Modular clean room QleanSpace USP

QleanSpace USP is a customizable cleanroom solution designed to meet specific USP 797 or USP 800 classification needs. Utilizing airlocks and HEPA 14 fan filter units to generate positive or negative pressure, this cleanroom creates a highly controlled and sterile environment. As a freestanding, independent room-within-a-room solution, QleanSpace can be installed in almost any environment and relocated if necessary. The solution includes consultation, design, installation, service, and a functional guarantee. - 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: QleanSpace USP classified cleanroom solution is designed specifically for drug compounding where a high level of cleanliness is critical for patient health and safety. The customizable design allows for easy tailoring to specific needs and requirements, and the solution can be relocated, changed, or expanded as needed. All exposed surfaces are non-porous and easy to clean, and the floor meets strict requirements for particle release behavior, reducing contamination risk. - Benefits: - Modular, compact, and independent solution, working adjacent to the HVAC system, allowing placement almost anywhere - Constant monitoring of selected data points (differential pressure, relative humidity, temperature, particle amounts) with display screens visible to staff inside and outside - Solid hard wall construction for durability comparable to permanent fixed-wall cleanrooms, with flexibility for redesign, relocation, or expansion - Comprehensive support from needs analysis to installation and maintenance - Lifetime Performance Guarantee, including regular maintenance, filter capacity inspection, and performance checks - Example layout features: - Modular, durable walls - Pass-through cabinet - LED lighting - Fan filter units/HEPA filter - 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 environmental monitoring - HEPA 14 fan filter units (EN 1822 certified) - Automated, interlocking doors - Personnel airlocks, pass-through cabinets, laminar airflow cabinets - Preventive service and maintenance for USP 797/800 compliance - Solid hard wall construction - Lifetime Performance Guarantee