ISO Cleanroom 7 vs. 8: What’s the Difference?
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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.
Clean Room Classifications (ISO 8, ISO 7, ISO 6, ISO 5)
Clean rooms are classified according to the cleanliness level of the air inside the controlled environment. The clean room class is the level of cleanliness the room complies with, according to the quantity and size of particles per cubic meters of air. The primary authority in the US and Canada is the ISO classification system ISO 14644-1.
This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. Even if it’s classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room.
The most common ISO clean room classes are ISO 7 and ISO 8. The Federal Standard 209 ( FS 209E ) equivalent for these ISO classes are Class 10,000 and Class 100 000.
The old Federal Standard 209E ( FS 209E ) includes these clean room classes : Class 100,000; Class 10,000; Class 1,000; Class 100; Class 10; Class 1. This standard was replaced in 1999 by ISO-14644-1. It was withdrawn in 2001, but it is still widely used.
Clean rooms must also follow industry-specific and international standards. For example, EU GMP (A-B-C-D), applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies.
You might also like this article —>How Classification Impacts your Cleanroom Design
Want to learn more about Clean Rooms? —>What is a Clean room?
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What are ISO 7 and ISO 8 Medical Cleanrooms?
A medical cleanroom differs from a normal room primarily due to its advanced HVAC system and filters.
HVAC System: The HVAC system used in a cleanroom is different from a standard system due to its ability to provide higher volumes and pressures of air when compared to normal HVAC systems. Each ISO level specifies the number of air volume changes per hour (ACH). This means that in the space of an hour the HVAC must cycle the entire volume of air by a defined number of times.
Filters: HEPA (High-Efficiency Particulate Air) filters are normally used in cleanroom applications. This is due to their ability to remove up to 99.97% of airborne particles with a size of 0.3 microns.
Construction Materials: A cleanroom needs to be constructed from materials that do not give off particulate matter, as this will degrade the performance of the room and reduce the effectiveness of the filters. In addition to this, the materials need to be easily cleanable.
How to Determine the Required ACH?
ISO 14644-1 clearly defines the required range of ACH for each level of a medical cleanroom. Specifically, ISO 7 and 8 requirements are listed below. More detail can be obtained here.
ISO 7: Between 60 and 90 air volume changes per hour required
ISO 8: Between 5 and 48 air volume changes per hour required
How to Size the HVAC Unit?
HVACs are sized by their volumetric flow rate, i.e. CFM (cubic feet per minute). To determine the CFM required for a specific cleanroom, the total volume of the room needs to be determined in cubic feet. Multiply this number by the required ACH as listed in ISO 14644-1 and then divide by 60 minutes. The answer will then be the CFM required to achieve the stated ACH level.
How to Size the Filters?
The number of filters required depends on the amount of airflow moving through the room. HEPA filters typically have a set flow rate that they can effectively handle; this information is available from the filter supplier. Simply divide the CFM of the HVAC by the amount that can be handled by one filter to determine how many filters are needed.
Medical Cleanroom Configurations
Cleanrooms work on the principle of cascading airflow. For example, if an ISO 7 cleanroom is required, the room before it should be an ISO 8 cleanroom. However, a key factor is that the ISO 7 cleanroom needs to have a higher pressure than the ISO 8 cleanroom before it. This means that contaminated air cannot move from the dirtier room to the cleaner room due to the pressure differential. In most cases, an additional gowning room is used where employees can get dressed without dirtying the cleanroom.
It must be noted that in some cases negative-pressure rooms are required to stop the escape of harmful particles from a cleanroom. In this case, an ISO 7 room would have a lower air pressure than the ISO 8 room so that particles cannot travel from the ISO 7 room to the ISO 8 room.
