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July 1999

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The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Mon, 12 Jul 1999 13:50:54 -0500
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Catherine- I have used the SMA sampler with attached tubing and sampling probe 
to sample very close to Class 100 aseptic fill operations. The SMA requires a 
vacuum source, and obviously the length of sample tubing (between sampling site 
and sampler) should be minimized; but this tubing can be autoclaved, as can the 
whole SMA sampler itself. We sampled at 1.5 CFM, but experienced some 
desiccation of media if we sampled for more than one hour; with additional agar 
in the media and a thicker poured plate, we were able to validate 2-hour 
sampling. A lot depends on how close to your B/F/S machinery and the filling 
sites (within the Class 100 zone) you can get the SMA sampler itself; the vacuum
source can be extremely remote. SMA's themselves do not take up much room, and 
they do not appreciably disrupt laminar flows, so this might be ideal for your 
application.
        M.Carroll ([log in to unmask])

______________________________ Reply Separator _________________________________
Subject: [PMFLIST]RE:_[PMFLIST]_Réf:[PMFLIST]_Biocontamination_level_
Author:  <[log in to unmask]> at INTERNET-MAIL
Date:    7/12/99 8:41 AM


Dear Patrick
Thank you for your response.
I would like to know if you have an experience (or if you heard about one) 
with the SMA or with the MD8 Airscan (Sartorius), and what do you think 
about those systems.
At this moment, we are testing the MGAS/3 (Fred Baker): the recovary rate is 
relatively low and the problem is that we want to obtain the 
biocontamination level in a class 100. We think that it's may due to the 
tubing. In the other hand, this system seems to be easier to use that the 
MD8 wich need more manipulations ; so there is more biocontamination risks 
with the MD8.
     
Catherine DAUTUN
     
     
-----Message d'origine-----
De: No Name [mailto:[log in to unmask]] 
Date: lundi 12 juillet 1999 10:11
A: [log in to unmask]
Objet: [PMFLIST] Réf:[PMFLIST] Biocontamination level for Blow/fill/seal
     
     
Dear  Catherine,
In your case you should be looking for a remote air-sampler system like SMA 
sampler or Sartorius.
     
[log in to unmask]
     
____________________Séparateur de messages____________________ 
Objet : [PMFLIST] Biocontamination level for Blow/fill/seal 
Auteur :    The Pharmaceutical Microbiology Mail List 
<[log in to unmask]>
Date :  09/07/99 01:52
     
Trainee in ALCON France microbiology laboratory, I'm participating to the 
search for a system to control biocontamination level during a production 
process. ALCON uses a Blow/Fill/Seal Aseptic Packaging technology where 
container production is an integral part of packaging opération. We want to 
obtain a biocontamination level during the process in the area, called 
"shower", where the product is injected. However, at this point (class 100), 
it's very difficult to sampler air due to a lack of space and because it's 
impossible to operate there during the process which can last for a week.
     
        I would like to know if some one could help us to choose this
system.
     
Thanks in advance, all your comments are welcome.
     
     
     
        Catherine DAUTUN
        Trainee
     
     
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