burkholderia could colonize and create a serious respiratory infection.  In your case, I would certainly test for Bcc.

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Marianne Smith CW
Sent: Friday, May 8, 2020 6:59 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Testing on Non-Aqueous Inhalation Products

Hi Tim,

The non-aqueous inhalation product is for asthmatics or patients suffering from COPD.

Thanks,

Marianne

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Timothy Cser
Sent: Thursday, May 07, 2020 5:02 PM
To: [log in to unmask]
Subject: [EXTERNAL] Re: [PMFLIST] USP <60> Testing on Non-Aqueous Inhalation Products

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
>
>
>
>
>
>
>
> ------------------
> 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 - https://clicktime.symantec.com/3JYAGbWUXVVJvEfinwHwf1d6H2?u=http%3A%2F%2Fwww.sterislifesciences.com%2F
>
> Charles River Laboratories - https://clicktime.symantec.com/3XqTMDFiUDDETj5jBBgJt2G6H2?u=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6
>
> Veltek Associates, Inc - https://clicktime.symantec.com/3TmAKKswca2TX64iNgQxtCm6H2?u=http%3A%2F%2Fwww.sterile.com
>
> Microbiologics, Inc. - https://clicktime.symantec.com/33236DgNf7zyV9J67bPn2vk6H2?u=http%3A%2F%2Fwww.microbiologics.com
>
> BD Industrial Media - https://clicktime.symantec.com/3MetFQRqvXH7F6WEt8qwwZq6H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F
>
> Associates of Cape Cod, Inc. - https://clicktime.symantec.com/3MX55QN3RzVbnWPf7xa4jGt6H2?u=http%3A%2F%2Fwww.acciusa.com%2F
>
>
> =================================
> 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.


This message and any attachment are confidential and may be privileged or otherwise protected from disclosure. If you are not the intended recipient, you must not copy this message or attachment or disclose the contents to any other person. If you have received this transmission in error, please notify the sender immediately and delete the message and any attachment from your system. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not accept liability for any omissions or errors in this message which may arise as a result of E-Mail-transmission or for damages resulting from any unauthorized changes of the content of this message and any attachment thereto. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not guarantee that this message is free of viruses and does not accept liability for any damages caused by any virus transmitted therewith.



Click https://clicktime.symantec.com/3KzmVHygozAnbfk3sqHWocg6H2?u=http%3A%2F%2Fwww.merckgroup.com%2Fdisclaimer to access the German, French, Spanish and Portuguese versions of this disclaimer.

------------------
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 - https://clicktime.symantec.com/3YVmiyMwN9Troc5wN8w7mv86H2?u=http%3A%2F%2Fwww.sterislifesciences.com%2F

Charles River Laboratories - https://clicktime.symantec.com/3Ms9yhz7hfhnRxUV1q9iAWU6H2?u=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6

Veltek Associates, Inc - https://clicktime.symantec.com/32UarXpaMVYjqmn7uaje3SE6H2?u=http%3A%2F%2Fwww.sterile.com

Microbiologics, Inc. - https://clicktime.symantec.com/36XWYqKHTsNgq2cLohA75sG6H2?u=http%3A%2F%2Fwww.microbiologics.com

BD Industrial Media - https://clicktime.symantec.com/3DSQqcjotKoicAKjciBqLE26H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F

Associates of Cape Cod, Inc. - https://clicktime.symantec.com/3B89UJwWSjxxG1nHv9AVN746H2?u=http%3A%2F%2Fwww.acciusa.com%2F


=================================
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 - https://clicktime.symantec.com/3YVmiyMwN9Troc5wN8w7mv86H2?u=http%3A%2F%2Fwww.sterislifesciences.com%2F

Charles River Laboratories - https://clicktime.symantec.com/3Ms9yhz7hfhnRxUV1q9iAWU6H2?u=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6

Veltek Associates, Inc - https://clicktime.symantec.com/32UarXpaMVYjqmn7uaje3SE6H2?u=http%3A%2F%2Fwww.sterile.com

Microbiologics, Inc. - https://clicktime.symantec.com/36XWYqKHTsNgq2cLohA75sG6H2?u=http%3A%2F%2Fwww.microbiologics.com

BD Industrial Media - https://clicktime.symantec.com/3DSQqcjotKoicAKjciBqLE26H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F

Associates of Cape Cod, Inc. - https://clicktime.symantec.com/3B89UJwWSjxxG1nHv9AVN746H2?u=http%3A%2F%2Fwww.acciusa.com%2F


=================================
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.


This message and any attachment are confidential and may be privileged or otherwise protected from disclosure. If you are not the intended recipient, you must not copy this message or attachment or disclose the contents to any other person. If you have received this transmission in error, please notify the sender immediately and delete the message and any attachment from your system. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not accept liability for any omissions or errors in this message which may arise as a result of E-Mail-transmission or for damages resulting from any unauthorized changes of the content of this message and any attachment thereto. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not guarantee that this message is free of viruses and does not accept liability for any damages caused by any virus transmitted therewith.



Click http://www.merckgroup.com/disclaimer to access the German, French, Spanish and Portuguese versions of this disclaimer.

------------------
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.

ATOM RSS1 RSS2