Cleanroom Testing Services
We provide testing and validation of cleanroom ventilation, one of the most critical parameters in ensuring cleanroom compliance with EU GMP Annex 1 and/or ISO 14644-1.
Cleanroom Testing Services
We provide testing and validation of cleanroom ventilation, one of the most critical parameters in ensuring cleanroom compliance with EU GMP Annex 1 and/or ISO 14644-1.
How is cleanroom verification regulated?
A cleanroom is usually defined as ‘an environment free from dust and other contaminants.’ Cleanrooms are used every day across all sectors of industry primarily when small particles or impurities in the air can adversely affect the process the room is used for. Other environmental parameters such as temperature, humidity, air velocity and pressure are also tightly controlled under rigid specifications.
AirisQ can provide testing and validation of cleanroom ventilation; one of the most critical parameters in ensuring cleanroom compliance with EU GMP Annex 1 and/or ISO 14644-1.
Our cleanroom verification is carried out in accordance with HTM 03-01 and HBN 13. The Health & Safety at Work Act 1974, The Control of Substances Hazardous to Health (COSHH) Regulations 2002, EU GMP European guidelines to good manufacturing practice (GMP) published by the Medicines and Healthcare products Regulatory Agency (MHRA), ISO (the International Organization for Standardisation) 14644 and EU GMP classification.
Benefits of relying on AirisQ for Cleanroom testing & verification
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.
Demonstrate favourable conditions
Reassuring facility users and accreditation bodies the workplace environment is safe for continued use by staff and for the production of goods.
Independent assessments
AirisQ provide auditable reports ensuring that operational efficiency and maintenance, safety and quality standards are being achieved.
Ensure compliance
How can AirisQ help with Cleanroom testing and verification?
Our engineers are fully trained in the cleanroom verification process and have a sound understanding of BS EN ISO 14644. All testing services detailed below use equipment calibrated according to industry standards and copies of certification can be supplied if required.
Our verification includes:
- Measurement & analysis of airflow velocity and volumes
- Calculation of supply & extract room air changes
- Measurement & analysis of room pressure differentials
- Room schematic
- Duct Traverse readings
- HTM 03-01 AHU inspection
- HTM 03-01 Critical Inspection & HBN 13 Sterile Services
- HEPA filter leak/integrity testing
- Particle counting to relevant ISO room classification/grading in accordance with BS EN ISO 14644
- Test of unidirectional flow units (LAF) (if applicable)
- Test of (gloveboxes), isolators, clean benches and workstations, biosafety cabinets, fume hoods and vacuum cleaners (if applicable)
- Interim reports (issued by our engineers the day following their site visit)
- A final professional comprehensive visit report, archived and stored on our online data centre for easy 24/7 unlimited client access
Optional extras:
- Microbiological air sampling
- Settle plates
- Surface contact plate testing
Other services we can help with
Microbiological Sampling
LEV Testing
Safety Cabinet Servicing
