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February 2016

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Subject:
From:
Lou Fraser <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 25 Feb 2016 16:30:33 +0000
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Uday -

Seeing the seriousness of and ,I'll assume, the large number of particles in your WFI storage and recirculating system,  start with re-evaluating the system:
        - By all means filter the water at various points of the system and do particle counts and compare. The system  may be generating particles after a pump, valve, filter, etc. Study the particles; what is morphology of particles -    color, size, shape, numbers, etc.
        - Was the WFI system  installed properly - all 316L metal, proper joint welding, 90°C compatible gaskets, etc.
        - Why 'over' 90°C water temperature? Can it be lowered to 80° - 85°C? 'Over' 90C wreaks havoc on 316L SS.       Passivation won't help extend the life of the SS system.
        - Was all SS in contact with WFI properly passivated?
        - Have you flushed the system and how long after flushing do the particles reappear? Can you flush only portions        of the system and see if particles reappear or not? Isolate the source.

All this takes time and if you don't have the expertise to do all this in-house I strongly suggest you find someone from the outside (consultant) to come in and evaluate the problem. Work with the company that installed the system along with an independent consultant to find the cause of the problem.

Lou Fraser

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Uday Bhatambarekar
Sent: Saturday, February 20, 2016 3:49 AM
To: [log in to unmask]
Subject: [PMFLIST] Storage tank WFI

Storage tank WFI (to over 90 ° C and recirculating) no microbial contamination, but has particle contamination, which may be the reason and how can be treated?

Uday Bhatambarekar

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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.

Accuratus Lab Services http://www.accuratuslabs.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/

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

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

Biolog - http://www.biolog.com

Analytical Research Labs - http://arlok.com/

Charles River-Endosafe and Accugenix - http://www.criver.com/emd

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

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

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

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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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