Case Study

Mobile Sterile Compounding Pharmacy USP 797/800 At Duke Raleigh Cancer Center

Source: Germfree
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The goal of this project was to create a mobile cleanroom trailer for a sterile compounding pharmacy that adheres to the stringent pharmaceutical standards of USP 797 and 800.

To accommodate, Germfree developed a 53-foot mobile cleanroom trailer to ensure uninterrupted sterile drug compounding during a facility renovation, compliant with USP 797 and 800 standards. The trailer featured two ISO 7 buffer rooms, one with positive pressure and one with negative pressure, each supported by ISO 8 anterooms.

Equipped with biosafety cabinets, laminar flow hoods, and refrigerators, the cleanroom was designed for optimal cleanability and maintenance. First deployed in 2015, this state-of-the-art unit has been part of Germfree's lease fleet, demonstrating durability and adherence to stringent pharmaceutical standards, providing a safe and sterile environment for pharmaceutical manufacturing.

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