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What are ISO Level 1 Cleanroom

  • 2024-01-04
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Cleanrooms are a must-have for many industries today. From those used in data centers and the tech sector to biopharmaceuticals and space companies, the types of cleanrooms vary depending on how clean the room needs to be. The standards of cleanliness are so important that failure to maintain the room according to ISO’s standards may lead to a lot more than disruption of your services. On top of losing money due to paused operations, you can also get hefty fines and even lose your ISO cleanroom classification!

In this guide, we’ll take a look at the different cleanliness levels required for various ISO Levels and discuss what it means to have a Class 1 cleanroom. 

What Are ISO Levels?

Every cleanroom is assigned an ISO classification out of the nine levels available depending on how clean it needs to be to stay compliant according to ISO Standard 14644-1. ISO determines the cleanroom level depending on the number of contaminants per cubic meter. The levels range from ISO Class 1, the cleanest room in the standard, to Class 9, the ‘dirtiest’ in the classification - but still a very clean room. Before we take a look at what a Class 1 room is, here’s a quick explainer of what the ISO levels are. 

ISO Levels 1-9

Cleanrooms are assessed and categorized based on the size and the volume of contaminants present in the room. Each level has a particle concentration limit, measured in cubic meters of air that the cleanroom must not exceed. Measurements are taken:

just after the cleanroom is complete

at rest, after the equipment has been introduced into the room 

when the cleanroom is in use. 

The typical outdoor air in urban areas has about 35,000,000 particles in the 0.5-micron size. This is the limit that the controlled environment of an ISO Class 9 room has to maintain. In comparison, an ISO Class 1 cleanroom has just 12 particles per cubic meter in the 0.3-micrometer size. The Class 1 cleanroom doesn’t have any particles at the 0.5-micron size. 

ISO Class 8 and 7 cleanrooms are the most common, and they require much less particle concentration. Medical and food companies are some industries using Class 7 and Class 8 cleanrooms to avoid contamination of their product. Other industries that critically depend on cleanrooms such as biopharmaceutical companies use cleanrooms up to Class 5. 

Deep Dive Into ISO Class 1

For a cleanroom to be ISO Class 1 certified, it must comply with many rigorous requirements and standards. Therefore, it is unsurprising that only very few ISO 1 cleanrooms currently exist in the world. 

One of the primary characteristics of a Class 1 cleanroom is that they are capable of rigorous air filtration HEPA filters help to circulate the air required to minimize the number of contaminants in the room, handling between 500 and 750 air changes per hour. The number of air changes per hour is the volume of filtered air in respect to the cleanroom volume. 

The Fan Filter Modules (FFMs) also come into play for the ISO Class 1 cleanroom. The more FFMs there are in the cleanroom, the better the ISO classification. The FFM ceiling coverage for an ISO Class 1 cleanroom is 80-100%. For comparison, Class 8 requires 5-15% coverage while Class 7 requires 15-25%. 

Such strict requirements are required to keep the level of contamination required for Class 1 compliance - less than 12 particles below 0.3 microns. A strand of human hair is about 75 microns across and a speck of dust 60 microns across. The human eye can only see particles larger than 10 microns, which should tell you just how small 0.3 microns is! 

Why Is It Important To Have an ISO Level 1 Cleanroom? 

ISO Level 1 cleanrooms are necessary for operations that need absolutely spotless conditions. An example of ISO 1 cleanrooms is the European Space Agency that uses this cleanroom to examine materials sent to space, such as the temperature sensors designed for Mars surface missions. 

Level 1 cleanrooms are also used for researching clean environments and manufacturing cleanroom equipment Other industries that need ISO Level 1 cleanrooms are life sciences and electronics that use nanotechnology. 

Sustaining a cleanroom in pristine conditions is unlike any other process, especially for Level 1 cleanrooms. Whether you need a Level 1 room or not, you still have to keep your cleanroom as immaculate as possible. Take a look at our free cleanroom cleaning guide for your Cleanroom Cleaning, regardless of its classification.

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