Cleanrooms must comply with standards such as ISO 14644 and EU GMP, which regulate contamination control and ensure process quality and safety.
Cleanroom Regulations
CLEANROOM DESIGN
At Valtria, we design cleanrooms in accordance with standards such as ISO 14644 and EU GMP, ensuring regulatory compliance and process quality.
ISO 14644 standard
ISO 14644 is the international standard for cleanroom classification and contamination control.
It defines:
- Air cleanliness classification based on particle concentration
- Testing and certification methods
- Design and operational requirements
ISO 14644 classification
ISO 14644-1 classifies cleanrooms according to airborne particle concentration, ranging from ISO Class 1 (maximum cleanliness) to ISO Class 9.
The most commonly used classes in industry are:
- ISO 5 → critical processes (sterile areas, aseptic filling)
- ISO 7 → controlled production areas
- ISO 8 → support and preparation areas
Each class defines specific cleanliness levels and directly impacts HVAC system design, filtration systems, and environmental control strategies.
EU GMP in cleanrooms
In the pharmaceutical industry, Good Manufacturing Practices (GMP) apply to cleanroom environments.
EU GMP Annex 1 regulates cleanrooms for sterile manufacturing processes, classifying areas into:
- Grade A
- Grade B
- Grade C
- Grade D
Each grade establishes specific particle limits and operational requirements.
Relationship between ISO and GMP
ISO 14644 focuses primarily on air cleanliness, while GMP regulations include additional requirements related to processes, microbiological control, and validation.
Common equivalences
- Grade A: ISO 5
- Grade B: ISO 5 – 7
- Grade C: ISO 7
- Grade D: ISO 8
Validation and certification
Cleanrooms must be verified through testing procedures that ensure compliance with regulatory requirements, including:
- Particle counting
- Airflow testing
- Differential pressure control
- HEPA/ULPA filter integrity testing
- Temperature and humidity measurement
These tests are performed during commissioning and on a periodic basis thereafter.
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