USP Chapter 800 is a new American regulation for air cleanliness pertaining to hazardous drug compounding (Compound Pharmacies). It is a regulation that is not yet required here in Canada but will likely influence Canadian Compound Pharmacies to adjust their air quality requirements in the very near future. Upgrade now and be ahead of the curve!
Improve Sterile Compounding Air Quality to Help Pass USP 800 Testing
USP 800 standards protect both the patients receiving compounding drugs and workers who come into contact with the drugs. 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, compromising the patient’s health.
Why does sterile compounding need to comply with USP 800 standards?
USP 800 standards protect both the patients receiving compounding drugs and workers who come into contact with the drugs.
USP 800 Compliance Guidelines
You need your compounding pharmacy to stay open. To do that, it has to pass new USP 800 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. In this case, they’re pulled toward a controlled disinfection point. This keeps pathogens away from sensitive drug compounds, and keeps stray drug molecules away from pharmacists. SAM 400’s exclusive 360-degree air induction and discharge non-disturbance air flow 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. Because SAM 400 does not impact air flow, temperature, or humidity of the compounding pharmacy, your facilities will have no problem meeting these requirements. Further, since an external exhaust system rarely filters 100% of the room’s contaminants, SAM 400 assists with whole-room disinfection without impacting air evacuation.
USP 800 guidelines for patient safety
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. There have been cases of contamination from pathogens such as: • Mold spores • Bacteria • Viruses • Other infectious molecules One recent case involved a compounding pharmacy that was contaminated with Aspergillus spores. Aspergillus spores have very thick cell walls and are incredibly difficult to get rid of. Within 2 weeks of placing SAM 400 in the facility, the spores were completely eradicated.
USP 800 guidelines for worker safety
During the process of compounding, the drug molecules have a tendency to float up and discharge in the air. Compounding pharmacy workers spend all day breathing in these drugs and chemical compounds, many of which are powerful and dangerous with long-term exposure. New USP 800 guidelines specify an air disinfection standard that keeps these molecules in check.
Major Florida Hospital Chain uses SAM to pass USP-797-800 CAG-009 testing
Hospital Compounding Pharmacy was failing USP-797 testing with positive growth results of airborne Bacillus non-sporulating, and airborne Aspergillus flavus mold spores. Compounding Pharmacy places the SAM 400 into failing areas, in house test show overnight results, official USP-797 retest for airborne pathogens and particulates passes, showing the SAM 400 to eliminate all airborne bacteria and mold spores. SAM passes airborne inspection in spite of inefficiencies in laboratory HVAC system.