Navigating Cleanroom Certification: ISO 14644, FDA & CE Compliance | Dersion

In the global supply chain, a cleanroom is only as reliable as the certifications it holds. For stakeholders in the US, Europe, and the Middle East, compliance with international standards like ISO 14644, FDA GMP, and CE is not just a preference—it’s a legal and operational mandate. At Dersion, we understand that quality assurance (QA) is the bedrock of your production integrity.

The ISO 14644 standards are the universal benchmark for airborne particulate cleanliness.

• Why it matters: Whether you are operating an ISO 5 or ISO 8 facility, precise particulate counts dictate your operational classification.
• Dersion’s QA Protocol: We conduct rigorous on-site testing during the commissioning phase to ensure every cubic meter of air meets the specified particulate limits, providing you with a certified environment ready for production.

For pharmaceutical and medical device manufacturers, FDA compliance and GMP (Good Manufacturing Practice) are paramount.

• The Validation Lifecycle: Our modular solutions are designed to support the full validation lifecycle:
  • IQ (Installation Qualification): Verifying that all components are installed as designed.
  • OQ (Operational Qualification): Testing the HVAC and pressure systems under normal load.
  • PQ (Performance Qualification): Ensuring the cleanroom performs consistently over time.

The CE mark is a critical indicator that a product complies with EU safety, health, and environmental protection directives.

• System Integrity: Dersion’s modular systems and electronic components (such as FFU and control panels) are CE certified, ensuring they meet the stringent safety requirements of the European Economic Area (EEA) and global markets.

Certification is nothing without proof. Every Dersion project is accompanied by a comprehensive documentation package, including material certificates, pressure test reports, and filter leak test results. This transparency is why global leaders choose our Turnkey Delivery model.

Navigating the complex landscape of international certifications requires an experienced partner. Dersion provides the technical expertise and certified hardware needed to ensure your facility stands up to the most rigorous audits worldwide.