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May 2001

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Subject:
From:
Robert Friedel <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 3 May 2001 10:20:22 -0400
Content-Type:
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The reason that this type of sampling is used to evaluate non-sterile
facilities is to fullfill the requirements of 21 CFR 211.113 "Control of
Microbiological Contamination."  In order to control microbial
contamination, you must evaluate it and RODAC, AIR, SWAB, etc... are the
current mechanisms for doing so.

Non-sterile facilities are just what they say they are --NON-STERILE-- and
most environmental monitoring is only a "snapshot" of the microbial
bioburden at the time of sampling.  RODAC sampling of walls in a
non-sterile, solid oral dosage packaging facility seems extreme and is of
little practical value, particularly since the recovery rates are low.  I
prefer to use settling plates versus active air sampling due to the fact
that microorganisms generally don't get sucked into packaging containers
during filling.

Ask your non-microbiologist colleagues the following:

1) Who is going to interpret the RODAC data once it is generated?
2) What will the data tell me in terms of the sampling point?
3) What useful action can I take if the sample fails?
4) What value will the data produced add in producing a microbiologically
safe product?

Bob Friedel
Quality Assurance Manager
Perritt Laboratories, Inc.
[log in to unmask]


-----Original Message-----
From: Carol Lihs [mailto:[log in to unmask]]
Sent: Wednesday, May 02, 2001 4:11 PM
To: [log in to unmask]
Subject: [PMFLIST] RODAC plates


Greetings to all--

     Can anyone see the advantage to  doing RODAC plates on walls in a
packaging
area for a non-sterile solid oral dosage form?  I really think that air
sampling
would give more valuable results in this situation but I can't seem to get
my
point across.  I'm discussing this with some non-microbiologists who are (I
think) confusing  our packaging area with a Class 100 Clean Room.  Help,  I
really need some opinions from the experts.

          Carol Lihs
          Sr. Microbiologist
          GlaxoSmithKline


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