ISO Cleanroom Standards

Nordell's Cleanroom Standards

International Organisation for Standardisation (ISO) classifications are based on international standards that regulate the acceptable cleanliness levels of each room.

 

We are very proud of our cleanroom injection moulding facilities here in Worthing.

 

We are equipped to help cater to various industries with a wide range of clients. Find out what can be made in our ISO Class 7 cleanrooms.

 

Cleanroom ISO Class Codes

 

Knowing the precise cleanroom standards is crucial when deciding where to get your products manufactured.

 

Different levels or ‘classes’ of cleanroom can help determine what kind of materials can be created.

 

The following clean room classifications provide the recommended air changes per hour, per class of cleanroom:

  • ISO Class 1 – ISO 1 is used in industries such as life sciences and electronics that require nanotechnology or ultra-fine particulate processing. The recommended air changes per hour are 500-750, and the ceiling coverage should be 80–100%.
  • ISO Class 2 – 500-750 air changes per hour/ceiling coverage of 80-100%.
  • ISO Class 3 – 500-750 air changes per hour/ceiling coverage of 60-100%.
  • ISO Class 4 – 400-750 air changes per hour/ceiling coverage of 50-90%.
  • ISO Class 5 – 240-600 air changes per hour/ceiling coverage of 35-70%.
  • ISO Class 6 – 150-240 air changes per hour/ceiling coverage of 25-40%.
  • ISO Class 7 – 60-150 air changes per hour/ceiling coverage of 15-25%.
  • ISO Class 8 – 5-60 air changes per hour/ceiling coverage of 5-15%.

 

Nordell’s ISO Cleanroom Standards

 

Our cleanrooms adhere to the ISO Class 7 cleanroom classification.

 

To obtain this, there are several stringent measures that we must abide by to manufacture parts, including:

 

• 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.

 

You can find out more about what we can manufacture in our cleanrooms.

 

Below we have outlined the full standards that our cleanroom facilities adhere to.

 

ISO 14644-1 describes the classification of air cleanliness in classrooms and related environments. Air cleanliness is classified based on the concentration of airborne particulates present in the environment.

 

ISO 14644 is divided into nine different sections, ranging from the classification of air cleanliness in controlled environments to sorting out particle contamination stages.

 

The table below shows the air cleanliness class by particle concentration required to meet ISO 14644-1:2015 standards.

 

Click the table to see a high-res version.

 

 

ISO Internationall Organization for Standardization logo

 

Learn More About Our Cleanroom Standards

 

You can learn more about cleanroom standards and watch a timelapse video of our cleanroom facilities being built.

 

Contact us today to speak to our team if you have any queries about our cleanroom standards and facilities.

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