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April 2017

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Subject:
From:
ASHUTOSH NICHRAL <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sat, 1 Apr 2017 09:45:53 +0530
Content-Type:
text/plain
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text/plain (110 lines)
Hllo
Dear mam what type of dilution are you using for sample preparation i means
is it 1:10. For such products u can also use 990 or 490 ml of diluent for
better suspension preparation.


On Fri, Mar 31, 2017 at 12:00 PM, Selena Rossi <[log in to unmask]>
wrote:

> Dear forum member,
> We have to convalidate the bioburden test of one of our finished product
> (tablets).
>
> We crash the tablets using a mortar and pestle. Then we mix it with Tween
> 20 at the beginning and we perform a diluiton with Phosphate Buffer
> Solution pH 7.2 to make suspension.
>
> I have severals doubts:
>
> 1) first of all, even after one hour of mixing, when I perform the
> bioburden test  using pour plate method, I have noticed some little pieces
> of samples that are not completely dissolved. I crashed accurately but some
> pieces remain.
> How I can do to better dissolve my sample? I have to prefilter it? Or
> after mixing I have to wait a while to let the big pieces go down and so I
> can take only an aliquot of the surnatant? But in this way my sample is
> correctly mixed?
>
> 2) Since these are testing to find the best method for the sample
> preparation, we are not working in sterile way yet. I'm looking for
> steriled Tween 20 but I can't find it? How do you work with it? Do you
> filter it to sterilize or any other way?
>
> Thanks to everybody for the help.
> Have a good day and weekend,
> Selena
>
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-- 
Thanks &regards
Ashutosh Nichral
8261990530

------------------
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.


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/

MilliporeSigma  http://www.emdmillipore.com/

Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   - www.criver.com/micro

Avista Pharma Solutions  http://www.avistapharma.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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