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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 08:22:58 +0000
Content-Type:
text/plain
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Tony,

Thank you for your answer, I am with you on that.

In my opinion it is a matter of sampling point (batch preparation or not) and the results trend i.e. frequency of occurence, also ID trend. Microbial growth in WFI is very rare anyway (especially on batch preparation points) but Gram negatives are not something one should not expect when growth occurs. In-process BET testing is also there.

Jovan
QC Microbiologist

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Tony Cundell
Sent: Thursday, May 10, 2018 6:12 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Are Gram negatives in WFI always a deviation

Jovan,

Very misguided. A gross lack of microbiological knowledge and judgement on the part of your management.

If microorganisms are found in a pharmaceutical water system they most likely be Gram-negative, oxidase-positive bacteria.

The industry standard of not more than 10 cfu/100 mL is extremely conservative and would eliminate any concerns about endotoxin contamination and the sterility assurance of sterile filtered drug products.

Tony

On Thu, May 10, 2018 at 8:39 AM, Jovan Rankov <[log in to unmask]>
wrote:

> 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:
> Ovaj dokument namenjen je samo licima kojima je upu?en i za pozivanje
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--
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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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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