Cleanroom certification and ISO standards
Why a cleanroom certificate is indispensable
Cleanroom certification, such as ISO certificate 14644, provides assurance that you meet the strict international requirements in sectors such as pharmaceuticals, technology and healthcare. The process starts with a specialist who inspects and commissions the installation. An independent body will then carry out a validation to determine whether your cleanroom is in compliance. Finally, after approval, you will receive a detailed report with results, including information on the equipment used. This certificate confirms that your cleanroom prevents contamination and disruptions and ensures that your processes are reliable and safe.
ISO certification: Strict air purity standards
The ISO 14644-1 standard covers air purity, ranging from class 3 (1,000 particles per m³) to class 8 (100 million particles per m³). Our ISO certified cleanrooms meet these standards thanks to advanced airflow systems that supply clean air through the ceiling and extract polluted air at plant level, ensuring constant airflow and uniform air quality.
Continuous cleanroom monitoring and validation for ISO certification
An ISO certified clean room system requires regular testing and monitoring according to ISO 14644-2:2015 standards. These ongoing inspections include particle concentration measurements, air velocity measurements and HEPA filter integrity testing, so you can be assured of continued performance. Validation is mandatory every six months for ISO class 5 and lower, while higher classes are tested annually to maintain your ISO cleanroom certification.
Certified cleanrooms that grow with you
Highcare’s modular certified clean room systems are designed to easily adapt to changing production requirements. With our Industrial Flexible Demountable (IFD) system, walls and ceilings can be quickly moved or expanded without disrupting your production process. This saves time and costs, while ensuring that your cleanroom continues to function optimally.
Our systems are available as ‘box-in-box‘ and ‘stand-alone’ solutions for maximum flexibility. Equipment can be placed outside the cleanroom for optimal indoor air quality and easy maintenance. In addition, our cleanrooms are completely plug & play, meaning they can be quickly installed without any modifications to your building.
Sustainability and prefabricated production
Our cleanrooms are made of durable, hygienic materials. Thanks to careful prefabricated production, where each component is rigorously inspected, you are assured of consistent quality. The result is a cleanroom that always meets the latest certification requirements, without compromising functionality or performance.
Opt for ISO certified cleanroom quality
With over 25 years of experience, we help companies worldwide optimize their processes and comply with international standards. Highcare cleanrooms are advanced systems that provide continuous air purification, a stable temperature and reliable relative humidity. This allows you to meet the requirements for ongoing ISO certification while maintaining international recognition for optimal performance, even with intensive use.
Contact us today for a free quote and discover how our modular cleanrooms can save time and money while meeting the highest international standards.