Clean room validation
Clean room validation including particle counting
AirisQ provide testing and validation of cleanroom ventilation; this is one of the most critical parameters in ensuring EU GMP Annex 1 and/or ISO 14644-1 compliance. It can be challenging to achieve the expected particle classification grade.
Are cleanliness measurements required?
YES – to ensure compliance with EU GMP Annex 1 and/or ISO 14644-1 and MHRA and site quality systems and SOPS.
What is involved?
Our team performs the testing services detailed below using equipment calibrated according to industry standards:
- Measurement and analysis of airflow velocity and volumes in cleanrooms
- Calculation of room air changes
- Measurement and analysis of room pressure differential
- HEPA filter leak/integrity testing
- Non-viable airborne particulate counts for room classification
- Test of unidirectional flow units (LAF)
- Test of (gloveboxes), isolators, clean benches and workstations, biosafety cabinets, fume hoods and vacuum cleaners
- Microbiological air sampling
How can AirisQ help with your clean room validation including particle counting?
Our service, using qualified experience ventilation and validation surveyors, offers comprehensive validation to the requirements of all current standards and guidelines.
Benefits of using AirisQ for your clean room validation including particle counting?
Ensuring that you fully understand our findings and your results, we will present you with a clear, concise report including details of the acceptance criteria we have tested against and the site-specific methods relating to them. Initially issue an interim report on completion of our site services summarising results, therefore minimising the downtime of your operations.
Ensure compliance and current guidance is being met by having regular testing and validation.
Independent assessments provide auditable reports ensuring that operational efficiency, maintenance standards, safety and quality are being achieved.
Demonstrate to facility users and accreditation bodies that conditions are favourable for safe and continued use of workplace environment and for the production of product.