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May 2020

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 29 May 2020 16:31:23 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (218 lines)
The justification is to comply with standard water testing methods, i.e.
AWWA/APHA standards as recommended in USP <1031>

On Fri, May 29, 2020 at 4:26 PM Kyriaki Antoniou <[log in to unmask]>
<[log in to unmask]> wrote:

> Thank you for you input.
> We currently use duplicate testing (2 plates) with the membrane
> filtration. In order to switch from the duplicate to single testing (1
> plate), we have to justify this change. How can I justify it? I am thinking
> if I prove that between the 2 plates there is a good RSD it will be
> accepted by the inspectors. But, I couldn’t find any source of RSD in
> microbial counts.
>
>
> Best Regards
>
> Kyriaki Antoniou
> Microbiology Department Manager
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> On Behalf Of Tony Cundell
> Sent: 29 May 2020 06:04
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Microbiological water analysis
>
> With pharmaceutical grade water, the standard practice is to use the
> membrane filtration method where you use a single plate. No issue there!
>
> On Thu, May 28, 2020 at 7:18 PM Kyriaki Antoniou <
> [log in to unmask]> <[log in to unmask]> wrote:
>
> > Dear all,
> >
> > Could you give me your knowledge/opinion on the below matter?
> >
> > Microbiological water analysis, in pharmaceutical company, is
> > performed in duplicate for each sample. What is the best (allowable)
> > Standard deviation/RSD between the two results from the duplicate
> > testing? Is there any guideline to follow? If not, can you set your own
> RSD as per USP <1225>?
> >
> >
> >
> > Best Regards
> >
> > Kyriaki Antoniou
> >
> > Microbiology Department Manager
> >
> >
> > Remedica Ltd
> >
> > Tel.: +357 25-553000 | Direct Tel.: +357 25-553508 (Internal: 508) | Fax:
> > +357 25-390192
> > Site address: Remedica Ltd, Aharnon Street, Limassol Industrial
> > Estate,
> > 3056 Limassol, Cyprus-EU
> > Mailing address:  Remedica Ltd, P.O. Box 51706, CY-3508, Limassol
> > Cyprus-EU
> > Web: www.remedica.eu<http://www.remedica.eu/>
> >
> >      [cid:image007.png@01D4FB72.4AE7DD60]
> > [cid:image008.png@01D4FB72.4AE7DD60]
> > [cid:image009.png@01D31FE5.C193D820]
> > <https://twitter.com/remedica?lang=en>
> > [cid:image010.png@01D4FB72.4AE7DD60]
> > [cid:image011.png@01D4FB72.4AE7DD60]
> > [EBA_OneToWatch_Ribbon_Horizontal][EBA_NationalWinner_Ribbon_Horizonta
> > l]
> > [cid:image008.png@01D6350C.E02A3330]
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> >
> > Charles River Laboratories -
> > https://www2.criver.com/l/60962/2020-03-27/h6jqv6
> >
> > Veltek Associates, Inc - http://www.sterile.com
> >
> > Microbiologics, Inc. - http://www.microbiologics.com
> >
> > BD Industrial Media - http://www.bd.com/ds/
> >
> > Associates of Cape Cod, Inc. - http://www.acciusa.com/
> >
> >
> > =================================
> > The nature of this service is to provide a medium for communication.
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>
>
> --
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
> Phone: 914 725-3947
> Cell: 914 841-0074
>
> ------------------
> The PMFList is 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]
>
>
>
> Steris - http://www.sterislifesciences.com/
>
> Charles River Laboratories -
> https://www2.criver.com/l/60962/2020-03-27/h6jqv6
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> BD Industrial Media - http://www.bd.com/ds/
>
> 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 PMF or the sponsors of the
> list.
>
> ------------------
> The PMFList is 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]
>
>
>
> Steris - http://www.sterislifesciences.com/
>
> Charles River Laboratories -
> https://www2.criver.com/l/60962/2020-03-27/h6jqv6
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> BD Industrial Media - http://www.bd.com/ds/
>
> 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 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 is 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]



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

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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

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

BD Industrial Media - http://www.bd.com/ds/

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 PMF or the sponsors of the list.

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