Purpose of Clean Area Classification

  • Define Cleanliness Levels: Establish acceptable levels of particulate and microbial contamination.
  • Regulatory Compliance: Meet standards set by regulatory bodies for sterile manufacturing.

Classification Standards

  • ISO 14644-1: International standard for cleanrooms and associated controlled environments.
  • EU GMP (European Union Good Manufacturing Practice): Provides guidelines for manufacturing medicinal products.
  • FDA and USP Guidelines: US-specific regulations for sterile pharmaceutical production.

ISO Cleanroom Classifications

  • ISO Class 5 (Class 100): Maximum of 3,520 particles ≥0.5 μm per cubic meter.
  • ISO Class 7 (Class 10,000): Maximum of 352,000 particles ≥0.5 μm per cubic meter.
  • ISO Class 8 (Class 100,000): Maximum of 3,520,000 particles ≥0.5 μm per cubic meter.

GMP Cleanroom Grades

  • Grade A:

    • Highest level of cleanliness, for high-risk operations like filling and aseptic connections.
  • Grade B:

    • Background environment for Grade A activities, such as the background for aseptic preparation and filling.
  • Grade C:

    • Clean areas for less critical stages in sterile product manufacturing.
  • Grade D:

    • Clean areas for less critical processes, such as handling of components after final cleaning.

Microbial Limits of Clean Area Classification

  • Non-Viable Particles: Limits set for airborne particles based on cleanroom classification.
  • Viable Microbial Counts:
    • Air Samples: Colony-forming units (CFUs) per cubic meter.
    • Surface Samples: CFUs per plate or swab area.

Monitoring and Compliance

  • Environmental Monitoring Program:

    • Regular Testing: Scheduled monitoring of air and surfaces.
    • Trend Analysis: Evaluate data over time to detect deviations.
  • Certification and Recertification:

    • Initial Qualification: Validate cleanroom performance upon setup.
    • Periodic Requalification: Regular re-testing to ensure ongoing compliance.

Cleanroom Design Considerations

  • Airflow Patterns: Design to prevent turbulence and recirculation of particles.
  • Room Pressurization: Positive pressure gradients from cleaner to less clean areas.
  • Material and Personnel Entry: Use airlocks and gowning rooms to maintain pressure differentials.

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