Cleanroom & Aseptic Suite Validation

ISO & GMP Compliant We provide full lifecycle validation and re-qualification of cleanrooms and aseptic environments to meet ISO and GMP requirements.

Core Services: 

 Commissioning (IQ, OQ, PQ) 

 Routine validation and re-qualification 

 Airflow velocity and volume measurements 

 Air change rate (ACR) verification 

 Pressure differential testing 

 HEPA filter integrity testing (including Air Handling Units (AHUs) and terminal (filters) 

 Particle counting (ISO classification & GMP grading) 

 Temperature and humidity mapping 

 Recovery time and recovery rate testing

Additional Testing:

 Airflow visualisation (smoke studies) 

 Microbiological monitoring (active air, settle plates, swabs) 

 Pressure cascade balancing 

 Containment leak testing 

 Lighting and noise level verification

All testing is performed in both “at rest” and “operational” states to meet GMP Annex 1 and ISO14644 requirements.

HEALTHCARE VERIFICATION ,VALIDATION & CONTAINMENT

We support a wide range of healthcare ventilation systems, ensuring safe and compliant operation across critical environments.

Services Include: 

 AHU inspection and performance testing 

 HEPA filter integrity testing within Air Handling Units (AHUs) 

 Operating theatre validation (conventional & non-conventional) Ultraclean Ventilation (UCV) Theatres: 

 HEPA filter integrity testing of UCV canopies 

 Airflow velocity and volume measurements 

 Airborne particle counting to verify ultraclean performance 

 Airflow visualisation and canopy performance verification

Additional Services: 

 Room pressurisation and depressurisation testing 

 Noise rating (NR/NC) analysis 

 Compressed air quality testing (particles, moisture, oil, gases, microbiological) 

Containment Laboratories (BSL3 & BSL4): 

 Room seal-ability testing 

 Air leakage path identification and mitigation 

 Pressure containment verification 

 Ventilation system performance testing 

 Fumigation system validation

All services align with HTM 03-01, ISO standards, HSE and ACDP guidance to ensure safe containment and infection control. 

Clean Air Device Testing

We provide comprehensive testing and certification of clean air devices used in laboratories, healthcare and research environments.

Devices Covered: 

 Microbiological Safety Cabinets (Class I, II, III) 

 Laminar flow cabinets (horizontal & vertical) 

 Isolators (positive & negative pressure) 

 PCR workstations 

 UV disinfection cabinets 

 Fume cupboards and powder booths

Testing & Services: 

 Commissioning, routine certification and decommissioning 

 Airflow testing (inflow, downflow, exhaust) 

 HEPA filter integrity testing 

 Operator protection testing  (KI Discus) 

 Particle and microbiological testing 

 Pressure decay testing (isolators) 

 Electrical safety and functional checks 

 Maintenance, calibration and repairs

All work is delivered in line with BS EN 12469, BS EN 14175 and ISO standards.

HEPA Filtration Services

We support the installation, testing and maintenance of HEPA filtration systems across both equipment and infrastructure.

Services Include: 

 HEPA filter installation and replacement 

 Integrity testing of HEPA filters within AHUs and critical ventilation systems 

 HEPA filter leak testing (terminal and in-duct) 

 Pressure drop verification

Delivered in accordance with ISO 14644 and ISO 29463, ensuring filtration performance

meets required cleanroom classifications. 

Local Exhaust Ventilation (LEV) Testing

We carry out comprehensive LEV testing to ensure effective control of airborne contaminants and compliance with HSE regulations.

Technologies: 

 Vaporised Hydrogen Peroxide (VHP) 

 Formaldehyde fumigation 

 Chlorine dioxide gas sterilisation

Applications: 

 Cleanrooms and controlled environments 

 Safety cabinets and isolators 

 Containment laboratories

All processes comply with ISO 22441, ISO 14937 and HSE guidance

Local Exhaust Ventilation (LEV) Testing

We carry out comprehensive LEV testing to ensure effective control of airborne contaminants and compliance with HSE regulations.

Service Scope:

 Visual and structural inspection of systems 

 Airflow and pressure measurements 

 System performance benchmarking 

 Exposure control assessment 

 Smoke visualisation testing

Deliverables: 

 Detailed compliance reports 

 Performance analysis and recommendations 

 Documentation aligned with HSG 258 requirements

All testing and reporting in line with HSE guidelines – HSG 258