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July 2020

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Subject:
From:
Stephen Langille <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 21 Jul 2020 14:03:13 -0400
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Don and Alison,

I can't speak for all regulatory authorities but the FDA almost never requires speciation of WFI isolates due to the significant downstream sterilization controls that are implemented to neutralize the bulk drug product bioburden.  Speciation could be requested to investigate a catastrophic sterility assurance failure but it's rare.  The choice not to speciate WFI organisms is supported by a risk assessment showing that the levels of microbial contamination in the raw materials (including water) and pre-filtration bioburden cannot withstand the sterilization process and are not of a sufficient population to affect the purity, strength, potency or quality of the finished drug product.  The same risk assessment process can be used to determine if testing for B. cepacia complex in pharmaceutical water systems used for the manufacture of non-sterile drug products is necessary.  Usually it is not, but there are instances where testing water systems for B. cepacia complex may be beneficial due to factors such as manufacturing/product history, weak downstream controls, or the unique nature/intended patient population of the drug product.  

Best,

Steve  

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Donald English
Sent: Sunday, July 19, 2020 8:06 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Chapter <60>

Hi Allison,

I see that no one had responded back to your posting about using USP Chapter 60 in a sterile manufacturing facility.

In the introduction of USP Chapter 60, it is stated as follows:

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.

In reality, there is no reason for using USP Chapter 60 because the chapter is for non-sterile aqueous and inhalation products based upon the introduction of the chapter.  However, it is stated in the testing product section that it may be used for the testing of pharmaceutical waters.  It would be interesting to see if regulatory authorities would require Water-for-Injection that is used for making sterile product formulations be tested for the presence of Burkholderia cepacia complex by using the methodology of this chapter by having this particular sentence in the chapter.

By having this sentence present in the chapter, I would suspect that you would be required to conduct Burkholderia cepacia complex of collected Water-for-Injection samples because it is kind of vague of what is meant as pharmaceutical water in the chapter.  From my perspective, the presence of any Gram-negative bacterial species in Water-for-Injection samples would be objectionable.

Regards,
Don

Donald J. English Microbiological Quality Consulting LLC Florham Park, New Jersey 07932







On Fri, Jul 17, 2020 at 7:35 AM Berman, Alison <[log in to unmask]>
wrote:

> Hello,
>
> Is anyone performing chapter <60> testing at a sterile injectable 
> manufacturing company, at any stage of manufacturing?
> Is there any reason one may do so and if yes, on what would the test 
> be performed?
>
>
> Thanks
>
>
>
> Alison Berman, MFS
> Supervisor
> Quality Control - Microbiology
>
> [AMR_Logo_for Email Signatures_19DEC]
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> O 631.924.4000 ext. 379
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> Veltek Associates, Inc - http://www.sterile.com
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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.
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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 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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