ISO compliance

Challenges

When you develop, manufacture or compound drugs, manufacture medical equipment, electronics, optics or other sensitive products, good air quality is essential to guarantee technical cleanliness and quality. Airborne particles can contaminate sensitive products and equipment and need to be kept at a minimum level. Hazardous drugs and volatile powder ingredients can also harm the staff handling them in both the short term and the long term. Static electricity and electromagnetic interference are challenges when it comes to producing electronics. An ISO classified cleanroom will provide a solution to all these challenges.

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Application areas

ISO cleanrooms are classified from ISO Class 1 to ISO Class 9 according to ISO 14644 Standards with ISO Class 1 being the cleanest. The classifications regulate the maximum number of particles in the air for different particle sizes and recommended air change rates. For example, only robots are allowed to work in cleanrooms classified from ISO Class 1 to ISO Class 4, due to the strict requirements of particle release. Production industries, where electronics, optics, and other sensitive proccesses happen, are often recommended to have a cleanroom of ISO Class 5 to ISO Class 7. Life sciences research facilities, medicine production facilities, and drug compounding pharmacies generally also use cleanrooms of ISO Class 5 to ISO Class 7.

Compounding
Medtech
Pharma
Production industry
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Solutions

QleanSpace is a freestanding room-within-a-room cleanroom solution that ensures a controlled environment. We offer a customizable solution to meet your specific needs for ISO classification, room size, and other requirements. QleanSpace can be installed in most environments, often independently of ventilation. It uses multiple independent and redundant HEPA 14 fan filter units and airlocks to generate positive or negative pressure, and the monitoring system controls particle levels, airflow, humidity, and air pressure. In addition, it uses non-organic materials with smooth surfaces and corners that meet the most strict requirements for particle release, which ensure easy cleaning. Project management, installation, and functional guarantee come with the cleanroom to give you a hassle-free solution. Function control, preventive service and regular maintenance all help you maintain your desired ISO classification for your cleanroom.

contolled

Controlled
environment

Ensured quality
of products

Hassle-free installation and use

Hassle-free
solution

Reduced risk

Recommended products

QleanAir QleanSpace ISO

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QleanAir QleanSpace GMP

Our customizable and flexible turnkey cleanroom can be constructed in accordance with GMP standards.