Clean room for the pharmaceutical industry QleanSpace FDA cGMP

for medical devicesmodular

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 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. Benefits: - Tailored for your needs - Standalone and independent solution - Modular and adaptable - Performance guarantee - Cost efficient - Hassle-free solution delivered as a service Example layout features: - Modular, durable walls - Pass-through cabinet - LED lighting - Fan filter units/HEPA 14 filters - Continuous monitoring - Windows/glass panels - Smooth surfaces and rounded corners - Material air lock - Anteroom - Changing room - Door automation Technical specifications / features: - Customizable, modular design - Non-porous, flush surfaces - Continuous monitoring (particle levels, humidity, pressure, temperature) - HEPA 14 filters (EN 1822 certified) - Automated, interlocking doors - Personnel airlocks, pass-through cabinets, laminar airflow cabinets - Freestanding, independent room-within-a-room - Installation, maintenance, and service included