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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