PMFLIST Archives

November 2018

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced 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:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 14 Nov 2018 11:50:31 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (328 lines)
Dear Frank,

I believe that the FDA makes a recommendation to use selective media for conducting microbial testing on purified and WFI water is based upon good intentions, but has very little scientific justification especially if a company is performing microbial identifications directly on recovered microbial isolates from the plate count.  Besides, some of the recovered microorganisms that are being isolated on PCA or R2A will not be to grow on selective media due to their inhibition characteristics of the media.  However, you can not fight city hall at times.

Don
Consultant
Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932
1-732-208-3072

Sent from my iPhone

> On Nov 14, 2018, at 9:33 AM, Tony Cundell <[log in to unmask]> wrote:
> 
> Daniela,
> 
> Don is a gentleman not wanting to criticize you.
> 
> If your WFI is a hot water system it may be be difficult to justify doing
> microbial counts with R2A agar and certainly not using selective media.
> 
> One problem I routine encounter is companies are struggling with justifying
> eliminating test and reducing testing levels. A simple approach is too
> review the regulations and guidance documents and if the testing is not
> specifically cited it is not required. Look back to determine when and why
> the tests were introduced. The reasons may include response to a regulatory
> inspection, interval audit or the appoint of a poorly informed manager. The
> next step is to review the historic recored to demonstrate these organisms
> are not being isolated and writing a change control including a
> justification to eliminate the testing
> 
> These tests are not value added and if you get a failure it will lead to an
> unnecessary investigation.
> 
> Tony
> 
> 
> On Wed, Nov 14, 2018 at 12:06 AM Donald English <
> [log in to unmask]> wrote:
> 
>> Dear Daniela,
>> 
>> 
>> 
>> I’m not going to criticize you for using selective media such as Cetrimide
>> Agar and M-Endo Broth in the first place for conducting microbial content
>> testing of WFI samples.  Before you make a change in how you are testing
>> WFI samples from your current practice, you will need to justify as to why
>> you are no longer using M-Endo Broth for the detection of coliforms and
>> Cetrimide Agar for the detection of fluorescent Pseudomonas species (e.g.
>> Ps. aeruginosa, Ps. fluorescens and Ps. putida).  I would not consider it
>> to be a validation document, but you can call it whatever you want to call
>> it.  In going forward, I would suggest that you stay with either PCA or R2A
>> to determine the enumeration levels of WFI samples.  To justify the change
>> in not using M-Endo Broth and Cetrimide Agar, I would go back to your past
>> generated microbial test data (counts and identification of recovered
>> isolates) for each of the used microbial media that was used in testing all
>> of your WFI sampling points.  If you can demonstrate that you are also
>> obtaining the sample types of microorganisms that had been isolated on your
>> microbial count media PCA or R2A) as to what had been selected on your
>> microbial selective media (M-Endo Broth and Cetrimide Agar), you can then
>> delete the use of the selective microbial growth media for the microbial
>> analysis of WFI samples because you are obtaining the same types of
>> microorganisms on your count plates and selective media..  After you have
>> generated this justification document for the proposed change, you will
>> need to change your microbial test methods for conducting microbial testing
>> of WFI samples.
>> 
>> 
>> 
>> Don
>> 
>> Consultant
>> 
>> Donald J. English Microbiological Quality Consulting LLC
>> 
>> Florham Park, New Jersey 07932
>> 
>> 1-732-208-3072
>> 
>> 
>> On Tue, Nov 13, 2018 at 4:26 PM Bob Friedel <[log in to unmask]>
>> wrote:
>> 
>>> Why are you using selective media in an oligotrophic environment such as
>>> WFI?  m-Endo would only apply to raw, incoming, city-supplied or well
>>> water, as E. coli would not be present in WFI.
>>> 
>>> Bob
>>> 
>>> 
>>>> On Nov 12, 2018, at 2:11 PM, Daniela Lento <[log in to unmask]>
>>> wrote:
>>>> 
>>>> Hello,
>>>> 
>>>> How do you go about removing media for testing?
>>>> For example, we filter WFI on PCA, R2A, m-Endo and CETA. We identify
>> the
>>> microbial recovery on all media and we have data supporting the removal
