Cleanrooms / clean zones

Regulatory classified spaces
Storage of hazardous / sensitive material
Pharmaceuticals / medtech industry
Other ISO classified spaces

Read below about our specific spaces to see which ones are right for you

SOME CLIENTS WHO TRUST US

EXPLORE OUR SOLUTIONS


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.

Future-proof your operations


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.


What is the USP 797?


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.

Turn-key cleanrooms with guaranteed functionality

Continuous monitoring




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.



STICK-BUILT CLEANROOM vs. QLEANAIR ADAPTABLE CLEANROOM


Primary consideration rating in choosing a cleanroom solution for today and beyond


STICK-BUILT
CLEANROOM*

*Triplett, Choosing a Pharmacy Clean Room Solution For 2014 and Beyond, 2014

QLEANAIR ADAPTABLE
CLEANROOM

LOW 
When you finish a stick-built room and you have subsequent growth or need to place new automation or equipment inside, it is not usually feasible to think about expanding it. Expansion entails taking the facility offline and starting a new construction project.
HIGH
QleanSpace will help you transform your existing pharmacy environment into a fully compliant USP <797/800> certified cleanroom with a full guarantee to certify and meet USP and Federal requirements. QleanSpace’s team of professionals work with you to design, deliver, install, and maintain your new cleanroom and can be virtually built anywhere in a short period of time and is highly customizable to your own specifications. Our innovative Panel and nonporous materials increase cleanliness and visibility into work areas and offers continuous monitoring of airborne particles, air pressure, temperature, and humidity along with data recording and alarms.
NOT APPLICABLE 
Not feasible.
HIGH
QleanSpace can be made smaller/larger and reconstructed at a new space entirely with ease and no cost to you. 
LOW 
Being complicated construction projects, these rooms bring high cost in both time and construction management to build, and considerable risk if any important factor is overlooked. Depreciation schedule is very long.
VERY HIGH
QleanSpace rooms are cost effective and can be rented or purchased to meet your financial needs. “Pay for what you need now and expand later when future needs change”. We take the guesswork out of affordability and function.
HIGH for immediate needsLESS for Future regulatory 
Ability to Meet Regulatory Requirements – is quite high, when you’ve designed and built it perfectly taking in account future calculations, leaving a lot of guess work.
HIGH for immediate needs and Future
QleanSpace has a successful track record in certi­fica­tion towards USP <797> regulatory standards.  With our “no risk and full liability guarantee”, we ensure the quality of our cleanrooms perform in accordance with USP <797> and Federal standards. We offer quarterly performance audits to service, maintain, and document the cleanroom's performance giving you the peace of mind you require for patient and healthcare worker safety.

Where we make a difference today

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.


INSTALLATION


Delivery and installation with start and control of the function “As Built”  and
“At Rest”
.

MONITORING


Free regular software upgrade of the central monitoring software.

MAINTENANCE


Regular preventive maintenance and function control of products to ensure full functionality and to ensure full filter efficiency.

COMPLIANCE


Regular audits to ensure regulatory compliance with ISO and USP certification standards.

BENEFITS OF BEING A QLEANAIR PARTNER


Become a QleanAir partner, and future proof your operations with adaptable, innovative solutions

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