IEST members establish cleanroom design Working Group

The Recommended Practice being developed by WG-CC048 will benefit designers, facility directors, operators, contractors, and quality assurance personnel who deal with compounding pharmacies

The Institute of Environmental Sciences and Technology (IEST) is to create a new Working Group: WG-CC048: Guidance for Design, Performance, and Operations of Controlled Environments per USP 797. This is in response to regulatory changes that have had a significant impact on contamination control practices in compounding pharmacies. USP 797 requirements have shifted what is expected of professionals who operate cleanrooms, and more changes are on the horizon.

IEST Working Groups are designed to create and update the Standards and Recommended Practices used by professionals around the world every day. The Recommended Practice being developed by WG-CC048 will benefit designers, facility directors, operators, contractors, and quality assurance personnel who deal with compounding pharmacies.

Drawing from the considerable expertise of its membership, the Working Group will seek to address standards for:

  • The design of a cleanroom
  • Specification, selection, and siting of fixtures and equipment
  • Construction materials
  • Environmental monitoring and cleaning
  • Successful certification of the cleanroom and its operations

The document produced will keep the industry updated on those changes and expectations, and highlight how they differ from what has been expected in the past. This Working Group will meet at the IEST Fall Conference, 27-30 October in Research Triangle Park in North Carolina, and the public can observe that meeting.

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