Facility Testing & Validation

Cleanroom Certification & Environmental Validation

Cleanrooms require routine testing, monitoring and certification to ensure that these critical controlled environments continue to perform in accordance with regulatory standards enforced by such bodies as MHRA and FDA. Clean Air Technologies specialise in the testing, validation and certification of cleanrooms to ensure this element of the pharmaceutical process will conform with any MHRA or FDA inspection.

Our technicians are trained and internally accredited to work to any of the following international standards: ISO14644, BSEN12469, cGMP Annex 1.

Clean Air Technologies through use of state of the art technology, can guarantee reports within 10 working days of completion of site visit.

Air Change Rates

Cleanroom Validation requires the measurement of supply Air Change Rates, in accordance with ISO14644-3.

Clean Air Technologies utilise 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.

Room Pressures

Cleanrooms and BSL3 / BSL4 facilities utilise room pressure differentials for air contamination control.

Clean Air Technologies 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.

Light & 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 (Bioburden) Testing

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

Clean Air Technologies 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 Plates

Non-Viable Airborne Particle Counting

To enable classification of Cleanroom environments, Particle Counting is used to assess air contamination control, as an integral part of the cleanroom certifications.

Clean Air Technologies technicians are experienced in these techniques of cleanroom monitoring, utilising state of the art test equipment, and can assess the performance of the HVAC system, and its ability to meet the Functional Design Specification of the cleanroom facility.

Testing is conducted in accordance with ISO14644-1, cGMP Annex 1, and any other applicable test standards, with results being presented graphically in test reports.

Room Recovery / Cleanup Rates

To demonstrate the efficacy of air contamination control by the HVAC Air Conditioning system within the cleanroom, to satisfy MHRA Inspection requirements, it is necessary to measure the room recovery rate from a contamination episode, or calamity, thereby validating the cleanroom design and efficiency of the cleanroom HEPA filters.

Clean Air Technologies provide fully trained cleanroom testing technicians with calibrated test equipment to provide the cleanroom certifications within 10 working days of completion of site activities.

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 the 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.

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 / Air Conditioning Systems or within the cleanroom or containment facility itself. These filters will need testing with associated certification, to 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.

HEPA 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 Replacement

Clean Air Technologies can provide a one-stop-shop for users of HEPA Filters in Air Handling Units or Cleanrooms.

Utilising our experience in designing and validating cleanrooms and bio-safety labs, we will select, procure, install and test HEPA Filters, taking full responsibility for the replacement and certification of these mission-critical components.

With an in-house team of 20 fully trained mobile HEPA Filter Specialists, we have the resource to handle any size of Cleanroom HEPA Filter replacement project.

HEPA Filter Sales

With our extensive knowledge of HVAC serving Cleanrooms and Bio-Safety Labs, we can identify and source the appropriate HEPA filters for any contamination control or cleanroom equipment application.

Filters of any size and performance specification can be supplied at a competitive rate, and we can make recommendations for selection of more energy efficient HEPA Filter technologies, with the associated cost savings.

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
  • 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

Healthcare Premises to HTM03-01

Hospitals and healthcare premises require routine verification and validation of critical ventilation systems and clinical environments, to ensure that the highest standards of air contamination control are being achieved, and that the HVAC Air Conditioning plant is fit for purpose and adequately maintained. Requirements for the design and testing of these specialist systems is laid out in HTM03-01 (formerly HTM2025) and provides prescriptive performance criteria.

Clean Air Technologies provide fully trained technicians with calibrated test equipment to provide the verification and validation of these facilities, including: –

  • Critical HVAC Verification Checks
  • UCV Theatre Validation
  • Conventional Theatre Validation
  • Aseptic Pharmacy Validation
  • Clinical Area Validation