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Altro floors and walls installed in a clean environment

USP 797 Regulations 

Standards for compounding sterile preparations help promote patient safety and prevent harm

USP (United States Pharmacopeia) 797 is a comprehensive regulation applying to institutions within healthcare and pharmaceutical industries where sterile compounds are prepared, stored and dispensed. The purpose of the regulation is to prevent infections in patients using pharmaceutical products, as well as to protect pharmacy staff members that are ordinarily exposed to pharmaceutical products.

The legislation affects facilities in which sterile products are prepared or compounded according to the manufacturer’s labeling and instructions.

Typical facilities affected by USP 797

  • ​Laboratories
  • Pharmaceutical manufacturing plants
  • Compounding facilities
  • Hospitals
  • Pharmacies

Requirements of floors and walls

  1. Surfaces of ceilings, walls and floors shall be smooth, impervious, free from cracks and crevices and non-shedding – required to meet ISO Class cleanrooms

  2. Surfaces must be resistant to damage by disinfectant agents

  3. Preferably, floors are overlaid with wide sheet vinyl flooring with heat-welded seams and coving to the sidewall

Areas must meet a range of ISO Cleanroom compliance for the area they will be installed

  1. ISO Class 5 for Critical Areas

    • Segregated compounding areas

    • Aseptic processing rooms

    • Primary engineering control rooms

  2. ISO Class 7 for buffer zones and low risk compounding areas

  3. ISO Class 8 for ante-areas