Testing and validation

Enbloc’s experienced cleanroom validation team can carry out all routine cleanroom testing, to meet the requirements of BS EN ISO 14644 and EU cGMP. Enbloc’s Validation Team are CTCB trained.

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Validation Protocol writing and execution

Our in-house validation team are experienced in the preparation, writing and execution of validation protocols for a variety of facilities. These protocols include;

  • Design Qualification
  • Installation Qualification
  • Operation Qualification
  • Performance Qualification

We can also assist with re-writing existing protocols to suit new demands on your facility modifying your current site protocols. All our documentation is of the highest standard and meets the requirements of the MHRA.
We are frequently engaged to support our clients in User Requirement Specification (URS) document generation and Impact Assessments (IA).

techwin digimax

Air velocity and uniformity

Demonstrates the effective unidirectional airflow for laminar flow workstations and good air distribution in rooms. We use smoke aerosol or monofilament to demonstrate air flow patterns.

Air volumes and air change rates

Shows that the correct volume (turbulent ventilated cleanroom) or the velocity (unidirectional cleanroom) is entering the clean area. This information is then used to calculate the number of air changes within the area to ensure compliance with specification. The air change rates are typically measured using a Balometer or vane anemometer depending on the application.

testing ventilation

Room air tightness / containment leak test

Demonstrates that airborne contamination cannot enter adjacent areas by means of leaks in the room fabric. This is typically performed on negative pressure containment suites but can also be carried out on positively pressurised cleanrooms to test the quality of the room seal.

Airborne particulate counts

Proves the classification of the area has been achieved with regards to the concentration of airborne particulate. See table below for selected BS EN ISO 14644-1 cleanroom classifications. The classification can be provided to any Standard required by the Client, e.g. ISO14644, EU cGMP.

cleanroom testing and validation equipment

Clean-up and recovery

Demonstrates the ability of the room to remove particulate by purging the area with filtered air and that the room can change from a “dirty” to “clean” state within the specified time.

Airflow visualisation and smoke

This test, usually with video evidence, will show the airflow patterns and movement within the cleanroom, to show good coverage of critical operator and / or machine areas and highlight any zones with poor air movement.

testing and validation equipment

HEPA filter integrity

The filter media and the housing will be checked to ensure that no airborne contamination passes into the cleanroom as a result of bypassing the filter installation.
We offer both conventional DOP Aerosol testing method using a Photometer or the DPC method using a particle counter with DEHS Aerosol. The later becoming more popular due to health concerns using DOP Aerosol.

Pressure differential

Demonstrates that the airflow between areas in the cleanroom suite cascades in the correct direction in accordance with the ISO14644 standards.

testing and validation

Other tests include:

  • Temperature and Humidity & Mapping
  • Noise
  • Lighting Level

A full comprehensive validation report will be issued to the Client following each visit which will include current calibration certificates, drawings detailing test locations and all the raw data taken during the attendance.