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May 2020

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Subject:
From:
Leonard Mestrandrea <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 11 May 2020 11:45:00 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (233 lines)
Dear Frank and Don,
I could not disagree with both of. Gram negative microorganisms should never be allowed in the product category you both mentioned,
Len

Sent from my iPad

> On May 11, 2020, at 9:32 AM, Frank Settineri <[log in to unmask]> wrote:
> 
> Don, 
> I couldn't agree more.  In addition, CF patients are susceptible to gram positive microorganisms as well, such as  Mycobacterium abscessus and Staph aureus.  Stenotrophomonas maltophilia (gram negative) is also pathogenic for these patients.  
> Although it's remote that these microorganisms would be found in dry powders, I would test for them as an extra measure of safety. 
> 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 Saturday, May 9, 2020, 10:15:52 AM EDT, Donald English <[log in to unmask]> wrote:  
> 
> Dear Frank, 
> 
> I agree with you that sometimes you have to conduct testing on a product formulation no matter what is indicted in the USP to have that assurance that your product would not cause any harm to the patient or consumer even though the possibility of having the presence of a particular type of microbial contamination is remote.  From my perspective, the presence of any type of a Gram-negative bacilli in an inhalation product would be unacceptable.
> 
> Regards,
> Don
> 
> Sent from my iPhone
> 
>> On May 8, 2020, at 1:12 PM, Frank Settineri <[log in to unmask]> wrote:
>> 
>> Yes, USP is clear, however if I were manufacturing the product I would feel more comfortable exceeding the regs and testing the powder for Bcc.  I like to get a good night's sleep. 
>> 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, 09:53:55 AM EDT, Jeanne Moldenhauer <[log in to unmask]> wrote:  
>> 
>> The USP is very clear that the requirement for BCC testing is for aqueous,
>> nonsterile products.
>> 
>> Jeanne Moldenhauer
>> 
>>>> On Thu, May 7, 2020 at 6:58 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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>>> 
>>> 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
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>> 
>> ------------------
>> 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.
> 
> 
> ------------------
> 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.

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