ISO 7 Cleanroom Standards
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Understanding ISO 7 Cleanroom Standards

At Nordell, we prioritise precision and cleanliness in our manufacturing processes, especially within our ISO Class 7 Cleanrooms.


Certified to meet stringent ISO 14644 standards, these facilities ensure optimal air quality and cleanliness, which are crucial for the production of medical devices and pharmaceutical products.


Explore how our adherence to these cleanroom standards can elevate the quality and compliance of your products.


Contact us today to learn more about our capabilities and how we can assist your manufacturing needs.

What is an ISO 7 Cleanroom?

An ISO 7 Cleanroom, defined under ISO 14644-1, is a controlled environment with stringent air cleanliness criteria.


It permits no more than 352,000 particles per cubic meter of air, measuring 0.5 microns each. The design includes features like HEPA filters with 99.997% efficiency at 0.3 microns and requires 60 to 90 air changes per hour.


This setup is essential for industries where ultra-clean environments are critical, such as pharmaceuticals and medical device manufacturing.


Certification and Compliance


For a cleanroom to achieve ISO 7 classification, it must undergo rigorous testing and validation processes.


This includes airflow and velocity tests, HEPA/ULPA filter integrity leak tests, airborne particle count assessments, and more, ensuring the cleanroom meets the necessary standards.


Nordell's cleanrooms are certified to these standards, ensuring consistent compliance and performance.


Benefits for Nordell's Clients


Utilising an ISO 7-certified cleanroom brings numerous benefits to our clients:


  • Enhanced Product Integrity: The controlled environment minimises the risk of contamination, crucial for producing high-quality medical devices and pharmaceutical products.
  • Compliance Assurance: Adhering to ISO 7 Cleanroom standards ensures that products meet both regulatory and client-specific cleanliness requirements.
  • Versatility in Production: Our facilities are equipped to handle a diverse range of products, supporting various industries that require cleanroom manufacturing.


Our Commitment to Cleanroom Standards


At Nordell, we understand the importance of cleanroom standards in maintaining product quality and regulatory compliance.


Our ISO Class 7 Cleanrooms are an integral part of our commitment to delivering excellence in manufacturing.


We proudly maintain our facilities to meet and exceed the requirements set by ISO 14644, ensuring optimal conditions for all cleanroom manufacturing needs.


Learn More About Our ISO 7 Cleanroom Standards


Discover more about what can be manufactured in our ISO Class 7 cleanroom environment and how we uphold the highest cleanliness and quality control standards.


Contact us today to learn how our cleanroom solutions can benefit your manufacturing requirements.

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