With General Chapter USP <800> creating quite the buzz, we are fielding tons of questions regarding refrigeration in the hazardous drug clean room. We have recapped some of the most common refrigeration questions below. You can also download these questions and answers by following the link at the end of the post.
Is this USP 800 Compliant?
There is no such thing as a piece of USP 800 compliant equipment; however, Helmer equipment does not hinder compliance in any way.
Do I have to vent the refrigerator?
If a refrigerator is placed in a negative pressure buffer room, an exhaust located adjacent to the refrigerator's compressor and behind the refrigerator should be considered. The hazardous materials stored inside of the refrigerator are the concern here.
Helmer refrigerators do not introduce any additional particles into the clean room environment. The low wall return is so any particles get swept out. Returns can be placed anywhere that makes sense based on the location of refrigerators, computers, etc.
The question is, can the room meet ISO 7 or ISO 8 (whichever is required, based on the design)? We have customers with refrigerators in various environments with no issues.
My refrigerator can’t have a compressor, do you have any solutions?
There is no statement in USP 800 claiming that the refrigerator inside the hazardous drug room cannot have a compressor. Compressor technology is the gold standard for cooling large cabinet sizes storing expensive and sensitive drugs. In fact, General Chapter <800> actually addresses the compressor which will be in your cleanroom. However, we do offer a compact thermoelectric unit. Please note that, thermoelectric units have fans and move around air just like traditional medical refrigerators.
Is there a compressor?
Our compact refrigerator uses thermoelectric cooling, however, compressors are the gold standard for full-sized medical-grade refrigerators. They are essential for maintaining precise temperature control and recovery in larger sized cabinets. There is no issue with putting a refrigerator with a compressor in a USP 800 clean room.
Where is the compressor located?
Compressors are located at the top of Helmer units.
Can I continue to use my pass-thru?
The pass-thru refrigerator cannot be used to move products in/out of the USP 800 room. However, you can move your pass-thru fully inside of the room, lock one side, and continue using it as a normal refrigerator. Facilities undergoing construction should ensure that their refrigerator will be positioned fully inside of the clean room.
Do your refrigerators generate particulates?
The reasoning behind locating an exhaust adjacent to the compressor is to help sweep out any hazardous materials that the supplies stored inside the refrigerator may introduce into the environment. Helmer refrigerators do not release any additional particles into the environment. As long as your room can maintain the correct classification and pass air quality testing, there is no issue with putting a refrigerator inside of the room.