In sectors where hygiene and precision are essential, such as the pharmaceutical industry, biotechnology and healthcare, Clean Rooms must comply with strict ISO standards. A Clean Room is only truly reliable when it has been validated: tested, certified and continuously monitored.
A Clean Room is a controlled environment in which contaminants in the air such as dust particles and microorganisms are carefully regulated. ISO 14644 is the international standard that defines the classification of air cleanliness in Clean Rooms and controlled environments.
At REMAG Medical Solutions, we value transparency and measurable quality. That is why we perform every validation in collaboration with MedicCleanAir, a specialist in air purification and certified measurement methods.
Why validation is essential
Validation confirms that a room consistently meets the required ISO classification (for example ISO 5, 6 or 7). This is crucial for product quality, patient safety and regulatory compliance. A properly validated environment prevents contamination and ensures reliable conditions in operating rooms and laboratories.
Our collaboration with MedicCleanAir
At REMAG Medical Solutions, we work closely with MedicCleanAir, a specialist in air quality measurement and Clean Room validation. Their advanced systems meet the highest ISO standards and are specifically designed for medical and pharmaceutical uses.
One of their innovations is the Combi 1.5, a compact air purification system that can upgrade rooms to ISO 6 or even ISO 5 levels. The system combines filtration, cooling, heating and positive pressure in one integrated unit. It can be installed within a single day and delivers measurable results within 30 minutes.
The validation process consists of several phases:
- Design Qualification (DQ): Evaluation of the design to ensure it meets all required specifications.
- Installation Qualification (IQ): Verification that the systems are correctly installed.
- Operation Qualification (OQ): Testing the systems under operational circumstances.
- Performance Qualification (PQ): Assessing system performance over a defined period.
- Certification: Official approval that the Clean Room meets the requirements.
Our partner MedicCleanAir supports this process with precise measurements and detailed reporting, which are essential for compliance with standards such as ISO 14644.
A validated Clean Room is the foundation of safe, reliable and high-quality operations. Through our collaboration with MedicCleanAir, we ensure that every space meets the strictest quality and safety standards.
