Questions and Answers on USP 797
RJLG Question 6: I have received some conflicting information regarding USP 797 standards related to the presence of a sink in an anteroom meeting ISO Class 7. In reviewing the Revision Bulletin (copyright 2008), an ISO Class 7 buffer area shall not contain sinks or floor drains, but would the presence of a sink in a physically separate, positive pressure ISO Class 7 anteroom adjacent to a negative pressure ISO Class 7 buffer area somehow detract from the anteroom's ISO classification?
Specifically, I have a new hospital pharmacy which has provided certification documentation that the small anteroom leading into the hazardous drug preparation area (negative pressure ISO Class 7 buffer area containing ISO Class 5 PEC) meets the established guidelines for ISO Class 7 with the presence of a sink with a drain (located next to the doorway separating the anteroom from the buffer area). This was in a pre-operational, non-dynamic state. There are now some conflicting opinions about the sink and its impact on the ISO classification of the anteroom. Any guidance on this situation would be much appreciated.
RJLG Answer 6: USP<797> states “The buffer area shall not contain sources of water (sinks) or floor drains.” This is intended to reduce airborne microbial and other particulate contamination adjacent to critical sites such as ISO Class 5 primary engineering controls (PECs). The ante area sink is a critical component to personnel cleansing and garbing prior to entrance into the buffer area. Your environmental sampling programs (non-viable and viable particle testing), conducted before commissioning of the pharmacy and periodically thereafter during dynamic operating conditions, will determine the impact of a sink or other objects on the ISO classifications of your ante and buffer areas.
Answer provided as a courtesy to USP797.org 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 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 ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mailto:613-2709mzock@rjlg.com
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