Cleanroom

Cleanroom Design Best Practices for Pharmaceutical Facilities

Essential guidelines for designing GMP-compliant cleanrooms with optimal airflow, contamination control, and regulatory compliance.

Pharma Solutions Team••8 min read

Introduction to Pharmaceutical Cleanrooms

Cleanroom design for pharmaceutical facilities requires meticulous attention to contamination control, regulatory compliance, and operational efficiency. A well-designed cleanroom protects both product quality and patient safety.

Understanding ISO Classifications

ISO 14644-1 defines cleanroom classifications based on particle counts:

  • ISO Class 5 (Class 100): Aseptic processing areas
  • ISO Class 6 (Class 1,000): Sterile product filling
  • ISO Class 7 (Class 10,000): Support areas, gowning rooms
  • ISO Class 8 (Class 100,000): Material preparation, packaging

Key Design Considerations

1. Wall and Ceiling Systems

Cleanroom partitions must provide:

  • Smooth, non-porous surfaces for easy cleaning
  • Minimal joints and crevices
  • Chemical resistance to cleaning agents
  • Integration with HVAC systems

2. Flooring Solutions

Cleanroom flooring requirements include:

  • Seamless, monolithic surfaces
  • Antistatic properties where required
  • Chemical and abrasion resistance
  • Coved edges for easy cleaning

3. Door Systems

Cleanroom doors should feature:

  • Flush-mounted design
  • Interlocking systems for pressure cascade
  • Vision panels for safety
  • Appropriate fire ratings

4. Ceiling Systems

Cleanroom false ceilings should accommodate:

  • HEPA filter integration
  • Lighting fixtures
  • Walkable design for maintenance access
  • Proper sealing to prevent particle ingress

Airflow Patterns

Two primary airflow strategies:

  • Unidirectional (Laminar) Flow: For ISO Class 5 and below
  • Non-Unidirectional (Turbulent) Flow: For ISO Class 6-8

Material Selection Guidelines

Materials must be selected based on:

  • Chemical compatibility with cleaning agents
  • Particle generation characteristics
  • Durability and maintenance requirements
  • Fire safety ratings

PHOENIXX Cleanroom Solutions

PHOENIXX offers complete cleanroom solutions including GMP-compliant panels, doors, ceilings, and flooring systems. Our turnkey approach ensures seamless integration of all components.

Conclusion

Successful cleanroom design requires a holistic approach considering all building elements, HVAC systems, and operational workflows. Partner with experienced cleanroom specialists to ensure compliance and efficiency.

Need cleanroom expertise? Contact PHOENIXX for a detailed assessment of your requirements.

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