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May 2018

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Subject:
From:
Dale Kelley <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 16 May 2018 14:15:43 +0000
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Natalia,
The inspector does not have a full understanding of the science or the purpose of the expiration date on the ATCC supplied cultures. In these cases, it is your responsibility to have a full understanding of what you are doing and why, AND to be able to communicate that to the inspector.
The expiration date on the vial you purchased is to ensure that you will be able to revive a viable culture from that vial. It has no bearing on how long you can use the culture.
When you freeze your culture you are placing the cells into stasis, they do not grow or divide so there can be no genetic changes. With the exception of some portion of the cells not surviving the freezing and thawing process, they are the same at the end regardless of how long you keep them frozen. There is also loss of viability over time, which you need to account for with your frozen culture expiration dating.

Hope this helps,

Dale Kelley
Director
Protocol Link, Inc.
175 E. Hawthorn Parkway, Suite 210
Vernon Hills, IL 60061 USA
cell +1-224-565-2790 || office +1-847-549-0390
www.protocollink.com





-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Natalia Ruiz
Sent: Wednesday, May 16, 2018 6:58 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Test microorganisms suitable in the method suitability test

Thank you very much for your reply.
I have had that consideration, but  an inspector invalidated me a suitability test because of my frozen culture was maintained for a period of time longer than the expiration date of the original strain from which I started. His explanation was that my reserve strain, althoug it was viable and pure, could have changed in some gene.

-----Mensaje original-----
De: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] En nombre de Samir Shah Enviado el: martes, 15 de mayo de 2018 15:09
Para: [log in to unmask]
Asunto: Re: [PMFLIST] Test microorganisms suitable in the method suitability test

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
>
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>
> E-mail:  <mailto:[log in to unmask]> [log in to unmask]
>
>
>
>
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Veltek Associates, Inc - http://www.sterile.com

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

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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/


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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/


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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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