Servicing Testing Validation For Cleanrooms

Total Clean Air lead the way in designing and installing a wide range of customised Cleanrooms, including modular, monobloc, hardwall, and softwall Cleanrooms that meet the highest international standards across various industries.

At Total Clean Air, our priority is to ensure your Cleanroom meets International Standards such as EU GMP classification, ISO 14698 and ISO 14644-1: 2015. We do this by providing Cleanrooms tailored to meet your exact requirements and by testing pre-installed Cleanrooms in your facility, without disrupting workflow.

ISO 14644-1:2015 specifies that maximum time limits between testing of airborne particle concentration in an ISO Class 5 Cleanroom environment or below is every six months or. Cleanrooms of ISO Class 6 and upwards should not exceed a maximum time interval of 12 months. It also recommends risk assessments be carried out to determine frequency of monitoring to provide evidence of performance.

Upon request, our qualified CTCB-I trained engineers will be deployed to your UK facility to test and validate your Cleanroom, using state-of-the-art testing protocols. We also provide a process-based periodic testing and validation of your Cleanroom to ensure it meets the required standards. Contact us today for a scheduled testing and validation of your Cleanroom.

Testing and Validation

Cleanroom testing and validation ensures a totally secure environment and ISO compliance. Total Clean Air testing and validation is performed by CBCB-I trained engineers and to international standard ISO 14644-1:2015. Tests to be carried out at your facility can include:

Modular Cleanroom Benefits

  • Modular Construction
  • Quick Assembly Time
  • Versatility
  • Reconfiguration
  • Airflow Control
  • Inexpensive Modifications

Airborne Particle Counts

This is a necessity for ISO Class 4 and higher. Airborne particle counters provide vital information for maintaining indoor air quality in healthcare facilities. Our counters monitor the contamination level in the facility by measuring the quantity of airborne particulate at the time of testing. The result is then used to proffer solutions on how best to maintain cleanliness in the facility.

Airflow Readings

The volume and velocity test ensures unidirectional zones are maintaining proper air patterns and that flow areas (unidirectional and non-unidirectional) are properly balanced. The test also demonstrates the Cleanroom’s effectiveness in preventing the transfer of contamination generated within that area.

Cleanroom Design, Build & Validation

  • Budgeting and planning
  • Engineering, design & layout
  • Airflow and filtration design
  • Construction and Installation
  • Full Certification of our product
  • Industry-specific equipment installation
  • Validation

Filter Integrity Testing or Dispersed Oil Particulate Testing

Conducted in line with ISO 14644-3:2005 and used to ascertain the integrity of an ULPA or HEPA filter, this involves introducing particulates steadily into the upstream flow of the filter media and measuring its downstream flow output using a calibrated photometer. ULPA filters are tested to 99.9995% at 0.12-micron efficiency, while HEPA filters are tested to 99.97% at 0.3-micron efficiency.

Air Pressure Differentials Test

This is used to check whether the airflow in a given facility derives from a clean area (the Cleanroom) to a less clean area and not vice versa. Quality Cleanrooms are expected to have a higher pressure compared to less clean areas, with a difference of between 10 to 15 Pa in pressure. The pressure differential test is used to ensure this difference is maintained.

Air Changes and Volumes

The air change rate test is used to calculate the number of times an exchange of air occurs within the Cleanroom per hour. The Air Change Rate per Hour (ACH) calculates the total airflow supplied to and returned from the Cleanroom, as well as measuring the overall volume of the Cleanroom.

Containment Leak Test

This is undertaken in line with ISO 14644-3:2005 and is used to ensure there is no airborne contamination in the Cleanroom through leaks from nearby higher pressure areas within the facility. ISO 14644-2 lists the containment leak test as being optional, but suggests it should be carried out every two years at least.

Smoke Visualisation Testing

This is carried out in line with ISO 14644-3:2005 and used to demonstrate visual evidence of airflow direction. With the aid of smoke, the movement and endpoint of an airborne contaminant particle can easily be determined.  Air should be flowing smoothly in one direction towards potential sources of contamination and away from the product path.

Safety Cabinet Assessment

Total Clean Air offers testing and maintenance services for Class I, II and III Bio-safety cabinets to ensure maximum protection. This includes KI Discuss testing and Fume Cabinet Testing. Carbon Breakthrough Testing in line with BS7989 is also available.

Recovery Rate Testing

This is performed to ISO 14644-3:2005 specifications and measures the recovery rate and recovery time of a Cleanroom upon contamination. Test particles are introduced into the Cleanroom, while the recovery time is sourced from measuring the time taken for the concentration of airborne particles to decay by a factor of 100:1. The recovery time is usually set at 15 to 20 minutes.

Comfort Tests

This includes optional tests such as noise levels, lux, RH readings, vibration and temperature tests, performed to design specifications in order to ensure worker comfort.

Provision of Particle Counter Calibration Certificates

ISO 14644–1:2015 specifies that each instrument should have a valid calibration certificate. Particle Counter certificates are expected to indicate compliance with ISO 21501-4:2007. This measures the uncertainty in flow rate, counting efficiency, size resolution, error and other required standards. A certificate will be issued once the standards are met, although approval notes can be issued for exceptional cases.

Servicing and Maintenance

Total Clean Air offers comprehensive maintenance services for Cleanrooms and Cleanroom equipment. Our maintenance services cover various aspects, such as HVAC servicing, Fume Cabinet servicing, laminar flow servicing, local exhaust ventilation servicing, Bio-Safety Cabinet servicing, downflow servicing, Filter replacements and periodic cleaning.

Regular maintenance and servicing procedures help ensure Cleanroom compliance. Contact us today for your scheduled and emergency Cleanroom maintenance and repair services.

Extra Guaranty

Total Clean Air offers 24-hour support services and extended warranty for facilities using our Cleanrooms. We can come in for tests and validation any time our services are required; we also carry out periodic checks and maintenance on all our Cleanrooms. This can be conducted during client work time, without disturbing or disrupting workflow. Our exceptionally brilliant engineers are trained to work with minimal distractions to your normal industrial activities.

Total Clean Air are the best there is, and we promise you the very best service possible. Contact us today for validation of your Cleanroom and to take advantage of our extra guarantee.

Phillip Godden

Phillip Godden is the Founder & Chief/Executive Officer at Total Clean Air.

Working Hours

  • Monday 08:00 - 19:30
  • Tuesday 08:00 - 19:30
  • Wednesday 08:00 - 19:30
  • Thursday 08:00 - 19:30
  • Friday 08:00 - 19:30
  • Saturday 08:00 - 19:30
  • Sunday 08:00 - 19:30