Cleanroom Verification

Fact: More than 150 cleanrooms verified in 2017

Cleanrooms are used in practically every industry where small particles can adversely affect the manufacturing process. Air quality in cleanrooms and clean air devices is critical in many areas of work including the process and manufacture of pharmaceutical products, operating theatres, food and laser technologies.

Our cleanroom verification will include plan drawings of all the areas surveyed, showing various testing locations and other information appropriate to the verification.

Tests carried out in accordance with HTM 03-01 (relating to HTM 2025 if necessary) and all relevant HTMs, Health & Safety at Work Act 1974, The Control of Substances Hazardous to Health (COSHH) Regulations 2002, EGGMP (Orange guide), 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 (see list below) and EU GMP classification.

Our engineers are fully trained in the cleanroom verification process and have a sound understanding of the requirements of BS EN ISO 14644 and GxP/GMP. All instruments used in testing are calibrated to national standards and copies of certification are supplied with reports

Cleanroom verification includes:

Supply and extract air change rates
Room pressure differentials
Light level test
Sound level test
Room schematic
Duct traverse reading
HTM 03-01 AHU inspection
HTM 03-01 suite inspection
Particle counts to relevant room ISO classification / grading
Filter integrity testing (DOP) of HEPA filters fitted
Full written report with conclusions and recommendations

Optional extras

Microbiological air sampling
Settle plates
Surface contact plates test

Our collaborative and proactive approach drives efficiency, cost savings and offers our clients peace of mind. We are committed to continuous improvement, through innovation and investment in our personnel, methodologies and equipment.

We offer extremely competitive rates and daytime, evenings or weekends to offer minimal disturbance to our customers.

ISO 14644 +

ISO 14644-1: Classification of air cleanliness
ISO 14644-2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
ISO 14644-3: Test Methods
ISO 14644-4: Design, Construction, and Start-up
ISO 14644-5: Operations
ISO 14644-6: Vocabulary
ISO 14644-7: Separative devices (clean air hoods, glove-boxes, isolators and mini-environments
ISO 14644-8: Classification of airborne molecular contamination
ISO 14644-9: Classification of surface particle cleanliness