USP 800 Compliance and the SAM 400®
Do you need to improve your compounding air quality to help pass USP 800 testing?
SAM 400® is a powerful, portable air disinfection device that removes up to 99.9995% of airborne pathogens. It is the ONLY proven and tested air disinfection system that eliminates airborne contaminants according to USP 800 standards.
USP 800 COMPLIANCE REQUIREMENTS
USP Chapter 800 provides new regulations for hazardous drug compounding, similar to the USP 797 non-hazardous drug compounding regulations. These new air cleanliness guidelines include two major changes:
1. Negative Pressure Requirements
In regular atmosphere conditions, a positive pressure environment causes molecules to spread outwards and fill a room somewhat evenly. Negative pressure means molecules in the air are pulled toward the center of the room and toward a controlled disinfection point. This keeps pathogens away from sensitive drug compounds,and keeps stray drug molecules away from pharmacists.
Solution: The SAM 400® exclusive 360-degree air induction and discharge non-disturbance airflow system is a passive neutral air scrubbing system. It will not affect overall air flow, temperature, or humidity, so it can be placed in any part of your compounding lab for air disinfection. SAM 400® can be placed in positive and/or negative air pressure environments.
2. External Contaminant Evacuation
Your air disinfection system must NOT recirculate filtered contaminants back into the room. Filtered air must be expelled via external exhaust to maintain a higher standard of air cleanliness in the compounding facility. This is difficult to achieve in facilities (modern or older) due to short comings in HVAC design, room air circulation prior to evacuation, and HEPA filtration with its 0.3-micron size limitations.If compounding pharmacy air does not meet USP 800 standards, smaller contaminants can get mixed with the drugs. Since these drugs are injected directly into the patient’s bloodstream, these small and otherwise unthreatening pathogens can bypass the immune system.
Solution: Since an external exhaust system rarely filters 100% of a room’s contaminants, and because the SAM 400® kills ALL pathogens smaller than the HEPA 0.3-micron mesh size, the SAM 400® assists with whole-room disinfection. There is no recirculation of contaminates in the room regardless of HEPA filtration and HVAC negative pressure inconsistencies. The SAM 400® will not impact air flow, temperature, or humidity of the compounding pharmacy, so facilities will have no problem meeting USP 797-800 Air Borne test requirements.
MAJOR FLORIDA HOSPITAL CHAIN USES THE SAM 400® TO PASS USP-797/800 CAG-009 TESTING
A major Florida hospital was failing USP 797 testing with positive growth results of airborne Bacillus non-sporulating and airborne Aspergillus flavus mold spores. After placing the SAM 400® into the failing areas, the official USP 797 retest showed overnight results with the elimination of all airborne bacteria and mold spores. The SAM 400® passed the airborne inspection in spite of inefficiencies in laboratory HVAC system.