USP compliance
Challenges
When compounding drugs, high levels of cleanliness are business-critical, and being USP compliant is mandatory. The USP 797 and USP 800 requirements are an important part of patient safety and environmental protection, as well as protecting staff from hazardous drugs and the production process from contamination. In other words, USP compliance is important, but because of the strict requirements, they can be hard to achieve without the right cleanroom solution for your business.
Application areas
In pharmacy compounding where high levels of cleanliness are critical to an organization and patient health, USP compliance is mandatory. USP guidelines play an important role in patient safety by reducing contamination as well as protecting staff from hazardous materials. USP guidelines are constantly changing and can be difficult to adhere to without changes at downtime that come at a high cost. Without the right cleanroom solution for your organization, you can suddenly find operations closed down and patients can be harmed.
Solutions
QleanSpace is a freestanding room-within-a-room cleanroom solution that ensures a controlled environment. We offer a customizable solution to meet your specific needs for USP classification, room size, and other requirements. QleanSpace can be installed in most environments, and changed or relocated if necessairy. It uses multiple individual HEPA 14 fan filter units and airlocks to generate positive or negative pressure. The monitoring system controls data points of interest, for example particle levels, airflow, relative humidity, and air pressure. In addition, it uses non-organic materials with smooth surfaces and corners that meet the strictest requirements for particle release to ensure easy cleaning. Consultation, design, installation, and functional guarantee come with the cleanroom to give you a hassle-free solution. Function control, preventive service and regular maintenance all help you maintain your desired USP classification for your cleanroom.
Safer work
environment
Compliance and
performance guarantee
Increased
product quality
A flexible and
independent solution
