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Welcome>Cleanroom Regulations

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 standard

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.

ISO 14644 classification

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.

Validation and certification

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IQM

Microelectronics

Saint-Gobain Sekurit

Automotive

Roche

Biopharmaceutical

Graphenea

Microelectronics

Qiagen

Biotechnology

Grupo MERCK

Biopharmaceutical

H&T Presspart

Medical Devices

Mabxience

Biotechnology

Merck Serono

Biopharmaceutical

FAE

Automotive

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