Adaptable cleanroom facilities for sterile compounding
QleanSpace is a turn-key cleanroom with guaranteed functionality. Our highly adaptable
solutions have short installation time, and provide a safe and efficient environment for your
pharmacy operation. All components are factory-assembled and tested before shipping.
Negative pressure Hazardous Drug storage and staging area
HD storage and staging area, separate from other inventory to prevent contamination and
personnel exposure. QleanStore is a negative pressure room with at least 12 air changes per
hour (ACPH) as required by USP 800.
QleanSpace will help you transform your existing pharmacy environment into a facility with USP 797/800 and/or cGMP compliance.
QleanSpace can be installed virtually anywhere, and is possible to move, expand or otherwise alter.
QleanSpace can be configured to meet cleanliness requirements to Class 100/ISO 5 using HEPA or ULPA fan/filter modules. All exposed surfaces are nonporous and easy to clean. QleanSpace utilizes a flat design with no protruding items. The flooring satisfies the strictest requirements for particle release behaviour, helping to reduce any threat of contamination.
QleanSpace constantly monitors the level of airborne particles, the pressure levels, the temperature and humidity, and displays them on screen to make all data easily readable by the staff inside and outside the area. Warning signals are issued at pre set levels when approaching the cleanroom rating limits.
RENTAL OPTION WITH PERFORMANCE GUARANTEE
Our RPG (Rental with Performance Guarantee) rental option includes full service and maintenance, with a full guarantee of the facility and its function with no upfront or start-up costs.
- Delivery and installation
- Start and control of the function “As Built” and “At Rest”
- Free regular software upgrade of the central monitoring software
- Regular preventive maintenance to ensure full filter efficiency
- Regular audits to ensure regulatory compliance with ISO and USP certification standards
- Regular maintenance & function control of products to ensure full functionality
- Free spare parts as part of the maintenance
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