ISO Cleanroom 7 vs. 8: What’s the Difference?

 

Here at MediSurge, we’re proud to manufacture medical devices inside of our ISO Class 7 cleanroom. We maintain this space in our facilities because it allows us to create high-quality medical devices that are ready to be used in surgery.

However, while many people know that our ISO Class 7 cleanroom is great for medical manufacturing, the difference in ISO classes can occasionally be confusing. That’s why we’re breaking down the differences between ISO Class 7 and ISO Class 8.

So why did we choose to build an ISO Class 7 cleanroom? Keep reading.

Basic ISO Distinctions

Cleanrooms are spaces that are kept particularly sterile or free of particles in order to provide a safe environment for anything that needs to be clean. These are measured from ISO Class 1 to 9, with 1 being the cleanest.

Each different class is measured by multiple factors, and a room must meet all of them to qualify for the classification.

Keeping It Clean

One of the key distinctions between cleanroom classes is the amount of air changes per hour. This is the amount of times that air is filtered through HEPA filters. The more times it’s filtered, the less particles there are in the air.

A typical room has between 2-4 changes every hour. ISO Class 8 cleanrooms typically have between 10-25 air changes every hour, while ISO Class 7 have between 30-60. That means that in our ISO Class 7 Cleanroom, the air is filtered at least thirty times every hour. Particles are consistently filtered out to provide clean air for medical device production.

Fewer Particles

Cleanrooms are also divided into classes based on the number of particles that are in the air. As a general rule, each class has ten times fewer particles than the class above it. While a Class 8 cleanroom can have 100,000 particles per square foot of air, Class 7 cleanrooms can only have 10,000.

Our team closely monitors this metric to ensure that we don’t fluctuate outside of the required levels. Plus, we watch trending metrics over time, so even if we’re within cleanroom regulations, we can consistently push to improve.

Our Class 7 cleanroom provides a space to craft high-quality medical devices that are ready for surgery. By combining our cleanroom with our other quality services, we strive to provide medical devices that impact lives in the best of ways.

Are you ready to bring your medical device dream to life? Request a quote from us today. We can’t wait to work together.

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