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Facility Classification, Cleanroom Validation And Servicing
Independent Validation and Servicing For Cleanrooms, Containment Laboratories And Operating Theatres
Fully independent servicing and validation of clean air containment systems in cleanrooms, laboratories and hospital operating theatres by specialist engineers with decades of experience.
BPS Crowthorne remains independent of any manufacturer, supplier or construction company – guaranteeing you completely unbiased and impartial reports on any facilities or equipment we inspect, test, repair, service or commission.
This impartiality is of critical importance to help ensure your facilities continue to operate safely, securely and with maximum productivity.
Cleanroom Services For ISO 14644:2015 Compliance
Specify fully independent specialist testing, servicing and classification of your cleanrooms to:
- control concentrations of airborne particles
- comply with ISO 14644:2015 and guidelines from the Medicines and Healthcare Products Regulatory Agency (MHRA), the Food and Drug Administration (FDA) and other agencies.
Cleanroom Classification And Testing
Get expert technical advice on conforming to Current Good Manufacturing Practice (cGMP) and ISO 14644:2015.
Our engineers can advise on cleanroom classification, based on the concentration of air particles from 0.1μm to 5μm. Further information on nanoparticles (smaller than 0.1μm) and macroparticles (larger than 5μm) is available on request.
Cleanroom validation testing includes:
- airborne particle concentrations (particle counting) to ensure cleanroom classification compliance
- pressure differential to ensure the correct direction of airflow throughout the cleanroom
- airflow velocity (to maintain the correct pressure) and volume (to ensure it meets the relevant standard)
- recovery rate to ensure integrity of HEPA filters – using either dispersed oil particulate (DOP) or discrete particle count (DPC) testing
- filter leak testing to see how quickly the cleanroom recovers after contamination
- containment leak – construction checks during high pressure works
- airflow visualisation – using smoke to view air movement
- temperature and humidity checks
- noise, light and vibration checks to ensure compliance with the relevant standard on-site operating procedures
- thermal mapping
- compressed air testing
- microbiological air sampling.
Cleanrooms must be tested regularly and within maximum specified intervals to ensure compliance. Airborne particle concentrations should be tested at least every six months for ISO Class 5 or lower – or at least every 12 months for facilities rated higher than ISO Class 5.
Pressure differential should be monitored continuously in all classes. Filters should be tested in situ for leaks/integrity (at least every 12 months for ISO Class 5 or above).
Airflow velocities should be tested in all classes of cleanrooms – at least every six months for unidirectional flow and every 12 months for non-unidirectional flow.
Why BPS Crowthorne For Cleanroom Services?
We are unbiased – fully independent from any cleanroom equipment designers or manufacturers.
We have a team of technical service engineers located throughout Ireland who are Cleanroom Testing and Certification Board (CTCB-I) qualified. They are highly experienced.
Specify commissioning and validation of all cleanroom facilities from small hospital pharmacies to ISO class 1 large scale pharmaceutical production and micro-electronics facilities.
All testing is to the latest standards (cGMP, national and international, ISO 14644) using equipment calibrated to national standards.
Comprehensive protocols are written to your requirements – from the initial URS (User Requirement Specification), IQ, OQ and PQ documentation to all on-site checks and tests.
All our work is backed by ISO 9001 registration and is supplied with full method statements and copies of calibration certificates for all test instrumentation.
Our engineers can perform any validation procedures associated with cleanroom commissioning for the micro-electronics, pharmaceutical and associated industries – tailoring generic specifications to suit your requirements.
Laboratories must have containment measures in place if staff are working on biological agents that can cause severe disease and pose a serious risk to health – as recommended by the Advisory Committee on Dangerous Pathogens (ACDP).
Containment laboratories must be able to control exposure to biological agents at source. Containment Level 2 (CL2) facilities require:
- benches resistant to water, acids, alkalis, solvents and disinfectants
- restricted access
- negative air pressure (if the workplace is mechanically ventilated).
Containment Level 3 (CL3) facilities require all of the above. They must also:
- have HEPA-filtered extract air
- be sealable for fumigation
- have floors and walls resistant to water, acids, alkalis, solvents and disinfectants (if they are animal labs)
- be separated from other activities
- have effective vector controls (for flies, mosquitoes and other pests)
- have an observation window
- contain their own equipment, preferably with a dedicated autoclave.
Containment Laboratory Inspection, Testing And Servicing
BPS Crowthorne provides fully independent commissioning and maintenance of containment facilities including ACDP and DEFRA Level 3 and 4 laboratories.
Our specialist teams recommend annual testing of CL3 laboratories as an absolute minimum. This should include:
- room integrity and sealability
- in situ HEPA filter integrity testing (DOP testing)
- measuring air volumes and calculating air change rates
- inspection to ensure functionality of controls, interlocks and anti-blowback devices.
Furthermore, all laboratories requiring fumigation must provide evidence to the Health and Safety Executive (HSE) that:
- sealability tests using smoke pencils have been undertaken
- any identified leak paths have been rectified.
Operating Theatres, Pharmacies, Sterile Services, Isolation Rooms, Mortuaries
Good air quality is vital to prevent the spread of Healthcare Associated Infections (HCAIs), also known as nosocomial or hospital infections.
Hospital patients will be at increased risk if air handling systems are not inspected quarterly and performance verified annually.
Why BPS Crowthorne For Operating Theatre Inspections?
Accuracy and consistency are crucial in the inspection, testing and maintenance of air handling systems for operating theatres and other critical healthcare environments.
Benefit from BPS Crowthorne’s technical maintenance team’s decades of experience in this specialised sector. All inspection and performance testing is undertaken by trained, experienced and qualified engineers.
We offer the following inspection and testing for hospital theatres:
- visual inspection of the theatre and Air Handling Unit (AHU)
- particle counting for air quality checks
- measurement of:
- supply and extract airflow rates
- dimensions and calculation of air change rates
- room pressure differentials
- room noise and light levels
- recording of room temperature and humidity
- checking/inspection of control functions
- microbiological air sampling (optional).
We recommend the following extra checks for Ultra-Clean Ventilation Canopy (UCV) hospital theatres:
- measurement of airflow velocities under the UCV canopy
- in situ HEPA filter integrity testing
- re-entrainment test (optional).
UCV theatres should have a minimum of twice-yearly servicing to ensure the canopy is working efficiently. Tests should include:
- visual theatre and AHU inspection
- check mechanical, electrical and control functions
- record room temperature and humidity
- measure room noise and light levels
- replace pre-filters
- measure airflow velocities under the UCV canopy (grid velocity profiles at 1m and 2m from the FFL).
Contact BPS Crowthorne For Cleanroom Services
Contact BPS Crowthorne for more information about inspection, validation and servicing of cleanrooms, containment laboratories and hospital operating theatres.