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May 2018

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Subject:
From:
Jovan Rankov <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 11 May 2018 08:49:37 +0000
Content-Type:
text/plain
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text/plain (167 lines)
Dear,

Sampling is performed in accordance with USP <1231> and no hose is used, never in our company. WFI is sampled in single-use sterile/pyrogen free bottles. Operator uses sterile gloves and sanitize its hands prior sampling.
When you have huge WFI distribution system that feeds multiple sterile product departments and plants it must be maintained properly (passivation, sanitization etc.) but realistically you cannot expect your WFI to be absolutely sterile. It is not a terminally sterilized product.

WFI is sampled every day and few times per year you will observe microbial growth and sometimes it will be Gram negative mo. Would you stop all your production lines and WFI distribution system in order to perform an investigation, because of 1 cfu of Gram negative bacteria which are commonly found in water? I don’t think so... Not to mention the fact that while your sample was incubated and identified (6 days min) many batches were produced meanwhile and their WFI results were 0 cfu/100ml.

Also, historically in our company anytime a Gram negative is recovered in WFI BET results for that sample are below limit of detection.

I don’t think that deviation should always be raised.

Kind regards,

Jovan
QDC Microbiologist



-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Nancy Tomoney
Sent: Thursday, May 10, 2018 5:18 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Are Gram negatives in WFI always a deviation

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

________________________________


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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.

________________________________


Odricanje od odgovornosti:
Ovaj dokument namenjen je samo licima kojima je upućen i za pozivanje na isti od strane bilo kog lica, neophodna je naknadna pismena potvrda njegovog sadžaja. Shodno tome, HEMOFARM A.D. Vrsac odrice svaku odgovornost i ne prihvata bilo kakvu obavezu (uključujuci slučaj nepažnje) za posledice koje moze pretpeti bilo koje lice zbog činjenja ili nečinjenja na bazi takve informacije pre nego što takva lica prime dodatnu pismenu potrvdu. Ukoliko ste greškom primili ovu elektronsku poruku, uništite i izbrišite istu sa vašeg računara. Svako umnožavanje, širenje, kopiranje, obelodanjivanje, izmena, distribucija i/ili objavljivanje ove elektronske poruke je strogo zabranjeno.Sadržaj ove elektronske poruke ne predstavlja nužno stavove HEMOFARM A.D. Vrsac.

Disclaimer:
This document should only be read by those persons to whom it is addressed and is not intended to be relied upon by any person without subsequent written confirmation of its contents. Accordingly, HEMOFARM A.D. Vrsac, disclaims all responsibility and accept no liability (including in negligence) for the consequences for any person acting, or refraining from acting, on such information prior to the receipt by those persons of subsequent written confirmation. If you have received this E-mail message in error, destroy and delete the message from your computer. Any form of reproduction, dissemination, copying, disclosure, modification, distribution and/or publication of this E-mail message is strictly prohibited. The contents of this e-mail do not necessarily represent the views of the HEMOFARM A.D. Vrsac.

------------------
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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