USP <800>: Is Your Refrigerator Putting Your Compliance at Risk?
June 13, 2019
Although the deadline for USP <800> compliance was pushed back to 2019, many healthcare systems are already well into their preparations to meet the new standards. If you’re not as far along as you planned to be at this point, it can be overwhelming to think about every aspect of your drug handling and storage and whether it is (or will be) in compliance.
One of the key aspects of USP <800> is related to refrigeration and the airflow and system pressure needed in cleanrooms to sustain requirements. According to the guidelines, when compounding hazardous (chemo) drugs:
Environmental chambers must operate at a negative pressure.
Pass-through refrigerators can no longer be used.
Conventional refrigerators must be vented outside the room.
Dedicated refrigeration must be maintained.
For many healthcare systems, ensuring compliance with these pending guidelines could cost more than $100K in potential renovations and take months to complete. Instead of diving right into any infrastructure modifications, take a minute to consider a different sort of cleanroom refrigeration option – solid state medical-grade refrigeration.
By doing away with compressors, fans and toxic refrigerants, solid state refrigerators are cleanroom-ready and meet USP <800> guidelines without renovations or special ventilation. Unlike compressor-based refrigeration, solid state refrigeration eliminates contamination and the vibrations that lead to particulates, and uses technology free of grease or oil. No compressors also means lower heat output, which allows you to use less energy when cooling the room.
Without the mechanical parts of compressors and fans that fail most often, solid state refrigerators require less maintenance and upkeep. And their modern, simple designs make them much easier to clean than refrigerators with hard-to-reach coils and compressors. All of these differences make it easier for you to ensure your refrigerator isn’t putting your USP <800> compliance at risk.
Failure to comply with USP <800> can result in fines, suspensions or loss of license. And with a deadline of December 1, 2019, healthcare systems are running short of time to identify and budget for the expenditures required for compliance. If you’re dreading the refrigeration-related renovations you’ll need to comply with USP <800>, consider Phononic, the simple choice for cleanroom-compatible refrigeration.
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