Technical Resources
Industry standards, certifications, and technical guidance for cleanroom design, construction, and compliance.
Cleanroom Standards & Classifications
Understanding ISO 14644 classification standards is essential for selecting the right cleanroom for your manufacturing environment. The chart below shows particle concentration limits across all ISO classes.
ISO Classes
ISO 14644 defines nine cleanroom classes (ISO 1-9) based on maximum allowable particle concentration levels.
- • ISO 1-3: Ultra-pure environments
- • ISO 4-5: High-precision manufacturing
- • ISO 6-8: Standard industrial cleanrooms
- • ISO 9: Controlled environments
Particle Sizing
Cleanroom classifications measure particles across multiple size ranges to ensure comprehensive environmental control.
- • 0.1 - 0.5 Micron: Ultra-fine particles
- • 0.5 - 1 Micron: Fine particles
- • 1 - 5 Micron: Standard particles
- • 5+ Micron: Visible particles
Your Industry
Different industries require specific ISO class cleanrooms based on product sensitivity and regulatory requirements.
- • Pharmaceutical: ISO 4-7
- • Electronics: ISO 5-6
- • Medical devices: ISO 6-7
- • Aerospace: ISO 5-6
Regulatory Compliance Standards
AAK CLEANROOMS AND SCIF'S LLC designs and constructs cleanrooms that exceed all major regulatory standards and certifications.
ISO 14644-1:2015
The international standard for cleanroom classification based on particle concentration. This is the primary standard for defining and maintaining cleanroom environments.
- ✓ Particle count measurement
- ✓ Classification methodology
- ✓ Monitoring and verification
- ✓ Documentation requirements
FDA GMP (21 CFR 211)
FDA Good Manufacturing Practice requirements for pharmaceutical and medical device manufacturing facilities, including environmental controls.
- ✓ Environmental controls
- ✓ Personnel training
- ✓ Equipment validation
- ✓ Maintenance procedures
IES RP CC 016.2
Institute of Environmental Sciences recommended practices for cleanroom design, construction, and operations. Provides comprehensive guidance beyond ISO standards.
- ✓ Design guidelines
- ✓ Construction standards
- ✓ Operating procedures
- ✓ Cleanroom lifecycle management
IEST Standards
International Society for Cleanroom and Environmental Sciences and Technology standards covering contamination control and cleanroom operations.
- ✓ Contamination control
- ✓ Personnel garment specifications
- ✓ Material compatibility
- ✓ Change management
Need Help Selecting the Right Cleanroom?
Our technical experts can guide you through cleanroom standards and help you select the optimal ISO classification for your manufacturing needs.
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