>> of
>>> filtering WFI on the selective media.
>>>> Is a retrospective validation sufficient? What is written in this
>>> document? Should it even be considered a validation document?
>>>> 
>>>> Thank you
>>>> 
>>>> ------------------
>>>> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated
>>> from
>>>> The Microbiology Network (http://microbiologynetwork.com) and
>> 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]
>>>> 
>>>> 
>>>> 
>>>> Science Advisory Board https://www.scienceboard.net/
>>>> 
>>>> Sartorius https://promotions.sartorius.com/real-heroes
>>>> 
>>>> Steris - http://www.sterislifesciences.com/
>>>> 
>>>> Avista Pharma Solutions  http://www.avistapharma.com
>>>> 
>>>> MilliporeSigma  http://www.emdmillipore.com/
>>>> 
>>>> Charles River Laboratories - http://www.criver.com/
>>>> 
>>>> Veltek Associates, Inc - http://www.sterile.com
>>>> 
>>>> Microbiologics, Inc. - http://www.microbiologics.com
>>>> 
>>>> Nelson Labs - http://www.nelsonlabs.com
>>>> 
>>>> BD Diagnostic Systems - http://www.bd.com/ds/
>>>> 
>>>> Boston Analytical http://www.bostonanalytical.com/
>>>> 
>>>> 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 Microbiology Network,
>>> Inc., the PMF, or the sponsors of the list.
>>> 
>>> ------------------
>>> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated
>> from
>>> The Microbiology Network (http://microbiologynetwork.com) and 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]
>>> 
>>> 
>>> 
>>> Science Advisory Board https://www.scienceboard.net/
>>> 
>>> Sartorius https://promotions.sartorius.com/real-heroes
>>> 
>>> Steris - http://www.sterislifesciences.com/
>>> 
>>> Avista Pharma Solutions  http://www.avistapharma.com
>>> 
>>> MilliporeSigma  http://www.emdmillipore.com/
>>> 
>>> Charles River Laboratories - http://www.criver.com/
>>> 
>>> Veltek Associates, Inc - http://www.sterile.com
>>> 
>>> Microbiologics, Inc. - http://www.microbiologics.com
>>> 
>>> Nelson Labs - http://www.nelsonlabs.com
>>> 
>>> BD Diagnostic Systems - http://www.bd.com/ds/
>>> 
>>> Boston Analytical http://www.bostonanalytical.com/
>>> 
>>> 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 Microbiology Network, Inc.,
>>> the PMF, or the sponsors of the list.
>>> 
>> 
>> ------------------
>> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
>> The Microbiology Network (http://microbiologynetwork.com) and 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]
>> 
>> 
>> 
>> Science Advisory Board https://www.scienceboard.net/
>> 
>> Sartorius https://promotions.sartorius.com/real-heroes
>> 
>> Steris - http://www.sterislifesciences.com/
>> 
>> Avista Pharma Solutions  http://www.avistapharma.com
>> 
>> MilliporeSigma  http://www.emdmillipore.com/
>> 
>> Charles River Laboratories - http://www.criver.com/
>> 
>> Veltek Associates, Inc - http://www.sterile.com
>> 
>> Microbiologics, Inc. - http://www.microbiologics.com
>> 
>> Nelson Labs - http://www.nelsonlabs.com
>> 
>> BD Diagnostic Systems - http://www.bd.com/ds/
>> 
>> Boston Analytical http://www.bostonanalytical.com/
>> 
>> 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 Microbiology Network, Inc.,
>> the PMF, or the sponsors of the list.
>> 
> 
> 
> -- 
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
> Phone: 914 725-3947
> Cell: 914 841-0074
> 
> ------------------
> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
> The Microbiology Network (http://microbiologynetwork.com) and 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]
> 
> 
> 
> Science Advisory Board https://www.scienceboard.net/
> 
> Sartorius https://promotions.sartorius.com/real-heroes
> 
> Steris - http://www.sterislifesciences.com/
> 
> Avista Pharma Solutions  http://www.avistapharma.com
> 
> MilliporeSigma  http://www.emdmillipore.com/
> 
> Charles River Laboratories - http://www.criver.com/
> 
> Veltek Associates, Inc - http://www.sterile.com
> 
> Microbiologics, Inc. - http://www.microbiologics.com
> 
> Nelson Labs - http://www.nelsonlabs.com
> 
> BD Diagnostic Systems - http://www.bd.com/ds/
> 
> Boston Analytical http://www.bostonanalytical.com/
> 
> 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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and 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]



Science Advisory Board https://www.scienceboard.net/

Sartorius https://promotions.sartorius.com/real-heroes

Steris - http://www.sterislifesciences.com/

Avista Pharma Solutions  http://www.avistapharma.com

MilliporeSigma  http://www.emdmillipore.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

ATOM RSS1 RSS2