PROJECT USP 800 & USP 797 CASE STUDY
BACKGROUND
USP 800 guidelines protect healthcare patients, professionals, and environments from hazardous drug compounds. Meanwhile, USP 797 protects individuals involved with sterile compounding sites, as well as their environments, against contaminations. Due to the recent changes and developments to the USP 800 and 797 requirements, many companies seeking new cleanrooms and metrology labs require the assistance of tenured design and construction experts, who can navigate them through the entire process. That’s exactly why an existing national company in Las Vegas, Nevada, contracted Western Environmental for such a project.
PROJECT CHALLENGE
In addition to ensuring each change to the USP 800 and 797 requirements were carefully considered in our planning and design, Western Environmental was tasked with creating and installing a cleanroom suite consisting of the following:
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Four USP 800 cleanrooms
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Four USP 797 cleanrooms
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A gowning and de-gowning area
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Two ISO 8 prep rooms
Because of the compounding materials utilized in these areas, as well as in multiple clean spaces, Western Environmental’s design had to be adjusted accordingly with the addition of two HVAC systems.
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RESULTS
With the final result adhering to USP 800 and 797 guidelines, our client’s new cleanroom suite achieved stringent specifications in every area. Thanks to the inclusion of the right HVAC systems, the suite is capable of maintaining temperature stability to +/- 1°C of set point and relative humidity of 30%-50%. Though the cascading room pressures between different cleanroom areas can provide challenges, Western Environmental also ensured plentiful fume hoods and exhaust fans were included in the design to help our client combat any complications.
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DESIGN PARAMETERS
– Temperature: 68°F
– Stability: +/- 3°F
– Relative Humidity: 30-50%
– Cleanliness: ISO 7 (Class 10,000)
– Enclosure Size: 1900 sq. ft.
