Picking the right cleanroom classification is crucial. Whether you’re in pharmaceuticals, electronics, or aerospace, cleanrooms play a key role in ensuring product quality, compliance, and contamination control. This guide will break down ISO classifications, industry-specific needs, and key factors to help you make the right choice.
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.
