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May 2006

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Subject:
From:
"Hewitt, Jackie" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 19 May 2006 08:46:06 -0400
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My responses are as follows:

(1)  Do you prefer a glove box or a half-suit design?  What are the 
advantages/disadvantages?  In particular, when using a glove-box isolator, 
are arm movements and manipulations more restrictive?
(A)  It depends on the use you will have for your unit. For large throughput a
half-suit isolator is best, allowing for flexibility of movement and reach
within the area of the workstation. There would be more restrictions with a
glove-box.

(2)  Is the isolator in a classified environment?  If yes, why was the 
decision made to do this?
(A) No, it is not in a classified area.

(3)  Must the room in which the isolator is located be temperature and 
humidity controlled?
(A) The room should be temperature and humidity controlled for optimum operation
of the units. Specifically, you need to maintain the parameters under which your
validation was performed.

(4)  What vendor did you use?
(A) La Calhene

(5)  Any other advice?
(A) Think hard about general operating requirements before you order. For
example, waste ports, ports for electric cable for equipment you might need to
use in the isoltor. Also, the racking you use within the isolator can be bought
inexpensively from any lab wholesaler and you can order to your needs once you
have a feel for what your needs are, whereas the supplier will offer a set
configuration and charge heavily for it. Also, I would research the best VHP
generator and not necessarily buy that as part of the package.

Jackie Hewitt
Microbiology Manager
Luitpold Pharmaceuticals
Tel.  (631) 924-4000 x 321
FAX (631)205-2075
E-mail  [log in to unmask]
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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

ATS Laboratories - http://www.ats-labs.com

Biolog - http://www.biolog.com

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

Dupont Qualicon - http://www.qualicon.com

EMD Chemicals - http://www.emdchemicals.com

EMSL Analytical, Inc. - http://www.emsl.com

Genomic Profiling Systems, Inc. - http://www.genprosys.com

MIDI, Inc. - http://www.midi-inc.com

Millipore - http://www.millipore.com

Pall - http://www.pall.com

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

Raven Biological Labs - http://www.ravenlabs.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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