Can a biological safety cabinet (BSC) and a laminar flow hood be in the same ISO 7 room that meets all other USP 797 requirements (ante-room etc.).

Questions and Answers on USP 797

RJLG Question 10: I have a question concerning the use of two different style hoods in the same area.
1. Can a biological safety cabinet (BSC) and a laminar flow hood be in the same ISO 7 room that meets all other USP 797 requirements (ante-room etc.). The BSC would not be used for hazardous products and is not vented to the outside air, but could be used short dated IV products (with exp2. If the answer to question 1 is yes is there a specific room arrangement? (i.e. the two hoods can be next to each other in the same plane vs. opposite each other, minimum distance apart, etc)

RJLG Answer 10:
Your policies & procedures for maintaining and working with your primary engineering controls (PECs) will be determined by scope (such as hazardous drug handling, etc.) and CSP microbial contamination risk levels. For non-hazardous drug compounding, any PECs such as laminar air flow workbenches (LAFWs), biological safety cabinets (BSCs), or other approved devices may be used to provide ISO Class 5 environments at your critical areas (direct compounding areas).

USP797 states that it is the responsibility of the compounding facility that all sources of ISO Class 5 environments (PECs such as LAFWs and BSCs) are properly located, operated, maintained, monitored, and verified. USP797 does not provide specific guidelines for room arrangements. PECs must be placed in the ISO Class 7 buffer area or clean room such that other PECs, supply-air diffusers, return air vents, doors, or other objects do not adversely impact the ISO Class 5 environments.

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 Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com