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From:
"Knutsen, Chris" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 14 May 2018 12:18:00 +0000
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The actual use of the water must also be taken into account. I know of a facility that had low level hits of GNR's (<<10/100 mL) and didn't respond.  The process was a several day process including a pH neutral buffer and sucrose.  In spite of all of the aseptic handling, they ended up with several batches of contaminated product, due to the presence of GNR's in the water that great out during the processing of the product.  There are times that low levels  of microorganisms are indicators of bigger problems in the system.


Chris Knutsen, Ph.D. 
Associate Director, Microbiology
ABO Microbiology Science and Technology
Bristol-Myers Squibb Company
1 Squibb Drive
New Brunswick, NJ 08902
Tel : +1-732-227-5375
Fax: +1-732-227-3071
Cell: +1-609-751-8362
e-mail: [log in to unmask]

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Tony Cundell
Sent: Friday, May 11, 2018 12:43 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Are Gram negatives in WFI always a deviation

Anthony

Yes I described NMT 10CFU/100 mL as an industry standard not a specification.

To me investigating the occasional isolation of 1 CFU/100 mL in a WFI system even if it B. cepacia found days after the sampling is not a value-added activity, i.e., bluntly a waste of time and resources.

Tony



On Fri, May 11, 2018 at 12:08 PM, Anthony Bevilacqua < [log in to unmask]> wrote:

> Jovan,
>
> 1. Going back to the original question, I assume you mean "1 cfu per 
> 100 mL"? You didn’t specify volume.
>
> 2. While the spec is 10cfu/100mL (and "spec" is really the wrong word 
> for USP, but it is the generally accepted number), 1cfu/100 mL may or may not
> trigger alarms depending on the usage of the water.   Your internal alarm
> level of "1/100mL" is an internal spec, and this is your (company) 
> decision.  There is no external pressure or standard to alarm at "1".
>
> 3. That being said, I would be looking at causes of "why do you get a 
> periodic 1 cfu/100mL".  Is it truly the water in the water system 
> (unlikely if it is hot), or is it the hose, the flushing, the sampling 
> method, the analyst, the procedure?  Is it a non-water-borne bacteria?  
> These would be the questions on my mind.
>
> Anthony
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] On Behalf Of Tony Cundell
> Sent: Thursday, May 10, 2018 8:09 PM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Are Gram negatives in WFI always a deviation
>
> Nancy I assume that by current acceptable technologies you mean 
> Distillation or RO. With Hot water system you would not expect a 
> bioburden so these systems are over monitored.
>
> I do not understand the impulse to implement stricter standards when 
> we are well served by the existing standards.
>
> On Thu, May 10, 2018, 7:15 PM Nancy Tomoney <[log in to unmask]> wrote:
>
> > Jovan,
> >
> >
> > There should be no Gram Negative Rods in WFI if it produced with 
> > current acceptable technology for WFI production and if you sampling 
> > is
> properly.
> > Hence it is a deviation  and a non-conformance investigation.  Is 
> > someone using hose to colelct water?  That is come error.
> >
> >
> >
> > -----Original Message-----
> > From: Jovan Rankov <[log in to unmask]>
> > To: PMFLIST <[log in to unmask]>
> > Sent: Thu, 10 May 2018 11:08 am
> > Subject: [PMFLIST] Are Gram negatives in WFI always a deviation
> >
> > Dear Forum members,
> >
> > In company where I work we have a procedure where we have to rise 
> > deviation if we recover 1 or more cfu of Gram negative 
> > microorganisms in WFI. No matter if it is WFI for the batch 
> > preparation, equipment washing or just sampling point. Gram negative equals deviation.
> >
> > It is clear that Gram negatives in the WFI are of great concern 
> > because of the endotoxins, but is it necessary to always rise 
> > deviation if we have only 1 cfu of Gram negative, even on rare 
> > occasions? We have very good results trend.
> >
> > Can you please give me some feedback on the expectations?
> >
> > Kind regards
> >
> > Jovan
> > QC Microbiologist
> >
> > ________________________________
> >
> >
> > Odricanje od odgovornosti:
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> >
> > 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/
> >
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> >
> >
> > =================================
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> ------------------
> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated 
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> Please take a second to visit our sponsors' web sites and say thank 
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> If your company would be interested in sponsoring this community, 
> please contact [log in to unmask]
>
> 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.
>
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> 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]
>
> 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]

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]

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.

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