USP <800>: 3 Refrigeration Compliance FAQs

June 13, 2019

As many healthcare systems begin to explore the detailed requirements of USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings, they often have questions concerning refrigeration equipment, placement of refrigeration, ventilation and other specifics. Here are the answers to a few of the most frequently asked questions about refrigeration-related compliance with USP <800>.

1. What special ventilation is required for refrigerators?

USP <800> mandates that refrigerators (or any device that could produce particulates) must be placed near an exhaust and/or low wall returns to allow the particulates generated to be swept out of the room. It suggests placing exhausts adjacent to the compressor and behind the refrigerator. Conventional, compressor-based refrigerators cannot simply be placed in cleanrooms without such exhaust systems because of contamination concerns. Their mechanical operation and forces create vibrations and cause cracks to form, generating particulates that are dispersed into the atmosphere.

2. Is refrigerator heat output a concern?

While USP <800> does not include specific guidelines about heat output, USP <797> requires that compounding facilities provide a comfortable and well-lighted working environment with a recommended maximum temperature of 20°C. For that reason, the heat generated by a compressor’s mechanical operation and duty cycle can be problematic. Compressor-based refrigerators elevate room temperatures, which ultimately stress the HVAC control of maintaining a cleanroom at or under 20°C.

3. Are there specific requirements regarding the cleaning and maintenance of refrigerators?

In order to maintain a 100% sterile cleanroom environment in compliance with USP <800>, all surfaces of a cleanroom must be routinely cleaned and all appliances need to be regularly maintained. The grease and oil in compressor-based refrigerators attract dust and debris, which can become a breeding ground for mold, fungus or bacteria. Coils and compressors are often difficult to access and clean. And more moving parts means that more frequent – and more complex – maintenance and repairs are needed.

If it seems like conventional, compressor-based refrigerators just aren’t built for USP <800> compliance, that’s because they aren’t. Luckily, there’s another cleanroom-ready cooling option. Built using solid state technology instead of compressors, Phononic refrigerators are low-exhaust, and without grease, oil or particulates. They are the only medical-grade refrigerators ready for use in cleanrooms that meet USP <800> guidelines without any necessary renovations or special ventilation.

Learn more about the simple choice for USP <800> compliance in this infographic: USP <800> Compliant Cleanroom Refrigeration.