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Are isolators acceptable alternatives for USP 797 compliance?

Accreditation Connection, December 12, 2005

Knowing the risk level of compounded sterile preparations and the proper environmental requirements will help determine whether a hospital can purchase barrier isolators to supplant a clean room and comply with U.S. Pharmacopeia (USP) Chapter 797.

USP 797 describes barrier isolators--sterile boxes with holes for staff to put their hands through to compound preparations--as an acceptable alternative to building a clean room. But they may only be acceptable if they meet certain requirements.

A well-designed barrier isolator can serve as an alternative to a laminar airflow workbench because it provides an ISO Class 5 environment for aseptic processing, USP spokesperson Sherrie Borden says.

The ISO class refers to the number of particles present in the air for the environment to be considered sterile. The basic equipment required to comply with USP 797 is an ISO Class 5 laminar airflow workbench, which is the hood under which staff prepare sterile compounds, says Steve MacArthur, a safety consultant with The Greeley Company, the Marblehead, MA-based consulting division of HCPro.

"When it comes to barrier isolators, they can be used as an alternative so long as they meet the ISO class specifications for environmental control," MacArthur says.

Adapted from the December issue of Hospital Pharmacy Regulation Report.

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