Cleanrooms / clean zones

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

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







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 – turnkey cleanrooms

With over 25 years of experience in indoor air purification, we have developed a worry-free solution for environments with extra high demands for cleanliness. We offer modular cleanrooms designed according to your needs in terms of size, purity class and accessories. Project management, service and a performance guarantee are all included.


QleanSpace™ - cleanroom solutions protecting people and products



Protection of your products, processes and people are the three pillars we base our company on. Because of this, we develop turnkey solutions for industries like yours who require the most stringent requirements in clean and sterile environments. Our solutions are installed in over 60 top hospitals and the pharmaceutical/medtech industry, and our reputation is unmatched in our field. Read below about our specific spaces to see which ones are right for you.

Modular, scalable, flexible, and relocatable

QleanSpace, our cleanroom concept, is designed according to your wishes regarding size, regulation standard and equipment. The room is built from modules that combined create a freestanding room, which can vary greatly in size – from a few square feet to several houndred square feet. The modular and freestanding design makes it possible to install QleanSpace in most environments, often within a short space of time and without impacting the existing ventilation. It is also possible to modify, expand or relocate the room if needed with ease and minimal downtime.

Easy to handle

Our products use inorganic and nonporous materials to increase cleanliness and safety glass for enhanced visibility into work areas. We offer continuous monitoring of air pressure, temperature, and humidity along with data recording and alarms.

Affordable

QleanSpace rooms are cost-effective and can be leased 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 performance.



Compliant

QleanSpace will help you transform your existing pharmacy environment into a fully compliant USP 797, USP 800, and cGMP cer¬tified cleanroom with a full guarantee to certify and meet USP and Federal requirements. We offer regular 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.

Continuous monitoring

QleanSpace constantly monitors the pressure levels, 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.

Floor Plan Monitors

Air Flow Analysis

What is the USP


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.

On March 28, 2014, The USP (United States Pharmacopeia) along with The National Formulary (USP-NF) published their USP General Chapter <800>, also referred to as USP 800, to serve as a new standard to guide the handling of hazardous drugs. The main advantage with the release of USP 800 is to extend the protection of health care personnel from exposure to Hazardous Drugs. This includes all healthcare personnel who handle hazardous drug preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians)

Our USP 800 compliant spaces allow hazardous drugs to be received, and unpacked in a negative pressure space.

What are the benefits of QleanSpace?

Tailored to your needs

USP class, size and accessories according to your user requirements specifications (URS).
A cleanroom within the room

Free-standing and can be installed in most environments.
Modular design

Cost-effective and can be reconfigured and expanded as needed.
Complete supplier

Own staff for the design, installation and service.
Lifetime performance guarantee

We ensure that the solution works over time.
Flexible financing

Buy or lease, long or short term. What suits you best?

A COMPLETE SUPPLIER



From needs analysis to continuous maintenance

Experience the benefits of a complete supplier. We are with you throughout the journey, from a needs analysis and user requirements specification (URS) for purity class to continuous maintenance of the finished room. We will help you with the design, equipment, project design, installation, classification, and validation.

Lifetime performance guarantee

Once the room has been installed, cleaned, and validated, we offer continuous service to ensure performance over time. Our solutions have a lifetime performance guarantee, which means that we maintain the product to ensure the same high levels as at the time of installation. Regular maintenance, performance checks, and inspection of filter capacity are included in our service.

Financial flexibility

Which is the best solution for you – buying with a service agreement or leasing, with service and a lifetime performance guarantee included? We can offer the type of contract that suits you best.

QleanSpace product film



STICK-BUILT CLEANROOM vs. QLEANAIR ADAPTABLE CLEANROOM

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


Lease option with a performance guarantee

Our lease option includes full service and maintenance, with a full guarantee of the facility and its function with no upfront or start-up costs.


STICK-BUILT
CLEANROOM

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’s team of professionals work with you to design, deliver, install, and maintain your new cleanroom. It can be built virtually anywhere in a short period of time and is highly customizable to your own specifications. It is easy to expand or shrink according to you needs.

Not applicable 

Not feasible.

High

QleanSpace can be made smaller/larger and reconstructed at a new space entirely with ease.

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 leased 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 biannual 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.

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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