QleanAir QleanSpace USP
Continually compliant
pharmaceutical
cleanrooms
QleanSpace USP is our customizable cleanroom solution made to meet your specific USP 797 or USP 800 classification needs. By using airlocks and HEPA 14 fan filter units to generate positive or negative pressure, our cleanroom solution makes it possible to create a highly controlled and sterile environment. Thanks to QleanSpace being a freestanding and independent room-within-a-room solution, it can be installed in almost any environment and even relocated if necessary. Consultation, design, installation, service, and functional guarantee are all included in our hassle-free cleanroom solutions.
Key components of the QleanSpace USP solution
- Customizable, modular design, tailored for your needs in any size
- Non-porous and flush surfaces for easy cleaning
- Continuous monitoring of data points of interest, such as particle levels, relative humidity, differential pressure, and temperature, with warnings at pre-set levels
- Individual fan filter units with HEPA 14 filters certified according to EN 1822
- Fully automated and interlocking door system
- Airlocks for clean passage of personnel, pass-through cabinets for material, laminar airflow cabinets and other options available
- Preventive service and maintenance to ensure compliance and performance according to USP 797 and USP 800 classification
Recommended areas
of application
Our QleanSpace USP classified cleanroom solution is designed specifically for drug compounding where a high level of cleanliness is absolutely critical for the health and safety of patients. Thanks to the customizable design, QleanSpace can be easily tailored for your specific needs and requirements, and can even be relocated, changed, or expanded when needed. All of the exposed surfaces are non-porous and easy to clean, and the floor meets the strictest requirements for particle release behavior, further reducing the risk of any contamination.
Benefits
QleanSpace is a modular, compact and independent solution, working adjacent to the HVAC system, allowing it to be placed almost anywhere. QleanSpace constantly monitors your selected data points of interest, such as differential pressure, relative humidity, temperature, and the amounts of particles in the cleanroom, while displaying them on screens that are visible to staff both inside and outside the area. Thanks to its solid hard wall construction, it matches the durability of a permanent fixed-wall cleanroom, while also being a flexible solution that can be re-designed, re-located, or expanded if needed.
We help our customers with everything from needs analysis to installation and maintenance. All of our solutions come with a Lifetime Performance Guarantee. Regular maintenance, inspection of filter capacity, and performance checks are also included.
Tailored for
your needs
Standalone and
independent solution
Modular and
adaptable
Compliance and
according to GMP
Cost efficient
Lifetime Performance
Guarantee
Example layout
1. Modular, durable walls
2. Pass-through cabinet
3. LED lighting
4. Fan filter units/HEPA filter
5. Continuous monitoring
6. Windows/glass panels
7. Smooth surfaces and rounded corners
8. Material air lock
9. Anteroom
10. Changing room
11. Door automation
