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Subject:
From:
Samir Shah <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 15 May 2018 14:08:49 -0400
Content-Type:
text/plain
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Hello,

The 5 transfer rule takes care of spontaneous mutation related changes. So,
as long as the frozen culture and retrieval of working culture process is
included in your 5 transfer rule, the results are valid. Many times
organizations make mistake in calculating number of transfers and create a
non-compliant situation.

*______________________________________________________________*
*Samir Shah Ph. D.*
*Global Microbiology, **Colgate-Palmolive Technology Center, NJ*
*Office 732.878.7772 / **VOIP 8-101-7772 / **Mobile 732.509.6666*



On Tue, May 15, 2018 at 9:10 AM, Natalia Ruiz <[log in to unmask]>
wrote:

> Dear forum members,
>
> I have a question about the strains of the Test Microorganisms Suitable for
> use in the Method Suitability Test.
>
> I use the ATCC strains indicated in Table 1 (Chapter 71) to carry out the
> Method Suitability Test. But from the subcultivation of a ATCC strain, i
> obtain reserve strains that i keep frozen to keep them for a long period of
> time. This reserve strains could differ genetically from the mother strain?
> If one of these reserve strain presented some mutation in a gene with
> respect to the original strain, but meets the same phenotypic
> characteristics, would my suitability test be invalid?
>
> Thank you for your answer.
>
> Best regards.
>
>
>
>
>
> Descripción: Descripción: Descripción: LOGO 2Natalia Ruiz
>
> Departamento Control de Calidad
>
> Calle 2 y 3 – Parque Industrial Gral. Savio – 7601 – Batán
>
> Tel/Fx: +54 223 464-2010 |2011| 3170 int. 168
>
> E-mail:  <mailto:[log in to unmask]> [log in to unmask]
>
>
>
>
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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.

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