
29 Oct ISO 7 vs ISO 8 Cleanrooms: What’s the Difference?
Understanding the differences between ISO 7 vs ISO 8 can be confusing, especially when you need to select the right classification for your project. The differences between them are not always clear, and are often couched in a lot of technical language. In this article, we’ll clear the air on the differences, covering particle counts, costs, applications, and more.
Comparing ISO 7 vs ISO 8 Cleanrooms
The main difference between ISO 7 and ISO 8 cleanrooms is the number of airborne particles allowed and the frequency of air changes required to maintain these levels.
ISO 7 cleanrooms are more strict, and therefore require a cleaner environment. ISO 8 cleanrooms, on the other hand, are technically the “dirtiest” classification of cleanrooms, and they limit fewer particles than ISO 7 cleanrooms.
Both ISO 7 and ISO 8 cleanrooms only measure particles greater than or equal to 0.5 micrometers, so neither of them are typically very useful in industries where the smallest particles can cause damage to sensitive products and processes.
Similarly, all else being equal, ISO 7 cleanrooms will generally be more expensive because they make the air cleaner than ISO 8 spaces.
ISO 7 Cleanrooms | ISO 8 Cleanrooms | |
---|---|---|
Particle Counts | Up to 352,000 particles per cubic meter (≥ 0.5 micrometers). | Up to 3,520,000 particles per cubic meter (≥ 0.5 micrometers). |
Air Changes per Hour | Approximately 60. | Typically between 5 to 48. |
Relative Cost | Higher costs because of stricter particle control and more frequent air changes. | Lower costs due to more relaxed particle control and fewer air changes. |
Common Applications | Biotechnology, medical device manufacturing, IV compounding. | Packaging, certain stages of medical device manufacturing, food processing. |
Particle Counts
- ISO 7 Cleanrooms: These spaces permit up to 352,000 particles per cubic meter for particles 0.5 micrometers or larger.
- ISO 8 Cleanrooms: In contrast, ISO 8 cleanrooms allow up to 3,520,000 particles per cubic meter for particles 0.5 micrometers or larger, which is ten times higher than the particle count in ISO 7.
As we’ve touched on already, both ISO 7 and ISO 8 cleanrooms do not measure particles smaller than 0.5 micrometers because smaller particles have a negligent/non-existent impact on the work carried out in these spaces.
Air Change Requirements
In cleanrooms, air change rates are an important factor in keeping the air clean. Air changes per hour (ACH) measures how frequently the air in a room is replaced, which has a direct impact on particle levels.
- ISO 7 Cleanrooms: These spaces require around 60 air changes per hour to keep particle levels in check.
- ISO 8 Cleanrooms: On the other hand, these environments require far fewer air changes, typically between 5 to 48 per hour.
Relative Costs
The costs associated with both building and operating a cleanroom are influenced in large part by air change rates, the strictness of particle control, and the features necessary to reach the proper particle limits.
- Costs for ISO 7 Cleanrooms: Since these spaces need more frequent air changes and stricter particle control, ISO 7 cleanrooms are more expensive, both to construct and maintain, than ISO 8 spaces. HVAC systems have to work harder, and air filtration must be more extensive.
- Costs for ISO 8 Cleanrooms: For ISO 8 spaces, fewer air changes are needed and particle control is less demanding; as a result, ISO 8 cleanrooms are less expensive, both to build and to operate.
Applications of ISO 7 Cleanrooms
ISO 7 cleanrooms are not the strictest spaces, but they still have a lot of important uses in many industries. Some common applications include:
- Biotechnology: Though biotech covers a huge range of subdisciplines, ISO 7 cleanrooms are often used to keep out microorganisms that could be dangerous to research or other processes.
- Medical Devices: Many medical devices are placed within the body, so it’s important that they do not carry any contaminants that could harm patients. ISO 7 spaces help remove such risk from many stages in the manufacturing process.
- IV Compounding: In compounding cleanrooms, the ISO 7 classification is the bare minimum for a space. They are often used in buffer zones in spaces that need to follow USP 797 guidelines.
Applications of ISO 8 Cleanrooms
ISO 8 cleanrooms are much less strict than the other classifications, but sometimes there is still a need to have some limitations on particles. Some common applications include:
- Packaging: In packaging rooms, ISO 8 cleanrooms are still important to reduce the risk of contaminating products.
- Medical Devices: Some stages of medical device manufacturing, such as assembly, require less strict limits on particles.
- Food Processing Cleanrooms: ISO 8 cleanrooms help reduce contamination during food processing so that microorganisms do not affect food quality.
The Bottom Line
Choosing between ISO 7 and ISO 8 cleanrooms depends largely on which particles affect the work performed, specific cleanliness requirements, and your budget. ISO 7 is best for processes needing stricter contamination control, while ISO 8 is better suited for environments with less important processes. To assess your exact project requirements, consider reaching out to the experts at Allied Cleanrooms for consultation and a free quote.