VALIDATION

Project Validation

YOUR EXPECTATION

A compliance inspection carried out by a reliable and experienced
partner for a long-term collaboration.

OUR OBJECTIVE

To ensure consistent monitoring and full compliance of your project with the latest industry regulations and international standards.

OUR EXPERTISE

Comprehensive inspection and validation of your cleanroom and laminar flow equipment to guarantee optimal performance and conformity.

Validation of Your Project

Following the installation phase, EUROFLUX performs the validation and qualification of all contamination control systems, in full accordance with current regulatory frameworks.
Our certified teams ensure that every component of your installation complies with the applicable ISO and GMP requirements.

We carry out a complete range of qualification and validation tests, including:

F.A.T. (Factory Acceptance Testing): Qualification tests performed
in our facility prior to shipment.
S.A.T. (Site Acceptance Testing): Qualification tests, including IQ (Installation Qualification)
and OQ (Operational Qualification), conducted after installation.
IQ / OQ Follow-Up: Detailed tracking and documentation of qualification operations.

Final Cleaning & Airflow Verification: Ensuring a particle-free environment and proper air balance.
Pressure Gradient Control & Integrity Tests: Verification of pressure differentials and HEPA/ULPA filter integrity.
Particle Count and Air Cleanliness Classification: Measurements according to ISO 14644-1 standards.

Next Step

Ongoing Control and Maintenance

Validation of Your Project

Following the installation phase, EUROFLUX performs the validation and qualification of all contamination control systems, in full accordance with current regulatory frameworks.
Our certified teams ensure that every component of your installation complies with the applicable ISO and GMP requirements.

We carry out a complete range of qualification and validation tests, including:

F.A.T. (Factory Acceptance Testing): Qualification tests performed
in our facility prior to shipment.
S.A.T. (Site Acceptance Testing): Qualification tests, including IQ (Installation Qualification)
and OQ (Operational Qualification), conducted after installation.
IQ / OQ Follow-Up: Detailed tracking and documentation of qualification operations.

Final Cleaning & Airflow Verification: Ensuring a particle-free environment and proper air balance.
Pressure Gradient Control & Integrity Tests: Verification of pressure differentials and HEPA/ULPA filter integrity.
Particle Count and Air Cleanliness Classification: Measurements according to ISO 14644-1 standards.

Next Step

Ongoing Control and Maintenance

Our Capabilities

Highly skilled technical teams with in-depth knowledge of quality and regulatory requirements.
Regular calibration and renewal of control and testing equipment.
Comprehensive and traceable validation reports provided at project completion.