What Is An ISO Class 7 Cleanroom?

Our Cleanroom Classification Explained

Our ISO Class 7 Cleanrooms are certified to ISO14644 standards.

 

That means they are capable of providing air cleanliness of a maximum of 352,000 particles per cubic meter at 0.5μm and 60 to 90 air changes per hour.

 

Our Cleanrooms comply with ISO 14644 standards on air cleanliness, which were established to address the need for uniform Cleanroom classification and testing.

 

What Is A Cleanroom?

 

A Cleanroom is usually required in the production of medical, consumable, and other hygiene-sensitive products. They are designed so that contaminants and particle flow can be managed and monitored closely to maintain requirements. ISO classifications run from one to nine, with nine being the least strict when measuring the allowed concentration of particles per cubic meter of air.

 

As well as air changes, changing / gowning rooms are required must be situated at entry and exit points to reduce the chances of contamination.

 

For Cleanrooms to adhere to the ISO Class 7 cleanroom classification, there are a number of stringent measures that manufacturers must abide by to manufacture parts including:

 

  • 60 to 90 air changes per hour.
  • 352,000 PPC (particles per cubic meter) at 0.5μm.
  • Required testing every six months.
  • HEPA filters (99.997% efficient @ 0.3 microns)
  • A separate room for owning.
  • Sticky mats at entry/exit points

 

Class I or Class II medical devices and pharmaceutical products all require a Class 7 Cleanroom to maintain cleanliness and the quality of the products produced.

 

For every cleanroom, testing and validation is an essential process.

 

A cleanroom testing and validation service is a process that ensures that the cleanroom is professionally installed and designed for its intended classification and that the regulations and other defined standards for all components are met. Nordell’s cleanroom is validated in line with the required testing schedule by Total Clean Air (TCA) of Portsmouth, Hampshire who built our cleanroom.

 

The cleanroom testing and validation consist of several phases from the design to the final certification. Airflow and velocity tests, a HEPA/ULPA filter integrity leak test, air movement visualisation, airborne particle count tests, room pressure tests, relative humidity and temperature testing are some of the tests conducted in these phases.

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