Understanding ISO 14644-1 Cleanroom Classifications

Understanding ISO 14644-1 Cleanroom Classifications

ISO 14644-1 is the international standard that defines cleanroom classifications based on airborne particle concentration. Understanding these classifications is essential for selecting appropriate gloves and protective equipment.

ISO 14644-1 Classification System

Cleanrooms are classified by the maximum number of particles per cubic meter at specific particle sizes:

Class 10 (ISO 5)

• Particles ≥0.1μm: ≤10 per m³
• Particles ≥0.2μm: ≤2 per m³
• Particles ≥0.3μm: ≤1 per m³
• Applications: Critical semiconductor processing, pharmaceutical sterile filling

Class 100 (ISO 6)

• Particles ≥0.1μm: ≤100 per m³
• Particles ≥0.2μm: ≤24 per m³
• Particles ≥0.3μm: ≤10 per m³
• Applications: Semiconductor assembly, pharmaceutical manufacturing

Class 1,000 (ISO 7)

• Particles ≥0.1μm: ≤1,000 per m³
• Particles ≥0.2μm: ≤237 per m³
• Particles ≥0.3μm: ≤102 per m³
• Applications: Pharmaceutical packaging, medical device assembly

Class 10,000 (ISO 8)

• Particles ≥0.1μm: ≤10,000 per m³
• Particles ≥0.2μm: ≤2,370 per m³
• Particles ≥0.3μm: ≤1,020 per m³
• Applications: General pharmaceutical production, laboratory work

Particle Size Considerations

Different particle sizes are measured because:

• 0.1μm particles: Can cause defects in semiconductor wafers
• 0.3μm particles: Visible under microscopy, critical for quality control
• 0.5μm particles: Standard measurement point for many applications

Glove Requirements by Classification

Class 10 Requirements

• Ultra-low particle shedding
• AQL 1.5 or better
• Powder-free formulation
• Gamma or ETO sterilization
• Certified cleanroom packaging

Class 100 Requirements

• Low particle generation
• AQL 1.5-2.5
• Powder-free
• Sterile packaging
• Cleanroom compatible

Class 1,000 Requirements

• Controlled particle release
• AQL 2.5 acceptable
• Powder-free preferred
• Sterile or clean packaging

Class 10,000 Requirements

• Standard particle control
• AQL 2.5-4.0 acceptable
• Powder-free recommended
• Clean packaging

Testing Methods

ISO 14644-1 specifies testing procedures:

1. Particle Count: Using particle counters
2. Sampling Locations: Minimum number based on room size
3. Test Frequency: Initial, periodic, and continuous monitoring
4. Documentation: Maintain test records

Glove Selection Guide

When selecting gloves for your cleanroom:

1. Match Classification: Choose gloves rated for your cleanroom class
2. Verify Certifications: Check ISO, AQL, and material certifications
3. Consider Application: Match glove properties to your process
4. Review Testing Data: Request particle count test results
5. Evaluate Packaging: Ensure cleanroom-compatible packaging

Sterimed Cleanroom Glove Solutions

Sterimed offers cleanroom gloves suitable for all ISO classifications:

• Class 10-10K Compatible: Versatile solutions for all levels
• AQL 1.5 Certified: Premium quality assurance
• Multiple Materials: Nitrile and latex options
• Sterilization Options: Gamma and ETO available
• Cleanroom Packaging: Certified packaging systems

Conclusion

Understanding ISO 14644-1 classifications helps ensure proper glove selection for your cleanroom environment. Matching glove specifications to your classification level protects product quality and ensures compliance.

Sterimed Cleanroom Glove Solutions

Sterimed offers cleanroom gloves suitable for all ISO classifications:

• Clean Room Nitrile - Long Cuff: Class 10-10K compatible, AQL 1.5 certified
• Clean Room Nitrile - Short Cuff: Class 10-10K compatible, AQL 1.5 certified
• Clean Room Latex - Long Cuff: Class 10-10K compatible, AQL 1.5 certified
• Clean Room Latex - Short Cuff: Class 10-10K compatible, AQL 1.5 certified

Contact Sterimed for expert guidance on cleanroom glove selection.