USP<797> Compliance

In an effort to increase patient safety, the U.S. Pharmacopeia has implemented USP<797> to control the compounding and administration of pharmaceutical products in the United States. The regulations comprising USP<797> are intended to protect patients by preventing the contamination of compounded sterile preparations.

With TSS’ nationwide staff of CETA registered cleanroom certification professionals, you’ll find that USP<797> compliance is as simple in practice as it is in principle. Outlined below are some basic guidelines involved in the implementation and maintenance of USP<797>. For more detailed information or to find out if you qualify for a complimentary USP<797> gap analysis, contact your local TSS representative today.

Primary Engineering Controls

Sterile compounding must be performed inside an ISO Class 5 (or better) Primary Engineering Control [PEC], such as a laminar airflow workbench, biological safety cabinet, or isolator. TSS can assist you in assuring that your PEC meets USP<797> certification standards every six months.
Your ISO Class 5 PEC must be operated within a cleanroom (buffer area) that meets ISO Class 7. Supply air HEPA filtration is required for the Class 7 area. This cleanroom also requires semiannual certification. (Note: The ISO Class 7 requirement may be circumvented in the compounding of 12-hour beyond use date pharmaceuticals or by the use of a barrier isolator.)

Cleanrooms

Cleanrooms (buffer area) must meet ISO Class 7, have supply air HEPA filtration, and be certified every six months. In addition, the cleanroom must be monitored for adherence to airflow and room pressurization standards.
For positively pressured, non-hazardous compounding areas, a buffer area and separate anteroom are required for medium to high risk compounding sterile preparations [CSPs]. An anteroom is not required for low risk CSPs with 12 hours or less beyond use date. In the case of negative pressure, hazardous compounding areas, a positive pressure buffer room with a combined anteroom is permissible.
Anterooms (combined with buffer area) must meet all standards applicable to ISO Class 7 cleanrooms. A physically separate anteroom may be operated to ISO Class 8 specifications and certified as such every six months. Anterooms should have a "hands-free" operating sink, air hand dryer, coat hooks, and uniform storage. All bulk supplies must be removed from cartons and disinfected. The anteroom may be used for gowning.
A room air exchange rate of greater than or equal to 30 air changes per hour must be documented for positive pressure compounding areas.

Environmental Monitoring

In addition to the semiannual monitoring and certification of ISO Class devices or areas, viable environmental monitoring should be conducted regularly. A written plan should be put in place for the implementation and schedule of environmental monitoring, including a diagram of intended sample locations and a baseline for the minimum acceptable limits of viable organisms. Regular sampling by TSS will assist you in monitoring trends in the presence of viable organisms, thus helping you evaluate the effectiveness of your cleaning and operating procedures.

TSS wants to make your transition to USP<797> as simple as possible. Contact us at 1.800.877.7742, or directly at our nearest regional office, to discuss your specific needs and to schedule services.