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March 2012

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Subject:
From:
Brian Matthews <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 8 Mar 2012 15:54:59 +0000
Content-Type:
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text/plain (197 lines)
The need for inclusion of bioindicators will depend on the type of process
and the information provided to the regulatory agency concerned.

For example, in the case of radiation sterilisation (for Europe at least -
and for pharmaceuticals) the use of BIs will not be expected and may not be
accepted.  However, for ethylene oxide sterilisation the use of BIs is
likely to be mandatory.  In the case of steam sterilisation there should be
no need to use BIs for routine product cycles unless this is required under
the terms of you MA.  For porous load cycles different expectations may
well apply..

Regards,

Brian Matthews.

On 7 March 2012 13:37, <[log in to unmask]> wrote:

> Dear Olga, Dear forum,
>
> It is just my feeling by I guess it a questionable practice for patient
> safety reason to include a BI within a commercial batch and my point of
> view their use just for initial or periodic validation is fine.  I should
> admit that I saw years ago in the litterature (compendial? GMP? PDA?...)
> that it was a practice to ban.  Unfortunately, I should admit I can not
> remember where.  I have looked for this reference several times without
> success.  Should someone of the forum knows this reference, I would be more
> than grateful if he/she could let me know it.  Many thanks in advance.
>
> Best regards
> OC
>
> -----Message d'origine-----
> De : The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] De la part de Defterigou Olga
> Envoyé : mercredi 7 mars 2012 08:57
> À : [log in to unmask]
> Objet : [PMFLIST] Biological Indicators in routine
>
> Dear forum,
>
> Do you use biological indicators in every steam sterilization cycle (for
> final product and equipment sterilization) in routine or only during
> initial validation studies and in  annual monitoring of the autoclave?
>
>
> Thank's a lot.
>
>
>
> Olga Defterigou
>
> Microbiologist, MPhil
>
> Microbiology Lab Supervisor
>
>
>
> Elpen Pharmaceutical Co. Inc
>
> 95, Marathonos Ave. 190 09 Pikermi, Greece
>
> Tel: (+30) 210 6039326-9 Fax: (+30) 2106039300
>
> E-mail:[log in to unmask]
>
>
>
>
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------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Biotest - http://www.BiotestUSA.com/micro

Lonza Rapid Testing Solutions - http://www.lonza.com/rts

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

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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

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