Questions and Answers on USP 797
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RJLG Question 9:
Is it acceptable to store a
refrigerator in the anteroom under any circumstance?
The only answer I find in the chapter is “Placement of
non-essential items within buffer and ante areas is
determined by the impact on environmental quality as
verified by monitoring.” Is there a more
straightforward answer to this question? Did I miss
the answer? We need a refrigerator in our anteroom to
store thawed premixed bags but don’t want to purchase
if the answer is a definite no. Thank you for your
assistance with this question.
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RJLG Answer 9:
Placement of a refrigerator in your anteroom is
acceptable if it is necessary for your compounding
process and if it does not negatively impact
environmental quality as per your viable and
non-viable environmental sampling program. Use should
be solely for the purposes of necessary tasks carried
out in your controlled air environments.
Answer provided as a courtesty to usp797.org, inc. by RJ Lee
Group, Inc. (RJLG) and/or associates of RJLG. We assume
no liability for the use or interpretation of this
information. Please note that usp797.org, inc. is not
responsible for this answer.
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Matthew
Zock is an industrial hygienist with the technical
consulting services group at RJ Lee Group, Inc. Mr. Zock
provides a variety of industrial hygiene, health & safety,
and environmental consulting services for heath care,
general industry, and litigation support. He manages
RJLG's USP 797 services including environmental sampling
(microbial), hazardous drug monitoring, and facility
design and operation audits. Mr. Zock received his
Bachelors in Biology from Clarion University of
Pennsylvania, and his Masters in Environmental and
Occupational Health Sciences from Hunter College. He can
be reached as follows:
Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com
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