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’s compliant cleanrooms extend the protection to health care personnel from exposure to hazardous drugs. Having a Qleanspace cleanroom means you have a future proof solution from both, regulatory mandates as well the ability to change, move or expand as you grow. Our turn-key cleanrooms include guaranteed functionality.

Other benefits to having Qleanspace cleanrooms are, short installation time to not interfere with a demanding schedule, being pharmacy retrofit, and most importantly, providing a safe and efficient environment for your pharmacy operation. QleanSpace can 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. All components are factory-assembled and tested before shipping.


QleanSpace – More than just modular 

To call QleanSpace a modular cleanroom is an understatement. For pharmacy  operation, regulations require certain features in a cleanroom; including a solid, hardwall construction able to match the dexterity of a permanent fixed wall cleanroom, but with the flexibility to redesign, grow and relocate virtually anywhere, as future needs change.

In some modular constructs, you will not find these features since they are made of softwall or porous material, unsuitable for pharmacy operations meeting certain ISO classifications, as well as USP 800 / USP 797 compliancy.

Besides being a turnkey solution, QleanSpace offers so much customization to tailor to any pharmacy’s specific needs, including wall material, power options, telecommunication/network ports, electrical outlets, and compliance.

 
Pharmacy retrofit 

QleanSpace will help you transform your existing pharmacy environment into a facility with USP and cGMP compliance. QleanSpace can be installed virtually anywhere, and is possible to move, expand or otherwise alter. 


From planning, to implementing and beyond

QleanAir Scandinavia offers sound advice to determine which classification and standards your cleanroom should adhere to in order to operate successfully. This includes assisting you through every step of the process; from planning and budgeting, to implementation, and follow–ups once it is completed. We ensure our customers are compliant at inspection and beyond (USP 797/800/cGMP). 

A typical consultation includes an on–site evaluation, surveying of existing or potential areas for modification, discussing your needs and requests, and creating a mockup/schematic for approval before construction. *For cleanroom compounding of HD’s, we’ll coordinate an on–site visit with your facility's project manager.

 

Regularly scheduled maintenance 

QleanAir Scandinavia conducts regular performance audits to service, maintain and document the cleanroom's performance and functionality, giving you the peace of mind you require for patients’ and healthcare workers’ safety. 


Budgeting and Financing

Whether you are established or a startup, we offer the flexibility to rent/lease or buy; along with an unbeatable service plan. Contact us here to speak to someone about options and a price quote. 


Compliance

We ensure our customers are USP 797/800/cGMP compliant at inspection and beyond, keeping you compliant throughout our partnership. 


For American Hospital Pharmacies

If your hospital pharmacy is operating in the United States, you’re most likely aware of the federal and state mandates to comply with USP 800 and USP 797 before November 19, 2019.


FAQs (common questions about our cleanrooms)


What materials are your cleanrooms made out of?

Safety Glass: All QleanSpace cleanrooms use tempered safety glass; not plastic or Plexiglas.

Walls: In complying with USP <800> and USP <797> guidelines, our load–bearing walls are made with medical grade aluminum that is anodized (closed pores). All our materials are inert (non organic), compact laminate (plastic) or aluminum laminate, which has a core of a polymer.

Flooring: Easy cleanup and sterility are of the most importance when maintaining a safe and operational cleanroom. QleanSpace cleanrooms offer a non–porous polyvinyl medical grade flooring that adheres to the strictest of hygienic requirements and particle release behavior, helping to reduce any threat of contamination.

Filtration/optimum airflow: Our cleanroom’s air filtration is integrated into our product and does not interfere with existing HVAC systems.

Real–time, continuous monitoring: We monitor the level of airborne particles, air pressure, temperature and humidity. The data is recorded in real time and can be recalled, and reviewed at any time. Warning signals are issued at pre set levels when approaching the cleanroom rating limits.


What design features do you offer in your cleanrooms?

Lighting, intercoms, teleports, electrical power outlets, size and shape, interlocking doors, anterooms, HD (hazardous drug) storage, etc. are all customizable options we offer to suit your specific needs. QleanSpace construction also:

• can be configured to meet specific workflow with pass–throughs that may be used for switching of supplies, and loading/unloading of carts.

• features a low energy model working off 120V.

• utilizes a floor/ceiling/wall flat design; meaning, no protruding surfaces or gaps on surfaces.

• adheres to cGMP (current good manufacturing practice)



What is the USP 800?


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.

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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