Cleanroom validation

We offer quick and reliable GMP and ISO 14644-compliant measurements and reports. Cleanroom validation is always based on materials and instructions approved by the client.

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.

Project phase

• 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

Operation phase

• 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

Operation phase support

• Change management
• Training and support
• Deviation management and CAPA process
• Maintenance schedule
• Regular assessments and revalidations

Please feel free to contact us if you have any questions about cleanroom validations.

See also: Cleanroom measurements and consulting services.