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Questions and Answers on USP 797
  • 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.
     
  • 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.

  • 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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