What is USP 800?

Is your pharmaceutical compounding facility ready for USP 800?

The USP 800 is a newly implemented regulation designed to promote patient health, worker safety, and address environment concerns. USP 800 applies to all pharmacies, hospitals, patient treatment centers, patient treatment clinics, physician practice facilities, surgical centers, veterinarians, home health centers, and skilled nursing facilities that handle or compound hazardous drugs. Hazardous drugs pose a threat to the safety of patients and employees due to the ability to cause cancer, affect fertility, damage DNA or cause organ damage.

Hazardous drug compounding will be required to be conducted in a ventilated device utilizing negative pressure with redundant HEPA filters or external ventilation for non-sterile preparations. Compliant devices include Ductless Fume Hoods, Containment Ventilated Enclosures, and Class II Biological Safety Cabinets. All facilities compounding hazardous drugs will be required to utilize these specific kinds of pharmaceutical powder containment hoods starting December 1, 20191.

Perfect Solutions from Sentry Air Systems

Higher Efficiency Ductless Fume Hoods

USP 800 Compliant Redundant HEPA Filters - Higher Efficiency Ductless Fume Hoods

Our line of Higher Efficiency Ductless Fume Hoods offers a portable, economical, and energy efficient solution for non-sterile compounding of hazardous drugs to satisfy USP 800 regulations. The dual HEPA air filters, or redundant HEPA filters, provide up to 99.97% efficiency for particles as small as 0.3 microns in size. Utilizing the specific redundant HEPA filters design, allows simple installation not requiring ductwork from an outside contractor. These units are available in 30” (SS-330-HEMS), 40” (SS-340-HEMS), and 50” (SS-350-HEMS) widths. Our specially designed units combine powerful airflow in a compact enclosure to filter harmful particulate protecting the operator and the environment. These units are available in a transparent version or to your custom specifications.

Contact us today to learn more or visit the individual product page for the Higher Efficiency Ductless Fume Hoods.

Sources

1.   United States Pharmacopeial Convention. (December 1, 2017). USP General Chapter <800> Hazardous Drugs-
  Handling in Healthcare Settings
. Rockville, MD: Author.