Clean room certification and environmental validation

Air Change Rates

ACC Cleanroom certification and environmental validation 1.jpgCleanroom Validation requires the measurement of supply Air Change Rates, in accordance with ISO14644-3. All Counties Commissioning utilises accurate, back-pressure compensated balometers for the room-side measurement of supply air volumes. Room volumes are measured utilising latest laser technology to ensure accurate and repeatable results. Where access to room side supply air grilles is restricted, alternative methods such as vane anemometer, pitot tube traverses can be utilised during the cleanroom certification process.

ACC Cleanroom certification and environmental validation 2.jpgRoom Pressures

Cleanrooms and BSL3/BSL4 facilities utilise room pressure differentials for air contamination control. All Counties Commissioning technicians are trained in utilising the latest cleanroom certification techniques to ensure that critical pressure cascades will meet the requirements of an MHRA inspection, or similar regulatory body.

Airflow Visualisation Testing

A straightforward way of assessing the Cleanroom design, and the suitability of the HVAC Air Conditioning system in terms of HEPA Filtered air diffusion, is to conduct smoke visualisation of air patterns and to record on a suitable media. This will highlight the efficacy of air contamination control and may be a requirement of an MHRA or similar regulatory inspection. Testing is recorded using digital media, and results presented on DVD.

ACC Cleanroom certification and environmental validation Labometer 3.jpgLight and Sound Levels

Cleanroom processes may involve activities which require high visual acuity.

The measurement of light (lux) levels will be needed to support the cleanroom certification process.

Similarly, noise levels can be intrusive and determination of the Noise Rating (NR) curve is necessary as part of the cleanroom validation.



Microbiological TestingACC Cleanroom certification and environmental validation 4.jpgACC Cleanroom certification and environmental validation 5.jpg

MHRA Inspections will require historical data relating to both non-viable and viable airborne particles, as part of the cleanroom certification process.

All Counties Commissioning can provide fully trained technicians to carry out sampling in accordance with ISO14698 and cGMP Annex 1 to include:

  • Air Impaction Sampling
  • Settle Plates
  • Contact Plates
  • Surface Swabs
  • Finger Plate

DOP Hepa Filter Validation Testing

Cleanrooms and Bio-Safety Labs require high levels of cleanliness and contamination control. To achieve this, HEPA Filters are installed in air handling and air conditioning systems or within the cleanroom or containment facility itself. These filters will need testing with associated certification, to ensure that they comply with MHRA inspection and ACDP 3 Containment guidelines. Clean Air Technologies provide fully trained cleanroom technicians with calibrated test equipment for the validation and certification of cleanrooms and BSL3/BSL4 facilities.

Testing would be conducted in accordance with ISO14644-3:2005, ACDP 3 Containment guidelines, BSEN12469 or other applicable standards.

EPA Filter Integrity Testing

Clean Air Technologies provide specialist HEPA Filter Integrity Testing services, to ensure that Cleanrooms and Bio-Safety Labs have the appropriate certification, for regulatory compliance.

HEPA Filter Housings“Total Filter Management for sensitive facilities ensuring regulatory compliance, maximum filter performance and effective stock control –all at a GUARANTEED annual cost.

Operators of sensitive facilities must comply with statutory regulations such as “The categorisation of biological agents according to hazards and categories of containment” by the Advisory Committee on Dangerous Pathogens (ACDP). Containment facilities and LEV devices require regular examination and testing. The HSE has powers to enforce the compliance of facilities to these standards and it is the responsibility of the site management to provide records that the facilities are in conformity.

We can provide a comprehensive service that ensures your compliance with these regulations. We provide you with fully trained technicians with calibrated test equipment, who take responsibility for:

  • Database Creation of all Pre-Filters and HEPA Filters
  • Monitoring of all Filter Performance
  • Supply and Installation of Replacement Filters together with associated safe change bags and rings
  • Annual Testing and Validation of the Supply and Extract HEPA Filters in accordance with current standards

Please contact us to receive benefits such as:

  • Total support in the specialist areas of containment facilities, contamination control and cleanrooms, freeing you to concentrate your resources on your core business
  • A fixed annual price for the maintenance of all the filters serving your facilities, incorporating a flexible program and approach that allows for the demands of your facilities’ users
  • Peace of mind derived from using an independent test house with an in-depth knowledge of regulatory compliance with HEPA Filters in this critical area
  • Efficient management of filter resource for the duration of the contract through the comprehensive database we generate for you