Protection of your products is one of the three pillars we base our company on. Because of this, we develop turn-key solutions for industries like yours who require the most stringent requirements in clean and sterile environments. Our solutions have become associated with top hospitals and the pharmaceutical/medtech industry, as well as a reputation that is unmatched in our field. Read below about our specific spaces to see which ones are right for you.
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. QleanSpace will help you transform your existing pharmacy environment into a facility with USP<797> and/or cGMP compliance.
QleanSpace can be installed virtually anywhere, and is possible to move, expand or otherwise alter to future proof your needs. QleanSpace can also be configured to meet cleanliness requirements to Class 100/ISO 5 using HEPA or ULPA fan/filter modules for control of submicron particles. All exposed surfaces are nonporous and easy to clean, as we utilize a flat design with no protruding items. The flooring satisfies the strictest requirements for particle release behavior, helping to reduce any threat of contamination.
USP 797 Compliant Cleanroom refers to chapter 797 "Pharmaceutical Compounding – Sterile Preparations,”. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP).
USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. QleanSpace is in compliance with these standards.
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.
Primary consideration rating in choosing a cleanroom solution for today and beyond
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