• RJLG Question 5: I read somewhere in the USP 797 that it was acceptable to mix a low volume of chemotherapy agents without a separate negative pressure room as long as CSTD's were used.  Is this correct?  Also--what is considered a low volume?
   
• RJLG Answer 5:  When a closed system transfer device (CSTD) is used within the ISO Class 5 biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) for low volume hazardous drug preparation only, a non-negative pressure room is acceptable provided other precautions and recommendations are followed.  For instance:  all hazardous drugs shall be separate from non-hazardous drugs in storage (separate storage area) and handling (dedicated BSC or CACI); the BSC or CACI shall be placed in a restricted access ISO Class 7 non-negative pressure buffer area, or a CACI may be used outside of the ISO Class 7 buffer area provided it is in a restricted access room that meets the conditions in the section of USP<797> entitled Placement of Primary Engineering Controls; proper procedures, training, and personal protective equipment (PPE) are employed; and containment should be verified by routine monitoring.
   
  The Hazardous Drugs as CSPs section of USP<797> does not describe low volume.  Our interpretation is, if the use of a CACI (100% vented glovebox) or two tiers of containment (CSTD within a CACI or BSC) will allow for the ability to handle the total peak volume of hazardous drugs at the given facility without compromising safety, sterility, quality, or workflow, then the non-negative pressure room is acceptable as described above. 

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