USP 797 Guidelines for the Cleanroom/Buffer Zone

Cleanroom Requirements Overview

ISO Class 7 Pharmacy Cleanrooms are designed to minimize airborne contamination from contacting critical sites. Care must be taken to maintain the cleanliness of the room and PECs. USP 797 guidelines outline minimal cleaning requirements and the following information is based on the typical Class 7 room. Some best practices for cleaning and disinfecting pharmacy cleanrooms include:

  • Always clean from cleanest to dirtiest and from top to bottom.
  • Choose non-shedding, non-linting single-use cleanroom wipes.
  • Use slightly overlapping, unidirectional strokes rather than circular motions.
  • Replace used wipes often.
  • Isolator cleaning tools, mops, and buckets should be dedicated to each room or area.
  • Disinfectant dwell time is critical. Consult the product label for the appropriate contact time.
  • Always follow your facility’s SOPs.

Group Purchasing Organizations

Nebo Content Management System Tracking