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November 2018

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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
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Thu, 1 Nov 2018 03:15:48 +0000
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Jeevanend Arumugam <[log in to unmask]>
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Hello Joshi,

As per my understanding, and referring to European Pharmacopoeia requirement  - Under Sterility Test Chapter - Table : Minimum quantity to be used for each medium - its stated that for Antibiotic solution minimum required to be filtered is 1ml.

You may use small volume for filtration as mentioned above, and at a same time you may also use washing solution (usually tween 80 and peptone solution), however, as usual the test method validation, B&F including local isolates (recommended) need toe done accordingly.

Thanks and Regards


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Nilay Joshi
Sent: Wednesday, October 31, 2018 10:33 PM
To: [log in to unmask]
Subject: [PMFLIST] Require suggestion for sterility test method validatio

Dear All,

I am facing a technical problem regarding the validation with respect to microbial recovery, mainly in 'sterility test method validation'

One of our plants is manufacturing 'levofloxacin' 'ofloxacin'
'ciprofloxacin' infusion through 100 ml BFS.

As per my understanding from each 100 ml container, I have to take not less than 40 ml/bottle of the solution for sterility test.

My microbiology team is facing the problem in microbial recovery during method validation or method suitability studies.

Any suggestions, to overcome antimicrobial effect of the 'floroquinolones'.


Thanking you,

Nilay Joshi

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________________________________

Jeevanend Arumugam
Microbiologist - Head of Microbiology Laboratory
B Braun Medical Industries Sdn. Bhd.
Bayan Lepas Free Industrial Zone
10810, Penang, Malaysia
Tel: 04-6323558 / 04-6323849 or speed dial *0410   Fax:
http://www.bbraun.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]



Science Advisory Board https://www.scienceboard.net/

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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