Products / Cleanrooms

QleanAir QleanSpace FDA cGMP

An adaptable and reliable cleanroom solution for high risk applications

QleanSpace FDA cGMP is our customizable cleanroom solution, developed to help meet FDA cGMP classification requirements. The cleanroom uses individual HEPA 14 fan filter units and airlocks to generate positive or negative pressure, allowing for a highly controlled environment. The monitoring system surveils airborne particle concentration, relative humidity, differential pressure, and temperature. Thanks to QleanSpace FDA cGMP being a freestanding and independent room-within-a-room solution, it can be installed quickly almost anywhere and is highly adaptable. Consultation, design, installation, service and functional guarantee are all included in our hassle-free cleanroom solutions.

Key components of the QleanSpace FDA cGMP 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
Including installation, preventative maintenance, and service

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Recommended areas of application

QleanSpace FDA cGMP is our FDA cGMP classified cleanroom solution, made specifically to help you meet the FDA cGMP classification requirements. All exposed surfaces are non-porous and easy to clean, and the floor meets the strictest requirements for particle release behavior, further minimizing the risk of bacterial growth and contamination. Thanks to its customizable and adaptable design, QleanSpace can be tailored to your specific needs and requirements and can even be changed or expanded when needed. It’s the perfect cleanroom solution for any business that needs an FDA cGMP classified cleanroom, for example, businesses in medical technology, pharmaceuticals, or outsourcing facilities.

Hazardous drugs

FDA cGMP compliance

Contamination of products

USP compliance

Healthcare

Pharma

Production industry

Compounding

Medtech

Benefits

Thanks to QleanSpace FDA cGMP being both modular and compact while also working working adjacent to the facility’s built-in ventilation, the cleanroom solution can be placed almost anywhere. QleanSpace FDA cGMP constantly monitors the cleanroom’s pressure levels, relative humidity, temperature, and the level of airborne particles, while displaying the information on screens visible to staff both inside and outside the area. Although the QleanSpace FDA cGMP cleanroom has rigid and durable walls that simulate the property of a permanent fixed-wall room, it is still a flexible solution that can be re-designed or expanded if needed. We help our customer with everything from needs analysis and design to installation and service. Regular maintenance, inspection of filter capacity, and performance checks are also included.