The Requirements Behind ISO Class 8 Cleanrooms
Maintaining precise air quality is critical for industries where even small amounts of dust or microbes can compromise product integrity. ISO Class 8 cleanrooms are among the most commonly used environments in manufacturing, research, and product handling. They strike a balance between effective contamination control and operational efficiency.
ISO cleanroom classifications are established under ISO 14644-1. Cleanrooms range from Class 9 to Class 1 (the cleanest). This scale gives you a universal framework for validating your controlled workspace and preventing product contamination. ISO 8 is one of the least stringent and easiest to maintain clean environments in use today.
At CleanAir Solutions, we specialize in designing cleanrooms that meet or exceed ISO standards, ensuring compliance while optimizing usability. Here’s everything you need to know about this classification so you can identify when and how it fits into your workflows.
What Is an ISO Class 8 Cleanroom?
An ISO 8 cleanroom is defined under the ISO 14644-1 cleanroom classification system, which measures the concentration of airborne particles per cubic meter of air. Specifically, ISO 8 cleanrooms:
Allow up to 3,520,000 particles ≥ 0.5 micrometers per cubic meter
Are designed with moderate environmental control for processes that don’t require ultra-stringent conditions
Achieve particle control through HEPA filtration, controlled airflow, and regulated entry/exit procedures
Historically, ISO 8 cleanrooms were referred to as “Class 100,000” under the now-retired Federal Standard 209 E. Many industry professionals still use “ISO class 8 cleanroom” and “Class 100,000” interchangeably.
Key Requirements for ISO Class 8 Cleanrooms
The most notable requirements for cleanrooms are the particle size and concentration per cubic meter. To qualify as an ISO 8 space, the cleanroom must meet these particle limit thresholds:
0.5 Micrometers: Less than or equal to 3,520,000 particles per cubic meter
1 Micrometer: Less than or equal to 832,000 particles per cubic meter
5 Micrometers: Less than or equal to 29,300 particles per cubic meter
HEPA filters are used to remove a high percentage of the particles to ensure consistent air cleanliness in accordance with class 8 cleanroom standards. These environments use higher air pressure inside the space than outside to prevent unfiltered air from flowing in.
Facilities that use ISO 8 cleanrooms must conduct regular particle counts and check the performance of filters to ensure they are staying within established thresholds. Surface sampling is another strategy to verify ongoing compliance.
Additionally, ISO 8 cleanrooms require close temperature and humidity control. Fluctuations in either variable can impact product quality and increase the risk of contamination. You also want to keep your space within comfortable operating temperatures to reduce staff fatigue.
Industries and Applications
Class 8 cleanrooms represent one of the least stringent classifications in frequent industrial use. As such, they are one of the most commonly used options. Industries that benefit include:
Pharmaceuticals: Non-sterile production, packaging, and compounding of certain medications
Biotechnology: Research environments, testing labs, and analytical facilities
Electronics: Assembly of circuit boards, displays, and components less sensitive than semiconductors
Food and Cosmetics: Controlled handling and packaging of consumer goods to reduce contamination risks
The versatility of ISO 8 cleanrooms makes them a practical choice for businesses balancing compliance with cost-effectiveness.
ISO Class 8 Vs. Other ISO Classes
To better understand where ISO 8 falls, here’s how it compares with classes 7 and 9. ISO 9 air quality thresholds mean that the air is closer to normal indoor air quality, which is why they are rarely used. ISO 7 offers better cleanliness and a stricter environment.
With each corresponding upgrade in class (i.e., moving from class 8 to class 7), the quantity of particles of a particular size that are allowed decreases by a factor of 10.
For instance, class 8 cleanrooms must maintain cleanliness levels of 3,520,000 0.5 micrometer particles per cubic meter or better. The 0.5 micrometer particle limit for class 7 cleanrooms is 352,000, and the limit for class 9 cleanrooms is 35,200,000 per cubic meter.
Class 5 and better cleanrooms include thresholds for particles that are greater than or equal to 0.3 micrometers in size. Class 6 and higher spaces do not have established limits for particles that small, as they are not designed to achieve that level of cleanliness.
In terms of operational intensity, the tighter your cleanliness requirements, the higher class you need. Class 8 environments are relatively cost-effective and easy to maintain compared to class 6 and 7 spaces. However, there is a huge jump in cost when you upgrade to a class 5 cleanroom or better.
Design and Operational Best Practices
ISO 8 cleanrooms have less stringent particle requirements than higher classes, but you must still remain diligent. Here are some tips to help you create and maintain a compliant space.
Room Layout and Zoning: Create dedicated areas for each activity, such as gowning, staging, and working
Material Transfer: Ensure that materials can be moved in and out without introducing contaminants
Airflow Management: Proper HEPA filter placement and return air vents maintain balanced airflow and reduce stagnant zones
Cleaning and Maintenance: Wipe down equipment and conduct testing to stay within limits
Personnel Practices: Training your team on gowning, movement, and contamination awareness is vital
Automation: Many facilities reduce manual handling by incorporating automated transfer systems
Supplemental tools, like a pass-through chamber, can help reduce contamination when you are bringing personnel and supplies into or out of the space.
Why Choose CleanAir Solutions?
Do you need an ISO 8 hardwall cleanroom to support your operations? Are you interested in a more flexible option that you can add to or modify as your needs change? CleanAir Solutions has everything you need to get the job done.
With our experience, you can be confident that your ISO 8 cleanroom will promote compliance and productivity. Ready to learn more about our solutions? Contact CleanAir Solutions today.