How Solid-State Refrigeration Can Make You USP <800> Complaint
June 13, 2019
When you’re just starting to smell spring’s freshly bloomed flowers or enjoying your first ballpark hot dog of 2018, a date like December 1, 2019 can seem very far away. But if you’re in charge of cleanroom regulatory compliance, you know the USP <800> deadline will be here before you know it.
Whether you’ve conducted a full compliance gap analysis or are just starting to explore the steps you’ll need to take to ensure compliance with USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings, it’s probably already clear that your existing compressor-based refrigeration setup needs to change. USP <800> requires unique controls for compounding hazardous (chemo) drugs. You can no longer use pass-through refrigerators, you must vent any conventional refrigerators outside the room, and you need to have a separate, dedicated refrigerator for hazardous drugs.
Before developing costly construction plans for ventilation, consider switching to a refrigerator that can be immediately used (wherever you need it) in a cleanroom environment without additional ventilation – a solid-state refrigerator.
Here are three ways that a solid-state refrigerator can ensure compliance with USP <800>:
1. No special ventilation is required.
Unlike refrigerators with compressors that generate and disperse particulates, solid-state refrigerators do not require added measures for venting outside of the room. Look for refrigerators that are USP <797> and <800> compliant, allowing you to avoid spending $100K or more on costly renovation projects to ensure the compliance of conventional refrigerators. And because a solid-state fridge is more portable and not tied to ventilation systems, you can also move it to another location as workflow demands.
2. It offers lower heat output.
Solid-state cooling delivers 40% energy savings and a cooler working environment than conventional, compressor-based systems. This lessens the burden on your facility to maintain temperature and environmental control.
3. It is easier to clean and maintain for a 100% sterile cleanroom environment.
A modern, simple design makes the solid-state refrigerator easier to clean than refrigerators that use grease and oil and include hard-to-reach coils. And without compressors or mechanical forces, there are fewer moving parts that weaken over time and fail. This translates to less preventive maintenance, increased dependability, and simpler service and repairs when needed.
As we get closer to 2019, many facilities will find themselves knee-deep in cleanroom construction and renovations to meet USP <800> compliance. If that’s not how you want to spend your time and budget, find out more about solid-state cooling in this infographic: USP <800> Compliant Cleanroom Refrigeration.
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