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.

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)