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March 2012

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Wed, 7 Mar 2012 14:37:58 +0100
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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
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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

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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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