Does Your Pharmacy Comply With The New USP 797?

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 thephysical 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 clean room 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 the pressure differential or air flow between the buffer area and the ante area and between the ante area and the general environment outside the compounding area.

The chapter also contains appendices which could be used as checklists for compliance.

If you need assistance in understanding more about USP 797 in your existing pharmacy HVAC systems or for your next pharmacy project, please do not hesitate to contact Joel Altland, PE at 717-854-7654 or jra@ba-inc.com.

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