USP <800>: The Simple Path to Refrigeration Compliance
June 14, 2019
At the American Society of Health-System Pharmacists (ASHP) Midyear and Clinical Meeting earlier this month, Phononic joined over 25,000 pharmacy professionals seeking to expand their industry knowledge and insights. One of the key concerns of many attendees was USP <800> readiness, which isn’t exactly a surprise since the deadline for compliance (December 1, 2019) is now officially less than a year away.
USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings was developed to protect patients and healthcare workers from potential harm. This set of standards helps ensure the safe handling of hazardous (chemo) drugs throughout the healthcare system, including their controlled storage.
How ready is your facility? To help you figure that out and determine what else you might need to do to ensure compliance, the USP Compounding Expert Committee has compiled an extensive list of FAQs and their answers. If you are using conventional, compressor-based refrigeration, you’re likely already well aware that you will need to make some major changes.
Not only do compressor-based refrigerators require dedicated ventilation (in other words, costly construction) to meet the upcoming USP <800> regulations, but their coils and compressors are difficult to access and clean. Compressors also use grease and oil, and their vibrations over time release particulates into the air. Plus, the mechanical parts of compressors and fans require frequent maintenance and upkeep.
Organizations with large cleanroom facilities could spend close to $100,000 in renovations for proper ventilation. However, before you begin any complex construction plans, consider a simpler path to USP <800> compliance: solid-state refrigeration. Here are five ways it can ease the compliance burden:
1. Replacing conventional compressors and toxic refrigerants with solid-state technology eliminates grease, oil or metal particles dispersed into the environment.
2. Solid-state, medical grade refrigerators are 100% cleanroom-ready – there’s no need for special ventilation or other adjustments and workarounds.
3. The modern, simple design makes all exposed parts easy to reach and clean.
4. Without compressors or mechanical forces, there are fewer moving parts to maintain and fix.
5. And as an added benefit, solid-state cooling delivers up to 40% energy savings and a cooler working environment with less exhaust. This lessens the burden on your facility to maintain temperature control within the cleanroom.
With 2019 right around the corner, the time to decide how you will ensure refrigeration compliance with USP <800> is now. If you’d like to learn more about the simple path to get there, connect with our healthcare team.
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