QleanAir QleanSpace FDA cGMP

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.

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.