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November 2013

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Wed, 13 Nov 2013 13:00:22 -0500
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Hi Evangelia,

Sorry to hear that you have a biofilm in your water system.  They are not 
easy to remove however, it is possible.  In regards to the microorganisms 
you mentioned, all 3 of them were once classified as a pseudomonas however 
they were renamed several years ago.

One thing to mention is that water systems, whether WFI/PW loops or HPW 
systems, are not sterile.  There is a microbial load allowed albeit very 
low.  This will include gram negative microorganisms.  There are gram 
negatives that do raise a red flag and burkholderia is one of them.  The 
best advise that I can give you is to pacify your water system ASAP to 
remove the biofilm and perform a risk assessment with QA and Engineering 
to determine how the water is used in your facility, what the impact is to 
the product, if the same microorganisms are recovered in routine product 
testing, how the product is administered etc.

Thank you,

Tricia Griffiths
Global Product Manager, Microbiology
Pall Life Sciences
New England Center of Excellence
20 Walkup Drive
Westborough, MA 01581

[log in to unmask]
P: 508-871-5404
M: 508-630-6790
www.pall.com




From:   Evangelia Georgiadou <[log in to unmask]>
To:     [log in to unmask]
Date:   11/13/2013 12:42 PM
Subject:        Re: [PMFLIST] Water System Biofilm
Sent by:        The Pharmaceutical Microbiology Forum Email List 
<[log in to unmask]>



Hello,

for purified water we perform total count with filtration in R2A and also 
testing for E coli and Ps aeruginosa. for water for injection we perform 
all the previously mentionted tests and also test for endotoxins.

i know that there is biofilm somewhere in the first softener. my problem 
is that despite from ps. aeruginosa i keep identifying microorganisms for 
which i dont know much. 

please inform me on sphingomonas, stenotrophomonas and burkholderia. are 
they pathogens? is it normal to identify such an organism on water system? 
how should i work on such a case?


Thank you very much in advance.

Evangelia Georgiadou
Micro Department Supervisor
--------------------------------------------
Στις Δευτ., 04/11/13, ο/η Philippe Boileau <[log in to unmask]> έγραψε:

 Θέμα: Re: [PMFLIST] Water System Biofilm
 Προς: [log in to unmask]
 Ημερομηνία: Δευτέρα, 4 Νοέμβριος 2013, 23:09
 
 Hello Evangelina,
 
 I wish I could discuss this in Greece rather than snow
 covered Québec!
 
 I was under the impression that the ultra pure water users
 were following
 endotoxins as an indicator for biofilms. Aren't you?
 
 
 2013/11/2 Evangelia Georgiadou <[log in to unmask]>
 
 > speaking on biofilms i would like to ask which
 microorganisms are trully a
 > concern to the system?i have identified ps. aeruginosa
 like a year ago and
 > after multiple  treatments i keep identifying
 sphingomonas and
 > stenotrophomonas. should i be alered?
 >
 >
 > ------------------------------
 > Στις Παρ, 1 Νοε 2013 4:11 μ.μ. EET Brianne
 Riley έγραψε:
 >
 > >Prior to using the sanitizer, I would recommend a
 caustic cleaning agent
 > to really remove the biofilm.  You can't sanitize
 without cleaning first.
 >  The sanitizer would be more effective after the
 caustic.  ProKlenz 1 (by
 > Steris) at 1-2%, heated to 65C if possible is very
 effective.
 > >After the cleaning agent is circulated and rinsed
 out (you can verify
 > complete rinsing with a pH test) I would recommend a
 premade solution of
 > the peracetic acid/H2O2 such as Minncare (Mar Cor
 Purification) or
 > SporKlenz (Steris).  The recommended concentration
 is usually on the
 > container or the data sheet, I believe our facility
 uses 400ppm Minncare.
 >  A minimum of 35 minute contact time is required
 although you can do longer
 > with no issue.  After the solution is circulated,
 you rinse it out with
 > purified water and you can use a test strip on the
 rinse water at the end
 > of your loop to ensure it is completely gone.
 > >
 > >Have you monitored other end use points in your
 system?
 > >
 > >Brianne K. Riley
 > >Plant Hygienist
 > >Tri Tech Laboratories, Inc – a division of KDC
 > >
 > >
 > >-----Original Message-----
 > >From: The Pharmaceutical Microbiology Forum Email
 List [mailto:
 > [log in to unmask]]
 On Behalf Of Chris Swoverland
 > >Sent: Thursday, October 31, 2013 5:11 PM
 > >To: [log in to unmask]
 > >Subject: [PMFLIST] Water System Biofilm
 > >
 > >All,
 > >
 > >We have a stainless steel (316ss) water filtration
 skid with some filters
 > and UV lights. I am thinking there may be a biofilm in
 the system somewhere
 > as the port immediately after the system has been
 showing low levels (<10
 > CFU/mL) of Pseudomonads (no Ps. aeruginosa has been
 found as of yet). I was
 > wondering what the best remedy for a biofilm is. I have
 heard of people
 > using a combination of Peracetic acid and H2O2. What
 concentrations of
 > these chemicals would be used? How do you get these
 chemicals out of the
 > system once they are in? I greatly appreciate any help
 in this matter.
 > >
 > >Thank you
 > >
 > >Chris Swoverland
 > >Rockline Industries
 > >Sr. QC Laboratory Technician
 > >[log in to unmask]
 > >(920) 452-3004 x3332
 > >
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 >
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 >
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 >
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 >
 > =================================
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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.
 
 
 Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics
 
 Accugenix - http://www.accugenix.com
 
 American Type Culture Collection - http://www.atcc.org
 
 ATS Labs - http://www.ats-labs.com
 
 BD Diagnostic Systems - http://www.bd.com/ds/
 
 Biolog - http://www.biolog.com
 
 EMD Millipore -  http://www.emdmillipore.com/biomonitoring
 
 MicroBioLogics, Inc. - http://www.microbiologics.com
 
 Microtest Laboratories, Inc. - http://www.microtestlabs.com
 
 Pall - http://www.pall.com
 
 NovaTek International - http://www.ntint.com
 
 Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)
 
 Steris - http://www.sterislifesciences.com/
 
 Veltek Associates, Inc - http://www.sterile.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.


Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

ATS Labs - http://www.ats-labs.com

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

Biolog - http://www.biolog.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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

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


Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

ATS Labs - http://www.ats-labs.com

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

Biolog - http://www.biolog.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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

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