The United States Pharmacopeial Convention published a revised edition of their document “A Guide for the Compounding Practitioner USP on Compounding,” in 2013. The document has many chapters and is a guide for those practicing in the pharmacy and compounding field. One chapter, titled USP 797 Pharmaceutical Compounding-Sterile Preparations defines minimum practice and quality standards for CSPs (compounded sterile preparations) of drugs and nutrients based on current scientific information and best sterile compounding practices. Within this chapter is a section titled Facility Design and Environmental Controls which discusses requirements relating to the physical environment of pharmacy spaces.
While the document is not directly referenced by the PA Department of Health, certifiers and state pharmacy boards review designs and installations to this standard.
The Facility Design and Environmental Controls section contains guidelines for maintaining specific spaces at ISO Class levels relating to particulate matter in the room air. It also describes requirements for:
- space temperature
- differential pressure
- air changes per hour (to meet the required ISO Class level) and
- filtration requirements.
In addition to HVAC-related items, the chapter also defines requirements for ceilings, walls, floors, fixtures, shelving, counters, and cabinet surfaces to create a cleanroom environment. One of the major recent changes in the standard is the requirement to monitor and report at least daily—or to use a continuous recording device—for pressure differential or airflow between the buffer area and the ante area, as well as between the ante area and the general environment. The chapter also includes appendices that can serve as useful checklists for compliance. Together, these requirements emphasize the importance of a comprehensive approach to maintaining compliant and controlled pharmacy environments.