Understanding Cleanroom Classifications: ISO 5 vs ISO 8 and More

In controlled environments such as cleanrooms, classification systems are essential for ensuring cleanliness and regulatory compliance. For laboratories in Melbourne, understanding the differences between ISO classes can help select the right setup and maintain quality standards. Whether you’re using ISO accredited lab equipment, installing precision lab equipment, or sourcing compliant lab supplies, choosing the correct cleanroom classification is critical to achieving safe, repeatable results.

What Are Cleanroom Classifications?

Cleanrooms are classified based on the maximum allowable number of particles per cubic metre of air. The International Organisation for Standardisation (ISO) standard 14644-1 outlines these classifications, with ISO 1 being the cleanest and ISO 9 being the least stringent. Most labs operate within the ISO 5 to ISO 8 range.

• ISO 5: Ideal for applications requiring ultra-clean environments such as semiconductor manufacturing or critical pharmaceutical processes.

• ISO 7-8: Commonly used in microbiology labs, compounding pharmacies, and general research environments.

The classification you choose should depend on your operational needs and the specifications of your ISO accredited lab equipment. Using equipment rated for a cleaner environment in a higher-class room may reduce its effectiveness.

ISO 5 vs ISO 8: What’s the Difference?

The primary difference lies in the permissible particle count:

• ISO 5 allows a maximum of 3,520 particles (≥0.5 μm) per cubic metre.

• ISO 8 allows up to 3,520,000 particles (≥0.5 μm) per cubic metre.

This vast difference means ISO 5 cleanrooms require more advanced HVAC systems, higher air change rates, and stricter maintenance protocols. If you’re working with sensitive lab equipment like laminar flow cabinets or clean benches, ISO 5 may be necessary.

ISO 8 environments, on the other hand, are suitable for basic cleanroom operations where general cleanliness is needed, such as equipment prep or packaging lab supplies. The key is to match your equipment and processes to the cleanliness level required.

How to Choose the Right Classification for Your Lab

To determine the appropriate ISO classification:

• Evaluate the sensitivity of your work: Processes involving cell culture, sterile compounding, or nanotech typically require ISO 5-6.

• Consider the specifications of your tools: Ensure your ISO accredited lab equipment is rated for the environment you intend to operate in.

• Think about scalability: Starting with ISO 7 or ISO 8 may be more cost-effective if your current requirements are low, with the option to upgrade.

Consulting with specialists in lab equipment and facility design is highly recommended to ensure optimal performance and compliance.

Maintaining Your Cleanroom Classification

Achieving a cleanroom classification is just the beginning. Maintaining it requires strict adherence to best practices:

• Routine environmental monitoring: Regular particle counts and air sampling.

• Proper gowning procedures: Staff must be trained to minimise contamination.

• Use of compatible equipment: Only use lab supplies that are certified for cleanroom environments.

• Scheduled maintenance: Regular servicing of HEPA filters, HVAC systems, and ISO accredited lab equipment.

Improper handling of tools or introducing non-compliant materials can easily degrade a cleanroom’s classification. Make sure your lab equipment is not only appropriate but also regularly calibrated and maintained.

Cleanrooms That Work for You

Understanding ISO cleanroom classifications is essential for Melbourne-based labs that want to operate efficiently and remain compliant. Whether you’re outfitting a new space or upgrading an existing one, aligning your ISO accredited lab equipment, and lab supplies with the right cleanroom class will protect both your research and your reputation. From ISO 5 precision to ISO 8 flexibility, getting the classification right is a cornerstone of cleanroom success.