How to Choose the Right Cleanroom Classification for Your Industry

Understanding Cleanroom Classifications

Cleanrooms are classified under ISO 14644-1, which sets cleanliness levels based on particle count per cubic meter of air.

• ISO 1: The cleanest (used for semiconductors).
• ISO 9: Closest to normal room air.
• Pharmaceuticals & medical devices typically require ISO 5–7, while electronics and aerospace often use ISO 1–6.

Common Misconceptions

• A higher ISO number = less clean. A lower ISO number means a cleaner environment.
• Cleanrooms are not always operational. They must meet standards even when “at rest.”

Process Sensitivity & Contamination Risk

• Aseptic processes (e.g., cell culture) require ISO 5 or better.
• Support areas (e.g., packaging) can function with ISO 8.

Balancing Cost & Compliance
Upgrading from ISO 7 to ISO 5 can increase costs by 25% or more. Choose a level that meets compliance without unnecessary expenses.

Industry-Specific Cleanroom Needs

Pharmaceutical & Biotech

• Requires GMP compliance and ISO 5–8 classification.
• Contamination risks include microbial growth and cross-contamination.

Electronics & Semiconductor

• ISO 1–5 prevents defects in microchips and circuit boards.
• Contamination by dust or static can ruin products.

Aerospace & Defence

• ISO 7–8 ensures high-precision manufacturing.
• Controlled environments prevent material degradation.

Designing a Cost-Effective Cleanroom

Ventilation & Airflow

• Unidirectional airflow (laminar) ensures particles are swept away.
• HEPA & ULPA filters trap contaminants down to 0.1 microns.

Scalability & Future Expansion

• Modular cleanrooms allow businesses to expand cost-effectively.
• Avoid over-designing—build only what your industry requires.

Environmental Monitoring

• Real-time monitoring of air quality, humidity, and pressure prevents contamination.

Maintaining Compliance & Performance

• Train staff on proper gowning and cleanroom protocols.
• Conduct regular validation & requalification (ISO 14644 testing).
• Keep detailed records for audits & inspections.

Final Thoughts

Choosing the right cleanroom classification isn’t just about compliance—it directly impacts product quality and operational costs. Whether you need ISO 1 for semiconductors or ISO 7 for aerospace, understanding industry-specific needs helps you make the best decision for efficiency and compliance.

Would you like expert guidance on cleanroom selection and design? Contact us today for tailored solutions.