Cleanroom Validation

Cleanroom validation includes four stages. Depending on the client’s needs, we can perform all the validation stages:

1. Design Qualification (DQ): The plans are in accordance with the requirements of the client and the authorities.
2. Installation Qualification (IQ): Installation is in compliance with the accepted design.
3. Operational Qualification (OQ): Testing the functionalities.
4. Performance Qualification (PQ): Testing the performance and the overall process.

Compliance with the cleanroom requirements must be verified at every stage of a project: As built, At rest, In operation. We perform individual cleanroom validations and measurements and control the entire validation process.

When needed, we can participate in compliance assessment even during the idea or design phase of a new plant, facility or process. We can also ensure the compliance of your cleanrooms during their entire life cycle.

• Creation of user requirement
• Risk assessments
• Creation of validation plan and testing protocol
• Performing the validation and reporting
• Creation of SOP instructions and implementation training

Compliance of cleanrooms must be regularly established. We perform:

• Regular assessments
• Maintenance measurements
• Revalidation of critical equipment
• Structural leakage measurement and pressure test
• HEPA filter leak test
• Particle measurements (Qualification measurement)
• Measurement of particles in compressed medical air (ISO 8573-1)
• Condition measurement (temperature and humidity)
• Data logger temperature mapping of storage facilities and refrigeration appliances
• Measurement of pressure differences
• Amounts of air and air exchange rates
• Visualization of air flow
• Recovery time testing
• Microbiological Qualification

• Change management

• Training and support

• Deviation management and CAPA process

• Maintenance schedule

• Regular assessments and revalidations